DEFERASIROX 90 mg Tabletki Powlekane

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1. Deferasirox Mylan 90 mg film-coated tablets, 180 mg film-coated tablets, 360 mg film-coated tablets
   1. What is Deferasirox Mylan and what it is used for
   2. What you need to know before taking Deferasirox Mylan
   3. How to take Deferasirox Mylan
   4. Possible side effects
   5. How to store Deferasirox Mylan
   6. Package contents and other information

Deferasirox Mylan 90 mg film-coated tablets, 180 mg film-coated tablets, 360 mg film-coated tablets

deferasirox

Read this leaflet carefully before you start 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 or for your child 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 Deferasirox Mylan is and what it is used for
• 2. What you need to know before you take Deferasirox Mylan
• 3. How to take Deferasirox Mylan
• 4. Possible side effects
• 5. How to store Deferasirox Mylan
• 6. Contents of the pack and other information

1. What is Deferasirox Mylan and what it is used for

What is Deferasirox Mylan
Deferasirox Mylan contains an active substance called deferasirox. It is an iron chelator, meaning
a medicine used to remove excess iron from the body (iron overload).
Deferasirox binds to excess iron and removes it by eliminating it mainly with the faeces.

What is Deferasirox Mylan used for
In patients with various forms of anaemia (for example thalassemia, sickle cell disease or
myelodysplastic syndromes (MDS)), repeated blood transfusions may be necessary. However, these
can cause an excess of iron in the body. This happens because blood contains
iron and the body does not have a natural way to remove the excess iron introduced with the
blood transfusions. In patients with thalassaemic syndromes who are not undergoing blood
transfusion, iron overload can also develop over time, mainly due to an
increased absorption of iron with the diet in response to a low number of blood cells.
Over time, excess iron can damage important organs such as the liver and heart. Medicines called iron chelatorsare used to eliminate excess iron and reduce the risk that
this may damage some organs.
Deferasirox Mylan is used for the treatment of chronic iron overload due to frequent
blood transfusions in patients with beta thalassemia major, aged 6 years and above.
Deferasirox Mylan is also used for the treatment of chronic iron overload, in patients with
beta thalassemia major with iron overload due to infrequent blood transfusions, in
patients with other forms of anaemia, and in children aged between 2 and 5 years, when deferoxamine therapy is contraindicated or inadequate.
Deferasirox Mylan is also used for the treatment of patients aged 10 years and above, who
have iron overload associated with non-transfusion-dependent thalassaemic syndromes,
when deferoxamine therapy is contraindicated or inadequate.

2. What you need to know before taking Deferasirox Mylan

Do not take Deferasirox Mylan

• if you are allergic to deferasirox or to any of the other ingredients of this medicine (listed in section 6). If this applies to you, tell your doctor before taking DeferasiroxMylan.If you think you may be allergic, ask your doctor for advice.
• if you have moderate or severe kidney disease.
• if you are currently taking any other iron-chelating medicine.

Deferasirox Mylan is not recommended

• if you are in an advanced stage of myelodysplastic syndrome (MDS: decreased production of blood cells by the bone marrow) or have advanced cancer.

Warnings and precautions
Talk to your doctor or pharmacist before taking Deferasirox Mylan:

• if you have a problem with your kidneys or liver.
• if you have a heart problem due to iron overload.
• if you notice a marked decrease in urine production (a sign of kidney problems).
• if you have a severe skin rash, or difficulty breathing and dizziness or swelling, especially in the face and throat (signs of a severe allergic reaction, see also section 4 “Possible side effects”).
• if you experience a combination of any of the following symptoms: skin rash, skin redness, blistering on lips, eyes or mouth, peeling of the skin, high fever, flu-like symptoms, swollen lymph nodes (signs of a severe skin reaction, see also section 4 “Possible side effects”).
• if you experience a combination of drowsiness, pain in the upper right side of your abdomen, yellowing or increased yellowing of the skin or eyes, and dark urine (signs of liver problems).
• if you experience difficulty thinking, remembering information, or solving problems, if you feel less alert or aware, or if you feel very sleepy with little energy (signs of a high level of ammonia in the blood, which may be associated with liver or kidney problems, see also section 4 “Possible side effects”).
• if you vomit blood and/or produce black stools.
• if you experience frequent abdominal pain, especially after eating or taking Deferasirox Mylan.
• if you experience frequent heartburn.
• if blood tests show low levels of platelets or white blood cells.
• if you have blurred vision.
• if you have diarrhoea or vomiting. If any of these situations apply to you, tell your doctor immediately.

Monitoring of treatment with Deferasirox Mylan
During treatment, you will have regular blood and urine tests. These will
check the amount of iron in your body (serum ferritinlevel) to see how
Deferasirox Mylan is working. The tests will also check your kidney function (serum
creatinine level, presence of protein in the urine) and your liver function (serum
transaminase level). If your doctor suspects significant kidney damage, they may ask you to undergo a
kidney biopsy. To determine the amount of iron in your liver, you may also undergo magnetic resonance imaging (MRI)scans. Your doctor will evaluate these tests to decide
which dose of Deferasirox Mylan is most appropriate for you and will also use these tests to decide
when you should stop taking Deferasirox Mylan.
As a precaution, your vision and hearing will be examined every year during treatment.

Other medicines and Deferasirox Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is particularly important for:

• other iron chelators, which should not be taken with Deferasirox Mylan,
• antacids (medicines used to treat heartburn) containing aluminium, which should not be taken at the same time of day as Deferasirox Mylan,
• cyclosporine (used to prevent organ rejection after a transplant or for other conditions such as rheumatoid arthritis or atopic dermatitis),
• simvastatin (used to lower cholesterol),
• some pain relievers or anti-inflammatory drugs (e.g., aspirin, ibuprofen, corticosteroids),
• oral bisphosphonates (used to treat osteoporosis),
• anticoagulant medicines (used to prevent or treat blood clots),
• hormonal contraceptives (birth control pills),
• bepridil, ergotamine (used for heart problems and migraines),
• repaglinide (used to treat diabetes),
• rifampicin (used to treat tuberculosis),
• phenytoin, phenobarbital, carbamazepine (used to treat epilepsy),
• ritonavir (used to treat HIV infection),
• paclitaxel (used in the treatment of cancer),
• theophylline (used to treat respiratory diseases such as asthma),
• clozapine (used to treat psychiatric disorders such as schizophrenia),
• tizanidine (used as a muscle relaxant),
• cholestyramine (used to lower cholesterol levels in the blood),
• busulfan (used as a treatment before transplantation to destroy the original bone marrow before the transplant),
• midazolam (used to relieve anxiety and/or sleep disorders).

Additional tests may be needed to monitor the levels in the blood of some of these
medicines.

Elderly (aged 65 years and over)
Deferasirox Mylan can be used by people aged 65 years and over at the same dose
used in adults. Elderly patients may experience more side effects (particularly
diarrhoea) than younger patients. They should be carefully monitored by the doctor
for side effects that may require a dose adjustment.

Children and adolescents
Deferasirox Mylan can be used in children and adolescents aged 2 years and over
who are receiving regular blood transfusions and in children and adolescents aged 10 years and over
who are not receiving regular blood transfusions. The doctor will adjust the dose based on the
patient’s growth.
Deferasirox Mylan is not recommended in children under 2 years of age.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.
Deferasirox Mylan is not recommended during pregnancy unless it is strictly
necessary.
If you are currently using a hormonal contraceptive to prevent pregnancy, you should
use an additional or different type of contraception (e.g., a condom), as Deferasirox
Mylan may reduce the effectiveness of hormonal contraceptives.
Breastfeeding is not recommended during treatment with Deferasirox Mylan.

Driving and using machines
If you feel dizzy after taking Deferasirox Mylan, do not drive or use tools or
machines until you no longer feel dizzy.

Deferasirox Mylan contains less than 1 mmol(23 mg) of sodiumper tablet, which is essentially
“sodium-free”.

3. How to take Deferasirox Mylan

Treatment with Deferasirox Mylan will be monitored by a doctor experienced in the treatment of
iron overload caused by blood transfusions.
Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult
your doctor or pharmacist.

How much Deferasirox Mylan to take
The dose of Deferasirox Mylan is based on body weight for all patients. The doctor will calculate the
necessary dose for you and tell you how many tablets to take each day.

• For patients receiving regular blood transfusions, at the beginning of treatment, the usual daily dose of Deferasirox Mylan film-coated tablets is 14 mg per kilogram of body weight. The doctor may recommend a higher or lower initial dose based on the need for personalized treatment.
• For patients who are not receiving regular blood transfusions, at the beginning of treatment, the usual daily dose of Deferasirox Mylan film-coated tablets is 7 mg per kilogram of body weight.
• Depending on how you respond to treatment, the doctor may subsequently modify the treatment by increasing or decreasing the dose.

The maximum recommended daily dose of Deferasirox Mylan film-coated tablets is:

• 28 mg per kilogram of body weight, for patients receiving regular blood transfusions,
• 14 mg per kilogram of body weight, for adult patients who are not receiving regular blood transfusions,
• 7 mg per kilogram of body weight, for children and adolescents who are not receiving regular blood transfusions.

Deferasirox is also available in “dispersible” tablet form. If you switch from dispersible tablets
to these film-coated tablets, a dose adjustment will be necessary.

When to take Deferasirox Mylan

• Take Deferasirox Mylan once a day, every day, at about the same time each day, with a little water.
• Take Deferasirox Mylan film-coated tablets on an empty stomach or with a light meal. Taking Deferasirox Mylan every day at the same time will also help you remember when to take the tablets.

For patients who cannot swallow the tablets whole, the film-coated tablets of
Deferasirox Mylan can be crushed and administered by sprinkling the entire dose on soft food
such as yogurt or applesauce (apple puree). The food must be consumed
immediately and completely. Do not save it for later use.

How long to take Deferasirox Mylan
Continue to take Deferasirox Mylan every day for the duration that your doctor has indicated.This is
a long-term treatment, which can last for months or years. Your condition will be monitored
regularly by your doctor to verify that the treatment is effective (see also paragraph 2:
“Monitoring treatment with Deferasirox Mylan”).
If you have questions regarding the duration of therapy with Deferasirox Mylan, talk to your doctor.

If you take more Deferasirox Mylan than you should
If you have taken too much Deferasirox Mylan, or if someone else has accidentally taken your
tablets, contact your doctor or hospital for advice immediately. Show the doctor the
tablet packaging. Urgent medical treatment may be necessary. Effects such as abdominal pain, diarrhea, nausea and vomiting, and kidney or liver problems
may occur, which can be serious.

If you forget to take Deferasirox Mylan
If you forget to take a dose, take it as soon as you remember during the same day. Take the
next dose as scheduled. Do not take a double dose the next day to make up for the
missed dose(s).

If you stop taking Deferasirox Mylan
Do not stop taking Deferasirox Mylan unless your doctor tells you to do so. If you stop
taking it, the excess iron will no longer be removed from the body (see also above the paragraph “How
long to take Deferasirox Mylan”).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are mild or moderate and usually disappear after a period of treatment between a few days and a few weeks.

Some side effects can be serious and require immediate medical attention.

These side effects areuncommon(may affect up to 1 in 100 people) orrare

(may affect up to 1 in 1,000).

• If you have a severe rash, or difficulty breathing or dizziness or swelling mainly of the face and throat (signs of a severe allergic reaction),
• If you experience a combination of any of the following symptoms: rash, skin redness, blisters on lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, swollen lymph nodes (signs of a severe skin reaction),
• If you notice a marked decrease in urine production (sign of kidney problems),
• If you experience a combination of drowsiness, pain in the upper right side of the abdomen, yellowing or increased yellowing of the skin or eyes and dark urine (signs of liver problems),
• If you experience difficulty thinking, remembering information or solving problems, if you feel less alert or aware or feel very sleepy with little energy (signs of a high level of ammonia in the blood, which may be associated with liver or kidney problems and lead to a change in brain function),
• If you vomit blood and/or have black stools,
• If you experience frequent abdominal pain, especially after eating or taking Deferasirox Mylan,
• If you experience frequent heartburn,
• If you experience partial loss of vision,
• If you experience severe pain in the upper part of the stomach (pancreatitis), stop taking this medicine and tell your doctor immediately.

Some side effects may become serious.

These side effects areuncommon.

• If you have blurred or cloudy vision,
• If you have a decrease in hearing, tell your doctor as soon as possible.

Other side effects
Very common(may affect more than 1 in 10 people)

• Changes in kidney function tests.

Common(may affect up to 1 in 10 people)

• Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, bloating, constipation, indigestion
• Rash
• Headache
• Changes in liver function tests
• Itching
• Changes in urine tests (protein in urine) If any of these effects is severe, tell your doctor.

Uncommon(may affect up to 1 in 100 people)

• Dizziness
• Fever
• Sore throat
• Swelling of the arms or legs
• Changes in skin color
• Anxiety
• Sleep disorder
• Fatigue If any of these effects is severe, tell your doctor.

Frequency not known(frequency cannot be estimated from the available data).

• A reduction in the number of cells involved in blood clotting (thrombocytopenia), red blood cells (worsened anemia), white blood cells (neutropenia) or all types of cells in the blood (pancytopenia)
• Hair loss
• Kidney stones
• Low urine production
• Tear in the wall of the stomach or intestine which may be painful and cause nausea
• Severe pain in the upper part of the stomach (pancreatitis)
• Increased acidity of the blood (metabolic acidosis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Deferasirox Mylan

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 blister and the carton after
“Exp.”.
The expiry date refers to the last day of that month.
Do not use the pack if it is damaged or shows signs of tampering.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Deferasirox Mylan contains
The active ingredient is deferasirox.

• Each film-coated tablet of Deferasirox Mylan 90 mg contains deferasirox 90 mg.
• Each film-coated tablet of Deferasirox Mylan 180 mg contains deferasirox 180 mg.
• Each film-coated tablet of Deferasirox Mylan 360 mg contains deferasirox 360 mg.

The other ingredients are microcrystalline cellulose; crospovidone; povidone; magnesium stearate; colloidal
anhydrous silica and poloxamer. The tablet coating contains: hypromellose, titanium dioxide
(E171); macrogol/PEG (6000); talc; aluminium indigo carmine lacquer (E132).

Description of the appearance of deferasirox and contents of the pack
Deferasirox Mylan is supplied in the form of film-coated tablets.

• Deferasirox Mylan 90 mg film-coated tablets are capsule-shaped, film-coated, blue, biconvex, with imprinted “ ” on one side and “DF” on the other side of the tablet.
• Deferasirox Mylan 180 mg film-coated tablets are capsule-shaped, film-coated, blue, biconvex, with imprinted “ ” on one side and “DF 1” on the other side of the tablet.
• Deferasirox Mylan 360 mg film-coated tablets are capsule-shaped, film-coated, blue, biconvex, with imprinted “ ” on one side and “DF 2” on the other side of the tablet.

Deferasirox Mylan is available in PVC/PVdC/Aluminium blisters, clear, transparent, containing 30 or
90 film-coated tablets and in single-dose blisters of 30 tablets and in white plastic bottles with
opaque white screw caps and aluminium seals containing 90 or 300 tablets.
Deferasirox Mylan 360 mg film-coated tablets are also available in blisters of
300 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan Pharmaceuticals Limited
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturer
Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary
McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Unit 35/36 Baldoyle
Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Germany GmbH, Zweigniederlassung Bad Homburg v. d. Hoehe
Benzstrasse 1, Bad Homburg v. d. Hoehe, Hessen, 61352, Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ s.r.o.
Tel: + 420 222 004 400

Magyarország
Viatris Healthcare Kft
Tel.: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: +31 (0)20 426 3300

Eesti
Viatris OU
Tel: + 372 6363 052

Norge
Viatris AS
Tlf: +47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 02

Österreich
Arcana Arzneimittel GmbH
Tel: +43 1 416 2418

España
Viatris Pharmaceuticals, S.L.
Tel: + 34 900 102 712

Polska
Mylan Healthcare Sp. z.o.o.
Tel.: + 48 22 546 64 00

France
Viatris Santé
Tél : +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 214 127 200

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
BGP Products
Tel: + 40 372 579 000

Ireland
Mylan Ireland Limited
Tel: +353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l.
Tel: + 39 02 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
Varnavas Hadjipanayis Ltd
Τηλ: + 357 2220 7700

Sverige
Viatris AB
Tel: + 46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: + 353 18711600

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu .