Allopurinol 100mg Tablets

Land: Malta

Taal: Engels

Bron: Malta Medicines Authority

Werkstoffen:

ALLOPURINOL

Beschikbaar vanaf:

Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

ATC-code:

M04AA01

INN (Algemene Internationale Benaming):

ALLOPURINOL 100 mg

farmaceutische vorm:

TABLET

Samenstelling:

ALLOPURINOL 100 mg

Prescription-type:

POM

Therapeutisch gebied:

ANTIGOUT PREPARATIONS

Autorisatie-status:

Withdrawn

Autorisatie datum:

2006-08-18

Bijsluiter

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
Allopurinol Tablets contain a medicine called allopurinol. It 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 is used:
•
to reduce or prevent the formation of urate/uric acid deposition in
conditions where
your body produces too much of a substance called uric acid. These may
include gout
or some types of kidney stones or certain other types of kidney
problems or when you
are having treatment for cancer or some other conditions. In gout the
uric acid builds
up in your joints and tendons as crystals. These crystals cause an
inflammatory
reaction. The inflammation causes the skin around certain joints to
become swollen,
tender and sore when only slightly touched. You can also find you get
severe pain
when the joint is moved.
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 not su

Productkenmerken

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Allopurinol 100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Allopurinol BP 100.00mg
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 11
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 removed b