Deferasirox Tarbis 360 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Deferasirox Tarbis 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

What is deferasirox

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 is deferasirox 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 does not have a natural way to remove excess iron obtained from blood transfusions. In patients with non-transfusion-dependent thalassemic syndromes, iron overload may also appear 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 chelatorsare 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 non-transfusion-dependent thalassemic syndromes, when treatment with deferoxamine is contraindicated or not suitable.

2. What you need to know before taking Deferasirox Tarbis

Do not take Deferasirox Tarbis

• if you are allergic to deferasirox or any of the other ingredients of this medicine (listed in section 6). If this is the case, 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 Tarbis 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 deferasirox.

• 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 produce (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 diarrhea or vomiting.

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

Monitoring your treatment with Deferasirox Tarbis

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 perform 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 Tarbis

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 aluminum, which must not be taken at the same time of day as deferasirox,
• cyclosporine (used to prevent organ rejection or to treat 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 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 transplantation),
• midazolam (used to relieve anxiety and/or sleep disturbances).

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

Elderly patients (65 years and older)

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 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.

Treatment with 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) because deferasirox may reduce the effectiveness of hormonal contraceptives.

Breastfeeding is not recommended during treatment with deferasirox.

Driving and using machines

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

Deferasirox Tarbis 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 Tarbis

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 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 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 is also available in “dispersible” tablets. If you switch from dispersible tablets to these film-coated tablets, you will need a dose adjustment.

When to take deferasirox

• 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 entire dose should be consumed immediately, without saving any for later.

How long to take deferasirox

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 your treatment with deferasirox»).

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

If you take more deferasirox 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, 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

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

If you stop taking deferasirox

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 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 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 can 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 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)

• 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.
• 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.

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 intestinal 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, 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 Tarbis

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging 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 disposed of via wastewater or household waste. 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 will help protect the environment.

6. Package Contents and Additional Information

Composition of Deferasirox Tarbis

The active ingredient is deferasirox.

Each film-coated tablet contains 360 mg of deferasirox.

The other ingredients are

Core: Microcrystalline cellulose, crospovidone (Type A), poloxamer, povidone, anhydrous colloidal silica, sodium stearyl fumarate.

Tablet coating: Hypromellose (E464), titanium dioxide (E171), macrogol (E1521), talc (E553b).

Appearance of Deferasirox Tarbis and Package Contents

Oval, biconvex, film-coated tablets, white to off-white in color, engraved with '58' on one side and "V" on the other side (Dimensions: 16.95 mm x 6.70 mm).

Deferasirox Tarbis is available in blister packs containing 30 or 90 film-coated tablets and multiple packs containing 300 (10 packs of 30) film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

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

Germany: Deferasirox Amarox 360 mg Filmtabletten

Spain: Deferasirox Tarbis 360 mg film-coated tablets EFG

Netherlands: Deferasirox Amarox 360 mg filmomhulde tabletten

Date of the last revision of this prospectus: July 2022

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/