In this manual :
1. WHAT IS NUROFEN 200 mg, coated tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING NUROFEN 200 mg, coated tablet
3. HOW DO I TAKE NUROFEN 200 mg, coated tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE NUROFEN 200 mg, coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS NUROFEN 200 mg, 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 over 20 kg (approximately 6 years of age) for the short-term treatment of fever and/or pain such as headaches, flu-like conditions, dental pain, aches and pains and painful periods.
2. WHAT YOU SHOULD KNOW BEFORE TAKING NUROFEN 200 mg, coated tablet
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
Never take NUROFEN 200 mg, coated tablet in the following cases:
- after 5 months of pregnancy (24 weeks of amenorrhea),
- a 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,
- active or recurrent ulcer or bleeding from the stomach or intestine,
- ongoing gastrointestinal hemorrhage, brain hemorrhage or other bleeding,
- severe liver disease,
- severe kidney disease,
- severe heart disease,
- systemic lupus erythematosus,
- children under 6 years of age because they may swallow incorrectly and choke.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special precautions with NUROFEN 200 mg, coated tablet:
At high doses, greater than 1200 mg/day, this medicine has anti-inflammatory properties and may cause the sometimes serious side effects seen with non-steroidal anti-inflammatory drugs.
Drugs such as NUROFEN 200 mg, coated tablet may 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 (for example, high blood pressure, diabetes, high cholesterol, or smoking), please talk to your doctor or pharmacist.
Special Warnings
If you are a woman, NUROFEN 200 mg coated tablets may affect your fertility. It is not recommended for use in women who wish to conceive a child. In women who have difficulty conceiving or in whom reproductive tests are being carried out, please talk to your doctor or pharmacist before taking NUROFEN 200 mg Coated Tablet.
Elderly subjects have a higher risk of adverse events, particularly gastrointestinal bleeding, ulcers and perforations. Renal, hepatic and cardiac function should be closely monitored. The dosage should be kept as low as possible for the shortest period of time necessary to relieve symptoms.
The use of this drug is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).
BEFORE USING THIS MEDICINE, CONSULT YOUR DOCTOR IN CASE OF:
- a history of asthma associated with chronic rhinitis, chronic sinusitis or polyps in the nose. The administration of this speciality may cause an asthma attack, particularly in certain subjects who are allergic to acetylsalicylic acid (aspirin) or to non-steroidal anti-inflammatory drugs(see section "Never take NUROFEN 200 mg, coated tablet in the following cases"),
- coagulation disorders, taking an anticoagulant treatment. This medicine may cause serious gastrointestinal symptoms,
- a history of digestive problems (hiatal hernia, digestive haemorrhage, ulcer of the stomach or duodenum),
- 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, talk to your doctor before taking NUROFEN 200 mg coated tablets(see "Taking or using other medicines"),
- concomitant treatment with methotrexate at doses higher than 20 mg per week or with pemetrexed(see section "Taking or using other medicines").
DURING TREATMENT, IN CASE OF:
- visual disturbances, Warn your doctor,
- gastrointestinal haemorrhage (discharge of blood from the mouth or stools, black stools), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY,
- signs on the skin or mucous membranes that resemble a burn (redness with bullae or blisters, ulcerations), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY,
- signs of allergy to this medicine, including asthma attack or sudden swelling of the face and neck(see "What are the possible side effects?"), 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 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 medications
Taking or using other medications:
PLEASE TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING OR HAVE RECENTLY TAKEN ANY OTHER MEDICINE, EVEN IF IT IS A MEDICINE OBTAINED WITHOUT A PRESCRIPTION.
SOME MEDICINES CANNOT BE USED AT THE SAME TIME, WHILE OTHER MEDICINES REQUIRE SPECIFIC CHANGES (E.G. IN DOSE).
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
- 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.
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 use of machinery
In rare cases, dizziness and blurred vision may occur when taking this medicinal product.
List of excipients with a notable effect
List of excipients with a notable effect: sucrose.
3. HOW TO TAKE NUROFEN 200 mg, 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 FROM 20 KG (approximately 6 years).
Painful and/or febrile conditions
In children, the usual dosage is 20 to 30 mg/kg/day in 3 doses per day (without exceeding 30 mg/kg/day).
In children from 20 to 30 kg (about 6 to 11 years): 1 tablet (200 mg), to be repeated if necessary after 6 hours. In all cases, do not exceed 3 tablets per day (600 mg).
In adults and children over 30 kg (about 11-12 years): 1 to 2 tablets (200 mg), to be repeated if necessary after 6 hours. In all cases, do not exceed 6 tablets per day (1200 mg).
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 6 tablets per day (1200 mg).
Mode and route of administration
Oral use.
Swallow the tablet without chewing, with a large glass of water, preferably during meals.
Frequency of administration
Systematic administration avoids peaks of fever or pain. 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 another disorder occurs, 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.
Symptoms and instructions in case of overdose
If you have taken more NUROFEN 200 mg Coated Tablets than you should have:
In case of accidental overdose or intoxication, STOP THE TREATMENT AND SEEK MEDICAL ADVICE QUICKLY.
Instructions in case of missed dose(s)
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.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, NUROFEN 200 mg Coated Tablet may have side effects, although not everyone is likely to have them.
Medicines such as NUROFEN 200 mg Coated Tablet 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,
- generalised: sudden swelling of the face and neck with breathing difficulties (angioedema).
In rare cases, gastrointestinal bleeding may occur(see "Special precautions with NUROFEN 200 mg, coated tablets"). The higher the dosage used, the more frequent it is.
In exceptional cases, headaches with nausea, vomiting and neck stiffness may occur.
Very exceptionally, bullous manifestations of the skin or mucous membranes may occur (burning sensation accompanied by redness with bullae, blisters, ulcerations).
In exceptional cases, serious skin infections have been observed with chickenpox.
In all such cases, treatment should 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 these cases, you must 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 tell your doctor or pharmacist.
5. HOW TO USE NUROFEN 200 mg, coated tablet
Keep out of the reach and sight of children.
Do not use NUROFEN 200 mg, coated tablet after the expiry date stated on the box. The expiry date refers to the last day of the month.
No special storage precautions
If necessary, warnings against certain visible signs of deterioration
Not applicable.
Medicines should not be disposed of in the sewage system or in the household waste. 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 NUROFEN 200 mg, coated tablet contain?
The active substance is:
Ibuprofen .................................................................................................................................. 200.00 mg
For one coated tablet.
The other components are:
Stearic acid, croscarmellose sodium, sodium laurilsulphate, sodium citrate, colloidal anhydrous silica, gum arabic nebulisate, talc, carmellose sodium, sucrose, macrogol 6000, titanium dioxide, black printing ink.
Pharmaceutical form and content
What is NUROFEN 200 mg, coated tablet and what does it contain?
This medicine is presented as a coated tablet.
Boxes of 10, 20 or 30.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
RECKITT BENCKISER HEALTHCARE FRANCE
15, RUE AMPERE
91748 MASSY CEDEX
Operator
RECKITT BENCKISER HEALTHCARE FRANCE
15, RUE AMPERE
91748 MASSY CEDEX
Manufacturer
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED
NOTTINGHAM SITE
THANE ROAD, NOTTINGHAM
NOTTINGHAMSHIRE, NG 90 2 DB
UNITED KINGDOM
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 of approval of this package insert was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
HEALTH ADVICE/EDUCATION
"WHAT TO DO IN CASE OF FEVER":
Normal body temperature varies from person to person 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 20 kg (about 6 years of age): If the symptoms are too severe, you can take a medicine containing ibuprofen in the indicated dosage.
With this medicine, the fever should fall quickly. However:
- if other signs appear (such as a rash),
- if the fever lasts more than 3 days or gets worse,
- if the headache becomes severe, or in case of vomiting,
CONSULT YOUR DOCTOR IMMEDIATELY.
"WHAT TO DO IN CASE OF PAIN":
- If there is no improvement after 5 days of treatment,
- If the pain returns regularly,
- If it is accompanied by fever,
- If it wakes you up at night,
CONSULT YOUR DOCTOR IMMEDIATELY.
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