Imuran 50 mg Film-coated Tablets

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Azathioprine

Предлага се от:

Aspen Pharma Trading Limited

АТС код:

L04AX; L04AX01

INN (Международно Name):

Azathioprine

дозиране:

50 milligram(s)

Лекарствена форма:

Film-coated tablet

Вид предписание :

Product subject to prescription which may not be renewed (A)

Терапевтична област:

Other immunosuppressants; azathioprine

Статус Оторизация:

Marketed

Дата Оторизация:

1979-04-01

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMURAN™ 25MG FILM-COATED TABLETS
IMURAN™ 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, nurse 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, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Imuran Tablets are and what they are used for
2.
What you need to know before you take Imuran Tablets
3.
How to take Imuran Tablets
4.
Possible side effects
5.
How to store Imuran Tablets
6.
Contents of the pack and other information
1. 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
ce

Данни за продукта

Health Products Regulatory Authority
01 November 2023
CRN00DXRS
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imuran 50 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg of the active substance azathioprine.
Excipient(s) with known effect
Each 50 mg tablet contains 74 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, round, biconvex, film-coated tablet, scored and branded 'IM
5'.
The scoreline should not be used to break the tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azathioprine is 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, 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. It also reduces
the corticosteroid requirements of renal transplant recipients.
Azathioprine is indicated for the treatment of moderate to severe
inflammatory bowel disease (IBD) (Crohn's disease or
ulcerative colitis) in patients in whom corticosteroid therapy is
required, in patients who cannot tolerate corticosteroid therapy,
or in patients whose disease is refractory to other standard first
line therapy.
Azathioprine, either alone or more usually in combination with
corticosteroids and/or other medicinal products 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 erythem