Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
DICLOFENAC SODIUM MISOPROSTOL
PCO Manufacturing
50/0.2 Milligram
Modified-release Tablets
2004-03-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arthrotec 50mg Modified-Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet consists of a gastro-resistant core containing 50 mg diclofenec sodium surrounded by an outer mantle containing 200 micrograms misoprostol. Excipient: contains lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified-release tablet _Product imported from Spain and the UK:_ White, round, biconvex tablets marked ‘Searle’ and ‘1411’ on one side and four ‘A’s on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Arthrotec 50 is indicated for patients who require the non-steroidal anti-inflammatory drug diclofenac together with misoprostol. The diclofenac component of Arthrotec 50 is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis. The misoprostol component of Arthrotec 50 is indicated for patients with a special need for the prophylaxis of NSAID-induced gastric and duodenal ulceration. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS One tablet to be taken with food, two or three times daily. Tablets should be swallowed whole, not chewed. ELDERLY/RENAL IMPAIRMENT/HEPATIC IMPAIRMENT No adjustment of dosage is necessary in the elderly or in patients with hepatic impairment or mild to moderate renal impairment as pharmacokinetics are not altered to any clinically relevant extent. Nevertheless patients with renal or hepatic impairment should be closely monitored (see also Section 4.8 - Undesirable Effects). CHILDREN The safety and efficacy of Arthrotec 50 in children has not been established Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). 4.3 CONTR Pročitajte cijeli dokument