Colchicine 500 microgram Tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Colchicine

Tersedia dari:

Renata (UK) Limited

Kode ATC:

M04AC; M04AC01

INN (Nama Internasional):

Colchicine

Dosis:

500 microgram(s)

Bentuk farmasi:

Tablet

Jenis Resep:

Product subject to prescription which may not be renewed (A)

Area terapi:

Preparations with no effect on uric acid metabolism; colchicine

Status otorisasi:

Authorised

Tanggal Otorisasi:

2017-12-15

Selebaran informasi

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 not sure whether any of the above apply to
you, talk to your doctor or pharmacist before

Karakteristik produk

Health Products Regulatory Authority
09 October 2019
CRN0094T9
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
09 October 2019
CRN0094T9
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 patie