Azathioprine 25mg tablets

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Azathioprine

Boleh didapati daripada:

Viatris UK Healthcare Ltd

Kod ATC:

L04AX01

INN (Nama Antarabangsa):

Azathioprine

Dos:

25mg

Borang farmaseutikal:

Oral tablet

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 08020100; GTIN: 5016695270708 5016695270067

Risalah maklumat

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AZATHIOPRINE TABLETS 25 MG
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 is and what it is used for
2.
What you need to know before you take Azathioprine
3.
How to take Azathioprine
4.
Possible side effects
5.
How to store Azathioprine
6.
Contents of the pack and other information
1.
WHAT AZATHIOPRINE IS AND WHAT IT IS USED FOR
Azathioprine belongs to a group of medicines called
immunosuppressants. Azathioprine helps to reduce or
suppress your body’s own immune system. Your immune system helps to
protect you against infections.
However, sometimes it can produce illness and unwanted effects. For
example, if you have just had an organ
transplant, your immune system will try to reject the new organ.
Azathioprine helps to prevent this immune
response, and so allows the organ to carry on working. It is therefore
used together with other medicines
such as corticosteroids to improve the survival of organ transplants.
Azathioprine is also used to treat conditions caused by your immune
system over reacting or reacting
abnormally. For example:
•
rheumatoid arthritis (inflammation and pain in your joints)
•
hepatitis (inflamed liver)
•
systemic lupus erythematosus (a disease which affects your skin and
major organs)
•
blood disorders such as thrombocytopenia (reduced numbers of blood
cells called platelets). This can
affect blood clotting and increase the risk of bleeding or bruising.
•
haemolyti

Ciri produk

OBJECT 1
Azathioprine Tablets 25mg
Summary of Product Characteristics Updated 05-Aug-2021 | Mylan
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Azathioprine Tablets 25mg
2. Qualitative and quantitative composition
Each tablet contains 25mg of azathioprine
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated Tablet
A pale yellow film-coated, round, biconvex tablet, marked 'AE' over
'25' on one side and 'G' on reverse
4. Clinical particulars
4.1 Therapeutic indications
Azathioprine is an antimetabolite which is used as an
immunosuppressant, either as monotherapy or more
often in combination with other drugs (mainly corticosteroids) and
procedures which modulate the immune
response. Therapeutic effect may be apparent only after weeks or
months. Combination therapy with
Azathioprine and corticosteroids may allow the dosage of
corticosteroids to be reduced, resulting in a
reduction of the toxicity associated with chronic use of
corticosteroid