Azathioprine 50mg tablets

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Azathioprine

Доступна з:

Teva UK Ltd

Код атс:

L04AX01

ІПН (Міжнародна Ім'я):

Azathioprine

Дозування:

50mg

Фармацевтична форма:

Oral tablet

Адміністрація маршрут:

Oral

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 08020100; GTIN: 5017007398851 5017007400110

інформаційний буклет

PACKAGE LEAFLET:
INFORMATION FOR THE USER
AZATHIOPRINE TABLETS 50 MG
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 Azathioprine Tablets are and what they are
used for
2. What you need to know before you take
Azathioprine Tablets
3. How to take Azathioprine Tablets
4. Possible side effects
5. How to store Azathioprine Tablets
6. Contents of the pack and other information
1. WHAT AZATHIOPRINE TABLETS ARE AND
WHAT THEY ARE USED FOR
Azathioprine Tablets contains the active substance
azathioprine which belongs to a group of medicines
called immunosuppressants. This means that they
reduce the strength of your immune system.
Azathioprine is used for protection against organ
transplant rejection.
It can also be used to treat various conditions in
which the usual treatment (with steroids) is not
working properly, is causing problems or where
steroids cannot be used. These conditions include
hepatitis, rheumatoid arthritis, systemic lupus
erythematosus (SLE), dermatomyositis and
polymyositis (conditions which affect the muscles
and skin), various blood and bleeding disorders and
skin disorders.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE AZATHIOPRINE TABLETS
DO NOT TAKE AZATHIOPRINE TABLETS IF YOU:
•
Are allergic to azathioprine, 6-mercaptopurine
or any of the other ingredients of this medicine
(listed in section 6)
•
Are pregnant or breast-feeding, unless your
doctor assess it is necessary (see “Pregnancy,
breast-feeding and fertility”)
•
Have recently had or are due to have a
vacci

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Azathioprine 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg azathioprine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Light yellow, round, biconvex tablet, engraved “AZA” and “50”
separated by a line
on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azathioprine is indicated in immunosuppressive regimens as an adjunct
to
immunosuppressive agents that form the mainstay of treatment (basic
immunosuppression).
Azathioprine is indicated in combination with other immunosuppressive
agents for
the prophylaxis of transplant rejection in patients receiving
allogenic kidney, liver,
heart, lung, or pancreas transplants.
Azathioprine is indicated either alone or in combination with
corticosteroids and/or
other drugs and procedures in severe cases of the following diseases,
in patients who
are intolerant to steroids or who are dependent on steroids and in
whom the
therapeutic response is inadequate despite treatment with high doses
of steroids:
-
Severe active rheumatoid arthritis that cannot be kept under control
by less
toxic agents (disease modifying anti-rheumatic drugs, DMARDs)
-
Severe or moderately severe inflammatory intestinal disease (Crohn’s
disease
or ulcerative colitis)
-
Systemic lupus erythematosus
-
Dermatomyositis
-
Auto-immune chronic active hepatitis
-
Polyarteritis nodosa
-
Refractory warm auto-immune haemolytic anaemia
-
Chronic refractory idiopathic thrombocytopenic purpura
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Transplantation
Depending on the immunosuppressive regime selected, a dosage of up to
5mg/kg/body weight/day may be given on the first day of therapy. The
maintenance
dose can range from 1-4 mg/kg/body weight/day and must be adjusted
according to
the clinical requirements and haematological tolerance.
Other conditions
In general, the starting dosage is 1-3mg/kg/body weight/day and shoul