Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
diclofenac (diclofenac sodium)
Novartis Farma S.p.A.
diclofenac (diclofenac sodium)
75mg
tablets film-coated prolonged-release
Prescription
SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Voltaren ® Retard 75mg or 100mg SR tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (diclofenac sodium). Each slow release tablet contains 75mg diclofenac sodium Ph.Eur. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Slow release tablet. Pale pink, triangular,biconvex, bevel edges tablets marked “ID” on one face, and “CG” on the other. in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults and Elderly_ : Relief of all grades of pain and inflammation in a wide range of conditions, including: (i) arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, (ii) acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis. (iii) other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery. _Children_ : Voltaren ® Retard 75mg or 100mg SR tablets are not suitable for children. 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 ADULTS One tablet once or twice daily, taken whole with liquid, preferably at meal times. The recommended maximum daily dose of Voltaren ® Retard is 150mg. SPECIAL POPULATIONS ELDERLY (aged 65 years or above) Although the pharmacokinetics of Voltaren ® Retard are not impaired to any clinically relevant extent in elderly patients, nonsteroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions. In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight Прочитать полный документ