国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indometacin
Waymade Healthcare Plc
M01AB01
Indometacin
25mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Indometacin Capsules BP 25 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 25 mg of indometacin For excipients, see 6.1 3 PHARMACEUTICAL FORM lndometacin capsules are presented as size 3, ivory opaque shells printed with ‘IND 25’ and company logo. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indometacin capsules are indicated for the pain and inflammation associated with the following conditions. Active stages of rheumatoid arthritis. Osteoarthritis. Ankylosing spondylitis. Degenerative joint disease of the hip. Acute musculoskeletal disorders. Low back pain. Acute gout. Inflammation, pain and oedema following orthopaedic procedures. Pain and associated symptoms of primary dysmenorrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. To be taken preferably with or after food, milk or an antacid. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Chronic conditions Adults: 25 mg two to four times daily increased if required, up to 200 mg daily. The recommended oral dose range is 50 – 200 mg daily in divided doses. Acute gouty arthritis Adults: 150 – 200 mg daily in divided doses until all signs and symptoms subside. Dysmenorrhoea Up to 75 mg daily until the symptoms subside. Paediatric dosage: Not established Elderly: 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 and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. 4.3 CONTRAINDICATIONS • Hypersensitivity to indometacin or to any of the excipients. • NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs 阅读完整的文件