COLCINE colchicine 500 microgram tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

colchicine, Quantity: 500 microgram

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: sodium starch glycollate; pregelatinised starch; magnesium stearate; microcrystalline cellulose; lactose monohydrate

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Relief of pain in acute gout. Colchicine should not be used unless NSAIDS are contraindicated, or have been used and found to lack analgesic efficacy or to have unacceptable side effects in the individual patient. Colchicine is not an analgesic and does not provide relief from other types of pain.

Product summary:

Visual Identification: Round, off white coloured biconvex, uncoated tablets embossed "C5" on one upper side and plain on the bottom face; Container Type: Bottle; Container Material: HDPE; Container Life Time: 31 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2021-03-22

Patient Information leaflet

COLCINE
Page
1
COLCINE
COLCHICINE
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
COLCINE. It does not contain
all the available information. It
does
not
take
the
place
of
talking
to
your
doctor
or
pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed the risks of you taking
against the benefits they expect
it will have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
_______________________
WHAT COLCINE IS USED
FOR
COLCINE contains colchicine
as the active ingredient.
COLCINE is used for the relief
of pain in acute attacks of gout.
It is not an analgesic and does
not provide relief from other
types of pain.
COLCINE
has
a
preventative
effect that helps to reduce the
incidence
of
acute
attacks.
It
will not reduce the amount of
uric acid in the body.
COLCINE belongs to a group of
medicines called antigout drugs.
ASK YOUR DOCTOR IF YOU HAVE
ANY
QUESTIONS
ABOUT
WHY
COLCINE
HAS
BEEN
PRESCRIBED FOR YOU.
Your
doctor
may
have
prescribed it for another reason.
This medicine is only available
with a doctor's prescription.
There is no evidence that it is
addictive.
_HOW COLCINE WORKS _
_ _
•
Colchicine
decreases
leucocyte
chemo
taxis
and
phagocytosis
and
thereby
inhibits
the
formation
and
release
of
a
chemotactic
glycoprotein
that
is
produced
during the phagocytosis of urate
crystals.
•
Colchicine
also
inhibits
urate crystal deposition, which
is enhanced by a low pH in the
tissues,
probably
by
inhibiting
oxidation
of
glucose
and
subsequent,
lactic
acid
production in leucocytes.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
COLCINE
HAS BEEN PRESCRIBED
FOR YOU.
Your
doctor
may
have
prescribed it for another reason.
This medicine is only available
with
a
doctor's
prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE
COLCINE
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE COLCINE IF YOU
HAVE AN ALLERGY TO:
�

Summary of Product characteristics

COLCINE
Page
1
AUSTRALIAN PRODUCT INFORMATION
COLCINE (COLCHICINE) TABLETS
1. NAME OF THE MEDICINE
Colchicine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
COLCINE- Each uncoated tablet contains 500 microgram of Colchicine
Excipient with known effect – contains lactose
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3. PHARMACEUTICAL FORM
Uncoated Tablets
COLCINE- Round, off white coloured biconvex, uncoated tablets embossed
“C5” on one upper side and
plain on the bottom face.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of pain in acute gout. Colchicine should not be used unless
NSAIDS are contraindicated, or have
been used and found to lack analgesic efficacy or to have unacceptable
side effects in the individual
patient.
Colchicine is not an analgesic and does not provide relief from other
types of pain.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS
1mg (2 tablets) at the first sign of the flare followed by 0.5mg (1
tablet) one hour later. Higher doses have
not been found to be more effective.
The maximum recommended dose for treatment of gout flares is 1.5 mg
over a one hour period.
Do not repeat the course within 3 days.
If gastrointestinal side effects occur, discontinue immediately.
Colchicine may be taken with or without food.
COLCINE
Page
2
CHILDREN:
The
safety
and
effectiveness
in
this
age
group
have
not
been
established.
See
SECTION
4.3
CONTRAINDICATIONS
.
ELDERLY:
The elderly, even those with normal renal and hepatic function, may be
more susceptible to cumulative
toxicity with colchicine. As the elderly are more likely to have age
related renal function impairment,
caution and careful attention to dosage is recommended.
In those elderly patients who are small and slight (less than 50kg)
and those with renal or hepatic
impairment, other treatments should be considered. If colchicine is
used in these patients a maximum
cumulative dose of 1.5mg over three days should be observed.
REDUCED HEPATIC AND RENAL FUNCTION:
A reduction in the size of individual doses, an in