Colchicine 500 microgram Tablets

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Colchicine

Pieejams no:

Renata Pharmaceuticals (Ireland) Limited

ATĶ kods:

M04AC; M04AC01

SNN (starptautisko nepatentēto nosaukumu):

Colchicine

Deva:

500 microgram(s)

Zāļu forma:

Tablet

Ārstniecības joma:

Preparations with no effect on uric acid metabolism; colchicine

Autorizācija statuss:

Marketed

Autorizācija datums:

2017-12-15

Lietošanas instrukcija

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
COLCHICINE 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 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.
In children, Colchicine Tablets are indicated in Familial
Mediterranean Fever for relief during attacks and to
prevent a build up of proteins happening.
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 breast feeding.

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

Produkta apraksts

Health Products Regulatory Authority
25 March 2022
CRN00CS1S
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colchicine 500 microgram Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 micrograms colchicine
Excipient(s) with known effect:
Each tablet contains 50.85 mg lactose monohydrate equivalent to 48.31
mg lactose (see section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
5.5 mm, round shallow biconvex white tablet, plain on both sides.
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
Paediatric population
Colchicine is indicated in Familial Mediterranean Fever for
prophylaxis of attacks and prevention of amyloidosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
_Treatment for acute gout attack_:
1 mg (2 tablets) to start followed by 500 micrograms (1 tablet) 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 (1 tablet) every 8 hours until
symptoms are relieved.
The course of treatment should end when symptoms are relieved or when
a total of 6 mg (12 tablets) has been taken. 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).
_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.
Health Products Regulatory Authority
25 March 2022
CRN00CS1S
Page 2 of 8
_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