APO-ALLOPURINOL allopurinol 100 mg tablets bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
06-02-2017
Summary of Product characteristics
(SPC)
06-02-2017
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
Allopurinol
Available from:
Arrow Pharma Pty Ltd
INN (International Name):
Allopurinol
Patient Information leaflet
APO-ALLOPURINOL™ TABLETS
1
APO-ALLOPURINOL™
TABLETS
_Contains the active ingredient allopurinol _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APO-
ALLOPURINOL (Allopurinol
tablets).
It does not contain all of the available
information about APO-
ALLOPURINOL tablets.
It does not replace talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child taking
APO-ALLOPURINOL against the
benefits he or she expects it will
have.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
ALLOPURINOL and is available in
tablets of two different strengths.
The active ingredient is called
allopurinol.
Allopurinol belongs to a group of
medicines called anti-uricaemic
agents and is used to reduce the
amount of uric acid in the body. Most
commonly, high levels of uric acid in
the body are related to gout.
APO-ALLOPURINOL is available
as a 100 mg and 300 mg tablet.
APO-ALLOPURINOL is used to
treat high levels of uric acid in the
blood (hyperuricaemia) associated
with gout or some other conditions.
Your doctor will identify these other
conditions if necessary, as they are
very uncommon (e.g. Lesch-Nyhan
Syndrome).
Your doctor however, may have
prescribed APO-ALLOPURINOL
for another purpose not listed above.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY APO-
ALLOPURINOL HAS BEEN
PRESCRIBED FOR YOU.
If you have any concerns, you should
discuss this with your doctor.
This medicine is only available with
a doctor’s prescription.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
Do not take APO-ALLOPURINOL if
you are allergic to:
•
Allopurinol or any of the
ingredients listed at the end of
this leaflet including lactose.
Some of the symptoms of an allergic
reaction to APO-ALL
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Summary of Product characteristics
APO-ALLOPURINOL- Product Information
Page 1 of 10
PRODUCT INFORMATION
APO-ALLOPURINOL (ALLOPURINOL) TABLETS
NAME OF THE MEDICINE
APO-ALLOPURINOL tablets contain 100 mg or 300 mg allopurinol.
DESCRIPTION
CHEMICAL STRUCTURE
CHEMICAL NAME:
1,5-dihydro-4
_H_
-pyrazolo[3,4-
_d_
]pyrimidin-4-one.
_ _
Allopurinol has the molecular formula C
5
H
4
N
4
O (
_CAS- 315-30-0)_
with a molecular weight of
136.1. Allopurinol is a white or off-white, almost odourless powder.
It is very slightly soluble
in water and in alcohol, and is practically insoluble in chloroform
and in ether. It dissolves in
dilute solutions of alkali hydroxides.
Each APO-ALLOPURINOL tablet contains the excipients povidone, maize
starch, lactose
monohydrate and magnesium stearate.
PHARMACOLOGY
ACTIONS:
Allopurinol
inhibits
xanthine
oxidase,
the
enzyme
which
catalyses
the
conversion
of
hypoxanthine to xanthine, and of xanthine to urate/uric acid.
Allopurinol decreases urate formation in two ways:
1. The inhibition of xanthine oxidase reduces the amount of
hypoxanthine and xanthine
converted to urate/uric acid.
2. This action makes more hypoxanthine and xanthine available for
reutilisation in the purine
metabolic cycle, which in turn, by a feedback mechanism, decreases
overall
_de novo_
purine
formation.
XO
XO
Hypoxanthine
→
xanthine
→
Urate/uric acid
N
N
N
N
OH
H
NH
N
N
N
O
H
APO-ALLOPURINOL- Product Information
Page 2 of 10
Since allopurinol decreases urate formation, it reduces urate/uric
acid concentrations in both
body fluids and urine. In contrast, the uricosuric agents which
increase urate/uric acid
excretion via the kidney will reduce the urate concentration in body
fluids, but increase
urate/uric acid concentration in urine. Reduction of the urate
concentrations in body fluids by
allopurinol permits mobilisation and dissolution of urate deposits
anywhere in the body, the
commonest
sites
being
those
in
the
skin,
bones,
joints
and
kidney
interstitial
tissue.
Therapeutic effects therefore include: the resolution of skin tophi
and the healing of
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