Deferasirox Mylan

Package leaflet: Information for the user

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

deferasirox
Read all of this leaflet carefully before taking this medicine because 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 your child only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including 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 taking 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 Deferasirox Mylan is and what it is used for

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

What Deferasirox Mylan is used for
Patients with various forms of anaemia (for example, thalassaemia, sickle cell disease, or
myelodysplastic syndromes (MDS)) may require repeated blood transfusions. However, these
can cause an excess of iron in the body. This occurs because blood contains iron, and the body has no natural way of removing the excess iron introduced through blood transfusions. In patients with thalassaemia syndromes who are not receiving blood transfusions, iron overload may also develop over time, primarily due to increased dietary iron absorption 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 chelators are used to eliminate excess iron and reduce the risk of organ damage.

Deferasirox Mylan is used to treat chronic iron overload due to frequent blood transfusions in patients with beta-thalassaemia major aged 6 years and older.
Deferasirox Mylan is also used to treat chronic iron overload in patients with beta-thalassaemia major who have iron overload due to infrequent blood transfusions, in patients with other forms of anaemia, and in children aged between 2 and 5 years, when therapy with deferoxamine is contraindicated or inadequate.
Deferasirox Mylan is also used to treat patients aged 10 years and older who have iron overload associated with non-transfusion-dependent thalassaemia syndromes, when therapy with deferoxamine is contraindicated or inadequate.

2. What you should 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, inform your doctor before taking Deferasirox Mylan. If you think you may be allergic, consult your doctor.
• if you have moderate to severe kidney disease.
• if you are currently taking any other iron chelating medicine.

Deferasirox Mylan is not recommended

• if you have advanced myelodysplastic syndrome (MDS: reduced production of blood cells by the bone marrow) or advanced cancer.

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

• if you have kidney or liver problems.
• if you have heart problems due to iron overload.
• if you notice a marked decrease in urine production (a sign of kidney problems).
• if you develop a severe skin rash, or have difficulty breathing, dizziness, or swelling, particularly of 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, skin peeling, 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 part 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, feel less alert or aware, or feel very drowsy with low energy (signs of high blood ammonium levels, which may be associated with liver or kidney problems; see also section 4 “Possible side effects”).
• if you vomit blood and/or have black stools.
• if you experience frequent abdominal pain, especially after eating or taking Deferasirox Mylan.
• if you frequently have 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, inform your doctor immediately.

Monitoring of treatment with Deferasirox Mylan
During treatment, you will have regular blood and urine tests. These will measure the amount of iron in your body (blood ferritin level) to assess how well Deferasirox Mylan is working. The tests will also monitor kidney function (blood creatinine level, presence of protein in urine) and liver function (blood transaminase levels). If your doctor suspects significant kidney damage, a kidney biopsy may be requested. To determine the amount of iron in your liver, you may also undergo magnetic resonance imaging (magnetic resonance imaging, MRI). Your doctor will use these tests to determine the most appropriate dose of Deferasirox Mylan for you and to decide when treatment should be stopped.
As a precautionary measure, your vision and hearing will be checked annually 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 must not be taken with Deferasirox Mylan,
• antacids (medicines used to treat heartburn) containing aluminium, which must not be taken at the same time of day as Deferasirox Mylan,
• ciclosporin (used to prevent rejection of a transplanted organ or for other conditions such as rheumatoid arthritis or atopic dermatitis),
• simvastatin (used to lower cholesterol),
• certain painkillers or anti-inflammatory medicines (e.g., aspirin, ibuprofen, corticosteroids),
• oral bisphosphonates (used to treat osteoporosis),
• anticoagulant medicines (used to prevent or treat blood clotting),
• hormonal contraceptives (medicines for birth control),
• 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 cancer treatment),
• theophylline (used to treat respiratory diseases such as asthma),
• clozapine (used to treat psychiatric disorders such as schizophrenia),
• tizanidine (used as a muscle relaxant),
• colestyramine (used to reduce blood cholesterol levels),
• busulfan (used as pre-transplant treatment to destroy the original bone marrow before transplantation),
• midazolam (used to relieve anxiety and/or sleep disorders).

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

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

Children and adolescents
Deferasirox Mylan can be used in children and adolescents aged 2 years and older who receive regular blood transfusions, and in children and adolescents aged 10 years and older who do not receive 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Deferasirox Mylan is not recommended during pregnancy unless 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 operate tools or machines until the dizziness has resolved.

Deferasirox Mylan contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Deferasirox Mylan

Treatment with Deferasirox Mylan will be supervised by a doctor experienced in managing iron overload due to blood transfusions.
Always take this medicine exactly as your doctor has instructed. 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. Your doctor will calculate the required dose and tell you how many tablets to take each day.

• For patients receiving regular blood transfusions, the usual initial daily dose of Deferasirox Mylan film-coated tablets is 14 mg per kilogram of body weight. Your doctor may recommend a higher or lower starting dose depending on your individual treatment needs.
• For patients not receiving regular blood transfusions, the usual initial daily dose of Deferasirox Mylan film-coated tablets is 7 mg per kilogram of body weight.
• Depending on your response to treatment, your doctor may later adjust your dose upward or downward.

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 adults not receiving regular blood transfusions,
• 7 mg per kilogram of body weight for children and adolescents not receiving regular blood transfusions.

Deferasirox is also available as dispersible tablets. If switching from dispersible tablets to these film-coated tablets, a dose adjustment will be necessary.

When to take Deferasirox Mylan

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

For patients unable to swallow the tablets whole, Deferasirox Mylan film-coated tablets may be crushed and administered by mixing the full dose with soft food such as yoghurt or applesauce (apple puree). The food should be consumed immediately and completely. Do not store it for later use.

How long to take Deferasirox Mylan
Continue taking Deferasirox Mylan every day for the duration prescribed by your doctor. This is a long-term treatment that may last for months or years. Your doctor will monitor your condition regularly to ensure the treatment is effective (see also section 2: "Monitoring of treatment with Deferasirox Mylan").
If you have any questions about the duration of treatment with Deferasirox Mylan, speak with 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 go to the nearest hospital immediately for advice. Show the doctor the tablet packaging. Urgent medical treatment may be required. Symptoms may include abdominal pain, diarrhoea, nausea and vomiting, and kidney or liver problems, which can be serious.

If you forget to take Deferasirox Mylan
If you miss a dose, take it as soon as you remember, provided it is still the same day. Take your next dose at the usual time. Do not take a double dose the next day to make up for the missed tablet(s).

If you stop taking Deferasirox Mylan
Do not stop taking Deferasirox Mylan unless instructed by your doctor. If you stop taking it, excess iron will no longer be removed from your body (see also above section "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 of the side effects are mild or moderate in severity and usually disappear after a period of treatment
ranging from a few days to a few weeks.
Some side effects may be serious and require immediate medical attention.
These side effects are uncommon (may affect up to 1 in 100 people) or rare
(may affect up to 1 in 1,000 people).

• If you have a severe skin rash, or difficulty breathing and dizziness or swelling mainly of the face and throat (signs of a severe allergic reaction),
• If you develop a combination of any of the following symptoms: skin rash, redness of the skin, blistering 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 reduction in urine output (sign of kidney problem),
• If you experience a combination of drowsiness, pain in the upper right part 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, feel less alert or aware, or feel very drowsy with low energy (signs of high blood ammonium levels, which may be associated with liver or kidney problems and may lead to changes in brain function),
• If you vomit blood and/or have black stools,
• If you experience frequent abdominal pain, particularly 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 contact your doctor immediately.

Some side effects could become serious.
These side effects are uncommon.

• If you have blurred or cloudy vision,
• If you have a decrease in hearing, contact 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, diarrhoea, abdominal pain, bloated stomach, constipation, indigestion
• Rash
• Headache
• Changes in liver function tests
• Itching sensation
• Changes in urine tests (protein in urine). If any of these effects becomes severe, inform your doctor.

Uncommon (may affect up to 1 in 100 people)

• Dizziness
• Fever
• Sore throat
• Swelling of arms or legs
• Change in skin colour
• Anxiety
• Sleep disorder
• Tiredness. If any of these effects becomes severe, inform 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), in the number of red blood cells (worsening anaemia), in the number of white blood cells (neutropenia), or in the number of all types of blood cells (pancytopenia)
• Hair loss
• Kidney stones
• Low urine output
• 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 blood acidity (metabolic acidosis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 stated on the blister and 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 via wastewater 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 substance 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 components are microcrystalline cellulose; crospovidone; povidone; magnesium stearate; anhydrous colloidal silica and poloxamer. The tablet coating contains: hypromellose, titanium dioxide (E171); macrogol/PEG (6000); talc; aluminium lacquer indigo carmine (E132).

Description of the appearance of deferasirox and package contents
Deferasirox Mylan is supplied as film-coated tablets.

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

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

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

Deferasirox Mylan is available in clear, transparent PVC/PVdC/Aluminium blisters containing 30 or 90 film-coated tablets and in unit dose blisters of 30 tablets, as well as in white plastic bottles with white opaque screw caps and aluminium seals containing 90 or 300 film-coated 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 about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OU Viatris AS
Tel: + 372 6363 052 Tlf: +47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Arcana Arzneimittel GmbH
Τηλ: +30 2100 100 02 Tel: +43 1 416 2418

España Polska
Viatris Pharmaceuticals, S.L. Mylan Healthcare Sp. z.o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél : +33 4 37 25 75 00 Tel: + 351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products
Tel: +385 1 23 50 599 Tel: + 40 372 579 000

Ireland Slovenija
Mylan Ireland Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 02 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
Varnavas Hadjipanayis Ltd Viatris AB
Τηλ: + 357 2220 7700 Tel: + 46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: + 353 18711600

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