APO-ALLOPURINOL allopurinol 100 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

allopurinol, Quantity: 100 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Allopurinol

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: stearic acid; maize starch; lactose monohydrate; sodium starch glycollate type A; povidone

Administration route:

Oral

Units in package:

200

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Main clinical manifestations of urate/uric acid deposition. These are gouty arthritis, skin tophi and/or renal involvement through crystal deposition or stone formation. Such clinical manifestations may occur in: idiopathic gout; uric acid lithiasis; acute uric acid nephropathy; neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously or after cytotoxic therapy, certain enzyme disorders which lead to overproduction of urate and involve:,? hypoxanthine guanine phosphoribosyltransferase including Lesch-Nyhan syndrome, ? glucose 6-phosphatase including glycogen storage disease, ? phosphoribosylpyrophosphate synthetase, ? phosphoribosylpyrophosphate amidotransferase.,Allopurinol is indicated for the management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyl transferase.,Allopurinol is indicated for the management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.

Product summary:

Visual Identification: White to off white colored, round biconvex, uncoated tablets with 'AL' & '100' separated by breakline on one side and plain on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-02-22

Patient Information leaflet

ALLOPURINOL APOTEX
TABLETS
_Contains the active ingredient, allopurinol (al-oe-PUR-in-ol)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about allopurinol. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor or pharmacist
has weighed the risks of you taking
this medicine 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 THIS MEDICINE IS
USED FOR
Allopurinol APOTEX Tablets is used
to treat:
•
gouty arthritis or gout
•
kidney stones
•
rare conditions where high levels
of uric acid occur in the blood
(for example, Lesch-Nyhan
syndrome).
It belongs to a group of medicines
called anti-uricaemic agents.
This medicine works by reducing the
production of uric acid in the body.
High levels of uric acid may cause
gout attacks or kidney stones.
Allopurinol is used to prevent gout
attacks, not to treat them once they
occur.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
_USE IN CHILDREN_
There is not enough information to
recommend the use of this medicine
for children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
Do not take this medicine if you have
an al

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – ALLOPURINOL APOTEX
(ALLOPURINOL)
1
NAME OF THE MEDICINE
Allopurinol
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
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 allopurinol tablet contains allopurinol as the active ingredient.
In addition, each tablet contains the following inactive ingredients:
lactose monohydrate,
maize starch, povidone, sodium starch glycollate type A, sunset yellow
FCF and stearic acid.
ALLOPURINOL APOTEX 100 MG TABLETS
White to off white, colored round biconvex, uncoated tablets with
‘AL’ & ‘100’ separated by
breakline on one side and plain on other side.
ALLOPURINOL APOTEX 300 MG TABLETS
Peach colored, round, biconvex, uncoated tablets with ‘AL’ &
‘300’ separated by breakline on
one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Main clinical manifestations of urate/uric acid deposition. These are
gouty arthritis, skin tophi
and/or renal involvement through crystal deposition or stone
formation. Such clinical
manifestations may occur in: idiopathic gout; uric acid lithiasis;
acute uric acid nephropathy;
neoplastic disease and myeloproliferative disease with high cell
turnover rates, in which high
urate levels occur either spontaneously or after cytotoxic therapy,
certain enzyme disorders
which lead to overproduction of urate and involve:

hypoxanthine guanine phosphoribosyltransferase including Lesch-Nyhan
syndrome,

glucose 6-phosphatase including glycogen storage disease,

phosphoribosylpyrophosphate synthetase,

phosphoribosylpyrophosphate amidotransferase.
Allopurinol is indicated for the management of 2,8-dihydroxyadenine
(2,8-DHA) renal stones
related to deficient activity of adenine phosphoribosyl transferase.
Allopurinol is indicated for the management of recurrent mixed calciu