Země: Arménie
Jazyk: angličtina
Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
diclofenac (diclofenac sodium)
KRKA d.d.
M01AB05
diclofenac (diclofenac sodium)
75mg
capsules prolonged-release
(20/2x10/) in blister
Prescription
Registered
2016-02-26
1.3.1 Diclofenac sodium SPC, Labeling and Package Leaflet SmPCPIL150431_2 25.05.2020 – Updated: 16.06.2020 Page 1 of 12 1. NAME OF THE MEDICINAL PRODUCT Naklofen duo 75 mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 75 mg diclofenac sodium (25 mg as gastro-resistant pellets and 50 mg as prolonged-release pellets). Excipient: - Sucrose: 88.32 mg/capsule For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release capsule. The capsule body is white and the capsule cap is blue. The capsules are filled with white to yellow- white coloured pellets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Naklofen duo is indicated for: - rheumatoid arthritis, - osteoarthrosis, - low back pain, - migraine attacks , - 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, - control of pain and inflammation in orthopaedic, dental and other minor surgery, - pyrophosphate arthropathy and associated disorders. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment may consist of taking only one form of the drug or a combination, but the total daily dose of 150 mg has to be taken into account. ADULTS DAILY DOSAGE INITIAL TREATMENT MAINTENANCE TREATMENT Capsules (75 mg) 2 x 1 capsule 1 capsule When the symptoms are very severe (especially in the morning), the patient may, for a shorter period of time, take the whole daily dose of Naklofen duo capsules (2 capsules) at once. CONFIDENTIAL Naklofen duo prolonged-release capsules 75 mg VOL: 1; P: 13 / 42 1.3.1 Diclofenac sodium SPC, Labeling and Package Leaflet SmPCPIL150431_2 25.05.2020 – Updated: 16.06.2020 Page 2 of 12 Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to controlsymptoms (see section 4.4 Special warnings and precautions for use). _Paediatric population_ Naklofe Přečtěte si celý dokument