Allopurinol 100mg tablets

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Allopurinol

Доступна з:

Teva UK Ltd

Код атс:

M04AA01

ІПН (Міжнародна Ім'я):

Allopurinol

Дозування:

100mg

Фармацевтична форма:

Oral tablet

Адміністрація маршрут:

Oral

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 10010400; GTIN: 5017007053033

інформаційний буклет

ALLOPURINOL 100 MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
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.
1. What Allopurinol is and what it is used for
2. What you need to know before you take Allopurinol
3. How to take Allopurinol
4. Possible side effects
5. How to store Allopurinol
6. Contents of the pack and other information
WHAT ALLOPURINOL IS AND WHAT IT IS USED FOR
•
Allopurinol belongs to a group of medicines called
enzyme inhibitors, which act to control the speed at
which special chemical changes occur in the body.
•
Allopurinol is used for the long term, preventative
treatment of gout and may be used in other
conditions associated with an excess of uric acid in
the body, including kidney stones and other types of
kidney disease.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ALLOPURINOL
DO NOT TAKE ALLOPURINOL IF YOU:
•
are allergic to Allopurinol or any of the other
ingredients of this medicine (listed in section 6)
•
are currently having an attack of gout or have
just had an attack of gout.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking your
medicine if you:
•
are of Han Chinese, African or Indian origin.
•
have problems with your liver or kidneys. Your
doctor may give you a lower dose or ask you to take
it less often than each day. They will also monitor
you more closely.
•
have heart problems or high blood pressure and
you take diuretics and/or a medicine called
ACE-inhibitors.
•
are currently having an attack of gout or have just
had an attack of gout.
•
have thyroid problems.
TAKE SPECIAL CARE WITH

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Allopurinol 100 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg Allopurinol.
Excipients with known effect
Each tablet contains 60 mg lactose (as monohydrate) and 1.2 mg sodium
laurilsulfate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, round, biconvex tablets, debossed “4K1 4K1” on one side and
with a breakline
on both sides.
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
Allopurinol is indicated for reducing urate/uric acid formation in
conditions where
urate/uric acid deposition has already occurred (e.g. skin tophi,
gouty arthritis, and
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: uric acid lithiasis;
idiopathic gout;
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
also indicated
for the management of 2,8-dihydroxyadenine (2,8-DHA) renal stones
related to
deficient activity of adenine phosphoribosyltransferase. Allopurinol
is also 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
Dosage should be modified by monitoring serum urate concentrations