מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLURBIPROFEN
RB (HEALTH) MALAYSIA SDN BHD
FLURBIPROFEN
16units Units; 8units Units
Reckitt Benckiser Healthcare International Limited
STREPSILS MAX PRO HONEY & LEMON 8.75mg LOZENGE Flurbiprofen 8.75 mg 1. Name of the medicinal product Strepsils Max P ro Honey & Lemon 8.75mg Lozenge 2. Qualitative and quantitative composition Active ingredient: Flurbiprofen 8.75mg For excipients, see 6 .1 3. Pharmace utical Form Lozenge A round, pale yellow to brown lozenge with an icon intagliated on both sides of the lozenge. 4. Clinical particulars 4.1 Therapeutic indications St repsils Max Pro Honey & Lemon 8.75mg Lozenge are indicated for the sympt omatic relief of sore throat. 4.2 Posology and method of administration Adults , the elderly and children over the age of 12 years : One lozenge sucked/dissolved slowly in the mouth every 3 -6 hours as required. Maximum 5 lozenges in a 24 hour period. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The patient should consult a d octor if symptoms persist or worsen, or if the product is required for more than 3 days. It is recommended that this product shoul d be used for a maximum of three days. As with all lozenges, to avoid local irritation, Strepsils Max Pro Honey & Lemon 8.75mg Lozenges should be moved around the m outh whilst sucking. 4.3 Contraindications Hypersensitivity to flurbiprofen, aspirin, other NSAIDs, other lozenge ingredients or any o f the excipients in the product. Patients who have previously shown hypersensit ivit y react ions ( e.g. bronchospasm, asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non -st ero ida l a nt i- inflammatory drugs. Exist ing or history of peptic ulcerations/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure, renal fa ilure or hepatic failure (see section 4.4) . Last trimester of pregnancy. 4.4 Special warnings and precautions for use Undesirable effects may be minimised by using the lowest effective dose for the shortest possible duration necessary to contr קרא את המסמך השלם