Allopurinol 300mg tablets

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Allopurinol

Доступна с:

Teva UK Ltd

код АТС:

M04AA01

ИНН (Международная Имя):

Allopurinol

дозировка:

300mg

Фармацевтическая форма:

Oral tablet

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 10010400; GTIN: 5017007052913

тонкая брошюра

Allopurinol, UK/H/1313/001-003, PSUSA, 05.02.2018
PACKAGE LEAFLET: INFORMATION FOR THE USER
[Product name] 100 MG TABLETS
[Product name] 200 MG TABLETS
[Product name] 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.

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 [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR

[Product name] belongs to a group of medicines called enzyme
inhibitors, which act to control the speed
at which special chemical changes occur in the body.

[Product name] tablets are used for the long term, preventive
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [PRODUCT NAME]
DO NOT TAKE [PRODUCT NAME]:

if you are allergic to allopurinol or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING [PRODUCT NAME] IF:

you have problems with your liver and 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.

you have heart problems or high blood pressure.

you are currently having an attack of gout.
Serious skin rashes have been rep

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Allopurinol 300 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg allopurinol.
Excipient(s) with known effect:
Each 300 mg tablet contains lactose monohydrate, equivalent to 171 mg
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, round, biconvex tablets, debossed “2K1 2K1” on one side and
break line on
the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses.
4.1
THERAPEUTIC INDICATIONS
ALLOPURINOL IS INDICATED IN ADULTS, CHILDREN AND ADOLESCENTS:
Adults
•
All forms of hyperuricaemia not controllable by diet including
secondary
hyperuricaemia of differing origin and in clinical complications of
hyperuricaemic
states, particularly manifest gout, urate nephropathy and for the
dissolution and
prevention of uric acid stones
•
The management of recurrent mixed calcium oxalate stones in concurrent
hyperuricaemia, when fluid, dietary and similar measures have failed.
Children and adolescents
•
Secondary hyperuricaemia of differing origin
•
Uric acid nephropathy during treatment of leukaemia
•
Hereditary enzyme deficiency disorders, Lesch-Nyhan syndrome (partial
or total
hypoxanthin-guanin phosphoribosyl transferase deficiency) and adenine
phosophoribosyl transferase deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For oral use.
_Adults: _
2 - 10 mg/kg bodyweight/day or 100 - 200 mg daily in mild conditions,
300 - 600 mg
daily in moderately severe conditions, or 700 - 900 mg daily in severe
conditions.
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
Dosage
recommendations in renal disorders).
_Paediatric population_ (up to the age of 15)
10 - 20 mg/kg bodyweight / day up to a maximum of 400 mg daily given