ARTHROTEC 50MG MODIFIED-RELEASE TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-03-2023
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Active ingredient:
DICLOFENAC SODIUM MISOPROSTOL
Available from:
PCO Manufacturing
Dosage:
50/0.2 Milligram
Pharmaceutical form:
Modified-release Tablets
Authorization date:
2004-03-31
Summary of Product characteristics
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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
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