Allopurinol 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Allopurinol

Available from:

Milpharm Ltd

ATC code:

M04AA01

INN (International Name):

Allopurinol

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010400; GTIN: 5060035111251

Patient Information leaflet

Package leaflet: Information for the user
ALLOPURINOL TABLETS BP 100MG
(allopurinol)
PREGNANCY AND BREAST-FEEDING 3. HOW TO TAKE ALLOPURINOL TABLETS
Allopurinol and its by-products are removed by
dialysis. If dialysis is done frequently 300 to
400mg of Allopurinol may be given after each
dialysis with none in the interim.
Blood count monitoring should therefore be
performed at regular intervals.
Allopurinol is excreted in the human
breast milk. Allopurinol during
breastfeeding is not recommended.
When allopurinol is taken at the same time as
some chemotherapy medicines (e.g.
cyclophosphamide, doxorubicin, bleomycin,
procarbazine, alkyl halogenides), blood
disorders occur more frequently.
USE IN CHILDREN: (UNDER 15 YEARS)
The lowest dosage possible will be given as
recommended by your doctor.
The level and frequency of dosage should be
recommended by your doctor. The dose may
need to be decreased depending on blood uric
acid levels due to kidney damage which mean it
takes longer to excrete Allopurinol.
Allopurinol Tablets may cause
drowsiness, affect your co-
ordination, affect your vision or
make you feel dizzy. If you
experience these symptoms you
should avoid driving or operating
machinery.
DRIVING AND USING MACHINES
USE IN PATIENTS ON KIDNEY DIALYSIS:
USE IN THE ELDERLY: (OVER 65 YEARS)
This medicine contains less than 1 mmol sodium
(23 mg) per tablet, that is to say essentially
'sodium-free'.
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
The recommended dose ranges from 100 to 900
mg each day. Initially 100 to 300mg per day is
taken as a single dose which will be increased if
necessary.
ALLOPURINOL TABLET CONTAINS LACTOSE
INFORMATION ON SODIUM CONTENT
You doctor will usually start with a low dose of
allopurinol (e.g. 100 mg/day), to reduce the risk of
possible side effects. Your dose will be increased
if necessary.
If you have been told by your doctor that you have
an intolerance to some s

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Allopurinol Tablets BP 100mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg Allopurinol.
Excipient with known effect:
Lactose
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
White round tablets with convex sides, with emboss MAL 100 on one side
and
plain on reverse.
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 introduced at low dosage e.g. 100mg/day to
reduce the risk of
adverse reactions and increased only if the serum urate response is
unsatisfactory.
Extra caution should be exercised if renal function is poor (see
Patients with renal
impairmen