Allopurinol 100mg Tablets

Pajjiż: Malta

Lingwa: Ingliż

Sors: Malta Medicines Authority

Ingredjent attiv:

ALLOPURINOL

Disponibbli minn:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

Kodiċi ATC:

M04AA01

INN (Isem Internazzjonali):

ALLOPURINOL 100 mg

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

ALLOPURINOL 100 mg

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

ANTIGOUT PREPARATIONS

L-istatus ta 'awtorizzazzjoni:

Withdrawn

Data ta 'l-awtorizzazzjoni:

2019-05-08

Fuljett ta 'informazzjoni

PAGE
2
of
8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALLOPURINOL 100 MG TABLETS
ALLOPURINOL 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 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.
Allopurinol is used to treat conditions where too much uric acid is
produced by 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 ALLOPURINOL
DO NOT TAKE ALLOPURINOL
•
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 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 experiencing an acute attack of gout
•
you are of Han Chinese, African or Indian origin
PAGE
3
of
8
•
you have thyroid problems.
Take special care with

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
Page
2
of
15
1.
NAME OF THE MEDICINAL PRODUCT
Allopurinol 100 mg Tablets
Allopurinol 300 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg Allopurinol.
Each tablet contains 300 mg Allopurinol.
Excipients with known effect:
Each 100 mg tablet contains 33 mg lactose (as monohydrate).
Each 300 mg tablet contains 99 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
FOR 100 MG TABLETS:
White to off white, round, biconvex, uncoated tablet with inscription
"AW" on one side and plain on the other side having approximate
diameter of 8.0 mm.
FOR 300 MG TABLETS:
White to off white, round, biconvex with beveled edge uncoated tablet
with inscription “AX” on one side and plain on the other side
having approximate diameter of
11.2 mm.
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;
Page
3
of
15
-
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
phosphoribos