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MICARDIS PLUS TBL 80/25MG N28

On 2019-Nov-18
MICARDIS-PLUS-drug/medicine -tablets aproximate price on "MICARDIS PLUS TBL 80/25MG N28 " in Riga city, Latvia is:

  • 14.26€  15.73$  12.22£  1004Rub  151.9SEK  61PLN  54.69₪ 


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -tablets  MICARDIS PLUS TBL 80/25MG N28     Recheck

 ATC codeC09DA07
 Active substances: Telmisartanum, Hydrochlorothiazidum


 Vendor, principal: Boehringer Ingelheim Intern. G
MICARDIS PLUS TBL 80/25MG N28 is compensated medicine in Latvia. 

 Prescription drug (℞) 

Similar or the same name medicines, products list
Medicament / Item title  Prices Pharmacies chain
MICARDIS PLUS 80/25MG Rx (Boehringer Ingelheim)
13.21€ , Oct‑2019 Internet pharmacy Latvija internetaptieka.lvProceed with order
MICARDIS PLUS TBL 80/25MG N28 (K)
14.26€, Jan‑2016 Internet pharmacy Latvija A-aptieka Riga
* This table was compiled fully automatically, independently from any advertisers, transparently and without any modification relaying the open offers available on the mentioned dates.Only the distribution of over-the-counter remedies through the website is permitted in Latvia in accordance with national laws and regulations.
 .

MICARDIS 40MG N28

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Micardis 20 mg tablets Micardis 40 mg tablets Micardis 80 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Micardis 20 mg tablets
Each tablet contains 20 mg telmisartan.
Micardis 40 mg tablets
Each tablet contains 40 mg telmisartan.
Micardis 80 mg tablets
Each tablet contains 80 mg telmisartan.
Excipients with known effect
Each 20 mg tablet contains 84 mg sorbitol (E420).
Each 40 mg tablet contains 169 mg sorbitol (E420).
Each 80 mg tablet contains 338 mg sorbitol (E420).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
Micardis 20 mg tablets
White round tablets of 2.5 mm engraved with the code number '50H' on one side and the company logo on the other side.
Micardis 40 mg tablets
White oblong tablets of 3.8 mm engraved with the code number '51H' on one side and the company logo on the other side.
Micardis 80 mg tablets
White oblong tablets of 4.6 mm engraved with the code number '52H' on one side and the company logo on the other side.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Hypertension
Treatment of essential hypertension in adults.
Cardiovascular prevention
Reduction of cardiovascular morbidity in adults with:
•   manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
•   type 2 diabetes mellitus with documented target organ damage

4.2 Posology and method of administration

Posology
Treatment of essential hypertension
The usually effective dose is 40 mg once daily. Some patients may already benefit at a daily dose of 20 mg. In cases where the target blood pressure is not achieved, the dose of telmisartan can be increased to a maximum of 80 mg once daily. Alternatively, telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure lowering effect with telmisartan. When considering raising the dose, it must be borne in mind that the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment (see section 5.1).
Cardiovascular prevention
The recommended dose is 80 mg once daily. It is not known whether doses lower than 80 mg of telmisartan are effective in reducing cardiovascular morbidity.
When initiating telmisartan therapy for the reduction of cardiovascular morbidity, close monitoring of blood pressure is recommended, and if appropriate adjustment of medications that lower blood pressure may be necessary.
Renal impairment
Limited experience is available in patients with severe renal impairment or haemodialysis. A lower starting dose of 20 mg is recommended in these patients (see section 4.4). No posology adjustment is required for patients with mild to moderate renal impairment.
Hepatic impairment
Micardis is contraindicated in patients with severe hepatic impairment (see section 4.3).
In patients with mild to moderate hepatic impairment, the posology should not exceed 40 mg once daily (see section 4.4).
Elderly
No dose adjustment is necessary for elderly patients.
Paediatric population
The safety and efficacy of Micardis in children and adolescents aged below 18 years have not been established.
Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.
Method of administration
Telmisartan tablets are for once-daily oral administration and should be taken with liquid, with or without food.
Precautions to be taken before handling or administering the medicinal product.
Telmisartan should be kept in the sealed blister due to the hygroscopic property of the tablets. Tablets should be taken out of the blister shortly before administration (see section 6.6).

4.3   Contraindications

•   Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
•   Second and third trimesters of pregnancy (see sections 4.4 and 4.6)
•   Biliary obstructive disorders
•   Severe hepatic impairment
The concomitant use of Micardis with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).

4.4   Special warnings and precautions for use

Pregnancy
Angiotensin II receptor antagonists should not be initiated during pregnancy. Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Hepatic impairment
Micardis is not to be given to patients with cholestasis, biliary obstructive disorders or severe hepatic impairment (see section 4.3) since telmisartan is mostly eliminated with the bile. These patients can be expected to have reduced hepatic clearance for telmisartan. Micardis should be used only with caution in patients with mild to moderate hepatic impairment.
Renovascular hypertension
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Renal impairment and kidney transplantation
When Micardis is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of Micardis in patients with recent kidney transplantation.
Intravascular hypovolaemia
Symptomatic hypotension, especially after the first dose of Micardis, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting. Such conditions should be corrected before the administration of Micardis. Volume and/or sodium depletion should be corrected prior to administration of Micardis.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Other conditions with stimulation of the renin-angiotensin-aldosterone system
In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system such as telmisartan has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
Primary aldosteronism
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system. Therefore, the use of telmisartan is not recommended.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy
As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Diabetic patients treated with insulin or antidiabetics
In these patients hypoglycaemia may occur under telmisartan treatment. Therefore, in these patients an appropriate blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated.
Hyperkalaemia
The use of medicinal products that affect the renin-angiotensin-aldosterone system may cause hyperkalaemia.
In the elderly, in patients with renal insufficiency, in diabetic patients, in patients concomitantly treated with other medicinal products that may increase potassium levels, and/or in patients with intercurrent events, hyperkalaemia may be fatal.
Before considering the concomitant use of medicinal products that affect the renin-angiotensin-aldosterone system, the benefit risk ratio should be evaluated.
The main risk factors for hyperkalaemia to be considered are:
-   Diabetes mellitus, renal impairment, age (>70 years)
-   Combination with one or more other medicinal products that affect the renin-angiotensin-aldosterone system and/or potassium supplements. Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
- Intercurrent events, in particular dehydratation, acute cardiac decompensation, metabolic
acidosis, worsening of renal function, sudden worsening of the renal condition (e.g. infectious diseases), cellular lysis (e.g. acute limb ischemia, rhabdomyolysis, extend trauma).
Close monitoring of serum potassium in at risk patients is recommended (see section 4.5).
Sorbitol
This medicinal product contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take Micardis.
Ethnic differences
As observed for angiotensin converting enzyme inhibitors, telmisartan and the other angiotensin II receptor antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.
Other
As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.

4.5 Interaction with other medicinal products and other forms of interaction

Digoxin
When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. When initiating, adjusting, and discontinuing telmisartan, monitor digoxin levels in order to maintain levels within the therapeutic range.
As with other medicinal products acting on the renin-angiotensin-aldosterone_system, telmisartan may provoke hyperkalaemia (see section 4.4). The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal antiinflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).
The occurrence of hyperkalaemia depends on associated risk factors. The risk is increased in case of the above-mentioned treatment combinations. The risk is particularly high in combination with potassium sparing-diuretics, and when combined with salt substitutes containing potassium. A combination with ACE inhibitors or NSAIDs, for example, presents a lesser risk provided that precautions for use are strictly followed.
Concomitant use not recommended.
Potassium sparing diuretics or potassium supplements
Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss. Potassium sparing diuretics e.g. spirinolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to a significant increase in serum potassium. If concomitant use is indicated because of documented hypokalaemia, they should be used with caution and with frequent monitoring of serum potassium.
Lithium
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor antagonists, including telmisartan. If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Concomitant use requiring caution.
Non-steroidal anti-inflammatory medicinal products
NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and non-selective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.
In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the co-administration of angiotensin II receptor antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC0-24 and Cmax of ramipril and ramiprilat. The clinical relevance of this observation is not known.
Diuretics (thiazide or loop diuretics)
Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may result in volume depletion, and in a risk of hypotension when initiating therapy with telmisartan.
To be taken into account with concomitant use.
Other antihypertensive agents
The blood pressure lowering effect of telmisartan can be increased by concomitant use of other antihypertensive medicinal products.
Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including telmisartan: Baclofen, amifostine. Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics, or antidepressants.
Corticosteroids (systemic route)
Reduction of the antihypertensive effect.

4.6 Fertility, pregnancy and lactation

Pregnancy
The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy (see section 4.4). The use of angiotensin II receptor antagonists is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
There are no adequate data from the use of Micardis in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of drugs. Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.
Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). (See section 5.3). Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension (see sections 4.3 and 4.4).
Breast-feeding
Because no information is available regarding the use of Micardis during breast-feeding, Micardis is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Fertility
In preclinical studies, no effects of Micardis on male and female fertility were observed.

4.7   Effects on ability to drive and use machines

When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy such as Micardis.

4.8   Undesirable effects

Summary of the safety profile
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (>1/10,000 to <1/1,000) , and acute renal failure.
The overall incidence of adverse reactions reported with telmisartan was usually comparable to placebo (41,4% vs 43.9 %) in controlled trials in patients treated for hypertension. The incidence of adverse reactions was not dose related and showed no correlation with gender, age or race of the patients. The safety profile of telmisartan in patients treated for the reduction of cardiovascular morbidity was consistent with that obtained in hypertensive patients.
The adverse reactions listed below have been accumulated from controlled clinical trials in patients treated for hypertension and from post-marketing reports. The listing also takes into account serious adverse reactions and adverse reactions leading to discontinuation reported in three clinical long-term studies including 21,642 patients treated with telmisartan for the reduction of cardiovascular morbidity for up to six years.
Tabulated list of adverse reactions
Adverse reactions have been ranked under headings of frequency using the following convention: very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Infections and infestations
Uncommon:   Urinary tract infection including cystitis, upper respiratory tract
infection including pharyngitis and sinusitis Rare:    Sepsis including fatal outcome1
Blood and the lymphatic system disorders Uncommon:    Anaemia
Rare:   Eosinophilia, thrombocytopenia
Immune system disorders
Rare:   Anaphylactic reaction, hypersensitivity
Metabolism and nutrition disorders
Uncommon:
Rare:
Hyperkalaemia
Hypoglycaemia (in diabetic patients)
Psychiatric disorders Uncommon: Rare:

Insomnia, depression Anxiety

Nervous system disorders Uncommon:
Rare:

Syncope
Somnolence

Eye disorders Rare:

Visual disturbance

Ear and labyrinth disorders
Uncommon:   Vertigo

Cardiac disorders Uncommon: Rare:

Bradycardia
Tachycardia

Vascular disorders Uncommon:

Hypotension2, orthostatic hypotension

Respiratory, thoracic and mediastinal disorders
Uncommon:   Dyspnoea, cough
Very rare:   Interstitial lung disease4

Gastrointestinal disorders
Uncommon:   Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting
9

Hepato-biliary disorders
Rare:   Hepatic function abnormal/liver disorder3
Skin and subcutaneous tissue disorders
Uncommon:   Pruritus, hyperhidrosis, rash
Rare:   Angioedema (also with fatal outcome), eczema, erythema,
urticaria, drug eruption, toxic skin eruption
Muscoloskeletal and connective tissue disorders
Uncommon:   Back pain (e.g. sciatica), muscle spasms, myalgia
Rare:   Arthralgia, pain in extremity, tendon pain (tendinitis like
symptoms)
Renal impairment including acute renal failure
Renal and urinary disorders Uncommon:
General disorders and administration site conditions
Uncommon:   Chest pain, asthenia (weakness)
Rare:   Influenza-like illness
Investigations
Uncommon:
Rare:
Blood creatinine increased
Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased
',2,3,4: for further descriptions, please see sub-section “Description of selected adverse reactions ” Description of selected adverse reactions
Sepsis
In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with placebo. The event may be a chance finding or related to a mechanism currently not known (see also section 5.1).
Hypotension
This adverse reaction was reported as common in patients with controlled blood pressure who were treated with telmisartan for the reduction of cardiovascular morbidity on top of standard care.
Hepatic function abnormal / liver disorder
Most cases of hepatic function abnormal / liver disorder from post-marketing experience occurred in Japanese patients. Japanese patients are more likely to experience these adverse reactions.
Interstitial lung disease
Cases of interstitial lung disease have been reported from post-marketing experience in temporal association with the intake of telmisartan. However, a causal relationship has not been established.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
10
professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
4.9 Overdose
There is limited information available with regard to overdose in humans.
Symptoms
The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia dizziness, increase in serum creatinine, and acute renal failure have also been reported.
Management
Telmisartan is not removed by haemodialysis. The patient should be closely monitored, and the treatment should be symptomatic and supportive. Management depends on the time since ingestion and the severity of the symptoms. Suggested measures include induction of emesis and / or gastric lavage. Activated charcoal may be useful in the treatment of overdosage. Serum electrolytes and creatinine should be monitored frequently. If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacement given quickly.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC Code: C09CA07. Mechanism of action
Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist. Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II. Telmisartan does not exhibit any partial agonist activity at the AT1 receptor. Telmisartan selectively binds the AT1 receptor. The binding is long-lasting. Telmisartan does not show affinity for other receptors, including AT2 and other less characterised AT receptors. The functional role of these receptors is not known, nor is the effect of their possible overstimulation by angiotensin II, whose levels are increased by telmisartan. Plasma aldosterone levels are decreased by telmisartan. Telmisartan does not inhibit human plasma renin or block ion channels. Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin. Therefore it is not expected to potentiate bradykininmediated adverse effects.
In human, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood pressure increase. The inhibitory effect is maintained over 24 hours and still measurable up to 48 hours.
Clinical efficacy and safety
Treatment of essential hypertension
After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 3 hours. The maximum reduction in blood pressure is generally attained 4 to 8 weeks after the start of treatment and is sustained during long-term therapy.
The antihypertensive effect persists constantly over 24 hours after dosing and includes the last 4 hours before the next dose as shown by ambulatory blood pressure measurements. This is confirmed by trough to peak ratios consistently above 80 % seen after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies. There is an apparent trend to a dose relationship to a time to recovery of baseline systolic blood pressure (SBP). In this respect data concerning diastolic blood pressure (DBP) are inconsistent.
In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without affecting pulse rate. The contribution of the medicinal product's diuretic and natriuretic effect to its hypotensive activity has still to be defined. The antihypertensive efficacy of telmisartan is comparable to that of agents representative of other classes of antihypertensive medicinal products (demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril, hydrochlorothiazide, and lisinopril).
Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment values over a period of several days without evidence of rebound hypertension.
The incidence of dry cough was significantly lower in patients treated with telmisartan than in those given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two antihypertensive treatments.
Cardiovascular prevention
ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at risk for cardiovascular events.
Patients were randomized to one of the three following treatment groups: telmisartan 80 mg (n = 8542), ramipril 10 mg (n = 8576), or the combination of telmisartan 80 mg plus ramipril 10 mg (n = 8502), and followed for a mean observation time of 4.5 years.
Telmisartan showed a similar effect to ramipril in reducing the primary composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure. The incidence of the primary endpoint was similar in the telmisartan (16.7 %) and ramipril (16.5 %) groups. The hazard ratio for telmisartan vs. ramipril was 1.01 (97.5 % CI 0.93 - 1.10, p (non-inferiority) = 0.0019 at a margin of 1.13). The all-cause mortality rate was 11.6 % and 11.8 % among telmisartan and ramipril treated patients, respectively.
Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5 % CI 0.90 -1.08), p (non-inferiority) = 0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo.
TRANSCEND randomized ACE-I intolerant patients with otherwise similar inclusion criteria as ONTARGET to telmisartan 80 mg (n=2954) or placebo (n=2972), both given on top of standard care. The mean duration of follow up was 4 years and 8 months. No statistically significant difference in the incidence of the primary composite endpoint (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure) was found [15.7 % in the telmisartan and 17.0 % in the placebo groups with a hazard ratio of 0.92 (95 % CI 0.81 - 1.05, p = 0.22)]. There was evidence for a benefit of telmisartan compared to placebo in the pre-specified secondary composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.87 (95 % CI 0.76 - 1.00, p = 0.048)]. There was no evidence for benefit on cardiovascular mortality (hazard ratio 1.03, 95 % CI 0.85 - 1.24).
Cough and angioedema were less frequently reported in patients treated with telmisartan than in patients treated with ramipril, whereas hypotension was more frequently reported with telmisartan.
Combining telmisartan with ramipril did not add further benefit over ramipril or telmisartan alone.
CV mortality and all cause mortality were numerically higher with the combination. In addition, there was a significantly higher incidence of hyperkalaemia, renal failure, hypotension and syncope in the combination arm. Therefore the use of a combination of telmisartan and ramipril is not recommended in this population.
In the "Prevention Regimen For Effectively avoiding Second Strokes" (PRoFESS) trial in patients 50 years and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan compared with placebo, 0.70 % vs. 0.49 % [RR 1.43 (95 % confidence interval 1.00 -2.06)]; the incidence of fatal sepsis cases was increased for patients taking telmisartan (0.33 %) vs. patients taking placebo (0.16 %) [RR 2.07 (95 % confidence interval 1.14 - 3.76)]. The observed increased occurrence rate of sepsis associated with the use of telmisartan may be either a chance finding or related to a mechanism not currently known.
Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage. For more detailed information see above under the heading “Cardiovascular prevention”.
VA NEPHRON-D was a study in patients with type 2 diabetes mellitus and diabetic nephropathy. These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as compared to monotherapy was observed. Given their similar pharmacodynamic properties, these results are also relevant for other ACE-inhibitors and angiotensin II receptor blockers.
ACE-inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in patients with diabetic nephropathy.
ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both. The study was terminated early because of an increased risk of adverse outcomes. Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.
Paediatric population
The safety and efficacy of Micardis in children and adolescents aged below 18 years have not been established.
The blood pressure lowering effects of two doses of telmisartan were assessed in 76 hypertensive, largely overweight patients aged 6 to < 18 years (body weight ≥ 20 kg and ≤ 120 kg, mean 74.6 kg), after taking telmisartan 1 mg/kg (n = 29 treated) or 2 mg/kg (n = 31 treated) over a four-week treatment period. By inclusion the presence of secondary hypertension was not investigated. In some of the investigated patients the doses used were higher than those recommended in the treatment of hypertension in the adult population, reaching a daily dose comparable to160 mg, which was tested in adults. After adjustment for age group effects mean SBP changes from baseline (primary objective) were -14.5 (1.7) mm Hg in the telmisartan 2 mg/kg group, -9.7 (1.7) mm Hg in the telmisartan 1 mg/kg group, and -6.0 (2.4) in the placebo group. The adjusted DBP changes from baseline were -8.4 (1.5) mm Hg, -4.5 (1.6) mm Hg and -3.5 (2.1) mm Hg respectively. The change was dose
13
dependent. The safety data from this study in patients aged 6 to < 18 years appeared generally similar to that observed in adults. The safety of long term treatment of telmisartan in children and adolescents was not evaluated.
An increase in eosinophils reported in this patient population has not been recorded in adults. Its clinical significance and relevance is unknown.
These clinical data do not allow to make conclusions on the efficacy and safety of telmisartan in hypertensive paediatric population.

5.2 Pharmacokinetic properties

Absorption
Absorption of telmisartan is rapid although the amount absorbed varies. The mean absolute bioavailability for telmisartan is about 50 %. When telmisartan is taken with food, the reduction in the area under the plasma concentration-time curve (AUC0.^) of telmisartan varies from approximately 6 % (40 mg dose) to approximately 19 % (160 mg dose). By 3 hours after administration, plasma concentrations are similar whether telmisartan is taken fasting or with food.
Linearitv/non-linearitv
The small reduction in AUC is not expected to cause a reduction in the therapeutic efficacy. There is no linear relationship between doses and plasma levels. Cmax and to a lesser extent AUC increase disproportionately at doses above 40 mg.
Distribution
Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1 acid glycoprotein. The mean steady state apparent volume of distribution (Vdss) is approximately 500 l.
Biotransformation
Telmisartan is metabolised by conjugation to the glucuronide of the parent compound. No pharmacological activity has been shown for the conjugate.
Elimination
Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination half-life of >20 hours. The maximum plasma concentration (Cmax) and, to a smaller extent, the area under the plasma concentration-time curve (AUC), increase disproportionately with dose. There is no evidence of clinically relevant accumulation of telmisartan taken at the recommended dose. Plasma concentrations were higher in females than in males, without relevant influence on efficacy.
After oral (and intravenous) administration, telmisartan is nearly exclusively excreted with the faeces, mainly as unchanged compound. Cumulative urinary excretion is <1 % of dose. Total plasma clearance (Cltot) is high (approximately 1,000 ml/min) compared with hepatic blood flow (about 1,500 ml/min).
Paediatric population
The pharmacokinetics of two doses of telmisartan were assessed as a secondary objective in hypertensive patients (n = 57) aged 6 to < 18 years after taking telmisartan 1 mg/kg or 2 mg/kg over a four-week treatment period. Pharmacokinetic objectives included the determination of the steady-state of telmisartan in children and adolescents, and investigation of age-related differences. Although the study was too small for a meaningful assessment of the pharmacokinetics of children under 12 years of age, the results are generally consistent with the findings in adults and confirm the non-linearity of telmisartan, particularly for Cmax.
Gender
Differences in plasma concentrations were observed, with Cmax and AUC being approximately 3- and 2-fold higher, respectively, in females compared to males.
Elderly
The pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.
Renal impairment
In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations was observed. However, lower plasma concentrations were observed in patients with renal insufficiency undergoing dialysis. Telmisartan is highly bound to plasma protein in renal-insufficient patients and cannot be removed by dialysis. The elimination half-life is not changed in patients with renal impairment.
Hepatic impairment
Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100 %. The elimination half-life is not changed in patients with hepatic impairment.
5.3 Preclinical safety data
In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium in normotensive animals. In dogs, renal tubular dilation and atrophy were observed. Gastric mucosal injury (erosion, ulcers or inflammation) also was noted in rats and dogs. These pharmacologically-mediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation.
In both species, increased plasma renin activity and hypertrophy/hyperplasia of the renal juxtaglomerular cells were observed. These changes, also a class effect of angiotensin converting enzyme inhibitors and other angiotensin II receptor antagonists, do not appear to have clinical significance.
No clear evidence of a teratogenic effect was observed, however at toxic dose levels of telmisartan an effect on the postnatal development of the offsprings such as lower body weight and delayed eye opening was observed.
There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Povidone (K25)
Meglumine Sodium hydroxide
Sorbitol (E420)
Magnesium stearate.
6.2   Incompatibilities Not applicable.

6.3   Shelf life

Micardis 20 mg tablets
3   years
Micardis 40 mg and 80 mg tablets
4   years

6.4   Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.

6.5   Nature and contents of container

Aluminium/aluminium blisters (PA/Al/PVC/Al or PA/PA/Al/PVC/Al). One blister contains 7 or 10 tablets.
Micardis 20 mg tablets
Pack sizes: Blister with 14, 28, 56 or 98 tablets.
Micardis 40 mg and 80 mg tablets
Pack sizes: Blister with 14, 28, 56, 84 or 98 tablets or perforated unit dose blisters with 28 x 1, 30 x 1 or 90 x 1 tablets; multipacks containing 360 (4 packs of 90 x 1) tablets
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling

Telmisartan should be kept in the sealed blister due to the hygroscopic property of the tablets. Tablets should be taken out of the blister shortly before administration.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim International GmbH Binger Str. 173 D-55216 Ingelheim am Rhein Germany
8. MARKETING AUTHORISATION NUMBERS
Micardis 20 mg tablets EU/1/98/090/009 (14 tablets) EU/1/98/090/010 (28 tablets) EU/1/98/090/011 (56 tablets) EU/1/98/090/012 (98 tablets)
Micardis 40 mg tablets EU/1/98/090/001 (14 tablets) EU/1/98/090/002 (28 tablets) EU/1/98/090/003 (56 tablets) EU/1/98/090/004 (98 tablets) EU/1/98/090/013 (28 x 1 tablets) EU/1/98/090/015 (84 tablets) EU/1/98/090/017 (30 x 1 tablets) EU/1/98/090/019 (90 x 1 tablets) EU/1/98/090/021 (4 x (90 x 1) tablets)
Micardis 80 mg tablets EU/1/98/090/005 (14 tablets)
EU/1/98/090/006 (28 tablets)
EU/1/98/090/007 (56 tablets)
EU/1/98/090/008 (98 tablets)
EU/1/98/090/014 (28 x 1 tablets)
EU/1/98/090/016 (84 tablets)
EU/1/98/090/018 (30 x 1 tablets)
EU/1/98/090/020 (90 x 1 tablets)
EU/1/98/090/022 (4 x (90 x 1) tablets)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 16 December 1998 Date of last renewal: 16 December 2008
10. DATE OF REVISION OF THE TEXT
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.

1.


ANNEX II
A.   MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
B.   CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
C.   OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORIZATION
D.   CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturers responsible for batch release
Boehringer Ingelheim Pharma GmbH & Co. KG
D-55216 Ingelheim am Rhein
Germany
Delpharm Reims S.A.S.
10 rue Colonel Charbonneaux
51100 Reims
France
Boehringer Ingelheim Ellas A.E.
5th km Paiania - Markopoulo Koropi Attiki, 194 00 Greece
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to medical prescription.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORIZATION
• Periodic Safety Update Reports
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• Risk Management Plan (RMP)
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
An updated RMP should be submitted:
•   At the request of the European Medicines Agency;
•   Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
ANNEX III
LABELLING AND PACKAGE LEAFLET
A. LABELLING
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
1. NAME OF THE MEDICINAL PRODUCT
Micardis 20 mg tablets telmisartan
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 20 mg telmisartan.
3. LIST OF EXCIPIENTS
Contains sorbitol (E420).
Read the package leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
14 tablets 28 tablets 56 tablets 98 tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Read the package leaflet before use.
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
EXP
9. SPECIAL STORAGE CONDITIONS
Store in the original package in order to protect from moisture.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim International GmbH Binger Str. 173 D-55216 Ingelheim am Rhein Germany
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/98/090/009
EU/1/98/090/010
EU/1/98/090/011
EU/1/98/090/012
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Micardis 20 mg
17. UNIQUE IDENTIFIER - 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
PC: {number} [product code]
SN: {number} [serial number]
NN: {number} [national reimbursement number or other national number identifying the medicinal product]
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets
1. NAME OF THE MEDICINAL PRODUCT
Micardis 20 mg tablets telmisartan
2. NAME OF THE MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim (Logo)
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Batch
5. OTHER
MON
TUE
WED
THU
FRI
SAT
SUN
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
1. NAME OF THE MEDICINAL PRODUCT
Micardis 40 mg tablets telmisartan
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 40 mg telmisartan.
3. LIST OF EXCIPIENTS
Contains sorbitol (E420).
Read the package leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
14 tablets 28 tablets 56 tablets 98 tablets 28 x 1 tablets 84 tablets 30 x 1 tablets 90 x 1 tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Read the package leaflet before use.
6.   SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
9. SPECIAL STORAGE CONDITIONS
Store in the original package in order to protect from moisture.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim International GmbH Binger Str. 173 D-55216 Ingelheim am Rhein Germany
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/98/090/001
EU/1/98/090/002
EU/1/98/090/003
EU/1/98/090/004
EU/1/98/090/013
EU/1/98/090/015
EU/1/98/090/017
EU/1/98/090/019
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Micardis 40 mg
17. UNIQUE IDENTIFIER - 2D BARCODE
2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number} [product code]
SN: {number} [serial number]
NN: {number} [national reimbursement number or other national number identifying the medicinal product]
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 40 mg_
1. NAME OF THE MEDICINAL PRODUCT
Micardis 40 mg tablets telmisartan
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 40 mg telmisartan.
3. LIST OF EXCIPIENTS
Contains sorbitol (E420).
Read the package leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
Component of a multipack comprising 4 packs, each containing 90 x 1 tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Read the package leaflet before use.
6.   SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
EXP
9. SPECIAL STORAGE CONDITIONS
Store in the original package in order to protect from moisture.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim International GmbH Binger Str. 173 D-55216 Ingelheim am Rhein Germany
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/98/090/021
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Micardis 40 mg
17. UNIQUE IDENTIFIER - 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
PC: {number} [product code]
SN: {number} [serial number]
NN: {number} [national reimbursement number or other national number identifying the medicinal product]
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLED -INCLUDING THE BLUE BOX - 40 mg_
1. NAME OF THE MEDICINAL PRODUCT
Micardis 40 mg tablets telmisartan
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 40 mg telmisartan.
3. LIST OF EXCIPIENTS
Contains sorbitol (E420).
Read the package leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
Multipack comprising 4 packs, each containing 90 x 1 tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Read the package leaflet before use.
6.   SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
EXP
9. SPECIAL STORAGE CONDITIONS
Store in the original package in order to protect from moisture.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim International GmbH Binger Str. 173 D-55216 Ingelheim am Rhein Germany
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/98/090/021
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Micardis 40 mg
17. UNIQUE IDENTIFIER - 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
PC: {number} [product code]
SN: {number} [serial number]
NN: {number} [national reimbursement number or other national number identifying the medicinal product]
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets
1. NAME OF THE MEDICINAL PRODUCT
Micardis 40 mg tablets telmisartan
2. NAME OF THE MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim (Logo)
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Batch
5. OTHER
MON
TUE
WED
THU
FRI
SAT
SUN
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister


1.
NAME OF THE MEDICINAL PRODUCT
Micardis 40 mg tablets telmisartan
2. NAME OF THE MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim (Logo)
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Batch
5. OTHER
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
1. NAME OF THE MEDICINAL PRODUCT
Micardis 80 mg tablets telmisartan
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 80 mg telmisartan.
3. LIST OF EXCIPIENTS
Contains sorbitol (E420).
Read the package leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
14 tablets 28 tablets 56 tablets 98 tablets 28 x 1 tablets 84 tablets 30 x 1 tablets 90 x 1 tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Read the package leaflet before use.
6.   SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
EXP
9. SPECIAL STORAGE CONDITIONS
Store in the original package in order to protect from moisture.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim International GmbH Binger Str. 173 D-55216 Ingelheim am Rhein Germany
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/98/090/005
EU/1/98/090/006
EU/1/98/090/007
EU/1/98/090/008
EU/1/98/090/014
EU/1/98/090/016
EU/1/98/090/018
EU/1/98/090/020
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Micardis 80 mg
17. UNIQUE IDENTIFIER - 2D BARCODE
2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number} [product code]
SN: {number} [serial number]
NN: {number} [national reimbursement number or other national number identifying the medicinal product]
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 80 mg_
1. NAME OF THE MEDICINAL PRODUCT
Micardis 80 mg tablets telmisartan
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 80 mg telmisartan.
3. LIST OF EXCIPIENTS
Contains sorbitol (E420).
Read the package leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
Component of a multipack comprising 4 packs, each containing 90 x 1 tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Read the package leaflet before use.
6.   SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
EXP
9. SPECIAL STORAGE CONDITIONS
Store in the original package in order to protect from moisture.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim International GmbH Binger Str. 173 D-55216 Ingelheim am Rhein Germany
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/98/090/022
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Micardis 80 mg
17. UNIQUE IDENTIFIER - 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
PC: {number} [product code]
SN: {number} [serial number]
NN: {number} [national reimbursement number or other national number identifying the medicinal product]
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLED -INCLUDING THE BLUE BOX - 80 mg_
1. NAME OF THE MEDICINAL PRODUCT
Micardis 80 mg tablets telmisartan
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 80 mg telmisartan.
3. LIST OF EXCIPIENTS
Contains sorbitol (E420).
Read the package leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
Multipack comprising 4 packs, each containing 90 x 1 tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Read the package leaflet before use.
6.   SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
EXP
9. SPECIAL STORAGE CONDITIONS
Store in the original package in order to protect from moisture.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim International GmbH Binger Str. 173 D-55216 Ingelheim am Rhein Germany
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/98/090/022
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Micardis 80 mg
17. UNIQUE IDENTIFIER - 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
PC: {number} [product code]
SN: {number} [serial number]
NN: {number} [national reimbursement number or other national number identifying the medicinal product]
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets
1. NAME OF THE MEDICINAL PRODUCT
Micardis 80 mg tablets telmisartan
2. NAME OF THE MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim (Logo)
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Batch
5. OTHER
MON
TUE
WED
THU
FRI
SAT
SUN
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister


1.
NAME OF THE MEDICINAL PRODUCT
Micardis 80 mg tablets telmisartan
2. NAME OF THE MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim (Logo)
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Batch
5. OTHER
B. PACKAGE LEAFLET

Package leaflet: Information for the user Micardis 20 mg tablets

Telmisartan

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-   Keep this leaflet. You may need to read it again.
-   If you have any further questions, ask your doctor or pharmacist.
-   This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-   If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.   What Micardis is and what it is used for
2.   What you need to know before you take Micardis
3.   How to take Micardis
4.   Possible side effects
5.   How to store Micardis
6.   Contents of the pack and other information

1. What Micardis is and what it is used for

Micardis belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. Micardis blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
Micardis is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the high blood pressure is not caused by any other condition.
High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Micardis is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes. Your doctor can tell you if you are at high risk for such events.

2. What you need to know before you take Micardis

Do not take Micardis

•   if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6). if you are more than 3 months pregnant. (It is also better to avoid Micardis in early pregnancy -see pregnancy section.)
•   if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of the bile from the liver and gall bladder) or any other severe liver disease.
•   if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
If any of the above applies to you, tell your doctor or pharmacist before taking Micardis.

Warnings and precautions

Talk to your doctor before taking Micardis if you are suffering or have ever suffered from any of the following conditions or illnesses:
•   Kidney disease    or kidney    transplant.
•   Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
•   Liver disease.
•   Heart trouble.
•   Raised aldosterone    levels    (water and salt retention in the body along with imbalance of various
blood minerals).
•   Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting.
•   Elevated potassium levels in your blood.
•   Diabetes.
Talk to your doctor before taking Micardis:
•   if you are taking any of the following medicines used to treat high blood pressure:
-   an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
-   aliskiren.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the heading “Do not take Micardis”.
•   if you are taking digoxin.
You must tell your doctor if you think you are (or might become) pregnant. Micardis is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
In case of surgery or anaesthesia, you should tell your doctor that you are taking Micardis.
Micardis may be less effective in lowering the blood pressure in black patients.

Children and adolescents

The use of Micardis in children and adolescents up to the age of 18 years is not recommended.

Other medicines and Micardis

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to change the dose of these other medicines or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Micardis:
•   Lithium containing medicines to treat some types of depression.
•   Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
•   Diuretics ('water tablets'), especially if taken in high doses together with Micardis, may lead to excessive loss of body water and low blood pressure (hypotension).
•   If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Micardis” and “Warning and precautions”).
•   Digoxin.
The effect of Micardis may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Micardis may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine). Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or antidepressants. You may notice this as dizziness when standing up. You should consult with your doctor if you need to adjust the dose of your other medicine while taking Micardis.

Pregnancy and breast-feeding

Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Micardis before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Micardis. Micardis is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Micardis is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

Some people feel dizzy or tired when taking Micardis. If you feel dizzy or tired, do not drive or operate machinery.

Micardis contains sorbitol.

If you are intolerant to some sugars, consult your doctor before taking Micardis.

3. How to take Micardis

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet a day. Try to take the tablet at the same time each day.
You can take Micardis with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take Micardis every day until your doctor tells you otherwise. If you have the impression that the effect of Micardis is too strong or too weak, talk to your doctor or pharmacist.
For treatment of high blood pressure, the usual dose of Micardis for most patients is one 40 mg tablet once a day to control blood pressure over the 24-hour period. Your doctor has recommended a lower dose of one 20 mg tablet daily. Micardis may also be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Micardis.
For reduction of cardiovascular events, the usual dose of Micardis is one 80 mg tablet once a day. At the beginning of the preventive therapy with Micardis 80 mg, blood pressure should be frequently monitored.
If your liver is not working properly, the usual dose should not exceed 40 mg once daily.

If you take more Micardis than you should

If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.

If you forget to take Micardis

If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and need immediate medical attention

You should see your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these effects are not treated they could be fatal.

Possible side effects of Micardis

Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.
Uncommon side effects (may affect up to 1 in 100 people):
Urinary tract infections,upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Very rare side effects (may affect up to 1 in 10,000 people):
Progressive scarring of lung tissue (interstitial lung disease)**.
* The event may have happened by chance or could be related to a mechanism currently not known.
**Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. However, it is not known whether telmisartan was the cause.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Micardis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions. You should store your medicine in the original package in order to protect the tablets from moisture. Remove your Micardis tablet from the blister only directly prior to intake.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Micardis contains

The active substance is telmisartan. Each tablet contains 20 mg telmisartan.
The other ingredients are povidone, meglumine, sodium hydroxide, sorbitol (E420) and magnesium stearate.

What Micardis looks like and contents of the pack

Micardis 20 mg tablets are white, round and engraved with the code number '50H' on one side and the company logo on the other side.
Micardis is available in blister packs containing 14, 28, 56 or 98 tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder   Manufacturer

Boehringer Ingelheim International GmbH   Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Str. 173   Binger Str. 173
D-55216 Ingelheim am Rhein   D-55216 Ingelheim am Rhein
Germany   Germany
Delpharm Reims S.A.S.
10 rue Colonel Charbonneaux
51100 Reims
France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Belgie/Belgique/Belgien
SCS Boehringer Ingelheim Comm.V
Tel/Tel: +32 2 773 33 11
Lietuva
Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas
Tel.: +370 37 473922
Etnrapuu
EbopHHrep HHrenxaÖM P^B Tm6X h Ko. Kr -kuoh Ebnrapna
Ten: +359 2 958 79 98
Luxembourg/Luxemburg
SCS Boehringer Ingelheim Comm.V
Tel/Tel: +32 2 773 33 11
Česka republika
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111
Magyarorszag
Boehringer Ingelheim RCV GmbH & Co KG Magyarorszagi Fioktelepe
Tel.: +36 1 299 89 00
Danmark
Boehringer Ingelheim Danmark A/S
Tlf: +45 39 15 88 88
Malta
Boehringer Ingelheim Ltd.
Tel: +44 1344 424 600
Deutschland
Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 900
Nederland
Boehringer Ingelheim b.v.
Tel: +31 (0) 800 22 55 889
Eesti
Boehringer Ingelheim RCV GmbH & Co KG
Eesti Filiaal
Tel: +372 612 8000
Norge
Boehringer Ingelheim Norway KS
Tlf: +47 66 76 13 00
EkXüda
Boehringer Ingelheim Ellas A.E.
TpT,: +30 2 10 89 06 300
Österreich
Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105-0
Espana
Boehringer Ingelheim Espana, S.A.
Tel: +34 93 404 51 00
Polska
Boehringer Ingelheim Sp.zo.o.
Tel.: +48 22 699 0 699
France
Boehringer Ingelheim France S.A.S.
Tel: +33 3 26 50 45 33
Portugal
Boehringer Ingelheim, Unipessoal, Lda.
Tel: +351 21 313 53 00
Hrvatska
Boehringer Ingelheim Zagreb d.o.o.
Tel: +385 1 2444 600
Romania
Boehringer Ingelheim RCVGmbH & Co KG Viena - Sucursala Bucuresti
Tel: +40 21 302 28 00
Ireland
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620
Slovenija
Boehringer Ingelheim RCV GmbH & Co KG podružnica Ljubljana
Tel: +386 1 586 40 00

Island

Vistor hf.
Smi: +354 535 7000

Slovenska republika

Boehringer Ingelheim RCV GmbH & Co KG organizačna zložka Tel: +421 2 5810 1211

Suomi/Finland

Boehringer Ingelheim Finland Ky Puh/Tel: +358 10 3102 800

Sverige

Boehringer Ingelheim AB Tel: +46 8 721 21 00

United Kingdom

Boehringer Ingelheim Ltd.
Tel: +44 1344 424 600

Italia

Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1

Knrcpog

Boehringer Ingelheim Ellas A.E.
T^: +30 2 10 89 06 300

Latvija

Boehringer Ingelheim RCV GmbH & Co KG Latvijas filiāle Tel: +371 67 240 011

This leaflet was last revised in


Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the user Micardis 40 mg tablets

Telmisartan

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-   Keep this leaflet. You may need to read it again.
-   If you have any further questions, ask your doctor or pharmacist.
-   This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-   If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.   What Micardis is and what it is used for
2.   What you need to know before you take Micardis
3.   How to take Micardis
4.   Possible side effects
5.   How to store Micardis
6.   Contents of the pack and other information

1. What Micardis is and what it is used for

Micardis belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. Micardis blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
Micardis is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the high blood pressure is not caused by any other condition.
High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Micardis is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes. Your doctor can tell you if you are at high risk for such events.

2. What you need to know before you take Micardis

Do not take Micardis

•   if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).
•   if you are more than 3 months pregnant. (It is also better to avoid Micardis in early pregnancy -see pregnancy section.)
•   if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease.
•   if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
If any of the above applies to you, tell your doctor or pharmacist before taking Micardis.

Warnings and precautions

Talk to your doctor before taking Micardis if you are suffering or have ever suffered from any of the following conditions or illnesses:
•   Kidney disease    or kidney    transplant.
•   Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
•   Liver disease.
•   Heart trouble.
•   Raised aldosterone    levels    (water and salt retention in the body along with imbalance of various
blood minerals).
•   Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting.
•   Elevated potassium levels in your blood.
•   Diabetes.
Talk to your doctor before taking Micardis:
•   if you are taking any of the following medicines used to treat high blood pressure:
-   an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
-   aliskiren.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the heading “Do not take Micardis”.
•   if you are taking digoxin.
You must tell your doctor if you think you are (or might become) pregnant. Micardis is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
In case of surgery or anaesthesia, you should tell your doctor that you are taking Micardis.
Micardis may be less effective in lowering the blood pressure in black patients.

Children and adolescents

The use of Micardis in children and adolescents up to the age of 18 years is not recommended.

Other medicines and Micardis

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to change the dose of these other medicines or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Micardis:
•   Lithium containing medicines to treat some types of depression.
•   Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
•   Diuretics ('water tablets'), especially if taken in high doses together with Micardis, may lead to excessive loss of body water and low blood pressure (hypotension).
•   If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Micardis” and “Warnings and precautions”).
•   Digoxin.
The effect of Micardis may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Micardis may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine). Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or antidepressants. You may notice this as dizziness when standing up. You should consult with your doctor if you need to adjust the dose of your other medicine while taking Micardis.

Pregnancy and breast-feeding

Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Micardis before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Micardis. Micardis is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Micardis is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

Some people feel dizzy or tired when taking Micardis. If you feel dizzy or tired, do not drive or operate machinery.

Micardis contains sorbitol.

If you are intolerant to some sugars, consult your doctor before taking Micardis.

3. How to take Micardis

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet a day. Try to take the tablet at the same time each day.
You can take Micardis with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take Micardis every day until your doctor tells you otherwise. If you have the impression that the effect of Micardis is too strong or too weak, talk to your doctor or pharmacist.
For treatment of high blood pressure, the usual dose of Micardis for most patients is one 40 mg tablet once a day to control blood pressure over the 24 hour period. However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Micardis may be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Micardis.
For reduction of cardiovascular events, the usual dose of Micardis is one 80 mg tablet once a day. At the beginning of the preventive therapy with Micardis 80 mg, blood pressure should be frequently monitored.
If your liver is not working properly, the usual dose should not exceed 40 mg once daily.

If you take more Micardis than you should

If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.

If you forget to take Micardis

If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and need immediate medical attention

You should see your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these effects are not treated they could be fatal.

Possible side effects of Micardis:

Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.
Uncommon side effects (may affect up to 1 in 100 people):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia),low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Very rare side effects (may affect up to 1 in 10,000 people):
Progressive scarring of lung tissue (interstitial lung disease)**.
* The event may have happened by chance or could be related to a mechanism currently not known.
** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. However, it is not known whether telmisartan was the cause.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Micardis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions. You should store your medicine in the original package in order to protect the tablets from moisture. Remove your Micardis tablet from the blister only directly prior to intake.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Micardis contains

The active substance is telmisartan. Each tablet contains 40 mg telmisartan.
The other ingredients are povidone, meglumine, sodium hydroxide, sorbitol (E420) and magnesium stearate.

What Micardis looks like and contents of the pack

Micardis 40 mg tablets are white, oblong-shaped, and engraved with the code number '51H' on one side and the company logo on the other side.
Micardis is available in blister packs containing 14, 28, 56, 84 or 98 tablets, in unit dose blister packs containing 28 x 1, 30 x 1 or 90 x 1 tablets or in multipacks containing 360 (4 packs of 90 x 1) tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder   Manufacturer

Boehringer Ingelheim International GmbH   Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Str. 173   Binger Str. 173
D-55216 Ingelheim am Rhein   D-55216 Ingelheim am Rhein
Germany   Germany
Delpharm Reims S.A.S.
10 rue Colonel Charbonneaux
51100 Reims
France
Boehringer Ingelheim Ellas A.E.
5th km Paiania - Markopoulo Koropi Attiki, 194 00 Greece
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Belgie/Belgique/Belgien
SCS Boehringer Ingelheim Comm.V
Tel/Tel: +32 2 773 33 11
Lietuva
Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas
Tel.: +370 37 473922
Etnrapuu
EbopHHrep HHrenxaÖM P^B Tm6X h Ko. Kr -kuoh Ebnrapna
Ten: +359 2 958 79 98
Luxembourg/Luxemburg
SCS Boehringer Ingelheim Comm.V
Tel/Tel: +32 2 773 33 11
Česka republika
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111
Magyarorszag
Boehringer Ingelheim RCV GmbH & Co KG Magyarorszagi Fioktelepe
Tel.: +36 1 299 89 00
Danmark
Boehringer Ingelheim Danmark A/S
Tlf: +45 39 15 88 88
Malta
Boehringer Ingelheim Ltd.
Tel: +44 1344 424 600
Deutschland
Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 900
Nederland
Boehringer Ingelheim b.v.
Tel: +31 (0) 800 22 55 889
Eesti
Boehringer Ingelheim RCV GmbH & Co KG
Eesti Filiaal
Tel: +372 612 8000
Norge
Boehringer Ingelheim Norway KS
Tlf: +47 66 76 13 00
EkXüda
Boehringer Ingelheim Ellas A.E.
TpT,: +30 2 10 89 06 300
Österreich
Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105-0
Espana
Boehringer Ingelheim Espana, S.A.
Tel: +34 93 404 51 00
Polska
Boehringer Ingelheim Sp.zo.o.
Tel.: +48 22 699 0 699
France
Boehringer Ingelheim France S.A.S.
Tel: +33 3 26 50 45 33
Portugal
Boehringer Ingelheim, Unipessoal, Lda.
Tel: +351 21 313 53 00
Hrvatska
Boehringer Ingelheim Zagreb d.o.o.
Tel: +385 1 2444 600
Romania
Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucuresti
Tel: +40 21 302 28 00
Ireland
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620
Slovenija
Boehringer Ingelheim RCV GmbH & Co KG podružnica Ljubljana
Tel: +386 1 586 40 00

Island

Vistor hf.
Smi: +354 535 7000

Slovenska republika

Boehringer Ingelheim RCV GmbH & Co KG organizačna zložka Tel: +421 2 5810 1211

Suomi/Finland

Boehringer Ingelheim Finland Ky Puh/Tel: +358 10 3102 800

Sverige

Boehringer Ingelheim AB Tel: +46 8 721 21 00

United Kingdom

Boehringer Ingelheim Ltd.
Tel: +44 1344 424 600

Italia

Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1

Knrcpog

Boehringer Ingelheim Ellas A.E.
T^: +30 2 10 89 06 300

Latvija

Boehringer Ingelheim RCV GmbH & Co KG Latvijas filiāle Tel: +371 67 240 011

This leaflet was last revised in


Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the user Micardis 80 mg tablets

Telmisartan

Read all of this leaflet carefully before you start taking this medicine medicine because it contains important information for you.

-   Keep this leaflet. You may need to read it again.
-   If you have any further questions, ask your doctor or pharmacist.
-   This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-   If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.   What Micardis is and what it is used for
2.   What you need to know before you take Micardis
3.   How to take Micardis
4.   Possible side effects
5.   How to store Micardis
6.   Contents of the pack and other information

1. What Micardis is and what it is used for

Micardis belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. Micardis blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
Micardis is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the high blood pressure is not caused by any other condition.
High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Micardis is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes. Your doctor can tell you if you are at high risk for such events.

2. What you need to know before you take Micardis

Do not take Micardis

•   if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).
•   if you are more than 3 months pregnant. (It is also better to avoid Micardis in early pregnancy -see pregnancy section.)
•   if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease.
•   if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
If any of the above applies to you, tell your doctor or pharmacist before taking Micardis.

Warnings and precautions

Talk to your doctor before taking Micardis if you are suffering or have ever suffered from any of the following conditions or illnesses:
•   Kidney disease    or kidney    transplant.
•   Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
•   Liver disease.
•   Heart trouble.
•   Raised aldosterone    levels    (water and salt retention in the body along with imbalance of various
blood minerals).
•   Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting.
•   Elevated potassium levels in your blood.
•   Diabetes.
Talk to your doctor before taking Micardis:
•   if you are taking any of the following medicines used to treat high blood pressure:
-   an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
-   aliskiren.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the heading “Do not take Micardis”.
•   if you are taking digoxin.
You must tell your doctor if you think you are (or might become) pregnant. Micardis is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
In case of surgery or anaesthesia, you should tell your doctor that you are taking Micardis.
Micardis may be less effective in lowering the blood pressure in black patients.

Children and adolescents

The use of Micardis in children and adolescents up to the age of 18 years is not recommended.

Other medicines and Micardis

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to change the dose of these other medicines or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Micardis:
•   Lithium containing medicines to treat some types of depression.
•   Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
•   Diuretics ('water tablets'), especially if taken in high doses together with Micardis, may lead to excessive loss of body water and low blood pressure (hypotension).
•   If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Micardis” and “Warnings and precautions”).
•   Digoxin.
The effect of Micardis may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Micardis may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine). Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or antidepressants. You may notice this as dizziness when standing up. You should consult with your doctor if you need to adjust the dose of your other medicine while taking Micardis.

Pregnancy and breast-feeding

Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Micardis before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Micardis. Micardis is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Micardis is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

Some people feel dizzy or tired when taking Micardis. If you feel dizzy or tired, do not drive or operate machinery.

Micardis contains sorbitol.

If you are intolerant to some sugars, consult your doctor before taking Micardis.

3. How to take Micardis

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet a day. Try to take the tablet at the same time each day.
You can take Micardis with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take Micardis every day until your doctor tells you otherwise. If you have the impression that the effect of Micardis is too strong or too weak, talk to your doctor or pharmacist.
For treatment of high blood pressure, the usual dose of Micardis for most patients is one 40 mg tablet once a day to control blood pressure over the 24 hour period. However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Micardis may be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Micardis.
For reduction of cardiovascular events, the usual dose of Micardis is one 80 mg tablet once a day. At the beginning of the preventive therapy with Micardis 80 mg, blood pressure should be frequently monitored.
If your liver is not working properly, the usual dose should not exceed 40 mg once daily.

If you take more Micardis than you should

If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.

If you forget to take Micardis

If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and need immediate medical attention

You should see your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these effects are not treated they could be fatal.

Possible side effects of Micardis

Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.
Uncommon side effects (may affect up to 1 in 100 people):
Urinary tract infections,upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia),low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Very rare side effects (may affect up to 1 in 10,000 people):
Progressive scarring of lung tissue (interstitial lung disease)**.
* The event may have happened by chance or could be related to a mechanism currently not known.
** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. However, it is not known whether telmisartan was the cause.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Micardis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions. You should store your medicine in the original package in order to protect the tablets from moisture. Remove your Micardis tablet from the blister only directly prior to intake.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Micardis contains

The active substance is telmisartan. Each tablet contains 80 mg telmisartan.
The other ingredients are povidone, meglumine, sodium hydroxide, sorbitol (E420) and magnesium stearate.

What Micardis looks like and contents of the pack

Micardis 80 mg tablets are white, oblong-shaped and engraved with the code number '52H' on one side and the company logo on the other side.
Micardis is available in blister packs containing 14, 28, 56, 84 or 98 tablets, in unit dose blister packs containing 28 x 1, 30 x 1 or 90 x 1 tablets or in multipacks containing 360 (4 packs of 90 x 1) tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder   Manufacturer

Boehringer Ingelheim International GmbH   Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Str. 173   Binger Str. 173
D-55216 Ingelheim am Rhein   D-55216 Ingelheim am Rhein
Germany   Germany
Delpharm Reims S.A.S.
10 rue Colonel Charbonneaux
51100 Reims
France
Boehringer Ingelheim Ellas A.E.
5th km Paiania - Markopoulo Koropi Attiki, 194 00 Greece
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Belgie/Belgique/Belgien
SCS Boehringer Ingelheim Comm.V
Tel/Tel: +32 2 773 33 11
Lietuva
Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas
Tel.: +370 37 473922
Etnrapuu
EbopHHrep HHrenxaÖM P^B Tm6X h Ko. Kr -kuoh Ebnrapna
Ten: +359 2 958 79 98
Luxembourg/Luxemburg
SCS Boehringer Ingelheim Comm.V
Tel/Tel: +32 2 773 33 11
Česka republika
Boehringer Ingelheim spol. s r.o.
Tel: +420 234 655 111
Magyarorszag
Boehringer Ingelheim RCV GmbH & Co KG Magyarorszagi Fioktelepe
Tel.: +36 1 299 89 00
Danmark
Boehringer Ingelheim Danmark A/S
Tlf: +45 39 15 88 88
Malta
Boehringer Ingelheim Ltd.
Tel: +44 1344 424 600
Deutschland
Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 900
Nederland
Boehringer Ingelheim b.v.
Tel: +31 (0) 800 22 55 889
Eesti
Boehringer Ingelheim RCV GmbH & Co KG
Eesti Filiaal
Tel: +372 612 8000
Norge
Boehringer Ingelheim Norway KS
Tlf: +47 66 76 13 00
EkXüda
Boehringer Ingelheim Ellas A.E.
TpA,: +30 2 10 89 06 300
Österreich
Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105-0
Espana
Boehringer Ingelheim Espana, S.A.
Tel: +34 93 404 51 00
Polska
Boehringer Ingelheim Sp.zo.o.
Tel.: +48 22 699 0 699
France
Boehringer Ingelheim France S.A.S.
Tel: +33 3 26 50 45 33
Portugal
Boehringer Ingelheim, Unipessoal, Lda.
Tel: +351 21 313 53 00
Hrvatska
Boehringer Ingelheim Zagreb d.o.o.
Tel: +385 1 2444 600
Romania
Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucuresti
Tel: +40 21 302 28 00
Ireland
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620
Slovenija
Boehringer Ingelheim RCV GmbH & Co KG podružnica Ljubljana
Tel: +386 1 586 40 00

Island

Vistor hf.
Smi: +354 535 7000

Slovenska republika

Boehringer Ingelheim RCV GmbH & Co KG organizačna zložka Tel: +421 2 5810 1211

Suomi/Finland

Boehringer Ingelheim Finland Ky Puh/Tel: +358 10 3102 800

Sverige

Boehringer Ingelheim AB Tel: +46 8 721 21 00

United Kingdom

Boehringer Ingelheim Ltd.
Tel: +44 1344 424 600

Italia

Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1

Knrcpog

Boehringer Ingelheim Ellas A.E.
T^: +30 2 10 89 06 300

Latvija

Boehringer Ingelheim RCV GmbH & Co KG Latvijas filiāle Tel: +371 67 240 011

This leaflet was last revised in


Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
64





  Instruction, annotation source for medicine: State Agency of Medicines, Estonia




EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/568173/2015

EMEA/H/C/000413

EPAR summary for the public

MicardisPlus

telmisartan / hydrochlorothiazide

This is a summary of the European public assessment report (EPAR) for MicardisPlus. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for MicardisPlus.

What is MicardisPlus?

MicardisPlus is a medicine that contains two active substances, telmisartan and hydrochlorothiazide. It is available as oval tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide).

What is MicardisPlus used for?

MicardisPlus is used in adult patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone. NEssential' means that the hypertension has no obvious cause

The medicine can only be obtained with a prescription.

How is MicardisPlus used?

MicardisPlus is taken by mouth once a day with liquid. The dose of MicardisPlus to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets. The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to MicardisPlus.

An agency of the European Union

WC5EN00028545

30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

How does MicardisPlus work?

MicardisPlus contains two active substances, telmisartan and hydrochlorothiazide.

Telmisartan is an Angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.

Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension. It works by increasing urine output, reducing the amount of fluid in the blood and reducing the blood pressure.

The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.

How has MicardisPlus been studied?

MicardisPlus has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension. In four of these studies, MicardisPlus was compared with placebo (a dummy treatment) and with telmisartan taken alone in a total of 2,272 patients. The fifth study compared the effects of remaining on the 80/12.5 mg tablet with switching to the 80/25 mg tablet in 713 patients who had not responded to the 80/12.5 mg tablet. In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).

What benefit has MicardisPlus shown during the studies?

MicardisPlus was more effective at reducing diastolic blood pressure than telmisartan taken alone and than placebo. In patients who were not controlled on the 80/12.5 mg tablet, switching to the 80/25 mg tablet was more effective in reducing diastolic blood pressure than remaining on the lower dose.

What is the risk associated with MicardisPlus?

The most common side effect with MicardisPlus (seen in between 1 and 10 patients in 100) is dizziness. For the full list of all side effects reported with MicardisPlus, see the Package Leaflet.

MicardisPlus must not be used in women who are more than three months pregnant. Its use during the first three months of pregnancy is not recommended. MicardisPlus must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high. In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, MicardisPlus must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension). For the full list of restrictions, see the package leaflet.

Care must be taken when using MicardisPlus with other medicines that have an effect on blood potassium levels. The full list of these medicines is given in the Package Leaflet.

Why has MicardisPlus been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that MicardisPlus's benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone. The Committee recommended that MicardisPlus be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of MicardisPlus?

A risk management plan has been developed to ensure that MicardisPlus is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for MicardisPlus including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about MicardisPlus

The European Commission granted a marketing authorisation valid throughout the European Union for MicardisPlus on 19 April 2002

The full EPAR for MicardisPlus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with MicardisPlus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 08-2015.



 Instruction , annotation source: The European Medicines Agency


[*] Information source DDD German Institute of Medical Documentation and Information - DIMDI [23.11.2011]


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