Tipuric 300 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Allopurinol

Available from:

Clonmel Healthcare 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:

1983-07-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TIPURIC 100MG TABLETS
TIPURIC 300MG 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. 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 Tipuric tablets are and what they are used for
2. What you need to know before you take Tipuric tablets
3. How to take Tipuric tablets
4. Possible side effects
5. How to store Tipuric tablets
6. Contents of the pack and other information
1. WHAT TIPURIC TABLETS ARE AND WHAT THEY ARE USED FOR
Allopurinol, the active ingredient in these tablets belongs to a group
of medicines called enzyme inhibitors. It
controls the amount of uric acid in the body.
Tipuric tablets are used to prevent gout and other conditions
associated with excess uric acid in the body,
including kidney stones and certain types of kidney disease. Tipuric
tablets should not be used to treat a
sudden attack of gout.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TIPURIC TABLETS
DO NOT TAKE TIPURIC TABLETS
-
if you are allergic (hypersensitive) to allopurinol or any of the
other ingredients of Tipuric tablets (see
section 6.)
-
if you are breast-feeding
-
if you are having an attack of gout at the moment.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Tipuric tablets
-
if you suffer from a kidney or liver disorder
-
if you are taking medicines for heart disease or high blood pressure
-
if you are pregnant or planning to become pregnant
It is important to DRINK PLENTY OF WATER while you are taking these
tablets.
There is a POSSIBILITY THAT KIDNEY STONES MAY BECOME IMPACTED i

Summary of Product characteristics

Health Products Regulatory Authority
19 October 2022
CRN00D6X6
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tipuric 300 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300mg Allopurinol
Excipient(s) with known effect:
Lactose monohydrate 104.3mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, circular, biconvex tablet, 11 mm in diameter, marked with a
single breakline and the code 242 on one side with the
Clonmel logo on the reverse.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 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.
Allopurinol is indicated for the management of 2, 8-dihydroxyadenine
(2, 8-DHA) renal stones related to deficient activity of
adenine phosphoribosyltranferase.
Allopurinol is indicated for themanagement of recurrent mixed calcium
oxalate renal stones in the presence of hyperuricosuria,
when fluid, dietary and similar measures have failed.
Health Products Regulatory Authority
19 October 2022
CRN00D6X6
Page 2 of 11
4.2 POSOLOGY AND METHOD OF A