NOTICE
ANSM - Last updated: 30/01/2017
Name of the medicinal product
IBUPROFENE TEVA CONSEIL 400 mg film-coated tablet
Ibuprofen
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor, pharmacist or nurse.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
Do not use this medication for children.
What is in this leaflet?
1. What is IBUPROFENE TEVA CONSEIL 400 mg film-coated tablets and in which cases is it used?
2. What information should I take before taking IBUPROFENE TEVA CONSEIL 400 mg film-coated tablet?
3. How to take IBUPROFENE TEVA CONSEIL 400 mg film-coated tablet?
4. What are the possible side effects?
5. How to store IBUPROFENE TEVA CONSEIL 400 mg film-coated tablet?
6. Package contents and other information.
1. WHAT IS IBUPROFENE TEVA CONSEIL 400 mg film-coated tablet AND WHAT IT IS USED FOR?
This medication belongs to the class of analgesics and antipyretics.
This medicine contains a non-steroidal anti-inflammatory drug: ibuprofen. It is indicated in adults and children from 30 kg (approximately 11-12 years), in the short-term treatment of fever and / or pain such as headache, flu-like conditions, dental pain , aches and pains.
2. BEFORE YOU TAKE IBUPROFENE TEVA CONSEIL 400 mg film-coated tablet?
Do not take IBUPROFENE TEVA CONSEIL 400 mg film-coated tablets:
· after 5 months of pregnancy (24 weeks of amenorrhea),
· if you have a history of allergy or asthma triggered by taking this medication or a related drug, including other non-steroidal anti-inflammatory drugs, acetylsalicylic acid (aspirin),
· if you are allergic (hypersensitive) to Ibuprofen or any of the other ingredients of this medication mentioned in section 6.
· if you have a history of gastrointestinal bleeding or ulcers associated with previous NSAID treatments,
· ulceration or bleeding of the stomach or intestine in progress or recurrence,
· gastrointestinal haemorrhage, cerebral hemorrhage or other ongoing hemorrhage,
· severe liver disease,
· severe kidney disease,
· serious heart disease,
· systemic lupus erythematosus.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking IBUPROFENE TEVA CONSEIL 400 mg film-coated tablet .
Take special care with IBUPROFENE TEVA CONSEIL 400 mg film-coated tablet:
In high doses, greater than 1200 mg / day, this drug has anti-inflammatory properties and can cause serious disadvantages that are observed with non-steroidal anti-inflammatory drugs.
Drugs such as IBUPROFENE TEVA CONSEIL may increase the risk of heart attack ("myocardial infarction") or stroke. The higher the dose, the longer the treatment time, the greater the risk.
Do not exceed recommended dosage or treatment time.
If you have heart problems, have had a stroke, or if you think you have risk factors for this type of illness (eg high blood pressure, diabetes, high cholesterol, or please contact your doctor or pharmacist.
Special warnings
If you are a woman, IBUPROFENE TEVA CONSEIL 400 mg, film-coated tablet can alter your fertility. Its use is not recommended in women who wish to conceive a child. For women who have reproductive difficulties or who are undergoing reproductive function tests, please tell your doctor or pharmacist before taking IBUPROFENE TEVA CONSEIL 400 mg film-coated tablets.
Elderly patients have a higher risk of adverse effects, particularly for gastrointestinal haemorrhage, ulcers and perforations. Renal, hepatic and cardiac functions should be closely monitored. The dosage should be as low as possible for the shortest time needed to relieve symptoms.
BEFORE USING THIS MEDICATION, CONSULT YOUR PHYSICIAN IN CASE:
· a history of asthma associated with chronic rhinitis, chronic sinusitis or polyps in the nose. The administration of this specialty may lead to an asthma attack, especially in some people allergic to acetylsalicylic acid (aspirin) or a non-steroidal anti-inflammatory drug (see section "Do not take IBUPROFENE TEVA CONSEIL 400 mg film-coated tablet in the following cases "),
· coagulation disorders, and anticoagulant therapy. This medication may cause severe gastrointestinal symptoms,
· digestive antecedents (hiatal hernia, digestive hemorrhage, old stomach or duodenal ulcer),
· heart disease, liver or kidney disease,
· of varicella. This medication is not recommended because of exceptional severe infections of the skin,
· concomitant treatment with other drugs that increase the risk of peptic ulcer or haemorrhage, eg, oral corticosteroids, antidepressants (SSRIs, ie, Selective Serotonin Recapture Inhibitors), medicines preventing the formation of blood clots such as aspirin or anticoagulants such as warfarin. If you are in any of these conditions, talk to your doctor before taking IBUPROFENE TEVA CONSEIL 400 mg film-coated tablets (see section "Take or use other medicines"),
· concomitant therapy with methotrexate at doses greater than 20 mg per week or with pemetrexed (see section "Take or use other medicinal products").
DURING TREATMENT, IN CASE OF:
· vision problems, PREVENT YOUR DOCTOR,
· gastrointestinal haemorrhage (discharge from the mouth or stool, stool coloration in black), STOP TREATMENT AND IMMEDIATELY CONTACT AN EMERGENCY MEDICAL OR MEDICAL SERVICE,
· of appearances of cutaneous or mucosal signs that resemble a burn (redness with bubbles or blisters, ulcerations), STOP THE TREATMENT AND CONTACT IMMEDIATELY A DOCTOR OR AN EMERGENCY MEDICAL SERVICE,
· of allergy-related signs of asthma, such as an asthma attack or sudden swelling of the face and neck (see section "What are the possible side effects?"), STOP TREATMENT AND CONTACT IMMEDIATELY A MEDICAL OR MEDICAL SERVICE EMERGENCY.
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) at the same time as this medication. Read carefully the instructions for other medicines you are taking to ensure that there are no nonsteroidal anti-inflammatory drugs and / or acetylsalicylic acid (aspirin). |
Children and Youth
Not applicable.
Other medicines and IBUPROFENE TEVA CONSEIL 400 mg film-coated tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
CERTAIN DRUGS CAN NOT BE USED AT THE SAME TIME, WHILE OTHER MEDICINES REQUIRE SPECIFIC CHANGES (DOSE, FOR EXAMPLE).
Always inform your doctor, dentist or pharmacist if you are taking any of the following medicines in addition to IBUPROFENE TEVA 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,
· certain antidepressants (selective serotonin reuptake inhibitors),
· pemetrexed,
· ciclosporin, tacrolimus.
IBUPROFENE TEVA CONSEIL 400 mg, film-coated tablet with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or pharmacist before taking this medication.
ASK YOUR DOCTOR OR YOUR PHARMACIST BEFORE TAKING ALL MEDICINAL PRODUCTS.
Pregnancy
During the first trimester (12 weeks of gestation is 12 weeks after the 1st day of your last period), your doctor may, if necessary, to prescribe the drug.
For 2.5 to 5 months of pregnancy (12 to 24 weeks of amenorrhea), this medication will only be used on the advice of your doctor and in brief dosage. Prolonged use of this medication is strongly discouraged.
After 5 months of pregnancy (beyond 24 weeks of amenorrhea), you should NOT take this medication because its effects on your child can have serious consequences, especially on a cardiopulmonary level and renal, even with a single dose.
If you are taking this medication when you are more than five months pregnant, please speak to your obstetrician gynecologist for appropriate monitoring.
feeding
This drug passes into breast milk. As a precaution, it should be avoided during breastfeeding.
Sport
Not applicable.
Driving and using machines
In rare cases, taking this medicine may cause dizziness and blurred vision.
3. HOW TO TAKE IBUPROFENE TEVA CONSEIL 400 mg film-coated tablet?
Always use this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The occurrence of adverse reactions can be minimized by using the lowest possible dose for the shortest duration necessary to alleviate the symptoms.
Dosage
RESERVED FOR ADULTS AND CHILDREN FROM 30 kg (about 11-12 years).
Painful and / or febrile conditions
The usual dosage is 1 tablet (400 mg) per dose, to be renewed if necessary after 6 hours. In all cases, do not exceed 3 tablets per day (ie 1200 mg per day).
The tablet dosed at 400 mg is reserved for pain or fever more intense or not relieved by a tablet dosed with 200 mg of ibuprofen.
The elderly with an increased risk of adverse effects should use the lowest dose possible for the shortest time necessary to relieve symptoms.
Do not exceed the recommended doses or the duration of treatment (3 days in case of fever, 5 days in case of pain).
The maximum dose is 3 tablets per day (1200 mg).
Administration mode
Oral use
Swallow the tablet without chewing it, with a large glass of water.
The tablets should be taken preferably during a meal.
Frequency of Administration
Regular intakes help prevent fever or pain. They should be spaced at least 6 hours.
Duration of the treatment
The duration of use is limited to:
· 3 days in case of fever,
· 5 days in case of pain.
If the pain persists more than 5 days or fever more than 3 days, if they worsen or in case of a new disorder, inform your doctor.
If you feel that the effect of IBUPROFENE TEVA CONSEIL 400 mg film-coated tablet is too strong or too weak: talk to your doctor or pharmacist.
Use in children and adolescents
Not applicable.
If you take more IBUPROFENE TEVA CONSEIL 400 mg film-coated tablets than you should:
In case of overdose or accidental poisoning, STOP TREATMENT AND QUICKLY CONSULT A DOCTOR.
If you forget to take IBUPROFENE TEVA CONSEIL 400 mg film-coated tablet:
Do not take a double dose to make up for a missed dose.
If you stop taking IBUPROFENE TEVA CONSEIL 400 mg, film-coated tablet:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse for more information.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Drugs such as IBUPROFENE TEVA CONSEIL 400 mg, film-coated tablets may increase the risk of heart attack (myocardial infarction) or stroke.
May cause allergic reactions:
· rash: rash on the skin, itching, edema, aggravation of chronic urticaria,
· respiratory, asthma crisis,
· general: sudden swelling of the face and neck (angioedema).
In rare cases, gastrointestinal haemorrhage may occur ( see section "Warnings and Precautions for Use" ). This is all the more frequent when the dosage used is high.
Exceptionally, there may be headaches accompanied by nausea, vomiting and neck stiffness.
Very rarely, bullous manifestations of the skin or mucous membranes (burning sensation accompanied by redness with bubbles, blisters, ulcerations) may occur.
Exceptionally, severe skin infections have been observed in cases of chicken pox.
In all these cases, you should stop treatment immediately and notify your doctor .
During treatment, there may be:
· digestive disorders: stomach upset, vomiting, nausea, diarrhea, constipation,
· dizziness, headache, rare visual disturbances, significant decrease in urine, renal insufficiency.
In all these cases, you should tell your doctor .
Exceptionally, there have been changes in liver function or blood counts (decreased white blood cells or red blood cells) that may be severe.
Additional Adverse Events in Children and Adolescents
Not applicable.
Declaration of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE IBUPROFENE TEVA CONSEIL 400 mg film-coated tablet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton, the blister, the vial.
The expiry date refers to the last day of the month.
No special storage conditions.
Do not throw any into drains or household garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What IBUPROFENE TEVA CONSEIL 400 mg contains: film-coated tablet
The active substance is:
Ibuprofen ................................................. .................................................. 400.00 mg
For a film-coated tablet.
The other components are:
Core:
Microcrystalline cellulose, croscarmellose sodium, hydroxypropylcellulose, anhydrous colloidal silica, sodium lauryl sulfate, purified talc.
Coating:
OPADRY white 06B28499 (hypromellose, titanium dioxide (E171), macrogol 400).
What is IBUPROFENE TEVA CONSEIL 400 mg film-coated tablets and contents of the pack
This medication is in the form of a film-coated tablet.
Box of 10, 12 or 15 film-coated tablets
Box of 10 or 15 film-coated tablets in a vial.
Not all pack sizes may be marketed.
Marketing Authorization Holder
TEVA HEALTH
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Marketing Authorization Operator
TEVA HEALTH
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92931 PARIS LA DEFENSE CEDEX
Maker
ACTAVIS UK LTD
WHIDDON VALLEY, BARNSTAPLE
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UK
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BULGARIA
Or
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89100 SENS
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
{month YYYY}.
Other
Detailed information on this medicine is available on the ANSM website (France).
SANITARY EDUCATION COUNCILS
"WHAT TO DO IN THE EVENT OF FEVER":
The normal temperature of the body is variable from one individual to another and between 36.5 ° C and 37.5 ° C. An increase of more than 0.8 ° C is considered a fever.
In adults and children over 30 kg (approximately 11-12 years of age) : If the disorder is too troublesome, you can take this medication containing ibuprofen at the indicated dosage.
With this medication, the fever should drop rapidly. Nevertheless :
· if other signs appear (such as a rash),
· if the temperature persists for more than 3 days or if it worsens,
· if the headache becomes violent, or in case of vomiting,
CONSULT YOUR DOCTOR IMMEDIATELY.
"WHAT TO DO IN CASE OF PAIN":
· In the absence of improvement after 5 days of treatment,
· If the pain returns regularly,
· If accompanied by fever,
· If she wakes you up at night,
CONSULT YOUR DOCTOR.