This medicine contains a non-steroidal anti-inflammatory drug: ibuprofen. It is indicated for adults and children weighing more than 30 kg (approximately 11-12 years) for the short-term treatment of fever and/or pain such as headaches, flu, toothache, aches and pains, painful periods.
Suitable for adults and children weighing over 30 kg (11-12 years).
Painful and/or feverish conditions:
The usual dosage is 1 tablet of 400 mg per dose, to be repeated if necessary, without exceeding 3 tablets of 400 mg per day (i.e. 1200 mg per day).
The 400 mg tablet is reserved for pain or fever that is more intense or not relieved by a 200 mg ibuprofen tablet.
As the elderly are at increased risk of adverse effects, use the lowest possible dose for the shortest time necessary to relieve symptoms.
Do not exceed recommended doses or duration of treatment (3 days for fever, 5 days for pain).
The maximum dosage is 3 tablets per day (1200 mg).
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Mode and route of administration
Oral.
Swallow the tablet, without chewing, with a large glass of water.
The tablets should preferably be taken with a meal.
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Frequency of administration
Systematic administration avoids fluctuations in pain or fever.
They should be taken at least 6 hours apart.
Duration of treatment
The duration of use is limited to:
- 3 days in case of fever.
- 5 days in case of pain.
If the pain persists for more than 5 days or the fever for more than 3 days, or if they worsen, or if another disorder occurs, inform your doctor.
If you feel that the effect of Ibuprofen Biogaran Conseil 400mg is too strong or too weak: consult your doctor or pharmacist.
Precautions for use
If you are a woman, Ibuprofen Biogaran Conseil 400mg may affect your fertility. In women who have difficulty in conceiving or who are undergoing reproductive tests, please talk to your doctor or pharmacist before taking Ibuprofen Biogaran Conseil 400mg. Elderly patients have a higher risk of adverse reactions, especially gastrointestinal bleeding, ulcers and perforations. Renal, hepatic and cardiac function should be closely monitored. Dosage should be kept as low as possible for the shortest time necessary to relieve symptoms. Before using this medication, consult your physician if you have: A history of asthma associated with chronic rhinitis, chronic sinusitis or polyps in the nose. The administration of this speciality may lead to an asthma attack, especially in some people who are allergic to acetylsalicylic acid (aspirin) or to non-steroidal anti-inflammatory drugs. Coagulation disorders, taking an anticoagulant treatment. This drug may cause severe gastrointestinal manifestations. Digestive history (hiatal hernia, digestive hemorrhage, old stomach or duodenal ulcer). Heart, liver or kidney disease. Chicken pox. This medication is not recommended due to exceptional severe skin infections. Concomitant treatment with other drugs that increase the risk of peptic ulcer or bleeding, for example oral corticosteroids, antidepressants (those of the SSRI type, i.e. Selective Serotonin Reuptake Inhibitors), drugs that prevent blood clots such as aspirin, or anticoagulants such as warfarin If you have any of these conditions, consult your doctor before taking Ibuprofen Biogaran 400mg. Concomitant treatment with methotrexate at doses greater than 20 mg per week or with pemetrexed. During treatment, if you experience: Visual problems, tell your doctor. Gastrointestinal bleeding (blood in the mouth or stool, black stool), stop treatment and seek immediate medical attention. If any signs appear on the skin or mucous membranes that resemble a burn (redness with blisters or blisters, ulcerations), stop the treatment and contact a doctor or emergency medical service immediately. If there are any signs of allergy to this medicine, including an asthma attack or sudden swelling of the face and neck, stop the treatment and contact a doctor or emergency medical service immediately. This medicine contains a non-steroidal anti-inflammatory drug: ibuprofen. You should not take other medicines containing non-steroidal anti-inflammatory drugs (including selective cyclooxygenase 2 inhibitors) and/or acetylsalicylic acid (aspirin) with this medicine. Carefully read the package inserts of other medicines you are taking to make sure they do not contain non-steroidal anti-inflammatory drugs and/or acetylsalicylic acid (aspirin).
At high doses, above 1200 mg/day, this medication has anti-inflammatory properties and may cause sometimes serious inconveniences which are those observed with non-steroidal anti-inflammatory drugs.
Medicines such as Ibuprofen Biogaran Conseil 400mg could increase the risk of heart attack ("myocardial infarction") or stroke. The risk is greater the higher the doses used and the longer the duration of treatment.
Do not exceed the recommended doses or duration of treatment.
If you have heart problems, have had a stroke, or think you may have risk factors for these conditions (e.g. high blood pressure, diabetes, high cholesterol, or smoking), please talk to your doctor or pharmacist
Pregnancy and breastfeeding
During the first trimester of pregnancy (12 weeks of amenorrhea, i.e. 12 weeks after the first day of your last menstrual period), your doctor may prescribe this medicine if necessary.
From 2.5 to 5 months of pregnancy (12 to 24 weeks of amenorrhea), this medicine should only be used on the advice of your doctor and taken for short periods. Prolonged use of this medication is strongly discouraged.
If you are more than 5 months pregnant (more than 24 weeks of amenorrhea), you should not take this medicine under any circumstances, as its effects on your child may have serious consequences, particularly in terms of cardiopulmonary and renal health, even if you take it only once.
If you have taken this medicine when you are more than five months pregnant, please talk to your obstetrician so that you can be offered appropriate monitoring.
This medicine passes into breast milk. As a precautionary measure avoid using it while breastfeeding.
Contraindications
Never take Ibuprofen Biogaran Conseil 400mg in the following cases:
- after 5 months of pregnancy (24 weeks of amenorrhea).
- a history of allergy or asthma triggered by this or related medicines, including other non-steroidal anti-inflammatory drugs, acetylsalicylic acid (aspirin)
- history of allergy to other components of the tablet.
- history of gastrointestinal bleeding or ulcers from previous NSAID therapy.
- active or recurrent ulcer or bleeding from the stomach or intestine.
- ongoing gastrointestinal, brain or other bleeding.
- severe liver disease.
- severe kidney disease.
- severe heart disease.
- systemic lupus erythematosus.
In case of doubt, it is essential to ask your doctor or pharmacist for advice.
Undesirable effects
Like all medicines, Ibuprofen Biogaran Conseil 400mg is likely to have side effects, although not everyone is subject to them.
Medicines such as Ibuprofen Biogaran Conseil 400mg may increase the risk of heart attack (myocardial infarction) or stroke.
Allergic reactions may occur:
- skin: rash on the skin, itching, swelling, aggravation of chronic urticaria.
- respiratory: asthma attack type.
- general: sudden swelling of the face and neck (angioedema).
In some rare cases, gastrointestinal bleeding may occur. The higher the dosage used, the more frequent it is.
Headache with nausea, vomiting and neck stiffness may exceptionally occur.
In exceptional cases, severe skin infections have been observed with chickenpox.
Very exceptionally, bullous manifestations of the skin or mucous membranes (burning sensation with redness and bullae, blisters, ulcerations) may occur.
In all these cases, treatment must be stopped immediately and your doctor informed.
During treatment, the following may occur
- digestive disorders: stomach ache, vomiting, nausea, diarrhoea, constipation.
- exceptionally: dizziness, headaches, rare visual disturbances, significant decrease in urine output, kidney failure.
In all cases, you should inform your doctor.
Exceptionally, changes in the liver or blood count (decrease in white or red blood cells) have been observed, which may be serious.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please inform your doctor or pharmacist.
Composition
Active ingredients
Ibuprofen: 400 mg
For one film-coated tablet.
Pregelatinised starch, sodium carboxymethyl starch (type A), stearic acid, povidone K90, colloidal anhydrous silica.
Film coating: SEPIFILM white [hypromellose (E464), microcrystalline cellulose, macrogol 40 stearate (type I), titanium dioxide (E171)].
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