ARTHROTEC Modified-release Tablets 50/0.2 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-03-2023
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Active ingredient:
DICLOFENAC SODIUM MISOPROSTOL
Available from:
B & S Healthcare
Dosage:
50/0.2 Milligram
Pharmaceutical form:
Modified-release Tablets
Authorization date:
2012-02-17
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Arthrotec 50 modified-release tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet consists of a gastro-resistant core containing 50 milligrams diclofenac sodium surrounded by an outer
mantle containing 200 micrograms misoprostol.
Excipient(s):
Each tablet contains 13.0 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release Tablets
Product imported from the UK:
White, round, biconvex tablets marked '1141’ and ‘Searle' on one side with four ‘A’s on the reverse.
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 table
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