DEFERASIROX ZENTIVA 360 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Deferasirox Zentiva 360 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

This medicine contains the active substance deferasirox. It is an iron chelator, a medicine used to remove excess iron from the body (also called iron overload). It captures and removes excess iron, which is then mainly excreted in the feces.

What Deferasirox Zentiva is used for

Repeated blood transfusions may be necessary in patients with various types of anemia (e.g. thalassemia, sickle cell anemia or myelodysplastic syndromes (MDS)). However, repeated blood transfusions can cause an accumulation of excess iron. This is because blood contains iron and the body has no natural way to remove excess iron obtained from blood transfusions. In patients with non-transfusion-dependent thalassemic syndromes, iron overload may also occur over time, mainly due to increased absorption of iron from the diet in response to low blood cell counts. Over time, excess iron can damage important organs such as the liver and heart. Medicines called iron chelators are used to remove excess iron and reduce the risk of organ damage.

Deferasirox is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta thalassemia major, aged 6 years and older.

Deferasirox is also used to treat chronic iron overload when treatment with deferoxamine is contraindicated or not suitable in patients with beta thalassemia major with iron overload caused by infrequent blood transfusions, in patients with other types of anemia, and in children aged 2 to 5 years.

Deferasirox is also used to treat patients aged 10 years and older who have iron overload associated with thalassemic syndromes, but who are not transfusion-dependent, when treatment with deferoxamine is contraindicated or not suitable.

2. What you need to know before you take Deferasirox Zentiva

Do not take Deferasirox Zentiva

• if you are allergic to deferasirox or any of the other ingredients of this medicine

(listed in section 6). If this applies to you, tell your doctor before taking deferasirox.

If you think you may be allergic, consult your doctor.

• if you have moderate or severe kidney disease.
• if you are currently taking any other iron chelator medicine.

Deferasirox Zentiva 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

Consult your doctor or pharmacist before starting treatment with this medicine.

• if you have a kidney or liver problem.
• if you have a heart problem due to iron overload.
• if you notice a pronounced decrease in the amount of urine you pass (sign of a kidney problem).
• if you develop a severe rash, or difficulty breathing and dizziness or swelling

mainly 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: a rash,

redness of the skin, blisters on the 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 notice a combination of drowsiness, pain in the upper right abdomen, yellowing of the skin or eyes and dark urine (signs of liver problems).

if you notice difficulty thinking, remembering information or solving problems, or are less conscious or awake or feel drowsy and weak (signs of high ammonia levels 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 black stools.
• if you have frequent abdominal pain, particularly after eating or taking deferasirox.
• if you have frequent heartburn.
• if you have a low platelet or white blood cell count in your blood test.
• if you have blurred vision.
• if you have diarrhea or vomiting.

If you are in any of these situations, tell your doctor immediately.

Monitoring of your treatment with Deferasirox Zentiva

During treatment, you will have regular blood and urine tests. These tests will monitor the amount of iron in your body (ferritin level in the blood) to see how well the treatment with deferasirox is working. The tests will also monitor kidney function (creatinine level in the blood, protein in the urine) and liver function (transaminase level in the blood). Your doctor may ask you to have a kidney biopsy if they suspect significant kidney damage. They may also have you undergo MRI (magnetic resonance imaging) tests to determine the amount of iron in your liver. Your doctor will take these tests into account to decide on the most suitable dose of deferasirox for you and will also use these tests to decide when to stop your treatment with deferasirox.

Every year, your vision and hearing will be checked during treatment as a precaution.

Other medicines and Deferasirox Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes in particular:

• other iron chelators, must not be taken with deferasirox,
• antacids (medicines used to treat heartburn) that contain aluminum, must not be taken at the same time of day as deferasirox,
• cyclosporine (used to prevent organ rejection after a transplant or for other diseases such as rheumatoid arthritis or atopic dermatitis),

simvastatin (used to lower cholesterol levels),

• 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 clots),
• hormonal contraceptives (medicines for birth control),
• bepridil, ergotamine (used for heart problems and for 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 to treat 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 pre-transplant treatment to destroy the original bone marrow before the transplant).

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

Elderly (65 years and over)

Deferasirox can be used in people over 65 years of age at the same dose as other adults. Elderly patients may experience more side effects (especially diarrhea) than younger patients. The doctor should closely monitor the side effects that may require a dose adjustment.

Children and adolescents

Deferasirox can be used in children and adolescents aged 2 years and older who receive periodic blood transfusions and in children and adolescents aged 10 years and older who do not receive periodic blood transfusions. As the patient grows, the doctor will adjust the dose.

Deferasirox is not recommended in children under 2 years of age.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Deferasirox is not recommended during pregnancy unless clearly necessary.

If you are currently using an oral or patch contraceptive to prevent pregnancy, you should use an additional or different contraceptive (e.g. condom) because deferasirox may reduce the effectiveness of oral and patch contraceptives.

Breastfeeding is not recommended during treatment with deferasirox.

Driving and using machines

If you feel dizzy after taking Deferasirox Zentiva, do not drive or operate tools or machines until you feel normal again.

Deferasirox Zentiva contains lactose

Lactose is an excipient in this medicine. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Deferasirox Zentiva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

3. How to take Deferasirox Zentiva

Treatment with deferasirox will be supervised by a doctor with experience in the treatment of iron overload caused by blood transfusions.

Follow the instructions for administration of this medicine exactly as told by your doctor.

If you are in doubt, consult your doctor or pharmacist again.

How much Deferasirox Zentiva to take

The dose of deferasirox is related to body weight for all patients. Your doctor will calculate the dose you need and tell you how many tablets to take per day.

• The usual daily dose of deferasirox film-coated tablets at the start of treatment for patients who receive periodic blood transfusions is 14 mg per kilogram of body weight. Your doctor may recommend a higher or lower dose depending on your individual treatment needs.
• The usual daily dose of deferasirox film-coated tablets at the start of treatment for patients who do not receive periodic blood transfusions is 7 mg per kilogram of body weight.
• Depending on how you respond to treatment, your doctor may later adjust your treatment to a higher or lower dose.

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

• 28 mg per kilogram of body weight for patients who receive periodic blood transfusions,
• 14 mg per kilogram of body weight for adult patients who do not receive periodic blood transfusions,
• 7 mg per kilogram of body weight for children and adolescents who do not receive periodic blood transfusions

Deferasirox can also be found in "dispersible" tablets. If you switch from the dispersible tablets to these film-coated tablets, you will need a dose adjustment.

When to take Deferasirox Zentiva

• Take deferasirox once a day, every day, at the same time with some water.
• Take deferasirox film-coated tablets on an empty stomach or with a light meal

Taking deferasirox at the same time every day will also help you remember when to take your tablets.

Patient with difficulty swallowing tablets may crush deferasirox film-coated tablets and take the powder with a soft food, such as yogurt or apple sauce (apple puree). The whole dose should be consumed immediately, without saving any for later.

How long to take Deferasirox Zentiva

Continue taking deferasirox every day for as long as your doctor tells you. This is a long-term treatment, which may last for months or years. Your doctor will regularly check your condition to see if the treatment is having the desired effect (see also section 2: "Monitoring of your treatment with deferasirox").

If you have doubts about how long to take deferasirox, consult your doctor.

If you take more Deferasirox Zentiva than you should

If you have taken too much deferasirox, or if someone else has taken your tablets by mistake, contact your doctor or go to a hospital immediately. Show the doctor the pack of the tablets. You may need urgent medical treatment. You may notice effects such as abdominal pain, diarrhea, nausea and vomiting, and kidney or liver problems, which can be serious.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, go to a hospital immediately or call the Toxicology Information Service, Telephone: 915 620 420, indicating the medicine and the amount used. You may need medical treatment.

If you forget to take Deferasirox Zentiva

If you have missed a dose, take it as soon as you remember on the same day. Take the next dose according to your normal schedule. Do not take a double dose the next day to make up for the missed dose(s).

If you stop taking Deferasirox Zentiva

Do not stop your treatment with deferasirox unless your doctor tells you to. If you stop taking it, the excess iron will not be removed from your body (see also previous section "How long to take deferasirox").

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Most adverse effects are mild or moderate and

usually disappear after a few days or weeks of treatment.

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

These adverse effects are rare(may affect up to 1 in 100 people) or very rare(may affect up to 1 in 1,000 people)

• If you have a severe rash, or difficulty breathing and dizziness or swelling especially in the face and throat (signs of a severe allergic reaction),
• If you experience a combination of any of the following symptoms: rash,

redness of the skin, blisters on the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, swollen lymph nodes (signs of a severe skin reaction).

• If you notice a pronounced decrease in urine volume (sign of a kidney problem),
• If you notice a combination of drowsiness, pain in the upper right abdomen, yellowing or more yellowing of the skin or eyes and dark urine (signs of

liver problems),

• If you notice difficulty thinking, remembering information or solving problems, or are less

conscious or awake or feel drowsy and weak (signs of high ammonia levels in the blood, which may be associated with liver or kidney problems and cause a change in brain function),

• If you suffer from vomiting blood and/or black stools,
• If you suffer from frequent abdominal pain, particularly after eating or taking deferasirox,
• If you suffer from frequent heartburn,
• If you have partial loss of vision,
• If you have severe pain in the upper abdomen (pancreatitis),

Stop taking the medicine and inform your doctor immediately.

Some adverse effects can be serious.

These adverse effects are rare

• If you have blurred vision,
• If you lose hearing ability,

inform your doctor as soon as possible.

Other Adverse 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, swelling,

constipation, indigestion.

• Rashes
• Headache
• Changes in liver function tests
• Itching
• Changes in urine tests (protein in the urine)

If you suffer from any of these effects severely, inform your doctor

Rare(may affect up to 1 in 100 people)

• Dizziness
• Fever
• Sore throat
• Swelling in arms and legs
• Changes in skin color
• Anxiety
• Sleep disturbance
• Fatigue

If you suffer from any of these effects severely, inform your doctor.

Frequency Not Known(cannot be calculated from available data).

• Decrease in the number of cells involved in blood clotting

(thrombocytopenia), of the number of red blood cells (worsening of anemia), of the number of white blood cells (neutropenia) or of the number of all types of blood cells

(pancytopenia)

• Hair loss
• Kidney stones
• Low urine production
• Rupture of the stomach or intestinal wall that can be painful and cause nausea
• Severe pain in the upper abdomen (pancreatitis)
• Abnormal acid levels in the blood

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Deferasirox Zentiva

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and on the blister after CAD. The expiration date is the last day of the month indicated.

Do not use any packaging that is damaged or shows signs of tampering.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Deferasirox Zentiva

Each film-coated tablet of Deferasirox Zentiva 360 mg contains 360 mg of deferasirox.

The other components are: microcrystalline cellulose (types 101 and 102); povidone K-30; crospovidone (types A and B); poloxamer 188; colloidal anhydrous silica and magnesium stearate.

The tablet coating contains: lactose monohydrate, hypromellose (E464); titanium dioxide (E171); triacetin and aluminum lake of indigo carmine (E132) (contains sodium).

Appearance of the Product and Package Contents

Blue, oval, biconvex film-coated tablets, with impressions "D7FX" on one side and "360" on the other. Approximate tablet dimensions 15 mm in length x 9 mm in width.

Packaging containing 30 or 90 film-coated tablets. The blister may be perforated or non-perforated.

Only some package sizes may be marketed

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zentiva, k.s.

U kabelovny 130,

Dolní Mecholupy,

102 37 Prague 10

Czech Republic

Manufacturer:

Synthon Hispania S.L.

c/ Castelló, 1

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

Synthon B.V.

Microweg, 22

6545 CM (Nijmegen)

Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Deferasirox Synthon 360 mg, filmomhulde tabletten

Germany: Deferasirox Synthon 360 mg Filmtabletten

Bulgaria: ???????????? Synthon 360 mg

Spain: Deferasirox Zentiva 360 mg film-coated tablets EFG

United Kingdom: Deferasirox 360 mg film-coated tablets

Czech Republic: Deferasirox Synthon

Date of the Last Revision of this Prospectus:October 2019

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Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.