Deferasirox Abdi 360 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Deferasirox Abdi 90 mg film-coated tablets EFG

Deferasirox Abdi 180 mg film-coated tablets EFG

Deferasirox Abdi 360 mg film-coated tablets EFG

Read the entire leaflet carefully before you or your child starts 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 do, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents:

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

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

What is deferasirox

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

What deferasirox is used for

Repeated blood transfusions may be necessary in patients with various types of anaemia (e.g. thalassaemia, sickle cell anaemia or myelodysplastic syndromes (MDS)). However, repeated blood transfusions can lead to an accumulation of excess iron. This is because blood contains iron, and the body has no natural way of eliminating the excess iron obtained through blood transfusions. In patients with non-transfusion-dependent thalassaemia syndromes, iron overload may also develop over time, primarily due to increased absorption of dietary iron in response to low blood cell counts. Over time, excess iron can damage important organs such as the liver and heart. Medicines known as iron chelators are used to remove excess iron and to 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 who have iron overload due to infrequent blood transfusions, in patients with other types of anaemias, 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 thalassaemia syndromes but who are not transfusion-dependent, when treatment with deferoxamine is contraindicated or not suitable.

2. What you need to know before taking Deferasirox Abdi

Do not take deferasirox

• if you are allergic to deferasirox or any of the other ingredients of this medicine (listed in section 6). If this applies to you**, inform your doctor before taking this medicine**. 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 medicine.

Deferasirox 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 starting deferasirox.

• if you have kidney or liver problems.
• if you have heart problems due to iron overload.
• if you notice a marked decrease in the amount of urine you pass (a sign of kidney problems).
• if you develop a severe rash, or have 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, blistering of 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 part of the abdomen, yellowing or increased yellowing of the skin or eyes, and dark-colored urine (signs of liver problems).
• if you notice difficulty thinking, remembering information, or solving problems, or if you are less alert or awake, or feel drowsy and weak (signs of high blood ammonia levels, which may be associated with liver or kidney problems, see also section 4 "Possible side effects").
• if you have vomiting with blood and/or black stools.
• if you have frequent abdominal pain, especially after eating or taking deferasirox.
• if you have frequent heartburn.
• if you have low platelet or white blood cell counts 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

During treatment, you will have regular blood and urine tests. These tests will monitor the amount of iron in your body (blood ferritin levels) to assess how well deferasirox treatment is working. The tests will also monitor kidney function (blood creatinine levels, presence of protein in urine) and liver function (blood transaminase levels). Your doctor may request a kidney biopsy if significant kidney damage is suspected. You may also undergo MRI (magnetic resonance imaging) tests to determine the amount of iron in your liver. Your doctor will use these test results to determine the most appropriate dose of deferasirox for you and to decide when your treatment with deferasirox should be stopped.

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

Other medicines and deferasirox

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

• other iron chelators – these must not be taken with deferasirox,
• antacids (medicines used to treat heartburn) containing aluminium – these must not be taken at the same time of day as deferasirox,
• 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 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),
• colestyramine (used to reduce blood cholesterol levels),
• busulfan (used as a pre-transplant treatment to destroy the original bone marrow before transplant),
• midazolam (used to relieve anxiety and/or sleep disturbances).

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

Elderly (aged 65 years and over)

Deferasirox can be used in people over 65 years of age at the same dose as in other adults. Elderly patients may experience more adverse effects (especially diarrhea) than younger patients. Your doctor should closely monitor for adverse 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, your doctor will adjust the dose accordingly.

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 plan to become pregnant, consult your doctor before using this medicine.

Treatment with deferasirox during pregnancy is not recommended 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.

Breastfeeding is not recommended during treatment with deferasirox.

Driving and use of machines

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

Deferasirox Abdi contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., essentially "sodium-free".

3. How to take Deferasirox Abdi

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

Follow exactly the dosing instructions for this medicine as provided by your doctor. If in doubt, consult your doctor or pharmacist again.

How much deferasirox should you take

The dose of deferasirox is based on body weight for all patients. Your doctor will calculate the dose you require and will inform you how many film-coated tablets you should take each day.

• The usual daily starting dose of deferasirox film-coated tablets for patients receiving 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 starting dose of deferasirox film-coated tablets for patients not receiving regular blood transfusions is 7 mg per kilogram of body weight.
• Depending on your response to treatment, your doctor may later adjust your dose to a higher or lower level.
• The maximum recommended daily dose of deferasirox 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 adult patients 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 you switch from dispersible tablets to these film-coated tablets, a dose adjustment will be required.

When to take deferasirox

• Take deferasirox once daily, every day, at the same time, with a glass of water.
• Take deferasirox film-coated tablets either on an empty stomach or with light meals.

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

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

How long should you take deferasirox

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

If you have any doubts about how long you should continue taking deferasirox, consult your doctor.

If you take more deferasirox than you should

If you have taken too much deferasirox, or if someone accidentally takes your tablets, contact your doctor or go to a hospital immediately. Show the doctor the medicine packaging. You may require urgent medical treatment. You may experience effects such as abdominal pain, diarrhea, nausea and vomiting, and kidney or liver problems, which could be serious.

In case of overdose or accidental ingestion, contact your doctor or pharmacist, go to a hospital immediately, or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount taken. You may require medical treatment.

If you forget to take deferasirox

If you forget to take a dose, take it as soon as you remember on the same day. Take your 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 instructed by your doctor. If you stop taking it, excess iron will not be removed from your body (see also the previous section "How long should you take deferasirox").

4. Possible adverse effects

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

Some adverse effects may 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 develop a severe rash, or have difficulty breathing, dizziness, or swelling, especially of the face and throat (signs of a severe allergic reaction),
• If you experience a combination of any of the following symptoms: rash, skin redness, blistering of 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 marked decrease in urine volume (a sign of kidney problems),
• If you notice a combination of drowsiness, pain in the upper right part of the abdomen, yellowing or increased yellowing of the skin or eyes, and dark-coloured urine (signs of liver problems),
• If you have difficulty thinking, remembering information, or solving problems, or are less alert or awake, or feel drowsy and weak (signs of high blood ammonia levels, which may be associated with liver or kidney problems and may lead to changes in brain function),
• If you have vomiting with blood and/or black stools,
• If you have frequent abdominal pain, particularly after eating or taking deferasirox,
• If you have frequent heartburn,
• If you experience partial loss of vision,
• If you have severe pain in the upper part of the stomach (pancreatitis),

Stop taking the medicine and contact your doctor immediately.

Some adverse effects may become serious.

These adverse effects are uncommon

• If you have blurred vision,
• If you experience hearing loss,

inform your doctor as soon as possible.

Other adverse effects

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

• Abnormalities in kidney function tests.

Common (may affect up to 1 in 10 people)

• Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain, bloating, constipation, indigestion.
• Rash
• Headache
• Abnormalities in liver function tests
• Itching
• Abnormalities in urine tests (protein in urine)

If you experience 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 colour
• Anxiety
• Sleep disturbance
• Fatigue

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

Frequency not known (cannot be estimated from available data)

• Decrease in the number of blood cells involved in blood clotting (thrombocytopenia), decrease in red blood cells (worsening of anaemia), decrease in white blood cells (neutropenia), or decrease in all types of blood cells (pancytopenia)
• Hair loss
• Kidney stones
• Low urine output
• Rupture of the stomach or intestinal wall, which may be painful and cause nausea
• Severe pain in the upper part of the stomach (pancreatitis)
• Abnormal levels of acid in the blood

Reporting of adverse effects

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

5. Storage of Deferasirox Abdi

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister after CAD/EXP and on the outer packaging after CAD. The expiry date refers to the last day of the month indicated.
• Do not use any packaging that is damaged or shows signs of tampering.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Deferasirox Abdi

• The active substance is deferasirox.

• Each 90 mg film-coated tablet of Deferasirox Abdi contains 90 mg of deferasirox.

• Each 180 mg film-coated tablet of Deferasirox Abdi contains 180 mg of deferasirox.

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

  • The other components are:

Tablet core: microcrystalline cellulose (type 101), crospovidone (type A), poloxamer 188 (micronized), povidone, microcrystalline cellulose (type 102), silica (anhydrous colloidal), magnesium stearate.

Tablet coating: HPMC 2910/hypromellose, titanium dioxide (E171), macrogol / PEG, talc, indigo carmine aluminium lake (E132).

Appearance of Deferasirox Abdi and contents of the pack

Deferasirox Abdi is presented as film-coated tablets. The tablets are oval and biconvex.

• Deferasirox Abdi 90 mg film-coated tablets are light grey in colour and marked with the inscription «D1» on one side and the other side is smooth.
• Deferasirox Abdi 180 mg film-coated tablets are blue in colour and marked with the inscription «D2» on one side and the other side is smooth.
• Deferasirox Abdi 360 mg film-coated tablets are dark blue in colour and marked with the inscription «D3» on one side and the other side is smooth.

Pack sizes:

For all strengths: single packs containing 30 or 90 film-coated tablets.

In addition, for Deferasirox Abdi 360 mg: multiple packs containing 300 film-coated tablets (10 packs of 30).

Only certain pack sizes may be commercially available.

Marketing Authorization Holder:

ABDI FARMA GmbH

Donnersbergstraße 4

64646 Heppenheim, Germany

Manufacturer responsible:

Interpharma Services Ltd.

43A Cherni Vrach Blvd.,

1407 Sofia, Bulgaria

Or

Flavine Pharma France

3 Voie d’Allermagne, Vitrolles,

13127 France

You can request further information about this medicinal product by contacting the local representative of the marketing authorization holder:

Xentenel Pharma Europe, S.L.

Vallsolana Garden Business Park

Camí de Can Camps, 17-19 – Kibo Building

08174 Sant Cugat del Vallès, Spain

93 836 4600

[email protected]

Date of latest review of this leaflet: 03/2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)