ZYLORIC 100MG TABLETS

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

ALLOPURINOL

Inapatikana kutoka:

Aspen Medical Products Malaysia Sdn Bhd

INN (Jina la Kimataifa):

ALLOPURINOL

Vitengo katika mfuko:

100Tablet Tablets

Viwandani na:

Aspen SA Operations (Pty) Ltd

Taarifa za kipeperushi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
ZYLORIC TABLET
Allopurinol (100mg, 300mg)
WHAT IS IN THE LEAFLET
1.
What Zyloric is used for
2.
How Zyloric works
3.
Before you use Zyloric
4.
How to use Zyloric
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Zyloric
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ZYLORIC IS USED FOR
Zyloric is used to treat the
following conditions:
•
high levels of uric acid in
the blood (hyperuricemia)
associated with gout or
when you are having
treatment for cancer.
•
Kidney stones formation
or certain other types of
kidney problems.
HOW ZYLORIC WORKS
Zyloric contains Allopurinol as
the active ingredient. Allopurinol
works by reducing the amount of
uric acid in the body.
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.
BEFORE YOU USE ZYLORIC
-
_When you must not use it _
Do not take this medicine if
you have an allergy to:
•
Allopurinol
•
any of the other ingredients
listed at the end of this
leaflet
Do not take this medicine if serum
urate concentration is increased
without deposition signs of uric
acid.
Do not take this medicine after the
expiry date printed on the pack or
if the packaging is torn or shows
signs of tampering. If it has
expired or is damaged, return it to
your pharmacist for disposal.
If you are not sure whether you
should start taking this
medicine, talk to your doctor.
-
_Before you start to use it _
Tell your doctor if you have
allergies to any other medicines,
foods, preservatives or dyes.
Tell your doctor if you have or
have had any of the following
conditions:
•
Kidney disease
•
Liver disease
•
Heart problems or high
blood pressure and you are
taking diuretics and/or a
medicine called ACE-
inhibitors
•
Serious skin rashes
(Stevens-Johnson syndrome
(SJS), toxic epidermal
necrolysis (TEN),
hypersensitivity syndrome
called Drug Rash with
Eosinophilia and Systemic
Sympt

Tabia za bidhaa

1
ZYLORIC
TM
ALLOPURINOL
_To the Medical and Pharmaceutical professions. _
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Zyloric™ Tablet contains 100mg of the active ingredient
allopurinol (Ph. Eur.).
Each Zyloric™ Tablet contains 300mg of the active ingredient
allopurinol.
PHARMACEUTICAL FORM
Tablets 100mg:
Allopurinol tablets are round, white biconvex, bisected tablets,
debossed with Z1 on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide the tablet
into equal doses.
Tablets 300mg:
Allopurinol tablets are round, white biconvex, bisected tablets,
debossed with Z3 on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide the tablet
into equal doses.
CLINICAL INFORMATION
THERAPEUTIC INDICATIONS
Allopurinol is indicated for reducing urate/uric acid formation in
conditions where urate/uric
acid deposition has already occurred (e.g. gouty arthritis, skin
tophi, nephrolithiasis) or is a
predictable clinical risk (e.g. treatment of malignancy potentially
leading to acute uric acid
nephropathy).
The main clinical conditions where urate/uric acid deposition may
occur are:
•
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, for
example;
−
Hypoxanthine guanine phosphoribosyltransferase including Lesch-Nyhan
syndrome;
−
glucose-6-phosphatase including glycogen storage disease;
−
phosphoribosylpyrophosphate synthetase;
−
phosphoribosylpyrophosphate amidotransferase;
−
adenine phosphoribosyltransferase;
2
Allopurinol is indicated for the management of 2, 8-dihydroxyadenine
(2, 8-DHA) renal stones
related to deficient activity of adenine phosphoribosyltransferase.
Allopurinol is indicated for the management of recurrent mixed calcium
oxalate renal stones
in the presen