Azathioprine 25 mg, filmomhulde tablet

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

AZATHIOPRINE 25 mg/stuk

Beschikbaar vanaf:

Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)

ATC-code:

L04AX01

INN (Algemene Internationale Benaming):

AZATHIOPRINE 25 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOLSTEARAAT, TYPE I ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POVIDON (E 1201) ; SILICA, HYDRATE FORM UNKNOWN (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Azathioprine

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MACROGOLSTEARAAT, TYPE I; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; POVIDON (E 1201); SILICA, HYDRATE FORM UNKNOWN (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2002-02-20

Bijsluiter

Hexal A.G.
Page 1/9
Azathioprine 25/50 mg, filmomhulde tablet
RVG 27564-5
1313-v15
1.3.1.3 Bijsluiter
Juni 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AZATHIOPRINE 25 MG, FILMOMHULDE TABLET
AZATHIOPRINE 50 MG, FILMOMHULDE TABLET
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.
-
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
[nationally completed name] is and what it is used for
2.
What you need to know before you take [nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store
[nationally completed name]
6.
Contents of the pack and other information
1. WHAT [NATIONALLY APPROVED NAME] ARE AND WHAT THEY ARE USED FOR
[Nationally approved name] 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.
[Nationally approved name] 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

Productkenmerken

Hexal A.G.
Page 1/16
Azathioprine 25/50 mg, filmomhulde tablet
RVG 27564-5
1311-v11
1.3.1.1 Samenvatting van de Productkenmerken
Juni 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Azathioprine 25 mg, filmomhulde tablet
Azathioprine 50 mg, filmomhulde tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg azathioprine.
Excipient(s) with known effect:
Each film-coated tablet contains 42.75 mg lactose (as monohydrate)
Each film-coated tablet contains 50 mg azathioprine.
Excipient(s) with known effect:
Each film-coated tablet contains 85.50 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to yellowish-white film-coated tablet, biconvex, no score-line.
White to yellowish-white film-coated tablet, biconvex with a
score-line on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
[Nationally approved name] 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.
[Nationally approved name] 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.
[Nationally approved name] 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 thera