Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Azathioprine
Viatris UK Healthcare Ltd
L04AX01
Azathioprine
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08020100; GTIN: 5016695270708 5016695270067
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 Olvassa el a teljes dokumentumot
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 Olvassa el a teljes dokumentumot