Colchicine 500microgram Tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: myHealthbox

Aktif bileşen:

colchicine

Mevcut itibaren:

Actavis Group PTC ehf

ATC kodu:

M04AC01

INN (International Adı):

colchicine

Doz:

500micrograms

Farmasötik formu:

Tablets

Uygulama yolu:

Oral use

Paketteki üniteler:

Blisters : 20 and 100 tablets.

Reçete türü:

POM - Prescription Only Medicine

Tarafından üretildi:

Actavis Ltd

Terapötik grubu:

drugs for gout, with no effect on uric acid metabolism

Terapötik endikasyonlar:

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

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2015-04-07

Bilgilendirme broşürü

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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.
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 
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
•  

Ürün özellikleri

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 _
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 with hepatic i