Riik: Iisrael
keel: inglise
Allikas: Ministry of Health
DICLOFENAC SODIUM
DEXCEL LTD, ISRAEL
M01AB05
TABLETS SLOW RELEASE
DICLOFENAC SODIUM 100 MG
PER OS
Required
DEXCEL LTD, ISRAEL
DICLOFENAC
DICLOFENAC
Rheumatoid arthritis, osteoarthritis, low back pain and other acute musculoskeletal disorders such as periarthritis, tendinitis, tenosynovitis, bursitis, sprains, strains and dislocation, ankylosing spondylitis and acute gout.Control of pain and inflammation in orthopedic, dental, and other minor surgery.
2021-03-31
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Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betaren 100 S.R. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Diclofenac sodium 100 mg Excipient with known effect: Each tablet contains approximately 111.5 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Slow release tablets Pink, round, biconvex, film coated tablets, with an embossment "DICL100" on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatoid arthritis, osteoarthritis, low back pain and other acute musculoskeletal disorders such as periarthritis, tendinitis, tenosynovitis, bursitis, sprains, strains and dislocation, ankylosing spondylitis and acute gout. Control of pain and inflammation in orthopedic, dental, and other minor surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION As a general recommendation, the dose should be given for the shortest possible duration. Because of their dosage strength, Betaren is not suitable for children and adolescents. The tablets should be swallowed whole with liquid, preferably with meals and must not be divided or chewed. Generally 1 tablet daily is recommended. If gastrointestinal upset occurs, the dose may be taken with food, milk or antacids. Where the symptoms are most pronounced during the night or in the morning, Betaren should preferably be taken in the evening. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active, gastric or intestinal ulcer, bleeding or perforation. History of gastrointestinal bleeding or perforation, relating to previous NSAIDs therapy. Page 2 of 11 Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Last trimester of pregnancy (see section 4.6). Hepatic failure Renal failure Established congestive heart failure (NYHA-II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease Like other no Lugege kogu dokumenti