SANDOZ COLCHICINE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

COLCHICINE

Dostupno od:

SANDOZ CANADA INCORPORATED

ATC koda:

M04AC01

INN (International ime):

COLCHICINE

Doziranje:

0.6MG

Farmaceutski oblik:

TABLET

Sastav:

COLCHICINE 0.6MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

ANTIGOUT AGENTS

Proizvod sažetak:

Active ingredient group (AIG) number: 0107264001; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2017-11-10

Svojstava lijeka

1
PRESCRIBING INFORMATION
PR
SANDOZ
COLCHICINE
Colchicine
Tablets, 0.6 mg, Oral
USP
Antigout preparations
Sandoz Canada Inc.
Date of Revision:
145 Jules-Léger
December 8, 2017
Boucherville,
Quebec, Canada
J4B 7K8
Submission Control No: 205056
2
SANDOZ COLCHICINE 0.6 mg per Tablet
Proper name:
colchicine
Molecular formula and molecular mass: C
22
H
25
NO
6
399.44
Structural Formula:
SUMMARY PRODUCT INFORMATION:
PRESENTATION: Tablet for oral administration
available in bottles of 100’s for pharmacy and
hospital use only.
DESCRIPTION: Yellow, round, biconvex tablet plain on one side and
scored on the other side with
the engraving “E” above and “0.6” below the score line.
NON-MEDICINAL INGREDIENTS: Colloidal Silicon Dioxide, Lactose
Monohydrate, Magnesium
Stearate, Microcrystalline Cellulose,
Pregelatinized Starch. Color composition: D&C Yellow No.
10 Aluminum Lake; FD&C Yellow No. 6 Aluminum Lake.
INDICATIONS
Sandoz COLCHICINE is indicated for
gout therapy: prophylaxis
and treatment of gout flares in
adults.
CONTRAINDICATIONS
Sandoz COLCHICINE is contraindicated in patients with:

impaired renal or hepatic function who are also receiving a strong
CYP3A4 inhibitor
(clarithromycin, etc.).
3

impaired renal or hepatic function who are also receiving a
p-glycoprotein inhibitor
(cyclosporin, etc.).

a known hypersensitivity to colchicine.

serious gastrointestinal, hepatic, renal and cardiac disease.
DOSAGE AND ADMINISTRATION
ORAL ADMINISTRATION DOSAGES:

Administer orally with water and maintain adequate fluid intake.

May be administered without regard to meals.

May need to supplement with Vitamin B12.

Avoid grapefruit juice.

Sandoz COLCHICINE is not an analgesic
medication and should not be used to treat pain
from other causes.
SANDOZ COLCHICINE 0.6 MG TABLET
USE ONLY AS PRESCRIBED BY A PHYSICIAN.
PROPHYLAXIS OF GOUT FLARES IN ADULTS:
1 tablet once or twice daily. The maximum
recommended dose for prophylaxis is 2 tablets
per 24 hours.
Elderly use: use with caution; reduce
proph