Riik: Armeenia
keel: inglise
Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
colchicine
Pharmaselect International Beteiligungs GmbH
M04AC01
colchicine
0,5mg
tablets coated
(20/1x20/) in blister
Prescription
Registered
2022-09-12
SPC_AM_COL_renewal _16_08_2022 1/12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF MEDICINAL PRODUCTS Colchicum-Dispert ® coated tablets; 0.5 mg Colchicine per tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: total alkaloids expressed in 0.5 mg colchicine (colchicinum) [0,52 - 2,42 mg Dry extract preparation of seeds from colchicum autumnale (DER: 50-150:1) [correspondent to 0.5 mg total alkaloid calculated as colchicine])] per sugar coated tablets. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dark red to pale red, round, coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of acute gout attacks and prophylaxis of gout attacks. • Familiar Mediterrian Fever • Behcet’s disease 4.2 POSOLOGY AND METHOD OF ADMINISTRATION TREATMENT OF ACUTE GOUT ATTACKS: For acute gout attacks adults take 2 coated tablets (1.0 mg colchicine) followed by 1-2 coated tablets (0.5 – 1.0 mg colchicine) 1 hour later. The maximum dose is 3-4 coated tablets (1.5 - 2.0 mg) per 24 hours. Then the low dose treatment with 1-2 coated tablets/day (0.5mg-1.0 mg colchicine) can be continued until pain abates. The above-mentioned dosage applies to adults and adolescents above the age of 16 years. PROPHYLAXIS OF GOUT ATTACKS: For prevention of further gout attacks adults take 1 tablet (0.5 mg) once or twice daily. SPC_AM_COL_renewal _16_08_2022 2/12 The maximum dose are 2 coated tablets (1 mg) daily. With the prophylaxis dose the risk of further gout attacks can be reduced within the next 3 months. Colchicine is usually preferable to NSAIDs in patients with peptic ulcer, gastrointestinal bleeding or dyspepsia or who are taking anticoagulants. Its use is indicated especially in those patients with frequent and severe attacks, and in those with coexisting medical complications. TREATMENT OF FAMILIAL MEDITERRANEAN FEVER (FMF): Adults: The recommended dosage of Colchicum-Dispert ® for FMF in adults are 2-4 coated tablets (1,0 mg - 2,0 mg) daily. The usual starti Lugege kogu dokumenti