Colchicine Sigillata 500microgram tablets

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

colchicine

Available from:

Sigillata Limited

ATC code:

M04AC01

INN (International Name):

colchicine

Dosage:

500micrograms

Pharmaceutical form:

Tablets

Administration route:

Oral use

Units in package:

Blisters : 20 and 100 tablets.

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Watson Pharma Private Limited

Therapeutic group:

drugs for gout, with no effect on uric acid metabolism

Therapeutic indications:

Treatment of acute gout. Prophylaxis of gout attack during initiation of therapy with allopurinol and uricosuric drugs.

Authorization status:

Authorised

Authorization date:

2015-04-07

Patient Information leaflet

1 
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

_COLCHICINE SIGILLATA_ 500 MICROGRAM 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 Sigillata is and what it is used for 
2. 
What you need to know before you take Colchicine Sigillata 
3. 
How to take Colchicine Sigillata 
4. 
Possible side effects 
5. 
How to store Colchicine Sigillata 
6. 
Contents of the pack and other information 

1. 
WHAT COLCHICINE SIGILLATA IS AND WHAT IT IS USED FOR 

The active ingredient in _Colchicine Sigillata_  tablets is
colchicine. 
Colchicine is an anti-gout agent. 
Colchicine Sigillata 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 SIGILLATA 

DO NOT TAKE COLCHICINE SIGILLATA 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Colchicine Sigillata 500 microgram 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 _
Treatment of acute gout. 

Prophylaxis of gout attack during initiation of therapy with
allopurinol and 
uricosuric drugs. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 
_ _
_Adults_ 
_Treatment of acute gout attack:_ 
1 mg (2 tablets of 500 micrograms) to be taken
initially followed by 500 micrograms 
1 hour later, and then followed, as needed, after 12 hours,
by continued colchicine (up 
to 500 micrograms 3 times daily) until the acute
attack resolves_._ A total dose of 6 mg 
should not be exceeded. 
After completion of a course, another course should not be started
for at least three 
days. 

_Prophylaxis of gout attack during initiation 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_ 
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 wi