Colchicine Opocalcium tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

colchicine

Available from:

S.C Zentiva S.A

ATC code:

M04AC01

INN (International Name):

colchicine

Dosage:

1mg

Pharmaceutical form:

tablets

Units in package:

(20/1x20/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-11-10

Summary of Product characteristics

_ _
_ _
_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, SCORED TABLET
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Colchicine
...............................................................................................................................1
mg
Per scored 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 o