Allopurinol 300mg Tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Allopurinol

Disponibil de la:

Accord Healthcare Ireland Ltd.

Codul ATC:

M04AA; M04AA01

INN (nume internaţional):

Allopurinol

Dozare:

300 milligram(s)

Forma farmaceutică:

Tablet

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

Preparations inhibiting uric acid production; allopurinol

Statutul autorizaţiei:

Marketed

Data de autorizare:

1985-03-06

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALLOPURINOL 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 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 ALLOPURINOL IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALLOPURINOL
3.
HOW TO TAKE ALLOPURINOL
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ALLOPURINOL
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT ALLOPURINOL IS AND WHAT IT IS USED FOR
Allopurinol belongs to a group of medicines called enzyme inhibitors.
Allopurinol lowers the amount
of uric acid in the body. Allopurinol tablets are used in:

the management of gout and other conditions associated with too much
uric acid in the body, such
as kidney disease, metabolic disorders, certain skin diseases, cancer
and treatment with diuretic
(“water tablets”).

certain types of kidney stones.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALLOPURINOL
DO NOT TAKE
Allopurinol tablets:

if you are
ALLERGIC
to Allopurinol or any of the other ingredients of this medicine
(listed in section
6).

if you are currently suffering from an acute
ATTACK OF GOUT
.
If you are not sure, talk to your doctor or pharmacist before taking
Allopurinol.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Allopurinol tablets
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 currently having an attack of gout.

yo

Caracteristicilor produsului

Health Products Regulatory Authority
20 January 2022
CRN00CR3Y
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Allopurinol 300mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg Allopurinol.
Excipients with known effect - contains Lactose monohydrate 93.0mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, circular, biconvex, uncoated tablets impressed with the
identifying letters ‘AG’ and ‘C’ on either side of a central
scoreline imprinted on one face.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Allopurinol and its major metabolite, oxipurinol, act by inhibiting
the enzyme xanthine oxidase, which catalyses the end stage
of the metabolism of purines to uric acid. Allopurinol and its
metabolites are excreted by the kidney but the renal handling is
such that allopurinol has a plasma half-life of about 1 hour whereas
that of oxipurinol exceeds 18 hours. Thus therapeutic
effect may be achieved by once-a-day dosage.
1) _Prophylactic management of gout and other_ c_onditions of excess
body urate:_
Allopurinol is used to reduce excessive urate levels (serum is
theoretically saturated with urate at a concentration between
0.38-0.42mmol/l). The higher levels seen in practice may be accounted
for by: a) the formation of saturated solutions; b)
protein binding of urate. Excess body urate may be indicated by
hyperuricaemia and/or hyperuricosuria. It may lead to
disposition of urate in the tissues or it may be present with no
obvious signs or symptoms.
_The main clinical manifestations of urate disposition are gouty
arthritis, skin tophi and/or renal involvement:_ Excess body urate is
frequently of idiopathic origin but may also be found in association
with the following other conditions: neoplastic disease and
its treatment; certain enzyme disorders (especially Lesch-Nyhan
syndrome); renal failure; renal calc