AZATIOPRINA 50 mg Film-Coated Tablets

Зміст інструкції

1. Azatioprina Hexal 50 mg film-coated tablets
   1. What is Azatioprina Hexal and what is it used for
   2. What you need to know before taking Azatioprina Hexal
   3. How to take Azatioprina Hexal
   4. Possible side effects
   5. How to store Azatioprina Hexal
   6. Contents of the pack and other information

Azatioprina Hexal 50 mg film-coated tablets

Generic medicine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Azatioprina Hexal is and what it is used for
• 2. What you need to know before you take Azatioprina Hexal
• 3. How to take Azatioprina Hexal
• 4. Possible side effects
• 5. How to store Azatioprina Hexal
• 6. Contents of the pack and other information

1. What is Azatioprina Hexal and what is it used for

Azatioprina Hexal belongs to a group of medicines called immunosuppressants, a term that indicates
their function of reducing the response of the immune system.
Immunosuppressant medicines are sometimes necessary to help the body accept an organ
following a transplant, or for the treatment of certain diseases in which the immune system
reacts against the body itself (autoimmune diseases, such as rheumatoid arthritis).

2. What you need to know before taking Azatioprina Hexal

Do not take Azatioprina Hexal

• if you are allergic to azathioprine or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to mercaptopurine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Azatioprina Hexal:

• if you suffer from a condition known as Lesch-Nyhan syndrome. This is a rare inherited disease caused by a defect in the hypoxanthine-guanine-phosphoribosyl-transferase (HPRT) enzyme
• if you have liver or kidney problems
• if you are planning a pregnancy, or if your partner is planning a pregnancy (see section 2 “Pregnancy, breastfeeding and fertility”)
• if you suffer from a condition due to which the body produces an insufficient amount of a substance called thiopurine methyltransferase (TPMT)
• if you have ever had chickenpox or shingles (herpes zoster)
• if you are about to receive a vaccination (see section 2 “Other medicines and Azatioprina Hexal”).

If you are not sure whether any of these conditions apply to you, consult your doctor or pharmacist before taking this medicine.
During treatment with Azatioprina Hexal, your doctor will prescribe periodic blood teststo monitor any changes (see section 3 “How to take Azatioprina Hexal”).
If you are receiving immunosuppressive therapy, taking Azatioprina Hexal may increase the risk of developing:

• tumors, including skin cancer. Therefore, if you are taking Azatioprina Hexal you should avoid excessive exposure to sunlight, wear protective clothing and use a sunscreen with a high protection factor
• severe chickenpox or shingles infection. For this reason, during treatment with Azatioprina Hexal avoid contact with people who have chickenpox or shingles
• other infections, such as PML (Progressive Multifocal Leukoencephalopathy), an opportunistic infection. If you experience any signs of infection, contact your doctor (see section 4 “Possible side effects”).
• lymphoproliferative disorders or treatment with Azatioprina Hexal increases the risk of developing a type of cancer called a lymphoproliferative disorder. A treatment regimen based on multiple immunosuppressants (including thiopurines) can lead to death. or the simultaneous administration of a combination of multiple immunosuppressants increases the risk of developing disorders of the lymphatic system caused by a viral infection (lymphoproliferative disorders associated with the Epstein-Barr virus (EBV).

Taking Azatioprina Hexa may increase the risk of:

• developing a serious condition called macrophage activation syndrome (excessive activation of white blood cells associated with inflammation), which usually manifests in people with certain types of arthritis.
• InfectionsDuring treatment with azathioprine, the risk of viral, fungal and bacterial infections is increased and infections may be more severe. See also section 4. Before starting treatment, tell your doctor if you have had chickenpox, shingles or hepatitis B (a liver disease caused by a virus).

NUDT15 gene mutation
If you have an inherited mutation in the NUDT15 gene (a gene involved in the transformation of azathioprine in the body), you are at greater risk of infections and hair loss, and in this case your doctor may give you a lower dose.

• Other medicines and Azatioprina Hexal

Tell your doctor if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription and herbal medicines. This is because this medicine can affect the action of some medicines. Similarly, some other medicines can affect the action of this medicine. In particular, tell your doctor if you are taking, or intend to take:

• vaccines (used to prevent diseases) (see section 2, “Warnings and precautions”)
• ribavirin (used to treat viral infections)
• methotrexate (mainly used for the treatment of tumors)
• allopurinol, oxipurinol or thiopurinol (mainly used for the treatment of gout)
• penicillamine (mainly used for the treatment of rheumatoid arthritis)
• ACE inhibitors (mainly used to treat high blood pressure - hypertension)
• Anticoagulants, such as warfarin or acenocoumarol (used to prevent blood clots)
• cimetidine (used to treat stomach ulcers and indigestion)
• indometacin (used as a pain reliever and anti-inflammatory)
• cytostatic medicines (including some antibiotics and also drugs used to treat various types of cancer)
• aminosalicylates, such as olsalazine, mesalazine or sulfasalazine (mainly used for the treatment of ulcerative colitis and Crohn's disease)
• cotrimoxazole (an antibiotic, used to treat infections caused by bacteria).

If you are not sure whether any of these conditions apply to you, consult your doctor or pharmacist before taking Azatioprina Hexal.

Azatioprina Hexal with food and drink
Takethe tablets of Azatioprina Hexal at least one hour before or at least 3 hours after consuming food or milk. Swallow the tablet with a little water (see section 3, “How to take Azatioprina Hexal”).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine (see section 2, “Warnings and precautions”).
If you are pregnant or have a good chance of becoming pregnant, you should consult your doctor before taking Azatioprina Hexal. They will carefully assess whether or not you should take this medicine, based on the risks and benefits of treatment.
You should not breastfeed during treatment with Azatioprina Hexal, as small amounts of the medicine can pass into breast milk.
During treatment with Azatioprina Hexal, additional precautions must be taken, including the use of a contraceptive other than an intrauterine device (such as a coil, copper device).

Driving and using machines
It is not known whether Azatioprina Hexal affects the ability to drive or use machines. If you experience any side effects while using this medicine, this may impair your ability to drive or use machines.

Azatioprina Hexal contains lactose
Azatioprina Hexal contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Azatioprina Hexal

Take this medicine following exactly the instructions of your doctor. Do not changethe dosage
or stop taking Azatioprina Hexal without first consulting your doctor. If you have any doubts, consult
your doctor or pharmacist.
The dosage of Azatioprina Hexal may vary from patient to patient and will be established by your doctor. The
dosage depends on the disease for which you are being treated.
During treatment with Azatioprina Hexal, your doctor will prescribe you periodic blood tests, to
check for any abnormalities (see section 2 “Warnings and precautions”).

The recommended doses are described below
Adults who have undergone an organ transplant: on the first day of treatment, the usual dose is up to 5
mg per kilogram of body weight, followed by a daily dose of 1-4 mg per kilogram of body
weight. During treatment, the doctor will adjust the dosage, depending on your reaction to the
medicine.

Adults with other conditions: the usual daily dose is 1-3 mg per kilogram of body weight. In
course of treatment the doctor will adjust the dosage, depending on your reaction to the medicine.
Elderly patients may require a reduced dose.
Patients with kidney or liver problems may require a reduced dose.

Use in children
The dosage for children who have undergone an organ transplant is the same as for adults.
Children considered overweight may require a higher dose.

Method of administration
Take Azatioprina Hexal as prescribed by your doctor. It is important to respect the dosage. The prescription
indicates how much medicine to take and how often.
Swallow the tablets whole, with a little water. The tablet must not be divided or broken.
Take the tablets of Azatioprina Hexal at least one hour before consuming food or milk, or at least 3 hours
after consuming food or milk (see section 2 “Azatioprina Hexal with food and beverages”).

If you take more Azatioprina Hexal than you should
If you take an excessive amount of tablets, contact immediatelyyour doctor or pharmacist.

If you forget to take Azatioprina Hexal
Do not take a double dose to make up for a missed dose. If you forget a dose, inform your
doctor.
If it is almost time for the next dose, skip the missed dose and take the next dose at the usual time.
Otherwise, take it as soon as you remember, then take the next dose at the usual time.

If you stop taking Azatioprina Hexal
Before stopping treatment with Azatioprina Hexal, consult your doctor or pharmacist. Do not stop
taking Azatioprina Hexal until your doctor tells you it is safe to do so.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With this medicine, the side effects listed below may occur.

If you notice any of the following serious side effects, stop taking this medicine and
consult a doctor immediately: you may urgently need medical attention:

• Allergic reaction, the signs of which may include or general tiredness, dizziness, feeling unwell (nausea), feeling sick (vomiting) or diarrhoea or high temperature (fever), shaking or chills

or redness of the skin or rash
or muscle or joint pain
or changes in the amount and colour of urine (kidney problems)
or dizziness, confusion, feeling lightheaded or weak, caused by low blood pressure

• you bruise or bleed more easily
• you have a high temperature (fever) or other signs of infection
• you feel very tired
• you notice lumps anywhere in your body
• you notice skin changes, for example blisters or peeling
• your health suddenly gets worse
• you come into contact with people who have chickenpox or shingles. If you notice any of the above conditions, stop taking this medicine and consult a doctor immediately.

If you notice the appearance of the following side effects, inform your specialist doctor or go
immediately to hospital:

• Any sign of fever or infection (sore/inflamed throat or mouth or urinary problems). Other side effects include:Very common(may affect more than 1 in 10 people)
• infections caused by viruses, fungi or bacteria in patients undergoing transplantation
• reduction in the function of the bone marrow, which can cause feeling unwell or be detected in blood tests.

Common(may affect up to 1 in 10 people)

• nausea (feeling sick)
• low platelet count in the blood, which can increase the chances of developing bruises or bleeding.

Uncommon(may affect up to 1 in 100 people)

• anaemia
• hypersensitivity reactions (allergic reactions)
• pancreatitis (inflammation of the pancreas), which can cause severe pain in the upper part of the stomach, accompanied by feeling unwell (nausea) and feeling sick (vomiting)
• infections caused by viruses, fungi or bacteria
• liver problems, which can cause pale stools, dark urine, itching and yellowing of the skin and eyes, and abnormal liver function tests.

Rare (may affect up to 1 in 1000 people)

• severe liver damage, potentially fatal
• hair loss
• problems with the blood and bone marrow (the signs of which include weakness, tiredness, paleness, bruising or infections)
• various types of cancer, including those of the blood, lymph nodes and skin (see paragraph 2, “Warnings and precautions”).

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

• inflammation of the lungs, causing shortness of breath, cough and fever
• intestinal disorders, causing diarrhoea, abdominal pain, constipation, nausea or vomiting (intestinal perforation)
• skin rashes or redness, which can develop into potentially life-threatening skin reactions, including a widespread skin reaction, with blisters and peeling of the skin, which occurs particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), widespread peeling of the skin (toxic epidermal necrolysis).

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Azatioprina Hexal

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and the packaging, after the wording
“EXP”. The expiry date refers to the last day of that month.
If it is necessary to halve the film-coated tablet of Azatioprina 50 mg, avoid contact
of the skin with the powder or with the broken part of the tablet.
Any remaining residue must be disposed of with the same caution.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Azatioprina Hexal contains

• The active ingredient is azathioprine. Each film-coated tablet contains 50 mg of azathioprine.
• The other ingredients are: lactose monohydrate, corn starch, povidone, colloidal silicon dioxide, magnesium stearate, hypromellose, microcrystalline cellulose, polyoxyl 8 stearate, talc. Colourant: titanium dioxide (E171).

Description of the appearance of Azatioprina Hexal and contents of the pack
Azatioprina Hexal 50 mg film-coated tablets are presented in the form of biconvex, film-coated tablets
of a white-yellowish colour, with a fracture line on one side.
Pack sizes: 30, 50, 56 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz S.p.A. Largo U. Boccioni, 1 21040 Origgio (VA)
Manufacturer
SALUTAS Pharma GmbH Otto-von-Guericke-Allee, 1 - 39179 Barleben (Germany)

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
AT: Azathioprin "Hexal" 50 mg - Filmtabletten
BE: Azathioprine Sandoz 25/50 mg filmomhulde tabletten
DE: Azathioprin HEXAL® 25/50 mg Filmtabletten
IT: Azatioprina Hexal
NL: Azathioprine 25 mg, filmomhulde tablet
AZATHIOPRINE 50 MG, filmomhulde tablet
UK: Azathioprine 25/50 mg Tablets

The following information is intended exclusively for doctors or healthcare professionals:
Instructions for use, handling and disposal
There are no risks associated with handling the tablets with the coating intact. In this case
no special safety precautions are necessary.
However, immunosuppressants must be handled in strict accordance with the instructions when
healthcare personnel halve the tablets (see sections 4.2 and 4.4 of the Summary of Product
Characteristics).
Excess medicines, as well as contaminated devices, must be temporarily stored in
clearly labelled containers. Unused product or waste material must be disposed of in
accordance with local regulations.

Incompatibilities
Not applicable.

Administration
For oral use.
The tablet must be taken with at least one glass of liquid (200 ml).

Shelf life
3 years

Special precautions for storage
This medicinal product does not require any special storage conditions.