NOTICE
ANSM - Updated on : 17/10/2024
ATTENTION
NUROFEN 200 mg, coated tablet WHICH IS A NON-STEROIDIC ANTI-INFLAMMATORY (NSAID) MAY CAUSE Fetal death IF TAKEN FROM THE 6TH MONTH OF PREGNANCY (24 weeks of amenorrhea) EVEN AFTER A SINGLE TAKE.
Do not use if you are 6 months or more pregnant (24 weeks or more).
Before the 6th month or if you are planning a pregnancy, you should not take this medicine unless absolutely necessary, as determined by your doctor.
Product name
NUROFEN 200 mg, coated tablet
Ibuprofen
Box
Please read this leaflet carefully before taking this medicine. It contains important information for you.
You must always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after :
- 3 days in children and adolescents
- 3 days in case of fever and more than 5 days in case of pain in adults.
Keep out of the reach of children.
What does this leaflet contain?
1. What is NUROFEN 200mg, coated tablet and what is it used for?
2. What do I need to know before taking NUROFEN 200mg, coated tablet?
3. How do I take NUROFEN 200mg, coated tablet?
4. What are the possible side effects?
5. How to store NUROFEN 200mg, coated tablet
6. Package contents and other information.
1. WHAT IS NUROFEN 200 mg, coated tablet AND WHAT IS IT USED FOR?
OTHER ANALGESICS AND ANTIPYRETICS - ATC code: M0AE01/N02B
This medicine contains a non-steroidal anti-inflammatory agent: ibuprofen. It is indicated for adults and children weighing over 20 kg (approx. 6 years), for the short-term treatment of fever and/or pain such as headaches, flu-like symptoms, toothache, aches and painful periods.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING NUROFEN 200 mg, coated tablet?
Never take NUROFEN 200 mg, coated tablet if you are 24 weeks or more pregnant (6 months or more of pregnancy) (see "Pregnancy, breast-feeding and fertility" below).
During the first 5 months of pregnancy, you should not take NUROFEN 200 mg, coated tablet, unless absolutely necessary, as determined by your doctor.
If you are considering pregnancy and are taking an NSAID, talk to your health care professional.
Never take NUROFEN 200mg, coated tablet
- if you are allergic to the active substance or to any of the other components of this medicine, as listed in section 6.
- if you have a history of allergy or asthma triggered by this or a related drug, in particular other antidepressants.allergy or asthma triggered by this or a related drug, in particular other non-steroidal anti-inflammatory drugs, acetylsalicylic acid (aspirin), rhinitis, swelling or urticaria,
- If you are pregnant, from the beginning of the 6th month of pregnancy (beyond 24 weeks of amenorrhea),
- history of gastrointestinal bleeding or ulcers associated with previous NSAID therapy,
- ulcer or bleeding of the stomach or intestine in progress or recurrent,
- ongoing gastrointestinal, cerebral or other bleeding,
- severe liver disease,
- severe kidney disease,
- severe heart disease,
- Systemic lupus erythematosus,
- children under 6 years of age, who may swallow incorrectly and choke.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Warnings and precautions
Talk to your doctor or pharmacist before taking NUROFEN 200mg, coated tablet.
At high doses, in excess of 1200 mg/day, this medicine has anti-inflammatory properties and may cause the sometimes serious side-effects observed with non-steroidal anti-inflammatory drugs.
Anti-inflammatory/antalgic drugs such as ibuprofen may be associated with a slightly increased risk of heart attack or stroke, particularly when used in high doses. Do not exceed the recommended dose or duration of treatment.
Discuss your treatment with your doctor or pharmacist before taking NUROFEN 200 mg coated tablet if you :
- have heart problems, including heart failure, angina pectoris (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (poor circulation in the legs) or a heart attack.(poor circulation in the legs or feet due to narrowed or blocked arteries) or any kind of stroke (including "mini-strokes" or transient ischemic attacks (TIAs)),
- have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker.
There is a risk of renal failure in dehydrated children and adolescents.
Signs of allergic reaction to libuprofen, including difficulty breathing, swelling of the face and neck (angioedema) and chest pain, have been reported. Stop taking NUROFEN 200 mg, coated tablet immediately and contact your doctor or emergency room if you experience any of these signs.
Skin reactions
Severe skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome or hypersensitivity syndrome), acute generalized exanthematous pustulosis (AGEP), have been reported in association with libuprofen therapy. Stop using NUROFEN 200 mg, coated tablet and consult a doctor immediately if you notice any of the symptoms of these severe skin reactions, described in section 4.
Contact your doctor or pharmacist if you have an infection - see "Infections" below.
Infections
NUROFEN 200mg, coated tablet may mask signs of infection such as fever and pain. It is therefore possible that NUROFEN 200 mg, coated tablet may delay adequate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine while you have an infection and the symptoms of this infection persist or worsen, consult a doctor immediately.
If you are a woman, NUROFEN 200 mg, coated tablet may impair your fertility. Its use is not recommended in women who wish to conceive a child. Talk to your doctor or pharmacist before taking NUROFEN 200 mg, coated tablet, if you have difficulty conceiving or if you are undergoing tests on your reproductive function.
Elderly subjects are at greater risk of adverse reactions, particularly gastrointestinal bleeding, ulcers and perforations. Renal, hepatic and cardiac functions should be closely monitored. Dosage should be kept as low as possible for the shortest period necessary to relieve symptoms.
BEFORE USING THIS MEDICATION, CONSULT YOUR DOCTOR IN THE EVENT OF:
- a history of asthma associated with chronic rhinitis, chronic sinusitis or polyps in the nose. Administration of this product may trigger an asthma attack, particularly in certain patients allergic to acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs.
- coagulation disorders or anticoagulant therapy. This drug may cause serious gastrointestinal symptoms,
- digestive history (hiatal hernia, digestive hemorrhage, old stomach or duodenal ulcer),
- heart, liver or kidney disease,
- chickenpox. This drug is not recommended because of exceptional severe skin infections,
- concomitant treatment with other drugs that increase the risk of peptic ulcer or hemorrhage, e.g. oral corticosteroids, antidepressants (those of the SSRI type, i.e. Selective Serotonin Inhibitors, SSRIs, SSRIs, SSRIs, SSRIs, SSRIs, SSRIs, SSRIs, SSRIs, SSRIs, SSRIs).Selective Serotonin Reuptake Inhibitors), blood-clot-preventing drugs such as aspirin, or anticoagulants such as warfarin. If you have any of these conditions, consult your doctor before taking NUROFEN 200 mg, coated tablet.
- concomitant treatment with methotrexate at doses exceeding 20 mg per week or with pemetrexed
-DURING TREATMENT, IN THE EVENT OF:
- visual disturbances, PREVENT YOUR DOCTOR,
- gastrointestinal haemorrhage (discharge of blood by mouth or in the stools, black stools), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY,
- the appearance of skin or mucous membrane signs resembling a burn (redness with bubbles or blisters, ulcerations), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY,
- signs suggestive of allergy to this drug, in particular an asthma attack or sudden swelling of the face and neck, STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY.
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This medicine contains a non-steroidal anti-inflammatory drug:ibuprofen.
You must not take at the same time as this medicine other medicines containing non-steroidal anti-inflammatory drugs (including selective cyclooxygenase 2 inhibitors) and/or acetylsalicylic acid (aspirin). Carefully read the package inserts of any other medicines you are taking to ensure that they do not contain non-steroidal anti-inflammatory drugs and/or acetylsalicylic acid (aspirin).
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Other medicines and NUROFEN 200mg, coated tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
This medicine contains a non-steroidal anti-inflammatory drug: libuprofen.
This medicine must not be taken in combination with mifamurtide.
Always tell your doctor, dentist or pharmacist if you are taking any of the following medicines in addition to NUROFEN 200 mg, coated tablet:
- aspirin (acetylsalicylic acid) or other non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors
- corticosteroids, glucocorticoids
- lithium
- methotrexate
- certain antidepressants (selective serotonin reuptake inhibitors)
- pemetrexed
- ciclosporin, tacrolimus
- drugs used to treat pain and inflammation (e.g. acetylsalicylic acid), unless low doses have been advised by the doctor
- Cardiac glycosides such as digoxin, which are drugs used in many cardiac pathologies as their effects may be increased.
- Mifepristone (a drug used to terminate pregnancy). NUROFEN 200mg should not be used within 8-12 days of taking mifepristone, as the effect of mifepristone may be reduced.
- Zidovudine (a drug used in the treatment of AIDS), as the use of NUROFEN 200mg increases the risk of hemarthrosis and hematoma in hemophiliac patients with HIV.
- Quinolones (antibiotics), as their use may increase the risk of convulsions.
- Nicorandil,
- Cobimetinib,
- Tenofovir Disoproxil,
- Mixed adrenergic-serotonergic drugs,
- Pentoxifylline
NUROFEN 200 mg coated tablet may affect or be affected by certain other drugs. These include
o anti-coagulant drugs (i.e. those which thin the blood/prevent the formation of clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine)
o Drugs that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan).
Certain other drugs may also affect or be affected by treatment with NUROFEN 200mg coated tablet. You should therefore always ask your doctor or pharmacist for advice before using NUROFEN 200 mg Coated Tablet with other medicines.
NUROFEN 200 mg 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 are planning to become pregnant, ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
From the beginning of the 6th month (24th week of amenorrhea) until the end of pregnancy, NUROFEN 200 mg, coated tablet is contraindicated. Under NO CIRCUMSTANCES should you take this medicine during this period, as its effects on your unborn child may be serious or even fatal. In particular, toxicity to the heart, lungs and/or kidneys has been observed, even with a single dose. It can also affect you and your baby, promoting bleeding and leading to a later or longer-than-expected delivery.
Before the start of the 6th month (up to the 24th week of amenorrhea) or if you are planning a pregnancy, you should not take this medicine unless absolutely necessary. This will be determined by your doctor. In such cases, the dose should be as low as possible and the duration of treatment as short as possible.
NSAIDs, including NUROFEN 200 mg, coated tablet, can cause miscarriage and, in some cases, malformations after exposure in early pregnancy.
From 2 1/2 months of pregnancy (12 weeks of amenorrhea), NUROFEN 200 mg, coated tablet may cause kidney problems in your baby, if taken for several days, which may result in a low level of amniotic fluid in the baby (oligohydramnios).
From the beginning of the 5th month of pregnancy (20 weeks of amenorrhea), a narrowing of the blood vessels in your baby's heart (constriction of the ductus arteriosus) may be observed. If treatment lasting several days is required during the 5th month of pregnancy (between 20 and 24 weeks' gestation), your doctor may recommend additional monitoring.
If you have taken this medicine while pregnant, tell your doctor immediately, so that you can be offered appropriate monitoring if necessary.
Breast-feeding
As this drug passes into breast milk, it is not recommended to use it while breast-feeding.
Fertility
This drug, like all non-steroidal anti-inflammatory drugs (NSAIDs), may impair fertility in women, leading to difficulties in becoming pregnant, which may be reversible on discontinuation of treatment. Inform your doctor if you are planning a pregnancy or have difficulty conceiving.
Driving vehicles and using machines
In rare cases, this medicine may cause dizziness and blurred vision.
NUROFEN 200 mg coated tablet contains sucrose and sodium.
If your doctor has informed you that you are intolerant to certain sugars, contact your doctor before taking this medicine.
This medicine contains 17.34 mg sodium (main component of table salt) per tablet. This is equivalent to 0.87% of the maximum recommended daily allowance of sodium for an adult.
3. HOW DO I TAKE NUROFEN 200 mg, coated tablet?
Always take this medicine exactly as instructed in this leaflet, or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
To alleviate symptoms, the lowest effective dose should be used for the shortest possible time. If you have an infection and symptoms (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Dosage
Suitable for adults and children from 20 KG (approx. 6 years).
Painful and/or febrile conditions
In children, the usual dosage is 20 to 30 mg/kg/day in 3 doses per day (not to exceed 30 mg/kg/day).
In children weighing 20 to 30 kg (approx. 6 to 11 years): 1 tablet (200 mg), repeated if necessary after 6 hours. In all cases, do not exceed 3 tablets per day (600 mg).
Adults and children weighing over 30 kg (approx. 11-12 years): 1-2 tablets (200 mg), repeated if necessary after 6 hours. In all cases, do not exceed 6 tablets a day (1200 mg).
Elderly subjects are at greater risk of adverse effects, so use the lowest possible dose for the shortest duration necessary to relieve symptoms.
Do not exceed recommended doses or treatment duration (3 days for fever, 5 days for pain).
The maximum dosage is 6 tablets per day (1200 mg).
Method and route of administration
Take by mouth.
Swallow the tablet without chewing, with a large glass of water, preferably during meals.
Frequency of administration
Take systematically to avoid fever or pain peaks. 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 for pain
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In children and adolescents
If treatment is to be continued for more than 3 days, or if symptoms worsen, the patient is advised to consult a doctor.
In adults
If pain persists for more than 5 days or fever for more than 3 days, or if they worsen, or if any other condition develops, inform your doctor.
If you feel that the effect of NUROFEN 200 mg, coated tablet, is too strong or too weak: consult your doctor or pharmacist.
If you have taken more NUROFEN 200mg, coated tablet than you should have, or if children have taken the medicine accidentally, always contact a doctor or the nearest hospital for advice on the risk and the appropriate course of action.
Symptoms of overdose may include nausea, abdominal pain, vomiting (which may contain traces of blood), headache, ringing in the ears, confusion and unsteady eye movements. At high doses, the following symptoms have been reported: drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in the urine, low potassium levels in the blood, sensation of body cold and breathing problems.
If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.
If you forget to take NUROFEN 200 mg, coated tablet :
Do not take a double dose to make up for the single dose you forgot to take.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
The following list of side effects may occur if you are treated with ibuprofen on a short-term basis. For long-term treatment, or if your doctor prescribes a higher dose, more side effects may occur than those described below.
The following frequencies are used to assess side effects:
- Very common: affects more than 1 in 10 users
- Common: affects 1 to 10 users in 100
- Uncommon: affects 1 to 10 users in 1000
- Rare: affects 1 to 10 users in 10,000
- Very rare: affects less than 1 in 10,000 users
- Not known: Frequency cannot be estimated from available data.
If you develop any of the following side effects, or if any of them worsen, or if you notice any effects not listed here, please tell your doctor,
Blood disorders
Very rare: problems in the production of blood cells, the first signs are: Fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nasal and skin bleeding. In these cases, you should stop treatment immediately and consult a doctor. Avoid self-medication with painkillers or fever-reducing drugs (antipyretics).
Immune system problems
Uncommon: allergic reactions with itching and hives, asthma attacks and breathing difficulties. Stop taking NUROFEN and inform your doctor immediately.
Very rare: severe allergic reactions, signs may include swelling of the face, tongue and throat, shortness of breath, rapid heartbeat, low blood pressure, severe shock. If any of these symptoms occur, which can happen even with first-time use, immediate medical attention is required.
Nervous system disorders
Uncommon: headache
Very rare: aseptic meningitis
Not known: dizziness
Eye disorders
Not known: visual disturbances
Cardiac disorders
Not known: heart failure, edema, chest pain, which may be a sign of a potential severe allergic reaction called Kounis syndrome
Vascular disorders
Not known: arterial hypertension
Digestive and intestinal disorders
Uncommon: Abdominal pain, nausea and dyspepsia
Rare: diarrhea, flatulence, constipation and vomiting
Very rare: peptic ulcer, perforation, gastrointestinal haemorrhage, tarry black stools, vomiting of blood or dark particles resembling ground coffee,ulcerative stomatitis, gastritis.
Not known: aggravation of colitis and Crohn's disease.
Liver disorders
Very rare: liver damage (first signs may be skin discoloration),
Unknown: hepatitis, increased transaminases.
Skin disorders
Uncommon : various skin rashes
Very rare: reddish, target- or circular-shaped patches on the trunk, often accompanied by central blisters, desquamation of the skin, ulcers of the mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Not known :
- Infectious complication of the skin and soft tissues during chickenpox. A severe cutaneous reaction called hypersensitivity syndrome (DRESS syndrome) may occur. Symptoms of hypersensitivity include : widespread rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell).
- Widespread scaly red rash with masses under the skin and blisters mainly located in skin folds, on the trunk and upper extremities, accompanied by fever, swelling of the lymph nodes and an increase in eosinophils (a type of white blood cell).accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). If you develop these symptoms, stop using NUROFEN 200 mg, coated tablet and consult a doctor immediately. See also section 2.
- Skin sensitivity to light.
Renal disorders:
Very rare: kidney damage, papillary necrosis specifically during long-term treatment associated with increased uraemia and edema.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE NUROFEN 200 mg, coated tablet
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
No special storage precautions
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What NUROFEN 200 mg, coated tablet contains
- The active substance is:
Ibuprofen ............................................................................................................................... 200.00 mg
For one coated tablet.
Other ingredients are:
Stearic acid, croscarmellose sodium, sodium lauryl sulfate, sodium citrate, colloidal anhydrous silica, gum arabic nebulisate, talc, carmellose sodium, sucrose, macrogol 6000, titanium dioxide, black printing ink.
What NUROFEN 200 mg, coated tablet is and what it contains
This medicine takes the form of a coated tablet.
Boxes of 10, 20 or 30.
Not all presentations may be marketed.
Marketing authorization holder
RECKITT BENCKISER HEALTHCARE FRANCE
38 RUE VICTOR BASCH
CS 11018
91305 MASSY CEDEX
Marketing authorization holder
RECKITT BENCKISER HEALTHCARE FRANCE
38 RUE VICTOR BASCH
CS 11018
91305 MASSY CEDEX
Manufacturer
RB NL BRANDS B.V.
WTC SCHIPHOL AIRPORT,
SCHIPHOL BOULEVARD 207,
1118 BH SCHIPHOL,
NETHERLANDS
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.
Health education advice
"WHAT TO DO IN CASE OF FEVER":
Normal body temperature varies from one individual to another and lies between 36.5°C and 37.5°C. A rise of more than 0.8°C is considered a fever.
Adults and children over 20 kg (approx. 6 years of age): if the symptoms are too troublesome, you can take a medicine containing ibuprofen at the recommended dosage.
With this medication, fever should fall rapidly. However, if
- if other signs appear (such as a rash),
- if fever persists for more than 3 days or worsens,
- if headaches become severe, or if vomiting occurs,
CONSULT YOUR DOCTOR IMMEDIATELY.
"WHAT TO DO IN CASE OF PAIN":
- If there is no improvement after 5 days of treatment,
- If the pain recurs regularly,
- If it is accompanied by fever,
- If it wakes you up at night,
CONSULT YOUR DOCTOR IMMEDIATELY