Zyloric 100 mg Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
23-12-2021
Summary of Product characteristics
(SPC)
27-08-2022
Active ingredient:
Allopurinol
Available from:
Aspen Pharma Trading Limited
ATC code:
M04AA; M04AA01
INN (International Name):
Allopurinol
Dosage:
100 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Preparations inhibiting uric acid production; allopurinol
Authorization status:
Not marketed
Authorization date:
1978-04-01
Patient Information leaflet
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
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Summary of Product characteristics
Health Products Regulatory Authority
26 August 2022
CRN00CY3M
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Health Products Regulatory Auth
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