Patient Medication Information: uses, side effects, how to take - Mylan-Azathioprine
ABOUT THIS MEDICATION
What the medication is used for:
MYLAN-AZATHIOPRINE, an immunosuppressant agent is used in the following conditions:
- Renal Homotransplantations: as an adjunct (with other medications) in the prevention of rejection of kidney transplants.
- Rheumatoid Arthritis in adult patients who cannot be treated with other medications and treatments.
What it does:
MYLAN-AZATHIOPRINE belongs to a group of medicines called immunosuppressants. This means that it reduces the strength of your immune system.
Immunosuppressant medicines are sometimes necessary to help your body accept an organ transplant, such as a new kidney or to treat rheumatoid arthritis where your immune system is reacting against your own body (autoimmune diseases).
When it should not be used:
You should NOT take MYLAN-AZATHIOPRINE if you:
- are allergic to azathioprine or any of the other ingredients of MYLAN-AZATHIOPRINE (see What the non-medicinal ingredients are).
What the medicinal ingredient is:
Azathioprine
What the important non-medicinal ingredients are:
MYLAN-AZATHIOPRINE 50 mg tablets contain the following non-medicinal ingredients: lactose, magnesium stearate, potato starch, povidone, purified water and stearic acid.
What dosage forms it comes in:
MYLAN-AZATHIOPRINE 50 mg tablets are pale yellow, capsule-shaped biconvex tablets, embossed with "AE 50" on one side, and a break line on the other side.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
|
Patients taking immunosuppressive medicines may have an increased risk of developing tumours including skin cancer. Therefore while taking MYLAN-AZATHIOPRINE tablets you should avoid too much exposure to sunlight. You are advised to wear protective clothing and to use a sunscreen with a high protection factor.
Patients receiving MYLAN-AZATHIOPRINE alone or in combination with other immunosuppressants, particularly corticosteroids, have shown increased susceptibility to infections.
Infection with chickenpox or shingles can become severe in patients taking immunosuppressive medicine. Therefore you should avoid contact with anyone suffering from chickenpox or shingles.
Patients receiving MYLAN-AZATHIOPRINE have experienced gastrointestinal hypersensitivity reactions including severe nausea and vomiting.
BEFORE you use MYLAN-AZATHIOPRINE talk to your doctor or pharmacist if:
- you have rheumatoid arthritis and have been previously treated with alkylating agents (cyclophosphamide, chlorambucil, melphalan or others)
- you are under 18 years of age
you are pregnant or breast feeding
- you are planning to have a baby - discuss this with your doctor whether you are male or female
- you suffer from liver or kidney disease
you have been told you have any type of cancer
- you have a condition where your body produces too little of a natural chemical called thiopurine methyltransferase (TPMT)
- you have never suffered from chickenpox or shingles
INTERACTIONS WITH THIS MEDICATION
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those that you have bought yourself without a doctor’s prescription.
Certain medicines can interact with MYLAN-AZATHIOPRINE such as those listed below:
- angiotensin-converting enzyme inhibitors such as captopril (used mainly to treat high blood pressure and heart failure)
- co-trimoxazole also known as SEPTRA® (used to treat infections).
- allopurinol (used mainly to treat gout)
- curare, d-tubocurarine, tubocurarine, succinylcholine (used during anaesthesia and as muscle relaxants)
- warfarin (used to prevent blood clots)
- mesalazine, olsalazine or sulphasalazine (used mainly to treat ulcerative colitis).
PROPER USE OF THIS MEDICATION
It is important to take your medicine at the right times. You must take it in the way your doctor has told you to. Swallow the tablet whole with water, do not break the tablet.
It is important that you and/or your caregivers are aware of the need for safe handling of this medicine. Please consult your pharmacist or doctor for advice.
The amount of MYLAN-AZATHIOPRINE people take can be very different. Your dose will depend on the condition your doctor is treating.
Your doctor will tell you how long your treatment will last. Do not stop treatment early.
From time to time, while you are taking MYLAN-AZATHIOPRINE, your doctor will want you to have a blood test. This is to check your blood cell count and to change your dose if necessary.
Usual Dose for Adults for Renal Homotransplantation:
A starting dose of up to 5 mg/kg of your bodyweight is usually given on the first day of therapy.
You will then be given a maintenance dose of MYLAN-AZATHIOPRINE. This is likely to be between 1 to 3 mg/kg bodyweight per day.
Usual Dose for Adults for Rheumatoid Arthritis:
If you are receiving MYLAN-AZATHIOPRINE for rheumatoid arthritis the dose given is likely to start at approximately 1 mg/kg of your bodyweight. Depending on how your treatment is working, your dose may be adjusted, until an optimal maintenance dose is determined.
Overdose:
| In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed Dose:
If you forget to take a dose, do not take extra tablets to make up for the dose or doses you have missed. When you remember take your next dose at the usual time and continue as before. Speak to your doctor as soon as you can about the doses you may have missed.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, MYLAN-AZATHIOPRINE can cause side effects.
Some people can be allergic to medicines. If you have any of the following symptoms soon after taking MYLAN-AZATHIOPRINE STOP taking this medicine and tell your doctor immediately or go to the nearest hospital emergency department:
- you develop muscle or bone pain
- you develop kidney problems
- you start feeling faint especially on standing up
- you develop bad diarrhoea and/or abdominal pain
- you develop a serious skin reaction (e.g. blistering and/or peeling)
Tell your doctor immediately if any of the following happen to you while you are taking MYLAN-AZATHIOPRINE:
- you start to notice any signs of a fever or an infection
- you have any unexpected bruising or bleeding
- you develop any new marks on your skin or any change to marks that you may have had previously
- you develop a cough or difficulty breathing similar to a chest infection
- you have nausea and vomiting
- you feel tired, dizzy or generally unwell
- you come into contact with anyone who is suffering from chickenpox or shingles.
Stevens-Johnson syndrome and toxic epidermal necrolysis (skin conditions) have been reported very rarely in post-marketing surveillance.
Cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported.
You may notice some hair loss while taking MYLAN-AZATHIOPRINE. Often hair does grow again, even if you carry on taking MYLAN-AZATHIOPRINE. If you are worried ask your doctor.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency medical attention | ||
| Only if severe | In all cases | |||
| Common | signs of fever or infection (in the non-transplant population infection is uncommon) | |||
| unexpected bruising or bleeding | ||||
| nausea | ||||
| Uncommon | new marks on skin or a change to marks | |||
| cough or difficulty breathing similar to a chest infection | ||||
| tired, dizzy or generally unwell | ||||
| muscle or bone pain | ||||
| kidney problems | ||||
| feeling faint especially on standing up | ||||
| bad diarrhea and/or abdominal pain | ||||
| serious skin reaction (e.g. blistering and/or peeling) | ||||
If you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.
HOW TO STORE IT
MYLAN-AZATHIOPRINE Tablets should be stored between 15°C and 30°C in a well-closed container. Protect from light. Keep dry.
Do not take the medicine after the expiry date shown on the tablet pack.
If your doctor tells you to stop taking the tablets, please return any which are left over to your pharmacist. Only keep them if your doctor tells you to.
As with all medicines, keep MYLAN-AZATHIOPRINE tablets out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect. NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
This document can be found at: www.mylan.ca.
The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379.
Etobicoke, Ontario M8Z 2S6
Revised on: November 06, 2014
Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca