In this manual :
1. WHAT IS NUROFEN 200 mg, orodispersible tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING NUROFEN 200 mg, orodispersible tablet
3. HOW DO I TAKE NUROFEN 200 mg, orodispersible tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE NUROFEN 200 mg, orodispersible tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS NUROFEN 200 mg, orodispersible tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
ANTI-INFLAMMATORY, ANTIRHEUMATIC, NON-STEROIDAL
This medicine contains a non-steroidal anti-inflammatory drug: ibuprofen.
It is indicated for adults and children weighing more than 40 kg (approximately 12 years), for the short-term symptomatic treatment of fever and/or pain such as headaches, dental pain and painful periods.
2. WHAT YOU SHOULD KNOW BEFORE TAKING NUROFEN 200 mg, orodispersible tablet
List of information needed before taking the medicine
Not applicable.
Never take NUROFEN 200 mg, orodispersible tablet:
- from the 7th month of pregnancy,
- history of allergy, rhinitis, urticaria or asthma triggered by the use of this medicine or a related medicine, in particular other non-steroidal anti-inflammatory drugs, aspirin, or a history of allergy to other components of the tablet,
- history of stomach or duodenal ulcer or evolving stomach or duodenal ulcer, digestive bleeding,
- severe liver disease,
- severe kidney disease,
- severe uncontrolled heart disease
IF IN DOUBT, YOU SHOULD SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST
Precautions for use; special warnings
Be careful with NUROFEN 200 mg, orodispersible tablet:
KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN.
DO NOT EXCEED THE MAXIMUM DOSE of 1200 mg/day. In fact, at these doses, this medicine can cause sometimes serious inconveniences which are those observed with anti-inflammatory drugs.
Due to the presence of aspartam, this medicine should not be used in cases of phenylketonuria (hereditary disease detected at birth).
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. Administration of this medicine may cause an asthma attack, especially in some people who are allergic to aspirin or non-steroidal anti-inflammatory drugs(Never take NUROFEN 200 mg, orodispersible tablet).
- history of digestive problems (hiatal hernia, ulcerative colitis, Crohn's disease),
- of taking an anticoagulant treatment. This drug may cause serious gastrointestinal manifestations,
- high blood pressure,
- heart, liver or kidney disease,
- of systemic lupus erythematosus.
DURING TREATMENT, IN CASE OF:
- gastrointestinal haemorrhage (discharge of blood from the mouth or stool, black stool colour),
STOP THE TREATMENT AND CONTACT A DOCTOR OR AN EMERGENCY MEDICAL SERVICE IMMEDIATELY.
- signs of allergy to this medicine, including asthma attack or angioedema(see What are the possible side effects?),
DISCONTINUE USE AND CONTACT A DOCTOR 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 and/or aspirin at the same time as this medicine.
Read the package inserts of other medications you are taking carefully to make sure you are not taking non-steroidal anti-inflammatory drugs and/or aspirin.
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Interactions with other medicines
Taking other medications
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including oral anticoagulants, other non-steroidal anti-inflammatory drugs including aspirin and its derivatives, glucocorticoids, antihypertensive drugs, diuretics, zidovudine, lithium, methotrexate, even if obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breastfeeding
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Do not take this medicine without asking your doctor or pharmacist.
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Pregnancy
During the FIRST 6 MONTHS of pregnancy, it is recommended not to use this medicine.
THIS MEDICATION SHOULD NOT BE TAKEN AFTER THE SEVENTH MONTH, as its effects on your child may have serious consequences, particularly in terms of cardio-pulmonary and renal health, even if taken only once.
Breastfeeding
This medicine is passed, at very low concentrations, into breast milk. No harmful effects are known in children, so it is not necessary to interrupt breastfeeding in the case of short-term treatment at the recommended dose for mild to moderate pain and/or fever.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect:aspartam (source of phenylalanine) (E951).
3. HOW TO TAKE NUROFEN 200 mg, orodispersible tablet
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
RESTRICTED TO ADULTS AND CHILDREN OVER 40 KG (approximately 12 years).
Dosage
1 tablet to be renewed if necessary after 4 to 6 hours. In case of more intense pain or fever, 2 tablets, to be repeated after 4 to 6 hours.
In all cases, do not exceed 6 tablets per day (1200 mg per day).
Method of administration
Oral use.
Place one tablet on the tongue, wait until it dissolves and swallow it. No water is needed. In case of stomach sensitivity it is recommended to take NUROTABS 200 mg, orodispersible tablet with food.
How to take it
Take at least 4 to 6 hours apart.
Systematic intake avoids peaks of fever or pain.
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 formore than 5 days or the fever formore than 3 days or if they worsen or if any other condition occurs, consult your doctor or pharmacist.
Symptoms and instructions in case of overdose
If you have taken more NUROFEN 200 mg orodispersible tablet than you should have: In case of accidental overdose or intoxication, STOP THE TREATMENT AND SEEK MEDICAL ATTENTION QUICKLY.
Instructions in case of missed dose(s)
If you forget to take NUROFEN 200 mg, orodispersible tablet:
Do not take a double dose to make up for the 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, orodispersible tablet is likely to have undesirable effects, although not everyone is susceptible.
Allergic reactions may occur:
- skin: rash on the skin, skin allergy, itching, swelling, worsening of chronic hives.
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