Azathioprine 50mg tablets

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Azathioprine

Dostupno od:

Relonchem Ltd

ATC koda:

L04AX01

INN (International ime):

Azathioprine

Doziranje:

50mg

Farmaceutski oblik:

Oral tablet

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 08020100; GTIN: 5055144202013 5055144202020

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
AZATHIOPRINE 50MG FILM-COATED TABLETS
(Azathioprine)
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 or
nurse.
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 or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Azathioprine 50mg Tablets are and what they are used for
2.
What you need to know before you take Azathioprine 50mg Tablets
3.
How to take Azathioprine 50mg Tablets
4.
Possible side effects
5.
How to store Azathioprine 50mg Tablets
6.
Contents of the pack and other information
1.
WHAT AZATHIOPRINE 50MG TABLETS ARE AND WHAT THEY ARE USED FOR
Azathioprine 50mg Tablets belong to a group of medicines called
immunosuppressants. These
medicines reduce the activity of your body's immune system.
Azathioprine 50mg Tablets are used to:

stop your body rejecting an organ transplant

treat diseases where your immune system reacts against your own body
(called autoimmune
diseases, such as rheumatoid arthritis).
Ask your doctor, nurse or pharmacist if you would like any further
explanation about these uses.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AZATHIOPRINE 50MG TABLETS
DO NOT TAKE AZATHIOPRINE IF:

You are allergic to azathioprine, mercaptopurine or any of the other
ingredients of Azathioprine
(listed in section 6).






You are pregnant or likely to become pregnant (see Pregnancy,
breast-feeding and fertility).
Do not take Azathioprine if any of the above apply to you. If you are
not sure, talk to your doctor,
nurse or pharmacist before taking Azathioprine.
WARNINGS AND PRECAUTIONS
OTHER MEDICINES AND AZATHIOPR

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Azathioprine 50mg film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50mg Azathioprine.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated Tablet.
Azathioprine 50 mg Tablets are pale yellow, circular, film coated,
biconvex, tablets
engraved with “AZA”, score-line and “50” on one face. The
other face is plain.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azathioprine
50mg
Tablets
are
used
as
an
immunosuppressant
antimetabolite either alone or, more commonly, in combination with
other
agents
(usually
corticosteroids)
and
procedures
which
influence
the
immune response.
Therapeutic effect may be evident only after weeks or months and can
include a steroid-sparing effect, thereby reducing the toxicity
associated
with high dosage and prolonged usage of corticosteroids.
Azathioprine 50mg Tablets, in combination with corticosteroids and/or
other immunosuppressive agents and procedures, is indicated to enhance
the
survival
of
organ
transplants,
such
as
renal
transplants,
cardiac
transplants
and
hepatic
transplants;
and
to
reduce
the
corticosteroid
requirements of renal transplant recipients.
Azathioprine 50mg Tablets, either alone or more usually in combination
with corticosteroids and/or other drugs and procedures, has been used
with
clinical benefit (which may include reduction of dosage or
discontinuation
of corticosteroids) in a proportion of patients suffering from the
following:
Severe rheumatoid arthritis
Systemic lupus erythematosus
Dermatomyositis and polymyositis
Auto-immune chronic active hepatitis
Pemphigus vulgaris
Polyarteritis nodosa
Auto-immune haemolytic anaemia
Chronic refractory idiopathic thrombocytopenic purpura
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral
Transplantation - adults and children
Depending on the immunosuppressive regimen employed, a dosage of up
to 5 mg/kg body weight/day may be given on the first day of t