Šalis: Tanzanija
kalba: anglų
Šaltinis: Tanzania Medicinces & Medical Devices Authority
Ibuprofen , Paracetamol
Intas Pharmaceuticals Limited, INDIA
Ibuprofen + Paracetamol
400/325
Tablets
Intas Pharmaceuticals Limited , INDIA
Physical description: White to off white, coloured, oblong shaped, biconvex uncoated tablet with scoring line on one side of the tablet; Local technical representative: Metro Pharmaceuticals Co. Limited (2698)
Registered/Compliant
2021-03-29
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Intaflam (Ibuprofen & Paracetamol Tablets) 2. QUALITATIVE & QUANTITATIVE COMPOSITION Each uncoated tablet contains: Ibuprofen BP 400.0 mg Paracetamol BP 325.0 mg For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM White to off white, colored, oblong shaped, biconvex uncoated, tablet with bisecting line on one side of the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the temporary relief of mild to moderate pain associated with migraine, headache, backache, period pain, dental pain, rheumatic and muscular pain, pain of non-serious arthritis, cold and flu symptoms, sore throat and fever. This product is especially suitable for pain which requires stronger analgesia than ibuprofen or paracetamol alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY For short term-use only. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The patient should consult a doctor if the symptoms persist or worsen or if the product is required for more than 3 days. ADULTS One tablet to be taken up to three times per day with water. Leave at least six hours between doses. If the one tablet dose does not control symptoms, a maximum of two tablets may be taken up to three times a day. Leave at least six hours between doses. Do not take more than six tablets (3000mg Paracetamol, 1200mg Ibuprofen) in any 24 hours period. To minimize side effects, it is recommended that patients take Intaflam with food. ELDERLY No special dosage modifications are required (see section 4.4). The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used for the shortest possible duration. The patient should be monitored regularly for gastrointestinal bleeding during NSAID therapy. Not for use by children under 18 years. METHOD OF ADMINISTRATION For oral administratio Perskaitykite visą dokumentą