Prospecto:Information for the User

Deferasirox Aurovitas 360 mg Film-Coated Tablets

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• 1. If you have any doubts, consult yourdoctor or pharmacist.

-This medication has been prescribedonlyto you or your child, and should not be given to other people even if they havethe same symptomsas you, as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospectus. See section 4.

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

2.What you need to knowbeforestarting totake Deferasirox Aurovitas

3.How to take Deferasirox Aurovitas

4.Possible adverse effects

5Storage of Deferasirox Aurovitas

6.Contents of the package and additional information

This medication contains an active ingredient called deferasirox. It is an iron chelator, a medication used to eliminate excess iron from the body (also known as iron overload). It captures and eliminates excess iron, which is then primarily excreted in the feces.

What is Deferasirox Aurovitas used for

Repeated blood transfusions may be necessary in patients with various types of anemia (for example, 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 does not have a natural way to eliminate excess iron obtained through blood transfusions. In patients with non-transfusion-dependent thalassemic syndromes, iron overload can also appear over time, mainly due to an increase in iron absorption from the diet in response to low blood cell counts. Over time, excess iron can damage important organs such as the liver and heart. Iron chelating medications are used to eliminate excess iron and reduce the risk of causing damage to organs.

Deferasirox is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta thalassemia major, aged 6 years or 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 or older who have iron overload associated with thalassemic syndromes, but who are not dependent on transfusions, when treatment with deferoxamine is contraindicated or not suitable.

Do not take Deferasirox Aurovitas

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6). If this is the case, inform 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 chelating medication.

Deferasirox Aurovitas is not recommended

• if you are in an advanced stage of myelodysplastic syndrome (SMD, reduction in blood cell production by the bone marrow) or have advanced cancer.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication

• 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 eliminate (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: 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, upper right abdominal pain, yellow or more yellowish 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 experience vomiting with blood and/or black stools.
• if you experience frequent abdominal pain, particularly after eating or taking deferasirox.
• if you experience 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, inform your doctor immediately.

Monitoring your treatment with Deferasirox Aurovitas

During treatment, regular blood and urine tests will be performed. These tests will control the amount of iron in your body (blood ferritin level) to observe how the deferasirox treatment is working. The tests will also control kidney function (blood creatinine level, presence of protein in the urine) and liver function (blood transaminase levels). Your doctor may request a kidney biopsy if they suspect significant renal damage. They may also perform MRI scans 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 deferasirox treatment.

Your vision and hearing will be checked annually during treatment as a precaution.

Other medications and Deferasirox Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes in particular:

• other iron chelating medications, which should not be taken with deferasirox.
• antacids (medications used to treat heartburn) containing aluminum, which should not be taken at the same time of day as deferasirox.
• ciclosporin (used to prevent organ transplant rejection or for other diseases such as rheumatoid arthritis or atopic dermatitis).
• simvastatin (used to lower cholesterol levels).
• some analgesics or anti-inflammatory medications (e.g. aspirin, ibuprofen, corticosteroids).
• oral bisphosphonates (used to treat osteoporosis).
• anticoagulant medications (used to prevent or treat blood clots).
• hormonal contraceptives (medications for birth control).
• bepridilo, ergotamine (used for heart problems and migraines).
• repaglinida (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).
• colestiramine (used to reduce cholesterol levels in the blood).
• busulfan (used as a pre-transplant treatment to destroy the original bone marrow before the transplant).
• midazolam (used to alleviate anxiety and/or sleep problems).

Additional tests may be needed to control the levels of some of these medications in the blood.

Older adults (65 years and older)

Deferasirox can be used by people over 65 years old at the same dose as other adults. Older adults may experience more side effects (especially diarrhea) than younger patients. The doctor should closely monitor side effects that may require 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 old.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.

Deferasirox treatment 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 method (e.g. condom), as deferasirox may reduce the effectiveness of hormonal contraceptives.

Deferasirox treatment is not recommended during breastfeeding.

Driving and operating machinery

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

The treatment with deferasirox will be supervised by a doctor with experience in treating iron overload caused by blood transfusions.

Follow exactly the administration instructions of this medication indicated by your doctor.This medicationindicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

How much Deferasirox Aurovitas should be taken

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.

Deferasirox Aurovitas is not available in dispersible tablets. To use dispersible tablets, other medications containing deferasirox must 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 per day.

How often should Deferasirox Aurovitas be taken

Patients who have difficulty swallowing tablets can crush deferasirox film-coated tablets and take the powder with a soft food, such as yogurt or apple sauce (apple puree). The entire dose must be consumed immediately, without saving any for later.

How long should Deferasirox Aurovitas be taken

Continue taking deferasirox every day for the time your doctor tells you to.This is a long-term treatment that may last for months or years. Your doctor will monitor your situation periodically to check that the treatment is having the desired effect (see also section 2: "Monitoring your treatment with Deferasirox Aurovitas").

If you have doubts about how long you should 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 the hospital immediately. Show the doctor the packaging 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 could be serious.

If you forget to take Deferasirox Aurovitas

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

If you interrupt treatment with Deferasirox Aurovitas

Do not stop taking deferasirox unless your doctor tells you to. If you stop taking it, the excess iron will not be eliminated from your body (see also the previous section "How long should Deferasirox Aurovitas be taken").

Like all medicines, this medicine may cause side effects, although not everyone will experience them. Most side effects are mild or moderate and usually disappear within a few days or weeks of treatment.

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

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

Stop taking the medicine and inform your doctor immediately.

Some side effects may be serious.

These side effects are rare

Inform your doctor as soon as possible.

Other side effects

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

Common (may affect up to 1 in 10 people)

If you experience any of these side effects severely, inform your doctor.

Rare (may affect up to 1 in 100 people)

If you experience any of these side effects severely, inform your doctor.

Unknown frequency(cannot be calculated from available data).

Reporting of side effects

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

Keepthis medicationout of the sight and reach of children.

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need atthe SIGREpoint at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Deferasirox Aurovitas

• The active ingredient is deferasirox.

Each film-coated tablet contains 360 mg of deferasirox.

• The other components are :

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

Film-coatingHypromellose 2910 (6 mPas),titanium dioxide, macrogol 6000, talc, aluminum indigo carmine (3 % - 5%)lacquer of aluminum indigo carmine (11 % - 14 %)

Appearance of the product and contents of the package

Film-coated tablet.

Deferasirox Aurovitas 360 mg film-coated tablets EFG

Film-coated tablet, dark blue, oval, biconvex, with beveled edges, engraved with "DF" on one face and "360" on the other.

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid,

Spain

Responsible manufacturer:

APL Swift Services (Malta) Ltd,

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000,

Malta

or

Generis Farmacêutica S.A., Portugal

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

2700 487, Amadora

Portugal

or

Arrow Generiques

26 Avenue Tony Garnier,

69007, Lyon,

France

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany: DeferasiPUREN 360 mg Filmtabletten

Belgium:Deferasirox AB 360 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten

Spain Deferasirox Aurovitas 360 mg comprimidos recubiertos con película EFG

France: DEFERASIROX ARROW 360 mg, comprimé pelliculé

Italy: Deferasirox Aurobindo

Netherlands Deferasirox Aurobindo 360 mg filmomhulde tabletten

Portugal Deferasirox Generis

Last review date of thisleaflet:January 2023

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)