Alopur 300 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Allopurinol

Available from:

Rowex Ltd

ATC code:

M04AA; M04AA01

INN (International Name):

Allopurinol

Dosage:

300 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:

Marketed

Authorization date:

2009-04-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALOPUR 100 MG TABLETS
ALOPUR 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 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Alopur is and what it is used for
2.
What you need to know before you take Alopur
3.
How to take Alopur
4.
Possible side effects
5.
How to store Alopur
6.
Contents of the pack and other information
1.
WHAT ALOPUR IS AND WHAT IT IS USED FOR
Alopur 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.
Alopur Tablets are used to treat conditions where too much uric acid
is produced in 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 ALOPUR
DO NOT TAKE ALOPUR

if you ever had an allergy (rash, itching, shortness of breath) to
allopurinol or any of the other
ingredients of this medicine (listed in section 6).
If you are not sure, check with your doctor first before taking the
medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Alopur about/if:

you are of Han Chinese, African or Indian origin

you have problems with your liver or kidneys. Your doctor may give you
a lower dose or ask you
to take it less often than each day. They will also monitor you more
closely.

you have heart problems or high blood pressure and you take diuretics
and/or a

Summary of Product characteristics

Health Products Regulatory Authority
18 January 2022
CRN00CQV7
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alopur 300 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg of allopurinol.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White to off-white, biconvex oblong tablet with a score notch on both
sides. The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alopur 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;
Alopur is indicated for the management of 2, 8-dihydroxyadenine (2,
8-DHA) renal stones related to deficient activity of
adenine phosphoribosyltranferase.
Alopur 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
Alopur should be introduced at low dosage e.g. 100 mg/day to reduce
the risk of adverse reactions and increased only if the
serum urate response is unsatisfactory. Extra caution should be