Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
DICLOFENAC SODIUM MISOPROSTOL
LTT Pharma Limited
DICLOFENAC SODIUM MISOPROSTOL
75 Milligram
Modified-release Tablets
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-01-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arthrotec 75 modified-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet consists of a gastro-resistant core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 micrograms (0.2mg) misoprostol. Excipient(s): Each tablet contains 19.5 mg lactose monohydrate. For a full list of excipients, _see section 6.1._ 3 PHARMACEUTICAL FORM Modified-release tablet. _Product imported from the UK_ White, round, biconvex tablets marked 'SEARLE' over '1421' on one side, and four times 'A' around the circumference with '75' in the centre on the reverse side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Arthrotec 75 is indicated for patients who require the non-steroidal anti-inflammatory drug diclofenac together with misoprostol. The diclofenac component of Arthrotec 75 is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis. The misoprostol component of Arthrotec 75 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 times daily. Tablets should be swallowed whole, not chewed. Elderly/Renal, Cardiac and 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, elderly patients and patients with renal, cardiac or hepatic impairment should be closely monitored (see section 4.4 and section 4.8). Children (under 18 years) The safety and efficacy of Arthrotec 75 in children has not been established. 4.3 CONTRAINDICATIONS Arthrotec 75 is contrain Lestu allt skjalið