Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
DICLOFENAC SODIUM
Olinka (UK) Limited
DICLOFENAC SODIUM
100 Milligram
Tablets
Withdrawn
2006-04-12
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclofenac 100 mg Prolonged Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Diclofenac Sodium 100 mg For excipients, see 6.1 3 PHARMACEUTICAL FORM Prolonged release tablet. White, circular, biconvex tablets, diameter 12.0 mm with a Greek Delta symbol embossed on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of all grades of pain and inflammation in conditions such as: (i) arthritic conditions: rheumatoid arthritis, ankylosing spondylitis, acute gout, psoriatic arthropathy. (ii) acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis. (iii) other painful conditions resulting from trauma, including fracture, low back pain, sprains, bruises, strains, dislocations, orthopaedic, dental and other minor surgery. Dysmenorrhoea and associated menorrhagia. For the symptomatic treatment of osteoarthritis. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Dosage Route of administration: oral. Adults: One tablet daily, taken whole with liquid, preferably at meal times. Elderly: NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events. The lowest effective dosage of diclofenac compatible with adequate safe clinical control should be employed. (See also Special warning and precautions, Section 4.4). Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs. Children: Not recommended. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 11/11/2005_ _CRN 2016774_ _page number: 1_ 4.3 CONTRAINDICATIONS Patients with active or suspected peptic ulceration, peptic ulcer disease or gastro-intestinal bleeding. Previous sensitivity to diclofena Прочитать полный документ