Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
IBUPROFEN
Stasisport Pharma N.V.
M01AE01
IBUPROFEN
200 Milligram
Film Coated Tablet
Oral use
Blister: 12, 16, 20, 24 and 30 film-coated tablets Bottle: 16, 100 film-coated tablets
Product not subject to medical prescription
S.C. SANTA S.A, One Pharma Industrial Pharmaceutical Company S.A.
Anti-inflammatory and antirheumatic products, nonsteroids; propionic acid derivatives.
Propionic acid derivatives
For short-term symptomatic treatment of: - Pain of mild to moderate intensity. - Dysmenorrhoea with no organic cause. - Fever in adults and adolescents.
Authorised
2015-07-24
PACKAGE LEAFLET: INFORMATION FOR THE USER MIOFEN 200 MG FILM-COATED TABLETS ibuprofen [For medicines available only on prescription:] READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions`, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours - If you get any side effects, talk to your doctor or pharmacist. It includes any possible side effects not listed in this leaflet. See section 4]. _ _ WHAT IS IN THIS LEAFLET 1. What Miofen is and what it is used for 2. What you need to know before you take Miofen 3. How to take Miofen 4. Possible side effects 5. How to store Miofen 6. Contents of the pack and other information 1. WHAT MIOFEN IS AND WHAT IT IS USED FOR Miofen belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs), which reduces fever, relieves pain and has an anti-inflammatory effect. Miofen is used for short term symptomatic treatment of mild to moderate pain such as headache, period pain, dental pain, and fever and pain in common cold. Children 6-12 years can be treated with Miofen 200 mg tablets during acute painful conditions and fever associated with common cold. [For medicines available without a prescription:] READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Miofen 200mg Film-coated Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg ibuprofen Excipient(s) with known effect: lactose monohydrate 3.09 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White coloured, capsule shaped, 13 x 6mm, biconvex, film coated tablets, plain on both sides 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For short-term symptomatic treatment of: - Pain of mild to moderate intensity. - Dysmenorrhoea with no organic cause. - Fever in adults and adolescents. Children 6–12 years (>20 kg): Acute pain and fever associated with the common cold. The indications for children apply only to the 200 mg tablets. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The treatment should start with the lowest dose anticipated to be effective, which can subsequently be adjusted, depending on the therapeutic response and any undesirable effects. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Adults and adolescents over 12 years (>40 kg) One to two 200 mg tablets in a single dose or three to four times daily, without exceeding a maximum daily dose of 6 tablets (1200 mg). An interval of at least 4-6 hours should be allowed between doses. For treatment of dysmenorrhoea, treatment is started at the first sign of menstruation problems. If in adults this product is required for more than 3 days in the case of fever or migraine headache, or for more than 4 days for pain relief, or if symptoms worsen the patient is advised to consult a doctor. Paediatric population _Acute pain and fever in association with the common cold_ _C Lees het volledige document