Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
DICLOFENAC MISOPROSTOL
IPS Healthcare Limited
DICLOFENAC MISOPROSTOL
50/0.2 Milligram
Modified-release Tablets
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-03-29
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 50mg diclofenac sodium surrounded by an outer mantle containing 200 microgram misoprostol. Excipient: contains 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 on one side and 'Searle 1411' 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 Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Adults One tablet to be taken with food, two or three 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 50 in children has not been establish Lue koko asiakirja