In this manual :
1. WHAT IS IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet
3. HOW DO I TAKE IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
OTHER ANALGESICS AND ANTIPYRETICS
This medicine contains a non-steroidal anti-inflammatory drug: ibuprofen. It is indicated in 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-like conditions, toothache, aches and pains, painful periods.
2. WHAT YOU SHOULD KNOW BEFORE TAKING IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet
List of information needed before taking the medicine
Not applicable.
Never take IBUPROFENE BIOGARAN CONSEIL 400 mg film-coated tablets in the following cases:
- after 5 months of pregnancy (24 weeks of amenorrhea),
- history of allergy or asthma triggered by this or related drugs, 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,
- ulcer or bleeding in the stomach or intestine that has progressed or recurred,
- ongoing gastrointestinal bleeding, brain bleeding 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.
Precautions for use; special warnings
Take special precautions with IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet:
At high doses, greater than 1200 mg/day, this drug has anti-inflammatory properties and may cause sometimes serious inconveniences which are those observed with non-steroidal anti-inflammatory drugs.
Drugs such as IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet may increase the risk of heart attack ("myocardial infarction") or stroke. The higher the dose and the longer the duration of treatment, the greater the risk.
Do not exceed the recommended dose or duration of treatment.
If you have heart problems, have had a stroke, or think you may have risk factors for heart disease (e.g. high blood pressure, diabetes, high cholesterol, or smoking), please talk to your doctor or pharmacist.
Special Warnings
If you are a woman, IBUPROFENE BIOGARAN CONSEIL 400 mg film-coated tablets may impair your fertility. It is not recommended for use in women who wish to conceive a child. In women who have difficulty conceiving or are undergoing reproductive testing, please talk to your doctor or pharmacist before taking IBUPROFENE BIOGARAN CONSEIL 400 mg film-coated tablets.
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 MEDICINE, CONSULT YOUR DOCTOR IF YOU HAVE ANY QUESTIONS:
- history of asthma associated with chronic rhinitis, chronic sinusitis or polyps in the nose. Asthma attacks may occur with the use of this product, particularly in some individuals who are allergic to acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (see section "Never take IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet in the following cases"),
- of coagulation disorders, of taking an anticoagulant treatment. This medicine may cause serious gastrointestinal manifestations,
- a history of digestive problems (hiatal hernia, digestive haemorrhage, old stomach or duodenal ulcers),
- heart, liver or kidney disease,
- chickenpox. This medicine is not recommended because of exceptional serious skin infections,
- of concomitant treatment with other medicines 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), medicines that prevent the formation of blood clots such as aspirin or anticoagulants such as warfarin. If you have any of these conditions, talk to your doctor before taking IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet (see "Taking or using other medicines" section),
- of concomitant treatment with methotrexate at doses greater than 20 mg per week or with pemetrexed (see section "Taking or using other medicines").
DURING TREATMENT, IN CASE OF:
- visual disturbances, DO NOT take this medicine without consulting your doctor,
- gastrointestinal haemorrhage (discharge of blood through the mouth or in the stools, black stools), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY,
- skin or mucous membranes signs that resemble a burn (redness with blisters or blisters, ulcerations), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY,
- signs of allergy to this drug, including asthma attack or sudden swelling of the face and neck (see "What are the possible side effects?), STOP TREATMENT AND CONTACT A DOCTOR OR EMERGENCY ROOM IMMEDIATELY.
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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 medications you are taking to make sure you are not taking non-steroidal anti-inflammatory drugs and/or acetylsalicylic acid (aspirin).
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Interactions with other drugs
Taking or using other medications:
PLEASE TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING OR HAVE RECENTLY TAKEN ANY OTHER MEDICATION, EVEN IF IT IS OBTAINED WITHOUT A PRESCRIPTION.
SOME MEDICATIONS CANNOT BE USED AT THE SAME TIME, WHILE OTHER MEDICATIONS REQUIRE SPECIFIC CHANGES (E.G., DOSE).
Always tell your doctor, dentist or pharmacist if you are taking any of the following medicines in addition to IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet:
- aspirin (acetylsalicylic acid) or other non-steroidal anti-inflammatory drugs
- corticosteroids
- oral anticoagulants such as warfarin, injectable heparin, antiplatelet agents or other thrombolytics such as ticlopidine
- lithium
- methotrexate
- angiotensin-converting enzyme inhibitors, diuretics, beta-blockers and angiotensin II antagonists
- some antidepressants (selective serotonin reuptake inhibitors)
- pemetrexed
- ciclosporin, tacrolimus.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breastfeeding
ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE BEFORE TAKING ANY MEDICATION.
Pregnancy
During the first trimester of pregnancy (12 weeks of amenorrhea, i.e. 12 weeks after thefirst 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-gynecologist so that appropriate monitoring can be offered to you.
Breastfeeding
This medicine passes into breast milk. As a precautionary measure, it should not be used during breastfeeding.
Not applicable.
Effects on ability to drive and use machines
Driving and using machines
In rare cases, dizziness and blurred vision may occur when taking this medicine.
List of excipients with a known effect
Not applicable.
3. HOW TO TAKE IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet
Instructions for proper use
The occurrence of adverse reactions can be minimised by using the lowest possible dose for the shortest time necessary to relieve symptoms.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
Suitable for adults and children weighing more than 30 kg (11-12 years).
Painful and/or febrile 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 (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).
Method of administration
Take by mouth.
Swallow the tablet, without chewing, with a large glass of water.
The tablets should preferably be taken with a meal.
Frequency of administration
Systematic administration avoids fluctuations in pain or fever.
They should be taken at least 6 hours apart.
Duration of treatment
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The duration of use is limited to:
- 3 days in case of fever,
- 5 days in case of pain
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If the pain persists for more than 5 days or the fever for more than 3 days, or if they worsen, or if any other disorder occurs, inform your doctor.
If you feel that the effect of IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet, is too strong or too weak: consult your doctor or pharmacist.
Symptoms and instructions in case of overdose
If you have taken more IBUPROFENE BIOGARAN CONSEIL 400 mg film-coated tablets than you should have: in case of accidental overdose, or intoxication, STOP THE TREATMENT AND SEEK A MEDICINE QUICKLY.
Instructions in case of missed dose(s)
If you forget to take IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet:
Do not take a double dose to make up for the one you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet is likely to have side effects, although not everyone is susceptible.
Medicines such as IBUPROFENE BIOGARAN CONSEIL 400 mg film-coated tablets may increase the risk of heart attack (myocardial infarction) or stroke.
Allergic reactions may occur:
- skin: rash on the skin, itching, swelling, worsening of chronic hives,
- Respiratory: asthma attacks,
- general: sudden swelling of the face and neck (angioedema).
In rare cases, gastrointestinal bleeding (see section "Special precautions with IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet"). The higher the dosage used, the more frequent it is.
Exceptionally, headache with nausea, vomiting and neck stiffness may be observed.
In rare cases, severe skin infections have been observed with chickenpox.
Very exceptionally, bullous manifestations of the skin or mucous membranes may occur (burning sensation accompanied by redness with bullae, blisters, ulcers).
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, diarrhea, constipation,
- exceptionally dizziness, headaches, rare visual disturbances, significant decrease in urine output, kidney failure.
In all cases, you should inform your doctor.
- Changes in the liver or blood count (decrease in white blood cells or red blood cells) have been observed in exceptional cases and may be serious.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet
Keep out of the reach and sight of children.
Do not use IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablets after the expiry date stated on the box.
Store at a temperature not exceeding 30°C.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household garbage. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet contain?
The active substance is:
Ibuprofen ........................................................................................................................................ 400 mg
For one film-coated tablet.
The other ingredients are:
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)].
Pharmaceutical form and content
What is IBUPROFENE BIOGARAN CONSEIL 400 mg, film-coated tablet and what does it contain?
This medicine is presented as a film-coated tablet.
Box of 10, 12 or 15 tablets.
Not all presentations may be marketed.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Operator
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Manufacturer
ROTTENDORF PHARMA
Z.I. N°2
BATTERIE 1000
59309 VALENCIENNES CEDEX
or
DELPHARM BRETIGNY
USINE DU PETIT PARIS
91120 BRETIGNY SUR ORGE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicine is available on the Afssaps (France) website.
Information for health professionals only
Not applicable.
ADVICE / HEALTH EDUCATION
"WHAT TO DO IN CASE OF FEVER":
Normal body temperature varies from one individual to another and is between 36.5°C and 37.5°C. A rise of more than 0.8°C is considered a fever.
In adults and children over 30 kg (approx. 11-12 years): If the symptoms are too severe, you can take a medicine containing ibuprofen in the indicated dosage.
With this medicine, the fever should drop quickly. Nevertheless:
- if other signs appear (such as a rash),
- if the fever persists for more than 3 days or if it gets worse,
- if the
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