Deferasirox Zentiva 360 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Deferasirox Zentiva 360 mg film-coated tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

This medicinal product contains an active substance called deferasirox. It is an iron chelator, a type of 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 Zentiva 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 received 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 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 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 Zentiva

Do not take Deferasirox Zentiva

• 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 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 medicine.

Deferasirox Zentiva 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 taking this medicine if:

• you have kidney or liver problems.
• you have heart problems due to iron overload.
• you notice a marked decrease in the amount of urine you pass (a sign of kidney problems).
• you develop a severe rash, or have difficulty breathing, dizziness, or swelling,

mainly of the face and throat (signs of a severe allergic reaction, see also section 4

“Possible side effects”).

• 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”).

• 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).

• you notice difficulty thinking, remembering information, or solving problems, or 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”).

• you have vomiting with blood and/or black stools.

• you have frequent abdominal pain, particularly after eating or taking deferasirox.

• you have frequent heartburn.

• you have low platelet or white blood cell counts in your blood test.

• you have blurred vision.

• you have diarrhea or vomiting.

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

Monitoring your treatment with Deferasirox Zentiva

During treatment, you will have regular blood and urine tests. These tests will monitor the amount of iron in your body (serum 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 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 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 Zentiva

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,
• ciclosporine (used to prevent organ transplant rejection 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 (birth control medicines),
• 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 part of pre-transplant treatment to destroy the original bone marrow before transplant).

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 aged 65 years and over 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, the 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 during pregnancy is not recommended unless clearly necessary.

If you are currently using an oral or patch contraceptive to prevent pregnancy, you should use an additional or different contraceptive method (e.g. condom), as deferasirox may reduce the effectiveness of oral and patch contraceptives.

Breastfeeding is not recommended during treatment with deferasirox.

Driving and using machines

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

Deferasirox Zentiva contains lactose

Lactose is an excipient in this medicine. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Deferasirox Zentiva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; therefore, it is essentially “sodium-free”.

3. How to take Deferasirox Zentiva

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

Follow exactly the instructions for use of this medicine as given by your doctor.

If you are unsure, consult your doctor or pharmacist again.

How much Deferasirox Zentiva you should take

The dose of deferasirox is based on body weight for all patients. Your doctor will calculate the dose you require and will tell you how many tablets you should 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 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 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, a dose adjustment will be required.

When to take Deferasirox Zentiva

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

Taking deferasirox at the same time each day will 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 yoghurt or apple puree (applesauce). The entire dose must be consumed immediately; do not save any for later.

How long to take Deferasirox Zentiva

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 take deferasirox, consult your doctor.

If you take more Deferasirox Zentiva 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 tablet packaging. You may require urgent medical treatment. You may experience effects such as abdominal pain, diarrhoea, 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, indicating the medicine and the amount taken. You may require medical treatment.

If you forget to take Deferasirox Zentiva

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 Zentiva

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 may cause adverse effects, although not everyone experiences 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 develop a severe rash, or have difficulty breathing and 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, 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 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 urine (signs of liver problems),
• If you experience 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 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 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 disturbances such as nausea, vomiting, diarrhea, abdominal pain, bloating, constipation, indigestion.
• Rashes
• 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 color
• 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), in the number of red blood cells (worsening of anaemia), in the number of white blood cells (neutropenia), or in the number of 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 Zentiva

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. 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 a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Deferasirox Zentiva

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

The other components are: microcrystalline cellulose (types 101 and 102); povidone K-30; crospovidone (types A and B); poloxamer 188; anhydrous colloidal silica; and magnesium stearate.

The tablet coating contains: lactose monohydrate, hypromellose (E464); titanium dioxide (E171); triacetin; and indigo carmine aluminium lake (E132) (contains sodium).

Appearance of the product and contents of the pack

Blue, oval, biconvex film-coated tablets, imprinted with “D7FX” on one side and “360” on the other. Approximate tablet dimensions: 15 mm in length x 9 mm in width.

Packs containing 30 or 90 film-coated tablets. The blister may be perforated or non-perforated.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Zentiva, k.s.

U kabelovny 130,

Dolní Mecholupy,

102 37 Prague 10

Czech Republic

Manufacturer:

Synthon Hispania S.L.

c/ Castelló, 1

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

Synthon B.V.

Microweg, 22

6545 CM (Nijmegen)

The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1

28224 Pozuelo de Alarcón, Madrid

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

The Netherlands: Deferasirox Synthon 360 mg, filmomhude tabletten

Germany: Deferasirox Synthon 360 mg Filmtabletten

Bulgaria: ???????????? Synthon 360 mg

Spain: Deferasirox Zentiva 360 mg film-coated tablets EFG

United Kingdom: Deferasirox 360 mg film-coated tablets

Czech Republic: Deferasirox Synthon

Date of the most recent review of this summary: October 2019

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