Colchicine Tablet, film coated 0.5mg

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

COLCHICINE

Tilgjengelig fra:

Macleods Pharma UK Ltd Wynyard Park House, Wynyard Avenue, Wynyard, Billingham TS22 5TB , United Kingdom

ATC-kode:

M04AC01

INN (International Name):

COLCHICINE 500 µg

Legemiddelform:

FILM-COATED TABLET

Sammensetning:

COLCHICINE 500 µg

Resept typen:

POM

Terapeutisk område:

ANTIGOUT PREPARATIONS

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2018-06-18

Informasjon til brukeren

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COLCHICINE 500 MICROGRAM FILM-COATED TABLETS
colchicine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Colchicine tablets are and what they are used for
2.
What you need to know before you take Colchicine tablets
3.
How to take Colchicine tablets
4.
Possible side effects
5.
How to store Colchicine tablets
6.
Contents of the pack and other information
1.
WHAT COLCHICINE TABLETS ARE AND WHAT THEY ARE USED FOR
The
active
ingredient
in
Colchicine
tablets
is
colchicine.
Colchicine
is
an
anti-gout
agent.
Colchicine tablets are used to treat gout attacks in adults. They are
also used to prevent flare-ups of
gout in adults when treatment is started with other drugs such as
allopurinol, probenecid and
sulfinpyrazone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLCHICINE TABLETS
DO NOT TAKE COLCHICINE TABLETS:

If you are allergic to colchicine or any of the other ingredients of
this medicine (listed in section
6).

If you have a severe blood disorder.

If you are pregnant

If you are breastfeeding

If you are a woman of childbearing age, unless you are using effective
contraception

If you have severe kidney or liver problems

If you are undergoing haemodialysis

If you have kidney or liver problems and you are taking certain
medicines (see ‘Other medicines
and Colchicine tablets’).
If you are not sure whether any of the above apply to you, talk to
your doctor or pharmacist before
taking Colchicine tablets.
WARNIN

Preparatomtale

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Colchicine 500 microgram Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Film-coated tablet contains 500 micrograms of colchicine
Excipients with known effect: each tablet contains 59.3 mg of lactose
(see section 4.4 and 6.1).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated Tablet
Brown coloured, round shaped beveled edge, biconvex film coated
tablets debossed with “
I
1” on one
side and plain on other side (approx. diameter
6.1 mm ± 0.2 mm
).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
Treatment of acute gout.
Prophylaxis of gout attack during intiation of therapy with
allopurinol and uricosuric drugs.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults _
_Treatment of acute gout attack: _
1000 micrograms to start followed by 500 micrograms after 1 hour. No
further tablets should be taken
for 12 hours.
After 12 hours, treatment can resume if necessary with a maximum dose
of 500 micrograms every 8
hours until symptoms are relieved.
Total course of treatment should end when symptoms are relieved or
when a total of 6 mg has been
taken. No more than 6 mg should be taken as a course of treatment.
After completion of a course, another course should not be started for
at least 3 days (72 hours).
_Prophylaxis of gout attack during initaiton of therapy with
allopurinol and uricosuric drugs: _
500 micrograms twice daily.
The treatment duration should be decided after factors such as flare
frequency, gout duration and the
presence and size of tophi have been assessed.
_Patients with renal impairment _
Page 2 of 8
Use with caution in patients with mild renal impairment. For patients
with moderate renal impairment,
reduce dose or increase interval between doses. Such patients should
be carefully monitored for
adverse effects of colchicine (see also section 5.2). For patients
with severe renal impairment, see
section 4.3.
_ _
_Patients with hepatic impairment