Valsts: Armēnija
Valoda: angļu
Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
diclofenac (diclofenac potassium)
Novartis Saglik
M01AB05
diclofenac (diclofenac potassium)
25mg
tablets sugar-coated
(30/3x10/) in blister
Prescription
Registered
2021-02-12
SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Voltaren ® Rapid Tablets 25mg Voltaren ® Rapid Tablets 50mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25mg of diclofenac potassium Chemical name: Potassium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sugar-coated tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatoid arthritis Osteoarthrosis. Low back pain. Acute musculo-skeletal disorders and trauma such as periarthritis (especially frozen shoulder), tendinitis, tenosynovitis, bursitis, sprains, strains and dislocations; relief of pain in fractures. Ankylosing spondylitis. Acute gout. Migraine attacks. Control of pain and inflammation in orthopaedic, dental and other minor surgery. In keeping with standard therapeutic principles, the underlying disease should be treated with specific therapy as appropriate. Fever alone is not an indication. 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 Special warnings and precautions for use). For oral administration. The tablets should be swallowed whole with liquid, preferably before meals, and must not be chewed or divided. Adults The recommended daily dose is 100-150mg in two or three divided doses. For milder cases, 75-100 mg daily in two or three divided doses is usually sufficient. In migraine an initial dose of 50 mg should be taken at the first signs of an impending attack. In cases where relief 2 hours after the first dose is not sufficient, a further dose of 50 mg may be taken. If needed further doses of 50 mg may be taken at intervals of 4-6 hours, not exceeding a total dose of 150 mg per day. SPECIAL POPULATIONS Paediatric patients (below 18 years of age) For children over 14 years of age, the recommended daily dose is 50-100 mg in two or three divided doses. Izlasiet visu dokumentu