75 mg, 100 mg film-coated tablets 
azathioprine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Azathioprine 1A Farma is and what it is used for 
2. What you need to know before you take Azathioprine 1A Pharma 
3. How to take Azathioprine 1A Pharma 
4. Possible side effects 
5. How Azathioprine 1A Farma to be stored 
6. Contents of the packaging and other information 

1. What Azathioprine 1A Farma is and what it is used for

Azathioprine 1A Farma tablets contain the active ingredient azathioprine which belongs to a group of medicines called immunosuppressive agents. Immunosuppressive agents reduce the strength of your immune system. Your doctor has prescribed Azathioprine 1A Farma tablets for one of the following conditions:

  • to help your body accept a transplanted organ
  • to control certain diseases where your immune system reacts to your own body.

Azathioprine 1A Farma tablets can also be used alone or in combination with other medicines to treat severe rheumatic disease, severe inflammation of the intestine ( Crohn’s disease or ulcerative colitis ), or to treat certain diseases where your immune system reacts to your own body ( autoimmune disease ) including severe inflammatory diseases of the skin, liver, arteries are and some blood disorders.

Azathioprine contained in Azathioprine 1A Farma may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you take Azathioprine 1A Farma

Do not take Azathioprine 1A Farma if you:

  • is allergic (hypersensitive) to azathioprine, mercaptopurine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching , difficulty breathing or swelling of the face, lips, throat or tongue.
  • have a severe infection
  • have a severe liver or bone marrow disease
  • have pancreatitis ( inflammation of the pancreas)
  • have recently been vaccinated with a live vaccine such as BCG (used mainly against tuberculosis ), smallpox or yellow fever
  • is pregnant (unless your doctor tells you to)
  • ammar.

Warnings and cautions

Talk to your doctor, pharmacist or nurse before taking Azathioprin 1A Farma, in particular:

  • if you are going to be vaccinated while taking Azathioprine 1A Farma tablets
  • if you have a disease in which the body produces too little of a natural chemical called thiopurine methyltransferase (TPMT)
  • if you have had hepatitis B (a liver disease caused by a virus )
  • if you have a disease called Lesch-Nyhan syndrome.

It is important that you use an effective contraceptive (eg condom) as Azathioprine 1A Farma tablets can cause congenital malformations when taken by either man or woman.

Taking immunosuppressive therapy with Azathioprine 1A Farma may increase your risk of:

  • tumor er, including skin cancer. Therefore, when taking Azathioprine 1A Farma, you should avoid excessive sunbathing and wear protective clothing and use high-protection sunscreen.
  • lymphoproliferative diseases.
    • Treatment with Azathioprine 1A Farma increases your risk of developing a type of cancer called lymphoproliferative disease. During treatment regimens that contain several immunosuppressive drugs (including thiopurines), this can lead to death.
    • A combination of several concomitant immunosuppressive drugs increases the risk of diseases of the lymphatic system due to a viral infection (lymphoproliferative diseases associated with Epstein-Barr virus [EBV]).

Taking Azathioprine 1A Farma may increase your risk of:

  • development of a serious condition called macrophage activation syndrome (excessive activation of white blood cells associated with inflammation ), which usually occurs in people with certain types of arthritis .
  • infections: when you are treated with Azathioprine 1A Farma you have a higher risk of viral , fungal and bacterial infections and the infections can be more serious. Tell your doctor immediately if you get a sore throat, fever, infection , bruising or bleeding. See also section 4.
  • previous hepatitis B infection that becomes active again.

Tell your doctor before starting treatment if you have had chickenpox or shingles .

NUDT15 gene mutation

If you have a hereditary mutation in the NUDT15 gene (a gene that is involved in the breakdown of Azathioprine 1A Farma in your body), then the risk of you getting infection and hair loss is higher and the doctor can give you a lower dose in this case. .

Blood tests

During the first eight weeks of treatment, you will need to have a blood test once a week. You may need to have a blood test more often if you:

  • is older
  • takes a high dose
  • have a liver or kidney disease
  • have a bone marrow disease
  • has an overactive spleen .

You will not receive Azathioprine 1A Farma tablets if you can not be monitored for side effects .

All discontinuation of Azathioprine 1A Farma tablets should be discontinued under close supervision (see section 3). Consult your doctor.

Other medicines and Azathioprine 1A Farma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, for example:

  • Allopurinol, oxipurinol, thiopurinol or other xanthine oxidase inhibitors, such as febuxostat (used mainly to treat gout )
  • Penicillamine (mainly used to treat rheumatoid arthritis )
  • Other immunosuppressive agents such as ciclosporin or tacrolimus
  • Infliximab (mainly used to treat ulcerative colitis and Crohn’s disease )
  • Olsalazine, mesalazine or sulfasalazine (treatment for ulcerative colitis )
  • Warfarin or fenprocumon (blood thinners)
  • ACE inhibitors (treatment for high blood pressure or heart failure )
  • Trimethoprim and sulfamethoxazole ( antibiotics )
  • Cimetidine (a treatment for ulcers in the gastrointestinal tract)
  • Indomethacin or penicillamine (treatments for rheumatism)
  • Methotrexate (mainly used to treat cancer)
  • Vaccines such as hepatitis B
  • Ribavirin (treatment for viral infections).
  • Before undergoing surgery, tell your anesthetist that you are being treated with azathioprine, as the muscle relaxants used in anesthesia may affect or be affected by azathioprine.

Pregnancy and breastfeeding

You must not take Azathioprine 1A Farma tablets if you are pregnant unless your doctor tells you to.

Both male and female patients of reproductive age should use contraception, but not intrauterine drugs (eg pessaries , IUDs ).

You should continue to use contraception for another three months after stopping treatment with Azathioprine 1A Farma tablets.

You must not breast-feed during treatment with Azathioprine 1A Farma as degradation products produced in the body pass over to breast milk and may harm your baby.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine (see also section 2).

Driving and using machines

You can drive and use machines during treatment with Azathioprine 1A Farma tablets as long as you do not get dizzy. Dizziness can be aggravated by alcohol and you should not drive or use machines if you have been drinking alcohol.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Azathioprine 1A Farma contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Azathioprine 1A Farma contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, ie essentially ‘sodium-free’.

How to take Azathioprine 1A Farma

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The tablets should be taken at least 1 hour before or 3 hours after food or milk. The tablets should be taken with at least one glass of liquid (200 ml).

The recommended dose is:

Patients who have undergone a transplant

The usual starting dose is up to 5 mg / kg body weight per day. The usual dose is then 1–4 mg / kg body weight per day.

Other diseases

The usual dose is 1-3 mg / kg body weight per day.

Use for children and adolescents:

Due to insufficient data, Azathioprine 1A Farma is not recommended for use in children below 18 years for the treatment of juvenile chronic arthritis , SLE , dermatomyositis and polyarteritis nodosa .

For all other indications, the indicated dose recommendations can be used for children and adolescents as well as for adults.

Elderly patients:

Elderly patients may need a reduced dose .

Patients who have a liver or kidney disease may need to reduce dose one. Patients with severe liver disease should not take Azathioprine 1A Farma tablets.

The duration of treatment for Azathioprine 1A Farma is determined by your doctor. If you have the impression that the effect of Azathioprine 1A Farma is too strong or too weak, talk to your doctor.

Avoid sharing the tablets. If the tablets need to be split, avoid skin contact with the broken surface of the tablet or with the tablet dust. Inhalation of tablet dust should also be avoided. Wash hands immediately after handling split tablets. For appropriate long-term use, other lower-strength medicines should be used, if necessary.

If you forget to take Azathioprine 1A Farma

Do not take a double dose to make up for a forgotten dose . Tell your doctor if you miss a dose .

If it is almost time for your next dose , skip the missed dose and take the next dose at the usual time. Otherwise, take the missed dose one when you discover it and then take the next dose as usual.

If you stop taking Azathioprine 1A Farma

Ask your doctor or pharmacist for advice before stopping taking Azathioprine 1A Farma. Do not stop taking Azathioprine 1A Farma until your doctor tells you it is safe to do so.

If you have any further questions on the use of this product, ask your doctor or pharmacist .

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

The adverse reactions listed below are sequenced. Frequencies are divided as follows: 
Very common: may affect more than 1 user in 10

Common: may affect up to 1 in 10 users

Less common. may affect up to 1 in 100 users

Rare: may affect up to 1 in 1,000 users

Very rare: may affect up to 1 in 10,000 people

Has been reported: occurs in unknown number of users.

Contact a doctor immediately if you suddenly experience wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching (especially if it affects the whole body).

Serious side effects are

If you develop any of the following side effects , contact your doctor immediately:

  • Severe nausea
  • Diarrhea
  • Fever, chills
  • Muscle or skeletal pain, muscle stiffness
  • Fatigue, dizziness
  • Inflammation of the blood vessels
  • Kidney problems (symptoms may include changes in the amount of urine and its color)
  • Signs of fever or infection (sore throat, sore mouth or difficulty urinating)
  • You may get rashes (red, light red or purple rashes that are sore when you touch them), especially on the arms, hands, fingers, face and neck and which can also be accompanied by fever (Sweet’s syndrome, also called acute febrile neutrophildermatosis ). It is not known how common these side effects are (it is not possible to calculate from the available data).

The following side effects have also been reported:

Very common:

  • infection caused by viruses , fungi or bacteria in transplanted patients, even severe or atypical infections with chickenpox, herpes zoster and other infectious agents
  • impaired bone marrow function
  • low number of white blood cells in the blood, which can cause an infection .

Usual:

  • low platelet count , making it easier for you to get bruises or bleeding
  • nausea.

Uncommon:

  • infection is caused by viruses , fungi or bacteria in all patients except transplant patients
  • low number of red blood cells , which can cause fatigue, headache, shortness of breath during exercise, dizziness and pallor
  • Hypersensitivity reactions , which can lead to general discomfort, dizziness, nausea, vomiting, diarrhea, fever, tremors, skin reactions such as redness and rash, inflammation of blood vessels, muscle and joint pain, low blood pressure , kidney or liver disease and intestinal problems.
  • inflammation of the pancreas that can cause severe pain in the upper abdomen, with nausea and vomiting
  • liver problems that can cause pale stools, dark urine, itching and yellowing of the skin and eyes and abnormalities in liver function tests.

Rare:

  • problems with blood and bone marrow that can give weakness, fatigue, pallor, headache, sore tongue, wheezing, bruising or infection s
  • severe liver damage that can be life-threatening
  • hair loss that can be improved even if you continue to take Azathioprine 1A Farma tablets
  • various types of cancer including blood, lymph and skin cancers.

Very rare:

  • life-threatening allergic reactions leading to serious conditions affecting the skin ( Stevens-Johnson syndrome and toxic epidermal necrolysis )
  • pneumonia that causes shortness of breath, cough and fever
  • viral infection leading to brain damage (symptoms may include headache, altered behavior, impaired speech, impaired various functions such as memory, attention, and decision making [cognitive impairment]). Infection can be fatal (the condition is called JC virus-associated progressive multifocal leukoencephalopathy )
  • a certain type of lymphoma (hepatosplenic T-cell lymphoma). You may have nosebleeds, fatigue, heavy night sweats, weight loss and unexplained fever
  • colitis, inflamed intestinal pockets and perforation (holes) in the intestine have been reported in transplant patients and severe diarrhea in patients with inflammatory bowel disease.

Has been reported (occurs in an unknown number of users):

  • photosensitivity (sensitivity to light or sunlight).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Azathioprine 1A Farma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the can and carton after EXP. or EXP. The expiration date is the last day of the specified month.

Store in the original package. Sensitive to light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is azathioprine.

One film-coated tablet contains 75 or 100 mg of azathioprine.

Other ingredients are:

Tablet core: microcrystalline cellulose (E 460), lactose monohydrate , corn starch, povidone K25 (E 1201), croscarmellose sodium, magnesium stearate (E 572), colloidalanhydrous silica.

Film coating: polyvinyl alcohol, talc (E 553b), macrogol 3350, polysorbate 80 (E 433).

What the medicine looks like and the contents of the pack

Azathioprine 1A Farma 75 mg film-coated tablets are light yellow, round tablets with a scored score.

Azathioprine 1A Farma 100 mg film-coated tablets are light yellow, oblong tablets with a scored score.

Packaging:

The film-coated tablets are packaged in plastic containers made of polyethylene, with a PP screw cap, which contains 50 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

1A Farma A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Local representative

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Muhammad Nadeem

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