Allopurinol 300mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ALLOPURINOL

Available from:

Wockhardt UK Limited

ATC code:

M04AA01

INN (International Name):

ALLOPURINOL

Pharmaceutical form:

TABLET

Composition:

ALLOPURINOL 300 mg

Prescription type:

POM

Therapeutic area:

ANTIGOUT PREPARATIONS

Authorization status:

Authorised

Authorization date:

2006-08-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALLOPURINOL 100MG TABLETS
ALLOPURINOL 300MG TABLETS
Allopurinol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE 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 Tablets are and what they are 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 THEY ARE USED FOR
The name of your medicine is Allopurinol Tablets. Allopurinol comes in
two strengths and is
a medicine used to reduce the levels of a chemical in the blood called
uric acid. Uric acid is
associated with a number of conditions and in high levels can cause
gout, kidney disease and
kidney stones.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALLOPURINOL TABLETS
DO NOT TAKE ALLOPURINOL TABLETS:
• if you are allergic to allopurinol or any of the other ingredients
of this medicine (listed in
section 6)
• if you are suffering from an acute attack of gout and do not take
this medicine already.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE TAKING ALLOPURINOL TABLETS:
• if you suffer from kidney or liver disease. Your doctor may give
you a lower dose or ask
you to take it less often each day. They will also monitor you closely
• if you have heart problems or high blood pressure and you take
diuretics and/or medicines
called ACE-inhibitors
• if you suffer from heart failure
• if you suffer from diabetes
• if you are currently havin

Summary of Product characteristics

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Allopurinol 300mg_ _Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Allopurinol BP 300.00mg
3
PHARMACEUTICAL FORM
Oral Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GOUT PROPHYLAXIS
Allopurinol is used to treat primary or secondary hyperuricaemia,
associated with
chronic
gout,
uric
acid
nephropathy,
recurrent
uric acid
stone formation, enzyme
disorders, blood disorders, calcium oxalate renal lithiasis, renal
failure, diuretic therapy,
psoriasis and neoplastic disease and its treatment.
Allopurinol is not used to treat acute gout.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Adults:_
Initially 100mg daily as a single dose, after food, gradually
increased over 1 to 3 weeks
according to the plasma and/or urinary uric acid concentration.
The average daily dose is 200 to 300mg for mild gout and 400 to 600mg
for moderately
severe gout. Up to 300mg may be taken as a single daily dose; larger
amounts should be taken in divided doses preferably after food.
HYPERURICAEMIA ASSOCIATED WITH CANCER THERAPY: 600 to 800mg daily in
divided
doses for 2 or 3 days, starting 1 or 2 days before the cancer
treatment. Maintenance
doses are then given according to response. When given concurrently
with azothiaprine
or mercaptopurine the dose of the antineoplastic agent should be
reduced to one third to
one quarter of the usual dose. Treatment with allopurinol should
precede treatment with
cytotoxic drugs.
Page 2 of 12
DOSE IN IMPAIRED RENAL FUNCTION: amount and frequency of the dosage
may require
reduction as indicated by monitoring serum uric acid levels. As a
guide, if the creatinine
clearance is between 10 and 20ml per minute (moderate impairment), 100
to 200mg
daily should be given, if the creatinine clearance is less than
10ml/minute (severe
impairment) 100mg on alternate days, maximum 100mg daily, should be
given..
DOSE IN RENAL DIALYSIS: If frequent dialysis is required, doses should
be adjusted
accordingly as its metabolites are remov