DEFERASIROX AUROVITAS 90 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the user

Deferasirox Aurovitas 90 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, as 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 or for your child, and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Deferasirox Aurovitas and what is it used for
2. What you need to know before you take Deferasirox Aurovitas
3. How to take Deferasirox Aurovitas
4. Possible side effects

5 Storage of Deferasirox Aurovitas

1. Contents of the pack and other information

1. What is Deferasirox Aurovitas 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 faeces.

What Deferasirox Aurovitas is used for

Repeated blood transfusions may be necessary in patients with various types of anaemia (e.g. thalassemia, sickle cell anaemia or myelodysplastic syndromes (MDS)). However, repeated blood transfusions can cause a build-up of excess iron. This is because blood contains iron and the body has no natural way to remove the excess iron obtained from blood transfusions. In patients with non-transfusion-dependent thalassemia 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 thalassaemia 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 thalassaemia major with iron overload caused by infrequent blood transfusions, in patients with other types of anaemia, 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 thalassemia syndromes but are not transfusion-dependent, when treatment with deferoxamine is contraindicated or not suitable.

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

Do not take Deferasirox Aurovitas

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6). If this applies to you, tell your doctor before takingdeferasirox. 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 Aurovitas 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 starting this medicine

• if you have a kidney or liver problem.

• if you have a heart problem due to iron overload.
• if you notice a marked 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, skin redness, 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 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 a low platelet or white blood cell count in your blood test.
• if you have blurred vision.
• if you have diarrhoea or vomiting.

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

Monitoring of your treatment with Deferasirox Aurovitas

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 Aurovitas

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, which must not be taken with deferasirox,
• antacids (medicines used to treat heartburn) that contain aluminium, which must not be taken at the same time of day as deferasirox,
• ciclosporin (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),
• colestyramine (used to lower cholesterol levels in the blood).
• busulfan (used as pre-transplant treatment to destroy the original bone marrow before transplantation),
• midazolam (used to relieve anxiety and/or sleep problems).

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 diarrhoea) than younger patients. The doctor should closely monitor 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 regular blood transfusions and in children and adolescents aged 10 years and older who do not receive regular blood transfusions. As the patient grows, the doctor will adjust the dose.

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

Pregnancy andbreast-feeding

If you are pregnant or breast-feeding, 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 a hormonal contraceptive to prevent pregnancy, you should use an additional or different contraceptive (e.g. condom), as deferasirox may reduce the effectiveness of hormonal contraceptives.

Breast-feeding is not recommended during treatment with deferasirox.

Driving and using machines

If you feel dizzy after taking deferasirox, do not drive or use tools or machines until you feel normal again.

3. How to take Deferasirox Aurovitas

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 unsure, consult your doctor or pharmacist again.

How much Deferasirox Aurovitas 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 each day.

• The usual daily dose of deferasirox film-coated tablets at the start of treatment for patients who receive regular 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 regular 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 regular blood transfusions,
• 14 mg per kilogram of body weight for adult patients who do not receive regular blood transfusions,
• 7 mg per kilogram of body weight for children and adolescents who do not receive regular blood transfusions.

Deferasirox Aurovitas is not available in dispersible tablets. For dispersible tablets, other medicines containing deferasirox should be used. If you switch from these dispersible tablets to deferasirox film-coated tablets, your dose will change. Your doctor will calculate the dose you need and tell you how many film-coated tablets to take each day.

When to take Deferasirox Aurovitas

• 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.

Patients who have 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 entire dose should be consumed immediately, without saving any for later.

How long to take Deferasirox Aurovitas

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 Aurovitas»).

If you are unsure how long to take deferasirox, consult your doctor.

If you take more Deferasirox Aurovitas 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 tablets. You may need urgent medical treatment. You may notice effects such as abdominal pain, diarrhoea, nausea and vomiting, and kidney or liver problems, which can be serious.

If you forget to take Deferasirox Aurovitas

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

If you stop taking Deferasirox Aurovitas

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 Aurovitas»).

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 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 rash, or difficulty breathing and dizziness or swelling, especially on 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 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 can 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 uncommon

• 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)

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

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

Uncommon (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), red blood cells (worsening of anemia), white blood cells (neutropenia), or all types of blood cells (pancytopenia).
• Hair loss.
• Kidney stones.
• Low urine production.
• Rupture of the stomach or intestine wall, which can be painful and cause nausea.
• Severe pain in the upper abdomen (pancreatitis).
• Abnormal acid levels in the blood.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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 Aurovitas

Keep this medicine out of sight and reach of children.

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

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. 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 Aurovitas

• The active ingredient is deferasirox.
• Each film-coated tablet contains 90 mg of deferasirox.

• Other components are:

Core: Microcrystalline cellulose (Grade 101 and 102), crospovidone (Type A), poloxamer (Type 188), povidone (K 30), colloidal anhydrous silica, and magnesium stearate.

Tablet coating: Hypromellose 2910 (6 mPas), titanium dioxide, macrogol 6000, talc, aluminum indigo carmine (3% - 5%) aluminum indigo carmine lacquer (11% - 14%)

Appearance of the Product and Package Contents

Film-coated tablet.

Deferasirox Aurovitas 90 mg film-coated tablets EFG

Film-coated tablet, light blue, oval, biconvex, with beveled edges, engraved with "DF" on one side and "90" on the other.

Deferasirox Aurovitas film-coated tablets EFG are available in transparent PVC/PVDC/Aluminum and PVC/Aluminum blisters containing 30, 90, and 300 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid,

Spain

Manufacturer:

APL Swift Services (Malta) Ltd,

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000,

Malta

O

Generis Farmacêutica S.A., Portugal

Rua de João de Deus, nº 19, Venda Nova,

2700-487, Amadora

Portugal

O

Arrow Generiques

26 Avenue Tony Garnier,

69007, Lyon,

France

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

Germany: DeferasiPUREN 90 mg Filmtabletten

Belgium: Deferasirox AB 90 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten

Spain: Deferasirox Aurovitas 90 mg film-coated tablets EFG

France: DEFERASIROX ARROW 90 mg, comprimé pelliculé

Italy: Deferasirox Aurobindo

Netherlands: Deferasirox Aurobindo 90 mg filmomhulde tabletten

Portugal: Deferasirox Generis

Date of the Last Revision of this Prospectus:January 2023

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