Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
colchicine
S.C Zentiva S.A
M04AC01
colchicine
1mg
tablets
(20/1x20/) in blister
Prescription
Registered
2021-11-11
_ _ _ _ _1 _ SUMMARY OF PRODUCT CHARACTERISTICS COLCHICINE HAS A NARROW THERAPEUTIC WINDOW AND THE MAXIMUM DOSES STATED MUST NOT BE EXCEEDED. DIARRHOEA, NAUSEA AND VOMITING MAY BE THE FIRST SIGNS OF A COLCHICINE OVERDOSE. PATIENTS SHOULD BE INFORMED OF THESE SIGNS OF POSSIBLE OVERDOSE. A DECREASE IN DOSAGE OR DISCONTINUATION OF TREATMENT SHOULD THEN BE CONSIDERED. 1. NAME OF THE MEDICINAL PRODUCT COLCHICINE OPOCALCIUM 1 MG, TABLET 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Colchicine ...............................................................................................................................1 mg Per tablet. Excipients with known effect: lactose, sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM A pink, cylindrical, slightly biconvex scored tablet, engraved with “018” on one side and on each side of the scored line. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute gout attack, Prophylaxis of acute gout attack in patients with chronic gout, particularly during initiation of uricosuric therapy, Other acute attacks of microcrystalline arthritis: chondrocalcinosis and hydroxyapatite deposition disease, Familial Mediterranean fever, Behcet’s disease 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ACUTE GOUT ATTACK The dose should be adjusted on the basis of the efficacy achieved and the tolerance. Colchicine is most effective when given early (preferably within the first 12 hours and up to 36 hours after the acute attack), and low doses should be used preferentially. EARLY TREATMENT (UP TO 36 HOURS) OF ACUTE GOUT ATTACKS IN PATIENTS WITHOUT RISK FACTORS FOR TOXICITY MAXIMUM DOSAGE NEVER TO BE EXCEEDED IN PATIENTS WITHOUT RISK FACTORS FOR TOXICITY Day 1 1 mg to 2 mg (i.e., 1 mg taken once or twice daily) 3 mg (i.e., 1 mg taken three times daily) Day 2 1 mg to 2 mg (i.e., 1 mg taken once or twice daily) 2 mg (i.e., 1 mg taken twice daily) Day 3 1 mg to 2 mg (i.e., 1 mg taken once or twice d Read the complete document