Deferasirox Teva-Ratiopharm 360 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Deferasirox Teva-ratiopharm 360 mg film-coated tablets EFG

Read all of this leaflet carefully before you or your child 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 or your child only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you or your child experience any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What is Deferasirox Teva-ratiopharm and what is it used for

What is deferasirox

This medicine contains an active substance called deferasirox. It is an iron chelator, which is a type of medicine used to remove excess iron from the body (also known as iron overload). It binds to 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 (for example, 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 received from blood transfusions. In 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 thalassaemic 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 Teva-ratiopharm

Do not take deferasirox

• if you are allergic to deferasirox or to 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 low white blood cell counts in your blood test.
• if you have blurred vision.
• if you have diarrhoea or vomiting.

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

Monitoring your deferasirox treatment

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

As a precaution, your vision and hearing will be checked annually during treatment.

Other medicines and deferasirox

Tell 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 pre-transplant treatment to destroy the original bone marrow before transplant),
• midazolam (used to relieve anxiety and/or sleep problems).

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

Elderly patients (aged 65 years and over)

Deferasirox can be used in patients aged 65 years and over at the same dose as other adults. Elderly patients may experience more side effects (especially diarrhoea) than younger patients. Your doctor should closely monitor for 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, 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 are planning to become pregnant, consult your doctor before using 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 method (e.g. condom), as 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 machinery until you feel normal again.

3. How to take Deferasirox Teva-ratiopharm

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 given 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 need and will 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 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 dose of deferasirox film-coated tablets at the start of treatment 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 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 receiving regular blood transfusions,
• 14 mg per kilogram of body weight for adults 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, the dose you need will change. Your doctor will calculate the required dose and inform you how many film-coated tablets to take each day. Deferasirox Teva-ratiopharm is not available as dispersible tablets. For this pharmaceutical form, other deferasirox-containing medicines must be used.

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 puree (applesauce). The entire dose must be consumed immediately; do not save any for later.

How long to 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 periodically 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 take deferasirox, consult your doctor.

If you take more deferasirox than you should

If you have taken too much deferasirox, or if someone else accidentally takes your tablets, contact your doctor or go to a hospital immediately. Show the doctor the tablet 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, consult your doctor or pharmacist, go to a hospital immediately, or call the Toxicology Information Service at telephone number 915 620 420, stating the name of 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 previous section "How long to take deferasirox").

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Most 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 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, 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 notice 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 cause changes in brain function),
• If you vomit blood and/or have black stools,
• If you have frequent abdominal pain, particularly after eating or taking deferasirox,
• If you have frequent heartburn,
• If you have partial loss of vision,
• If you have severe pain in the upper part of the stomach (pancreatitis),

stop taking the medicine and inform 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 disturbances
• 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 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 type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 Teva-ratiopharm

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and on the outer packaging following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Return unused packs and medicines to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused packs and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Deferasirox Teva-ratiopharm

The active substance is deferasirox.

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

The other components are:

• Tablet core: crospovidone (E1202); povidone (E1201); microcrystalline cellulose (E460); magnesium stearate (E470b); poloxamer; and colloidal anhydrous silica (E551).
• Coating: hypromellose (E464); titanium dioxide (E171); macrogol (E1521); talc (E553b); indigo carmine aluminium lake (E132).

Nature and contents of the container

• Deferasirox Teva-ratiopharm 360 mg film-coated tablets are dark blue, oval-shaped, biconvex tablets with bevelled edges, printed with “360” on one side and smooth on the other. The approximate dimensions of the tablet are 16.6 mm x 6.6 mm.

Deferasirox Teva-ratiopharm is packaged in aluminium-PVC/PE/PVDC blisters. The following pack sizes are available:

• Blister packs containing 30, 90 or 100 film-coated tablets, or multiple packs containing 300 tablets (10 packs of 30) film-coated tablets.
• Unit-dose perforated blister packs containing 30x1 or 90x1 film-coated tablets, or multiple packs containing 300x1 (10 packs of 30x1) film-coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Spain

Manufacturer

PharOs MT LtdHF 62X, Hal-Far Industrial EstateBBG3000 BirzebbugiaMalta

Date of the most recent revision of this leaflet: May 2023

Other sources of information

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

QR code to be included>

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85516/P_85516.html