ZYLOPRIM allopurinol 100 mg tablet bottle

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

allopurinol, Quantity: 100 mg

Tersedia dari:

Arrotex Pharmaceuticals Pty Ltd

INN (Nama Internasional):

Allopurinol

Bentuk farmasi:

Tablet

Komposisi:

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

Rute administrasi :

Oral

Unit dalam paket:

200

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

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.

Ringkasan produk:

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

Status otorisasi:

Licence status A

Tanggal Otorisasi:

2017-02-22

Selebaran informasi

ALLOPURINOL TABLETS
1
ZYLOPRIM 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
Zyloprim 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

Karakteristik produk

1
AUSTRALIAN PRODUCT INFORMATION – ZYLOPRIM
(ALLOPURINOL)
1
NAME OF THE MEDICINE
Allopurinol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each allopurinol tablet contains allopurinol as the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For a full list of excipients, see Section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
ZYLOPRIM 100 MG TABLETS:
White to off white, coloured round biconvex, uncoated tablets with
‘AL’ & ‘100’ separated by
breakline on one side and plain on other side
ZYLOPRIM 300 MG TABLETS
Peach coloured, 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 calcium
oxalate renal stones
in the presence of hyperuricosuria, when fluid, dietary and similar
measures have failed.
4.2
DOSE AND METHOD OF ADMINISTRATION
The dosage should be adjusted by monitoring serum urate concentrations
and urinary
urate/uric acid levels at appropriate intervals.
2
DOSE FREQUENCY
Allopurinol may be taken orally o