国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibuprofen
A A H Pharmaceuticals Ltd
M01AE01
Ibuprofen
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5012252102826
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen 200mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient mg/tablet Ibuprofen 200mg Each tablet contains 13.333mg lactose monohydrate. For full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablets (Tablets) A white, pillow-shaped, film-coated, tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS P For the relief of pain of non-serious arthritic conditions and for the relief of rheumatic or muscular pain, backache, neuralgia, headache including migraine headache, dental pain, dysmenorrhoea, feverishness and the symptoms of colds and influenza. GSL For the relief of rheumatic or muscular pain, backache, neuralgia, headache including migraine headache, dental pain, dysmenorrhoea, feverishness and the symptoms of colds and influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION P and GSL: For oral administration and short-term use only. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Adults, the elderly and children over 12 years: The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days. One to two (200-400 mg) tablets to be taken up to three times a day, as required. Leave at least four hours between doses and do not take more than 6 tablets (1200mg) in any 24 hour period. Adolescents (12-18 years old): If this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. Children under 12 years: Not suitable for children under 12 years. 4.3 CONTRAINDICATIONS P and GSL Hypersensitivity to ibuprofen or any of the excipients in the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria), in response to ibuprofen, aspirin or other non-steroid 阅读完整的文件