Allopurinol 300 mg tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Allopurinol

Prieinama:

Accord Healthcare Ireland Ltd.

ATC kodas:

M04AA; M04AA01

INN (Tarptautinis Pavadinimas):

Allopurinol

Dozė:

300 milligram(s)

Vaisto forma:

Tablet

Gydymo sritis:

Preparations inhibiting uric acid production; allopurinol

Autorizacija statusas:

Marketed

Leidimo data:

2019-07-19

Pakuotės lapelis

DE/H/5351/001-002/II/010, version 01, Jan 2024
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).
If you are not sure, check with your doctor first before taking the
medicine.
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
•
y

Prekės savybės

Health Products Regulatory Authority
19 February 2024
CRN00F4JX
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Allopurinol 300 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg Allopurinol.
Excipients with known effect:
Each 300 mg tablet contains 99 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
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;
-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 the management of recurrent mixed calcium
oxalate renal stones in the presence of hyperuricosuria,
when fluid, dietary and similar measures have failed.
Children and adolescents
-Secondary hyperuricaemia of differing origin
-Uric acid nephropathy during tr