METOPROLOL MEDA TBL 50MG N30

ATC code: C07AB02 

Active substances: Metoprololi Tartras

Vendor, principal: Icn Polfa Rzeszow S.a.. 
METOPROLOL MEDA TBL 50MG N30 is compensated medicine in Latvia. 

 Prescription drug (℞) 

METOPROLOL-RATIOPHARM 50MG N30

Package leaflet: information for the user

Metoprolol-ratiopharm 50 mg tablets

Metoprolol tartrate

Read all of this leaflet carefully before you start using 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 symptoms are similar to 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 Metoprolol-ratiopharm 50 mg is and what it is used for
2.   What you need to know before you take Metoprolol-ratiopharm 50 mg
3.   How to take Metoprolol-ratiopharm 50 mg
4.   Possible side effects
5.   How to store Metoprolol-ratiopharm 50 mg
6.   Contents of the pack and other information

1.   What Metoprolol-ratiopharm 50 mg is and what it is used for

Metoprolol is a cardioselective beta-adrenergic blocker.
Metoprolol is used for:
-   Treatment of arterial hypertension (high blood pressure)
-   Treatment of angina (tightness and pain in the chest).
-   Treatment and prophylaxis of arrhythmias.
-   Prophylaxis of complications following acute myocardial infarction (heart attack).
-   Prophylaxis of migraines.

2.   What you need to know before you take Metoprolol-ratiopharm 50 mg Do not use Metoprolol-ratiopharm 50 mg:

-   If you are allergic to metoprolol or beta-blockers or any of the other ingredients of this medicine (listed in section 6).
-   If you are suspected of having an acute heart    attack.
-   If you heart rate is < 45 beats per minute.
-   If your PQ interval (according to ECG) is > 0.24 seconds.
-   If you have untreated heart failure.
-   If you have cardiogenic shock.
-   If you have type II or III AV block.
-   If you have sinus node dysfunction (sick sinus    syndrome).
-   If you have sinoatrial block.
-   If your heart rate is too slow (resting heart rate before starting treatment < 50 beats per minute).
-   If your blood pressure is too low (systolic blood pressure < 90 mmHg).
-   If you have severe peripheral vascular disease.
-   If you use medicines called MAO inhibitors (excluding MAO-B inhibitors).
You must not be intravenously administered calcium antagonists, such as verapamil and diltiazem or any other medicines used for treating arrhythmias (e.g. disopyramide) (except in intensive care) while taking metoprolol.

Warnings and precautions

Talk to your doctor or pharmacist before using Metoprolol-ratiopharm 50 mg, if you have:
-   Type I AV block.
-   Diabetes accompanied with strong fluctuations of blood sugar levels (your blood sugar may decrease to dangerously low levels).
-   After prolonged extreme fasting and/or strenuous physical exercise (your blood sugar may decrease to dangerously low levels).
-   Certain adrenal gland tumours (pheochromocytoma), in the case of which prior therapy with alpha-blockers is necessary.
-   Impaired liver function.
-   Psoriasis.
-   Obstructive lung diseases (e.g. asthma, chronic obstructive pulmonary disease).
-   Peripheral vascular disease.
Treatment with beta-blockers must not be stopped suddenly. If you need to stop treatment, it must be carried out by gradually lowering the dose of metoprolol. Stopping treatment suddenly may increase the risk of having a heart attack.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
As there is no experience with using this medicine during pregnancy (especially in the early stages), then metoprolol should only be used in cases of dire need. It has been reported that metoprolol decreases blood supply to the placenta and can therefore cause foetal deformities, premature birth or even intrauterine death. In order to prevent the risk of slow heart rate, low blood pressure and high blood sugar levels in the new-born, the treatment should be stopped 48...72 hours before expected childbirth. If the treatment was not stopped, the new-born should be closely monitored for 48...72 hours after birth.
Metoprolol is excreted into breast milk and therefore it is not safe to breast-feed until 3...4 hours have passed since taking the medicine.

Driving and using machines

Attention! The medicines can cause drowsiness. Avoid driving and using moving machines during treatment period. You should not consume alcohol during treatment.
Other medicines and Metoprolol-ratiopharm 50 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Certain medicines may influence the effect of metoprolol and metoprolol may influence the effect of certain medicines. If you are also using the following medicines, tell your doctor and ask how to correctly use them and whether there is a need for monitoring your condition.
-   Oral diabetes medicines.
-   Medicines that induce or inhibit certain liver enzymes (e.g. cytochrome P450 2D6), such as certain arrhythmia medicines, allergy medicines (antihistamines), medicines for lowering gastric acidity, antidepressants (serotonin reuptake inhibitors, monoamine oxidase inhibitors), antipsychotic medicines and anti-inflammatory medicines (COX-2 inhibitors), cimetidine, hydralazine and rifampicin.
-   The so-called calcium channel blockers and antiarrhythmic medicines (for arrhythmias).
-   Cardiac glycosides.
-   Clonidine.
-   Sympathomimetic medicines (also includes certain eye drops and nasal medicines).
-   Adrenaline.
-   Nonsteroidal anti-inflammatory drugs or NSAIDs    (e.g. indomethacin, ibuprofen).
-   Lidocaine.
If you are about to have an operation under general anaesthesia, make sure to tell your doctor and anaesthetist that you are taking metoprolol. You may need to stop taking metoprolol for a certain period of time. The anaesthetist may also need to adjust your dose of anaesthetics and muscle relaxants.

3. How to take Metoprolol-ratiopharm 50 mg

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The tablets must be swallowed whole with sufficient water after a meal. The tablets are taken in the morning if the daily dose is one tablet, and in the morning and evening if the daily dose is two tablets.
The duration of administration is determined by your doctor.
Stopping treatment with metoprolol, especially after long-term use, must be carried out by gradually lowering doses, because stopping suddenly may lead to cardiac ischaemia with exacerbation of angina, myocardial infarction, or exacerbation of hypertension.
The dosage is set individually for every patient depending mainly on the results of the treatment. The recommended dosage regimen is as follows:
Arterial hypertension
1 tablet 1...2 times a day or 1...2 tablets once a day (equivalent to 50...100 mg of metoprolol tartrate).
If necessary, the daily dose may be increased to 2 tablets twice a day (equivalent to 200 mg of metoprolol tartrate).
Heart ischaemia (angina)
1 tablet 1...2 times a day or 1...2 tablets once a day (equivalent to 50...100 mg of metoprolol tartrate).
If necessary, the daily dose may be increased to 2 tablets twice a day (equivalent to 200 mg of metoprolol) if blood pressure is monitored during treatment.
Hyperkinetic heart syndrome (so-called functional disorders)
1   tablet 1...2 times a day or 1...2 tablets once a day (equivalent to 50...100 mg of metoprolol tartrate). If necessary, the daily dose may be increased to 2 tablets twice a day (equivalent to 200 mg of metoprolol) if blood pressure is monitored during treatment.
Tachyarrhythmias
2   tablets 1...2 times a day (equivalent to 100...200 mg of metoprolol tartrate).
Prophylaxis of complications following a severe myocardial infarction The recommended maintenance dose of metoprolol tartrate after acute treatment is 100...200 mg of metoprolol tartrate a day, divided into single doses (respectively, 1...2 tablets twice a day; equivalent to 200 mg of metoprolol tartrate).
If you experience a sudden decrease in heart rate and/or blood pressure and/or other complications, stop taking Metoprolol-ratiopharm 50 mg immediately.
Migraine prophylaxis
2 tablets 1...2 times a day (equivalent to 100...200 mg of metoprolol tartrate).
In patients with severe liver damage, elimination of metoprolol is decreased, which may call for a lower dose.
Special groups of patients
Renal impairment
The dosage does not need to be adjusted.
Hepatic impairment
In patients with severe hepatic impairment, a lower dose should be considered.
Children
There is limited experience with use in children.

If you take more Metoprolol-ratiopharm 50 mg than you should

Overdosing may cause a severe decrease in blood pressure, a decrease in heart rate until cardiac arrest, as well as heart failure and shock. There may also occur breathing difficulties, bronchospasm, nausea, vomiting, loss of consciousness and cramps.
In the case of overdose or an alarming decrease in heart rate and/or blood pressure, you must stop taking Metoprolol-ratiopharm 50 mg.
In the case of suspected overdose, you must immediately contact your doctor or go to the emergency department. Take the remaining tablets and the pack with you, so that the doctor would know which medicine you have taken.
Do not take a double dose to make up for a forgotten dose, but continue taking the prescribed doses at the correct times.

4.   Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Talk to your doctor if you get any side effects.
Common side effects (affect up to 1 user in 100)
-   Overly low heart rate,    palpitations.
-   Cold fingers or toes.
-   Abdominal pain, nausea, diarrhoea, constipation.
Uncommon side effects (affect up to 1 user in 1,000)
-   Chest pain, temporary exacerbation of heart failure.
-   Confusion, hallucinations, dizziness, headache, depression, insomnia, oversleeping.
-   Central nervous system disorders, such as fatigue (especially at the beginning of treatment), headache, dizziness.
-   Vomiting.
-   Allergic skin reactions (redness, itching, rash, sensitivity to light), excessive sweating.
-   Weight gain.
-   Dyspnoea, bronchospasm.
Rare side effects (affect up to 1 user in 10,000)
-   Decreased impulse conductivity in the atrioventricular node of the heart, arrhythmias
-   Nightmares, depression, nervousness, anxiety.
-   Paraesthesias (tingling, prickling or numbness in hands or feet).
-   Impaired sense of taste, dry mouth.
-   Increase in transaminase (certain liver enzymes) activity (detectable in blood analyses).
-   Latent diabetes may surface and overt diabetes may be exacerbated. After prolonged extreme fasting or strenuous physical exercise, a persistent decrease in blood sugar levels may occur (hypoglycaemic condition). Warning signs of hypoglycaemia (especially trembling and slow heart rate) may be concealed.
-   Impaired vision, dryness and/or irritation of the eyes, decreased lacrimation (important for users of contact lenses).
-   Changes in sexual desire.
Very rare side effects (affect less than 1 user in 10,000, including isolated cases)
-   Fainting.
-   Gangrene in the case of vascular disease.
-   Changes in personality (e.g. mood swings, temporary memory loss), confusion, hallucinations, impaired concentration.
-   Inflammation of the liver (hepatitis).
-   Joint pain, muscle cramps.
-   Hair loss, psoriasis, exacerbation of existing psoriasis complaints, rash resembling psoriasis.
-   Reduced level of platelets (thrombocytopenia) or white blood cells (leukopenia) (detectable in blood analyses).
-   Inflammation of the eye conjunctiva    (Conjunctivitis).
-   Impaired hearing, ringing in the ears    (tinnitus).
-   Allergic rhinitis.
-   Potency disorders, Peyronie’s disease, i.e. deformation of the penis.
-   Deterioration of kidney function.
Other side effects:
-   Exacerbation of complaints in patients with peripheral vascular disorders (including patients with Raynaud’s syndrome).
-   Lipopathy (abnormalities in the composition of blood lipids) may occur during treatment with metoprolol. Reduced levels of HDL cholesterol and increased levels of triglycerides in plasma have been reported, usually in conjunction with normal total cholesterol.
-   Patients with a tendency for bronchospastic reactions (especially in the case of obstructive pulmonary diseases) may experience breathing difficulties.
-   Metoprolol may conceal the symptoms of an overactive thyroid (thyrotoxicosis).
-   Increased sensitivity to allergens and exacerbation of anaphylactic reaction.

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
www.ravimiamet.ee. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Metoprolol-ratiopharm 50 mg

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 25 °C.
Do not use this medicine after the expiry date which is stated on the carton after “Use by:”. The expiry date refers to the last day of that month.
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 Metoprolol-ratiopharm 50 mg contains

The active substance is metoprolol.
One tablet contains 50 mg of metoprolol tartrate, which is equivalent to 39 mg of metoprolol. The other ingredients are microcrystalline cellulose, corn starch, croscarmellose sodium, copovidone, colloidal anhydrous silicon, magnesium stearate (Ph. Eur.)

What Metoprolol-ratiopharm 50 mg looks like and contents of the pack

White biconvex tablet with a score line on one side and a marking “M” on the other side.
The tablet may be divided into equal doses.
The PVC/aluminium blister pack contains 30, 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: ratiopharm GmbH,
Graf-Arco-Str. 3,
89079 Ulm,
Germany
Manufacturer:
Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren Germany
For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Teva Estonia UAB Sicor Biotech Estonian branch Hallivanamehe 4 11317 Tallinn Phone: +372 661 0801

This leaflet was last revised in August 2016.