Allopurinol 300mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Allopurinol

Available from:

DE Pharmaceuticals

ATC code:

M04AA01

INN (International Name):

Allopurinol

Dosage:

300mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010400

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALLOPURINOL 100MG AND 300MG 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 symptoms 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 Tablets are and what are they used for
2.
What you need to know before you take Allopurinol Tablets
3.
How to take Allopurinol Tablets
4.
Possible side effects
5.
How to store Allopurinol Tablets
6.
Contents of the pack and other information
1.
WHAT ALLOPURINOL TABLETS ARE AND WHAT ARE THEY USED FOR
Allopurinol belongs to a group of medicines called enzyme inhibitors.
These medicines inhibit
the amount of uric acid production in your body.
Allopurinol works by slowing down the speed of certain chemical
reactions in your body to
lower the level of uric acid in the blood and urine.
Allopurinol Tablets are used to treat the following conditions:

Gout (increased uric acid quantity in the body). The uric acid builds
up in your joints
and tendons as crystals causing an inflammatory reaction. The
inflammation causes the
skin around certain joints to become swollen, tender and sore when
only slightly
touched. You may also get severe pain when the joint is moved.

Kidney stones formation and certain other types of kidney diseases due
to increase in the
amount of uric acid in the body

Some types of Cancer due to increase in the amount of uric acid in the
body

Enzyme disorders due to increase in the amount of uric acid in the
body
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALLOPURINOL TABLETS
DO NOT TAKE ALLOPURINOL TABLETS:

if you are

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Allopurinol 300 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Allopurinol 300mg
Excipients with known effect:
Each 300 mg tablets contains 149.6 mg of lactose monohydrate
Each 300mg tablet contains 2.6mg of Sunset Yellow FCF.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
300mg: Peach colored, approx 11mm round, biconvex, uncoated tablets
with 'AL' & '300'
separated by breakline on one side & plain on other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide the tablet into
equal doses.
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 management of 2,8-dihydroxyadenine
(2,8-DHA) renal stones related to
deficient activity of adenine phosphoribosyltransferase.
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
Allopurinol should be introduc