Colchicum-Dispert tablets coated

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

colchicine

Tersedia dari:

Pharmaselect International Beteiligungs GmbH

Kode ATC:

M04AC01

INN (Nama Internasional):

colchicine

Dosis:

0,5mg

Bentuk farmasi:

tablets coated

Unit dalam paket:

(20/1x20/) in blister

Jenis Resep:

Prescription

Status otorisasi:

Registered

Tanggal Otorisasi:

2022-09-12

Karakteristik produk

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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.
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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