País: Armênia
Língua: inglês
Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
diclofenac (diclofenac sodium)
KRKA d.d.
diclofenac (diclofenac sodium)
100mg
tablets film-coated prolonged-release
Prescription
Summary of product characteristics / CONFIDENTIAL 52 317 1.3.1 Diclofenac sodium SPC, Labeling and Package Leaflet AM SmPCPIL041905/1 17.09.2013 – Updated: 17.09.2013 Page 1 of 6 1. NAME OF THE MEDICINAL PRODUCT Naklofen 100 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 100 mg diclofenac sodium. For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablets: round, highly biconvex, smooth, red-brown tablets. 4. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Diseases in which anti-inflammatory and/or analgesic activity is required: inflammatory rheumatic diseases: rheumatoid arthritis, seronegative spondylarthritis, juvenile arthritis, arthritides of other etiologies, degenerative rheumatism of the musculoskeletal system: arthrosis, spondylosis, crystal-induced arthritides: gouty arthritis and pseudogouty arthritis, extra-articular rheumatism: periarthritis, bursitis, myositis, tendinitis, synovitis, other inflammatory and painful states of the musculoskeletal system, when pain syndrome is present. As an analgesic, Naklofen is used in soft tissue injuries, after delivery if the mother does not breastfeed, in primary and secondary dysmenorrhea, in various dental procedures, after surgery, in renal and biliary colics. POSOLOGY AND METHOD OF ADMINISTRATION The dosage for the initial and maintenance treatment is one tablet once daily. If a daily dosage of 150 mg diclofenac is required, Naklofen prolonged-release tablets can be combined with a 50 mg Naklofen gastro-resistant tablet or a 50 mg Naklofen suppository. The tablets should be taken during or immediately after meals and swallowed whole with some liquid. The prolonged-release tablets are not suitable for use in children. CONTRAINDICATIONS Hypersensitivity to any of the ingredients of the drug, salicylates and other nonsteroidal anti- inflammatory drugs, which is manifested as bronchial asthma, urticaria and rhinitis. Active gastric and duodenal ulcer Leia o documento completo