Colchicine 500microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Colchicine

Available from:

IVAX Pharmaceuticals UK Ltd

ATC code:

M04AC01

INN (International Name):

Colchicine

Dosage:

500microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010400

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COLCHICINE 500MICROGRAM TABLETS
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.
-
The full name of this medicine is Colchicine 500microgram Tablets but
within the leaflet it will
be referred to as Colchicine Tablets.
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.
It belongs to the group anti-gout agents and is used to prevent or
treat gout attacks in adults.
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)

have a severe blood disorder

have severe kidney or liver problems
If you are not sure whether any of the above apply to you, talk to
your doctor or pharmacist before
taking Colchicine Tablets.
WARNINGS AND PRECAUTIONS
There is a slight difference between an effective dose of Colchicine
Tablets and a dose that
causes symptoms of medicine intoxication, this means that even a
little too high a dose can cause acute
signs of a medicine intoxication. If you get symptoms such as nausea
(feeling sick), vomiting (being
sick), stomach pain and diarrhoea, stop taking Colchicine Tablets

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Colchicine 500microgram Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 micrograms of colchicine.
Excipient with known effect:
One tablet contains 59 mg lactose monohydrate (see section 4.4).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
A white to off white, round, 6 mm diameter, flat tablet with bevelled
edges, debossed
with “0.5” on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
_Adults _
•
Colchicine is indicated for the treatment of acute gout when NSAIDs
are
contraindicated or are not tolerated by the patient.
•
Colchicine is indicated for the prophylaxis of gout attack during
initiation of
urate-lowering therapy when NSAIDs are contraindicated or are not
tolerated
by the patient.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Gout_
_Treatment of acute gout attack:_
2 to 3 times daily 0.5 mg, possibly preceded by an initial dose of 1
mg. Treatment
should end until the acute attack resolves, or earlier in the event of
gastrointestinal
symptoms and no improvement after 2 to 3 days. No more than 6 mg (12
tablets)
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).
If diarrhoea or vomiting occurs, Colchicine Tablets should be
discontinued
immediately as these may be the first signs of an intoxication.
_Prophylaxis of gout attack: _
0.5 – 1 mg per day (to be taken in the evening).
_Paediatric population _
_ _
Colchicine should not be used in children and adolescents.
_Specific groups _
Concomitant treatment of colchicine with several drugs, mostly
inhibitors of
cytochrome P450 3A4 (CYP3A4)/P-glycoprotein have been shown to
increase the
risk for colchicine toxicity. If a patient has received concomitant
therapy with a
moderate or potent CYP3A4 inhibitor or with a P-glycoprotein
inhibitor, the
maximum recommended dosage of oral colchicine should be reduced and
sho