ALLOPURINOL-STR allopurinol 300mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

allopurinol, Quantity: 300 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Allopurinol

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 6 February 2003: 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 phosphoriboslytransferase including Lesch-Nyhan syndrome, glucose 6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate amidotransferase. ALLOPURINOL-STR is indicated for the management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyl transferase. ALLOPURINOL-STR is indicated for the management of recurred mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.

Product summary:

Visual Identification: White, biconvex round tablets, one side embossed with 'AP' and '300' separated by a break line and plain on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-05-03

Patient Information leaflet

ALLOSIG- Consumer Medicine Information
Page 1 of 4
ALLOSIG™
allopurinol
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ALLOSIG.
It does not contain all of the
available information about this
medicine.
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
ALLOSIG 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 ALLOSIG IS
USED FOR
The name of your medicine is
ALLOSIG 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.
ALLOSIG 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 may have prescribed
ALLOSIG for another purpose not
listed above.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
ALLOSIG HAS BEEN PRESCRIBED
FOR YOU.
This medicine is only available with
a doctor’s prescription.
BEFORE YOU TAKE IT
When you must not take it
DO NOT TAKE ALLOSIG 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 may include
urticaria and other skin rashes,
difficulty breathing, hay fever,
swelling of the face or throat or
faintness.
DO NOT TAKE THIS MEDICINE AFTER
THE EXPIRY DATE (EXP.) PRINTED
ON THE PACK.
If you take it after the expiry date
has passed, it may have no effect
at all, or worse, there may be an
entirely unexpected effect.
DO NOT

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – ALLOPURINOL-STR
(ALLOPURINOL) TABLETS
1
NAME OF THE MEDICINE
Allopurinol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALLOPURINOL-STR tablets contain 100 mg or 300 mg allopurinol.
Excipients with known effect: lactose monohydrate. For the full list
of excipients, see Section 6.1 LIST
OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ALLPURINOL-STR 100 mg tablets are white, biconvex round tablets, one
side embossed with ‘AP’ and
‘100’ separated by a break line and plain on the other side.
ALLOPURINOL-STR 300 mg tablets are white, biconvex round tablets, one
side embossed with ‘AP’
and ‘300’ separated by a break line and plain on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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.
2
ALLOPURINOL-STRALLOPURINOL-STR is indicated for the management of
2,8-dihydroxyadenine (2,8-
DHA) renal stones related to deficient activity of adenine
phosphoribosyl transferase.
ALLOPURINOL-STR 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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The dosage should be adjusted by monitoring serum urate concentrations
and urinary urate/uric
acid levels at appropriate intervals.
DOSE FRE