ALLOPURINOL 300 Milligram Tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

ALLOPURINOL

Beschikbaar vanaf:

Actavis UK Limited

ATC-code:

M04AA01

INN (Algemene Internationale Benaming):

ALLOPURINOL

Dosering:

300 Milligram

farmaceutische vorm:

Tablets

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

Preparations inhibiting uric acid production

Autorisatie-status:

Authorised

Autorisatie datum:

1985-03-06

Bijsluiter

148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Allopurinol Tablets
100mg & 300mg (Ireland)
148x210 (Reel Fed)
50943200
Leaflet for Blisters
4626
R.Wrey
15/11/17
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Details
ALLOPURINOL 100 AND 300MG TABLETS PIL IRELAND
Black
Profile
BBBA1492
C.Grant
21/11/17
27/11/17
C.Grant
148x210
8pt
Actavis UK
N/A
N/A
02
Version 2
01.11.2017
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE, BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Always take this medicine exactly as described in this
leaflet or as your doctor or pharmacist has told 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.
•
You must contact a doctor if your symptoms worsen or
do not improve.
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 low

Productkenmerken

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
calculus formation; diuretic therapy and psoriasis.
2)
_Calcium renal lithiasis: