Allopurinol Teva 300 mg tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Allopurinol

Διαθέσιμο από:

Teva Pharma B.V.

Φαρμακολογική κατηγορία (ATC):

M04AA; M04AA01

INN (Διεθνής Όνομα):

Allopurinol

Δοσολογία:

300 milligram(s)

Φαρμακοτεχνική μορφή:

Tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Preparations inhibiting uric acid production; allopurinol

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2010-09-10

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALLOPURINOL TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Allopurinol Teva
3.
How to take Allopurinol Teva
4.
Possible side effects
5.
How to store Allopurinol Teva
6.
Contents of the pack and other information
1.
WHAT ALLOPURINOL TEVA IS AND WHAT IT IS USED FOR
•
Allopurinol Teva belongs to a group of medicines called enzyme
inhibitors, which act to control the
speed at which special chemical changes occur in the body.
•
Allopurinol Teva tablets are used for the long term, preventive
treatment of gout and may be used in
other conditions associated with an excess of uric acid in the body,
including kidney stones and other
types of kidney disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALLOPURINOL TEVA
DO NOT TAKE ALLOPURINOL TEVA:
•
if you are allergic to allopurinol or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING ALLOPURINOL TEVA IF:
•
you have problems with your liver and 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 if you are taking
diuretics and/or a medicine called
ACE inhibitor.
•
you are currently having an attack of gout.
•
you are of Han Chinese, Thai or Kor

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
08 August 2022
CRN00D3R2
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Allopurinol Teva 300 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg allopurinol.
Excipient(s) with known effect:
Each tablet contains lactose monohydrate, equivalent to 171 mg
lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round biconvex tablets, debossed "2K1 2K1"on one side and break
line on the other side. 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 TEVA IS INDICATED IN ADULTS, CHILDREN AND ADOLESCENTS:
Adults

All forms of hyperuricaemia not controllable by diet including
secondary hyperuricaemia of differing origin and in
clinical complications of hyperuricaemic states, particularly manifest
gout, urate nephropathy and for the
dissolution and prevention of uric acid stones

The management of recurrent mixed calcium oxalate stones in concurrent
hyperuricaemia, when fluid, dietary and
similar measures have failed.
Children and adolescents

Secondary hyperuricaemia of differing origin

Uric acid nephropathy during treatment of leukaemia

Hereditary enzyme deficiency disorders, Lesch-Nyhan syndrome (partial
or total hypoxanthin-guanin
phosphoribosyl transferase deficiency) and adenine phosophoribosyl
transferase deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For oral use.
_Adults_
2 - 10 mg/kg bodyweight/day or 100 - 200 mg daily in mild conditions,
300 - 600 mg daily in moderately severe conditions, or
700 - 900 mg daily in severe conditions. Allopurinol should be
introduced at low dosage, e.g. 100mg/day, to reduce the risk of
adverse reactions and increased only if the serum urate response is
unsatisfactory. Extra caution should be exercised if renal
function is poor (see Dosage recommendations in renal disorders).
Health Products Regul