Alopron 300 mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ALLOPURINOL

Available from:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC code:

M04AA01

INN (International Name):

ALLOPURINOL 300 mg

Pharmaceutical form:

TABLET

Composition:

ALLOPURINOL 300 mg

Prescription type:

POM

Therapeutic area:

ANTIGOUT PREPARATIONS

Authorization status:

Authorised

Authorization date:

2006-11-15

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALOPRON 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.
WHAT IS IN THIS LEAFLET
1.
What Alopron is and what it is used for
2.
What you need to know before you take Alopron
3.
How to take Alopron
4.
Possible side effects
5.
How to store Alopron
6.
Contents of the pack and other information
1.
WHAT ALOPRON IS AND WHAT IT IS USED FOR
Alopron 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.
Alopron is used:
-
to reduce or to 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 ALOPRON
DO NOT TAKE ALOPRON
-
if you are allergic (hypersensitive) to allopurinol or any of the
other ingredients of this
medicine (listed in section 6). If you are not sure, talk to your
doctor or pharmacist
before taking Alopron.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking your medicine if:
-
you are of Han Chinese, African or Indian origin.
-
you have problems wi

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Alopron 300 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg allopurinol.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White, round, normal convex, scored tablets.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into
equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alopron 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.
Alopron is indicated for management of 2,8-dihydroxyadenine (2,8-DHA)
renal stones
related to deficient activity of adenine phosphoribosyltransferase.
Alopron 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
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_Adults_
Alopron should be introduced at low dosage e.g. 100 mg/day to reduce
the risk of adverse
reactions and increased only if the serum urate response is
unsatisfac