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IBUSTAR 400 FILM COATED TBL 400MG N10

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-28
IBUSTAR-drug/medicine -tablets aproximate price on "IBUSTAR 400 FILM COATED TBL 400MG N10" in Riga city, Latvia is:
  • 1.94€  2.1$  1.66£  224Rub  22.3SEK  8PLN  7.68₪ 

IBUSTAR, 400 mg, plėvele dengtos tabletės, N10


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -tablets  IBUSTAR 400 FILM COATED TBL 400MG N10     Recheck

ATC codeM01AE01 

Active substances: Ibuprofenum

 


Vendor, principal: Berlin-Chemie Ag
No prescription needed/Patient care products, dressings, gloves, medical devices,...

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IBUSTAR 400 mg tabletes, 10 gab.

 .

IBUSTAR 400MG N10

Package leaflet: Information for the user

Ibustar 400 mg film-coated tablets

Ibuprofen
For use in children above 6 years (from 20 kg) and adults.

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   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.
-   You must talk to a doctor if you do not feel better or if you feel worse after 3 days in children and adolescents after 3 days in the treatment of fever and after 4 days in the treatment of pain in adults.

What is in this leaflet:

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

1. What Ibustar is and what it is used for

Ibustar is an anti-inflammatory and pain-relieving medicine (non-steroidal anti-inflammatory drug, NSAID) with fever lowering (antipyretic) properties.
Uses of Ibustar Symptomatic treatment of
-   Mild to moderately severe pain
-   Fever

2. What you need to know before you take Ibustar Do not take Ibustar:

-   if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
-   in allergic reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatories in the past, like:
-   bronchospasm;
-   asthma attacks;
-   swelling of the mucous membrane of the nose;
-   skin reactions (e.g. reddening, hives or similar);
-   in unclarified blood-formation disturbances;
-   in active or history of recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (two or more distinct episodes of proven ulceration or bleeding);
-   in a history of gastro-intestinal bleeding or perforation, related to previous NSAIDs therapy;
-   in bleeding of the brain (cerebrovascular bleeding) or other active bleeding;
-   in severe kidney- or liver-function disturbances;
-   in severe heart failure;
-   in the last 3 months of pregnancy.
Children
Ibustar must not be given to children under 6 years or with a body weight under 20 kg, as the dose contained is not suitable as a rule.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ibustar
Side effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Consult a doctor before using the product if you have any of below mentioned conditions.
Safety in the gastro-intestinal tract
The use of Ibustar at the same time as NSAIDs, including so-called COX-2 inhibitors (cyclooxygenase-2 selective inhibitors) should be avoided.
Elderly:
The elderly have an increased frequency of adverse reactions to NSAIDs especially gastro-intestinal bleeding and perforation which may be fatal. Particularly careful monitoring by a doctor is therefore required in elderly patients.
Gastrointestinal bleeding, ulceration and perforation:
Gastro-intestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.
The risk of gastro-intestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 2: "Do not take Ibustar:"), and in the elderly. These patients should commence treatment on the lowest dose available.
Combination therapy with protective agents (e.g. misoprostol or proton-pump inhibitors) should be considered for these patients, and also for patients requiring an accompanying therapy with low-dose acetylsalicylic acid (ASA) or other active substances likely to increase gastro-intestinal risk.
If you have a history of gastro-intestinal side effects, particularly when elderly, you should report any unusual abdominal symptoms (especially gastro-intestinal bleeding) particularly in the initial stages of treatment.
Caution should be advised if you are receiving at the same time medicines which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulant medicines such as warfarin, selective serotonin-reuptake inhibitors, which are used amongst other things for the treatment of depressive mood, or anti-platelet medicines such as ASA (see section 2: " Other medicines and Ibustar").
If you experience gastro-intestinal bleeding or ulcers under Ibustar, treatment should be withdrawn.
NSAIDs should be given with care to patients with a history of a gastro-intestinal disease (ulcerative colitis, Crohn's disease), as these conditions may get worse (see section 4 "Possible side effects").
Effects on the cardiovascular system
Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking [Invented name] if you:
-   have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).
-   have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
Skin reactions
Serious skin reactions with reddening and blistering, some of them fatal, (exfoliative dermatitis, StevensJohnson syndrome and toxic epidermal necrolysis/Lyell's syndrome) have been reported very rarely in association with the use of NSAIDs (see section 4 "Possible side effects").
Patients appear to be at highest risk of these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment.
Ibustar should be discontinued and a doctor consulted at once at the first appearance of skin rash, mucous-membrane lesions, or any other signs hypersensitivity.
Other notes
-   In certain autoimmune disorders, (systemic lupus erythematosus and mixed-connective tissue disease), Ibustar should only be used with strict assessment of the benefit/risk ratio. There is an increased risk of developing symptoms of a non-infectious inflammation of the brain lining (aseptic meningitis) (see section 4.).
Particularly careful monitoring by a doctor is required:
-   in gastro-intestinal disturbances or a history of chronic-inflammatory intestinal disorders (ulcerative colitis, Crohn's disease);
-   in high blood pressure or heart failure;
-   in impaired kidney or liver function;
-   directly after maj or surgical procedures;
-   in allergies (e.g. skin reactions to other medicines, asthma, hayfever), chronic swelling of the mucous membrane of the nose or chronic airway disorders that narrow the airways.
-   Severe acute hypersensitivity reactions (for example anaphylactic shock) are observed very rarely. At the first sign of a severe hypersensitivity reaction after taking Ibustar, you must stop taking it immediately and go to a doctor.
-   Ibuprofen, the active substance of Ibustar, may temporarily inhibit the blood-platelet function (thrombocyte aggregation). Patients with blood-coagulation disturbances should therefore be monitored carefully.
-   If used at the same time as ibuprofen-containing medicines, the anticoagulant effect of low-dose acetylsalicylic acid (preventing the formation of blood clots) may be impaired. In this case, therefore, you should not use ibuprofen-containing medicines without the express instruction of a doctor.
-   If you are taking medicines at the same time to inhibit blood coagulation or to lower blood sugar, checks of the blood coagulation or the blood sugar should be performed as a precaution.
-   In prolonged administration of Ibustar, regular checking of the liver values, the kidney function, as well as of the blood count, is required.
-   The doctor or dentist is to be asked or informed if Ibustar is taken before surgical procedures.
-   Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.
-   In general terms, habitually taking painkillers, particularly on combination of several pain-relieving active substances, may lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).
-   During chicken pox (varicella) it is advisable to avoid use of Ibustar.

Children and adolescents

-   There is a risk of renal impairment in dehydrated children and adolescents.

Other medicines and Ibustar

Please tell your doctor or pharmacist if you are taking or if you have recently taken or might take any other
medicines, including medicines obtained without a prescription.
Ibustar may affect or be affected by some other medicines. For example:
-   medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
-   medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
Some other medicines may also affect or be affected by the treatment of Ibustar. You should therefore always
seek the advice of your doctor or pharmacist before you use Ibustar with other medicines.
The effect of the active substances or preparation groups stated below may be influenced in treatment with
Ibustar at the same time.
Increase in the effect and/or side effects:
-   If the following medicines are taken at the same time, the blood concentrations of these medicines may increase:
-   digoxin (agent for strengthening the output of the heart);
-   phenytoin (agent for treating seizures);
-   lithium (agent for treating psychiatric disorders).A check of serum-lithium levels, serum-digoxin and serum-phenytoin levels is not required as a rule if used correctly (see section 3: "How to take Ibustar"));
-   agents for inhibiting blood coagulation;
-   methotrexate (agent for treating cancer or certain rheumatic disorders): Do not take Ibustar within 24 hours before or after administration of methotrexate. This may lead to raised concentrations of methotrexate and to an increase in its side effects.
-   acetylsalicylic acid and other anti-inflammatory painkillers, including COX-2 inhibitors (non-steroidal anti-inflammatory drugs), selective serotonin-reuptake inhibitors (medicines for treating depressive mood), as well as cortisone preparations (glucocorticoids): An increased risk of ulcers and bleeding in the gastro-intestinal tract exists;
-   medicines that contain probenecid or sulfinpyrazone (agents for treating gout): These may delay the excretion of ibuprofen. There may be accumulation of ibuprofen in the body with an increase in its side effects through this.
Weakening of the effect:
-   Medicines for increasing fluid excretion (diuretics) and medicines for too high blood pressure (antihypertensives)
-   ACE inhibitors (agents for treating heart failure and high blood pressure): Risk of a kidney-function disturbance occurring is increased.
-   Acetylsalicylic acid in a low dose: The effect of low-dose acetylsalicylic acid on the coagulation-promoting blood platelets may be impaired (see section 2: " Warnings and precautions").
Other possible interactions:
-   Zidovudine (medicine for treating AIDS): An increased risk exists of bleeding of the joints and bruises in haemophiliacs with HIV infection.
-   Ciclosporin (medicine for suppressing the immune response, after a transplant for example, and for treating rheumatism): The risk exists of your kidneys being damaged.
-   Tacrolimus: The risk exists of your kidneys being damaged.
-   Potassium-sparing water-removing agents (certain diuretics): If taken at the same time, there may be an increase in potassium levels.
-   Sulphonylureas (agents for lowering blood sugar): Although interactions between ibuprofen and sulphonylureas, unlike other NSAIDs, have not yet been described, your blood-sugar values should be checked as a precaution if taken at the same time.
-   anticoagulant agents: There are isolated reports about interactions between ibuprofen and anticoagulant agents. In treatment at the same time, a check of the coagulation status is recommended.

Ibustar with alcohol

If possible, you should not drink alcohol during use of Ibustar, as side effects, particularly those that affect the gastro-intestinal tract or the central nervous system, are increased

Pregnancy, breast-feeding and fertility Pregnancy

If a pregnancy is established during use of Ibustar, then the doctor is to be notified.
You may only use ibuprofen in the first 6 months of pregnancy after consulting your doctor.
Because of an increased risk of complications for mother and child, Ibustar must not be used in the last 3 months of pregnancy.

Fertility

Ibustar belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may impair the fertility of women. This effect is reversible on stopping the medicine.

Breast-feeding

The active substance ibuprofen and its breakdown products only cross into breast milk in small quantities. As negative consequences for the infant have not yet become known, an interruption to breast-feeding is not required as a rule on short-term use. However, if prolonged use or taking higher doses is prescribed, early weaning should be considered.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

As central nervous side effects like tiredness and dizziness may occur if Ibustar is used at high dosage, reactions may be changed and the ability to take part actively in road traffic and to operate machines may be impaired in isolated cases. This applies to an increased extent in combination with alcohol. You are then no longer able to react fast and purposely enough to unexpected and sudden events. Do not drive cars or other vehicles in this case! Do not operate tools or machines! Do not work without a secure foothold!
3. How to take Ibustar
Always take this medicine exactly as described in this package leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose is:
Body weight (Age)
Single dose
Max. daily dose (24 hours)

54 a film-coated tablet
14 film-coated tablets
20 kg - 29 kg
(equivalent to 200 mg
(equivalent to 600 mg
6 - 9 years
ibuprofen)
ibuprofen)

4 a film-coated tablet
2 film-coated tablets
30 kg - 39 kg
(equivalent to 200 mg
(equivalent to 800 mg
10 - 12 years
ibuprofen)
ibuprofen)

54 - 1 film-coated tablet
3 film-coated tablets
≥ 40 kg
(equivalent to
(equivalent to 1200 mg
(adolescents above 12 years and adults)
200 - 400 mg ibuprofen)
ibuprofen)
If you have taken the maximum single dose, wait at least 6 hours until the next dose.
Elderly people and patients with a previous stomach or duodenal ulcer
These patients should begin with the lowest dosage (see section 2: " Warnings and precautions").
Impaired kidney or liver function
No dose reduction is required in mild to moderate impairment to kidney or liver function.

Children and adolescents

If in children aged from 6 years and in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

Method and route of administration

Oral use.
Please swallow the film-coated tablets whole with plenty of liquid (e.g. a glass of water) during or after a meal.
Note on dividing:
The tablet can be divided into equal halves.
Hold the tablet between the index fingers and thumbs of both hands with the break-mark facing downwards and break the tablet into two halves along the break-mark through downward pressure of the thumbs.

Duration of use

For short-term use only.
Do not take Ibustar for more than 3 days in children and adolescent and for more than 3 days in the treatment of fever and for 4 days in the treatment of pain in adults.without the advice of a doctor.
Please speak to your doctor if you have the impression that the effect of Ibustar is too strong or too weak.

If you take more Ibustar than you should

Take Ibustar according to the instructions of the doctor or the dosage guide stated in the package leaflet. If you have the feeling that you are not experiencing adequate pain relief, then do NOT increase the dose on your own, but ask a doctor.
If you have taken more Ibustar than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.
Possible symptoms of an overdose are:
-   The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsion (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.
-   central nervous disturbances like headache, dizziness, light-headedness and unconsciousness (also seizures in children);
-   gastro-intestinal disturbances like stomachache, nausea and vomiting, bleeding in the gastro-intestinal tract;
-   function disturbances of the liver and kidneys;
-   drop in blood pressure;
-   lessened breathing (respiratory depression);
-   blue-red coloration of skin and mucous membranes (cyanosis).
There is no specific antidote.
If an overdose with Ibustar is suspected, notify a doctor at once. According to the severity of the poisoning, they can decide about the measures that might be required.

If you forget to take Ibustar

Do not take a double dose to make up for a forgotten dose.
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. Should you observe that you have the following side effects, please discuss this with your doctor, who will then decide how to proceed further.
The list of the following side effects comprises all side effects that have become known under treatment with ibuprofen, also those under high-dose long-term therapy in rheumatism patients. The stated frequencies, which extend beyond very rare reports, refer to the short-term use of daily doses up to a maximum of 1200 mg ibuprofen for oral dosage forms (= 3 Ibustar) and a maximum of 1800 mg for suppositories.
It must be accounted for that the following adverse drug reactions are predominantly dose-dependant and vary from patient to patient.
The most commonly observed side effects are gastro-intestinal in nature.
Stomach/duodenal ulcers (peptic ulcers), perforation or gastro-intestinal bleeding, sometimes fatal, particularly in the elderly, may occur (see section 2: " Warnings and precautions").
Nausea, vomiting, diarrhoea, flatulence, constipation, digestive complaints, abdominal pain, tarry stool, vomiting blood, ulcerative stomatitis (inflammation of the mucous membrane of the mouth with ulceration), worsening of the intestinal disorders ulcerative colitis and Crohn's disease (see section 2: " Warnings and precautions") have been reported following use.
Less frequently, inflammation of the mucous membrane of the stomach has been observed. The risk of gastro-intestinal bleeding in particular occurring depends on the dose range and the length of use.
Should severe pains in the upper abdomen, vomiting blood, blood in the stool and/or a black coloration of the stool occur, then you must withdraw Ibustar and inform a doctor immediately.
Oedema, high blood pressure and heart failure have been reported in association with NSAID treatment. Medicines such as Ibustar may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
Common side effects (may affect up to 1 in 10 people):
•   Gastro-intestinal complaints like heartburn, stomachache, nausea, vomiting, flatulence, diarrhoea, constipation and slight gastro-intestinal blood losses that may cause a lack of red blood cells (anaemia) in exceptional cases
Uncommon side effects (may affect up to 1 in 100 people):
•   Hypersensitivity reactions with skin rashes and skin itching, as well as asthma attacks (possibly with drop in blood pressure):
A doctor is to be informed at once in this case, and Ibustar must no longer be taken.
•   Central nervous disturbances like headache, dizziness, light-headedness, agitation, irritability or tiredness
•   Visual disturbances
•   Stomach/duodenal ulcers (peptic ulcers), potentially with bleeding and perforation, inflammation of the mucous membrane of the mouth with ulceration (ulcerative stomatitis), increase of ulcerative colitis or Crohn's disease, inflammation of the mucous membrane of the stomach (gastritis)
Rare side effects (may affect up to 1 in 1,000 people):
•   Ear noises (tinnitus)
Very rare side effects (may affect up to 1 in 10,000 people):
•   Very rarely, a worsening of infection-related inflammations (e.g. development of necrotising fasciitis) coinciding with the use of certain anti-inflammatory medicines (non-steroidal anti-inflammatory drugs, to which Ibustar also belongs) has been described.
Symptoms of an inflammation of the brain lining (aseptic meningitis), like severe headache, nausea, vomiting, fever, neck stiffness or consciousness clouding have been observed. An increased risk appears to exist for patients who are already suffering from certain auto-immune disorders (systemic lupus erythematosus, mixed connective-tissue disease).
If signs of an infection (e.g. reddening, swelling, overheating, pain, fever) occur or get worse during use of Ibustar, a doctor should therefore be asked for advice without delay.
•   Disturbances to blood formation (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis)
The first signs may be fever, sore throat, superficial wounds in the mouth, influenza-like complaints, severe fatigue, nosebleeds and skin bleeding.
In these cases, the medicine is to be withdrawn immediately and a doctor visited. Self-treatment of any kind with pain- or fever-lowering medicines should not be carried out.
•   Severe general hypersensitivity reactions
They may emerge as face oedema, swelling of the tongue, internal swelling of the larynx with narrowing of the airways, breathlessness, racing heart, drop in blood pressure up to life-threatening shock.
If one of these symptoms occurs, which can happen even on first use, the immediate assistance of a doctor is required.
•   Psychotic reactions, depression
•   Pounding heart (palpitations), heart failure, heart attack ("myocardial infarction")
•   High blood pressure (arterial hypertension)
•   Inflammation of the gullet (oesophagitis) and of the pancreas (pancreatitis), formation of membranelike narrowing in the small and large intestines (intestinal, diaphragm-like strictures).
•   Liver-function disturbances, liver damage, particularly in long-term therapy, liver failure, acute inflammation of the liver (hepatitis)
On prolonged administration, the liver values should be checked regularly.
•   Severe skin reactions like skin rash with reddening and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia)
In exceptional cases, severe skin infections and soft-tissue complications may occur during a chicken-pox infection or facial erysipelas/shingles.
•   Kidney-tissue damage (papillary necrosis) and raised uric acid concentrations in the blood may also occur.
•   Increased water retention in the tissue (oedemas), particularly in patients with high blood pressure or impaired kidney function, nephrotic syndrome (water accumulation in the body [oedemas] and pronounced protein excretion in the urine), inflammatory kidney disorder (interstitial nephritis), which may be accompanied by acute kidney-function disturbance
•   Lessening of urine excretion, accumulation of water in the body (oedemas), as well as generally feeling unwell, may be a sign of a kidney disorder up to kidney failure.
Should the stated symptoms occur or get worse, then you must withdraw Ibustar and establish contact with a doctor immediately.

Not known (cannot be estimated from the available data)

•   A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).

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

5. How to store Ibustar

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 blister and folding box after "EXP". The expiry date refers to the last day of that month.

Storage conditions

This medicinal product does not require any special storage conditions.
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 Ibustar contains

The active substance is ibuprofen.
Each film-coated tablet contains 400 mg ibuprofen.
The other excipients are:
Tablet core
Maize starch, colloidal anhydrous silica, sodium starch glycolate (type A), magnesium stearate Film coating
Hypromellose, macrogol 4000, povidone K 30, titanium dioxide (E 171)

What Ibustar looks like and contents of the pack

White to almost white, oblong film-coated tablets with a break-mark on both sides, upper side with imprint "E" and "E" on both sides of the break-mark.
Blister (child-proof pack) consisting of white, rigid PVC film and either soft, paper-laminated aluminium foil or soft aluminium foil in folding box with 10, 20, 30 and 50 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Berlin-Chemie AG Glienicker Weg 125 D-12489 Berlin Germany

This leaflet was last revised in in February 2018.






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





• Medicaments images are for illustrative purposes only and may differ from the actual product.


[*1]

DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health


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