Zyloric 100mg Tablets

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

ALLOPURINOL

Disponibil de la:

Aspen Pharma Trading Limited 3016 Lake Drive City West Businees Campus Dublin 24, Ireland

Codul ATC:

M04AA01

INN (nume internaţional):

ALLOPURINOL 100 mg

Forma farmaceutică:

TABLET

Compoziție:

ALLOPURINOL 100 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

ANTIGOUT PREPARATIONS

Statutul autorizaţiei:

Authorised

Data de autorizare:

2005-11-10

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT.
ZYLORIC 100 MG AND 300 MG TABLETS
Allopurinol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
_- _
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, nurse or
pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours
-
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET
1.
What Zyloric is and what it is used for
2.
What you need to know before you take Zyloric
3.
How to take Zyloric
4.
Possible side effects
5
How to store Zyloric
6
Contents of the pack and other information
1.
WHAT ZYLORIC IS AND WHAT IT IS USED FOR
Zyloric contains the active substance allopurinol. This medicine
belongs to a group of medicines
called enzyme inhibitors, which control the speed at which certain
chemical changes occur in your
body.
Zyloric Tablets are used to treat conditions where too much uric acid
is produced by your body such
as: gout; certain types of kidney disease and kidney stones; cancer
and some enzyme disorders which
lead to the build-up of too much uric acid.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYLORIC
DO NOT TAKE ZYLORIC IF:
•
you ever had an allergy (rash, itching, shortness of breath) to
Zyloric, allopurinol or any of the
other tablet ingredients listed in section 6 of this leaflet
If you are not sure, check with your doctor first before taking the
medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Zyloric about/ if:
•
you are suffering, or have you suffered, from liver or kidney disease
•
you are taking medicines (diuretics and/or a medicine called ACE
inhibitors) for heart disease or
high blood pressure
•
you are experiencing an acute attack of gout
•
you are of Han Chinese, Afri

Caracteristicilor produsului

Page 1 of 13
1.
NAME OF THE MEDICINAL
PRODUCT
Zyloric 100 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each tablet contains 100 mg of
allopurinol.
Each tablet also contains 50 mg of the excipient lactose
monohydrate.
For the full list of excipients, see section
6.1.
3
PHARMACEUTICAL FORM
Tablet.
Round, white to off-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.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Zyloric 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.
Zyloric is indicated for the management
of 2,8-dihydroxyadenine
(2,8-DHA) renal stones
related to deficient activity of adenine
phosphoribosyltranferase.
Zyloric 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.
Page 2 of 13
4.2
POSOLOGY AND
METHOD
OF
ADMINISTRATION
Posology
_ _
_Adults _
Allopurinol should be introduced at low dosage e.g. 100 mg/day to
reduce the risk of adverse
react