Imuran 50 mg Film-coated Tablets

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Azathioprine

Disponibbli minn:

Lexon Pharmaceuticals (Ireland) Limited

Kodiċi ATC:

L04AX; L04AX01

INN (Isem Internazzjonali):

Azathioprine

Għamla farmaċewtika:

Film-coated tablet

Żona terapewtika:

Other immunosuppressants; azathioprine

L-istatus ta 'awtorizzazzjoni:

Not marketed

Data ta 'l-awtorizzazzjoni:

2022-07-29

Fuljett ta 'informazzjoni

IMURAN 50 MG FILM-COATED TABLETS
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:
What Imuran Tablets are and what they are used for
What you need to know before you take Imuran Tablets
How to take Imuran Tablets
Possible side effects
How to store Imuran Tablets
Contents of the pack and other information
WHAT IMURAN TABLETS ARE AND WHAT THEY ARE USED FOR
Imuran Tablets contain the active substance azathioprine. They belong
to a
group of medicines called immunosuppressives. This means that they
reduce
the strength of your immune system.
Imuran Tablets may be used to help your body accept an organ
transplant,
such as a new kidney, heart or liver, or to treat some diseases where
your
immune system is reacting against your own body (autoimmune diseases).
Autoimmune diseases may include:
- severe rheumatoid arthritis (a disease where the immune system
attacks
cells lining the joints causing swelling, pain, stiffness of the
joints),
- systemic lupus erythematosus (a disease where the immune system
attacks many of the body's organs and tissues, including skin, joints,
kidneys, brain, and other organs causing severe fatigue, fever,
stiffness and
joint pain),
- dermatomyositis and polymyositis (a group of diseases causing
inflammation of the muscles, muscle weakness and skin rash),
- auto-immune chronic active hepatitis (a disease in which the immune
system attacks liver cells causing liver inflammation, fatigue, muscle
aches,
yellowing of the skin and fever),
- pemphigus vulgaris (a disease in which the immune

Karatteristiċi tal-prodott

Health Products Regulatory Authority
29 July 2022
CRN00CVKC
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imuran 50 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg azathioprine.
Excipient(s) with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Romania:_
Yellow, round, biconvex, film-coated tablet, scored and branded 'GX
CH1' on one side and plain on the other.
The scoreline should not be used to break the tablet.
4 CLINICAL PARTICULARS
As per PA1691/003/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1691/003/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Lactose Monohydrate
Maize starch
Pregelatinised starch
Stearic acid
Magnesium stearate
Film-coat:
Hypromellose
Macrogol 400
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister and outer carton of the product as marketed in the
country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 25°C. Store in the original package in order to protect
from light.
Health Products Regulatory Authority
29 July 2022
CRN00CVKC
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/aluminium foil blister packs containing 100 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
Safe handling
Health professionals who handle uncoated azathioprine tablets should
follow guidelines for the handling of cytotoxic medicinal
products according to prevailing local recommendations and/or
regulations.
Provided that the film-coating is intact, there is no risk in handling
film-coated azathioprine tablets.
Film-coated azathioprine tablets should not be divided and, provided
the coating is intact, no additional precautions are
required when handling them.
Disposal
Azathioprine tablets should be disposed of in a ma