Deferasirox Stada 360 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Deferasirox Stada 90 mg film-coated tablets EFG

Deferasirox Stada 180 mg film-coated tablets EFG

Deferasirox Stada 360 mg film-coated tablets EFG

Read all of this 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 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 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.

Contents of the leaflet:

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

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

What deferasirox is

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 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 (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 who are 6 years of age 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 Stada

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: a 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-coloured 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 levels of ammonia in the blood, 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, particularly 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 diarrhoea 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 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. 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

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 for the treatment of HIV infection),
• paclitaxel (used for cancer treatment),
• 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 transplant preparation to destroy the original bone marrow before transplantation).

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 side effects (especially diarrhoea) than younger patients. Your doctor should closely monitor any 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 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 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, do not drive or operate tools or machinery until you feel normal again.

3. How to take Deferasirox Stada

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

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

How much deferasirox you should 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 is:
  • 14 mg per kilogram of body weight for patients receiving regular blood transfusions.
  • 7 mg per kilogram of body weight for patients not receiving regular blood transfusions.
• Depending on your response to treatment, your doctor may later adjust your dose upward or downward.
• 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 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 should be consumed immediately; do not save any for later use.

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 periodically monitor your condition 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 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, 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 the previous section "How long to take deferasirox").

4. Possible adverse effects

Like all medicines, this medicine may 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 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-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 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 have 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.
• 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 colour
• anxiety
• sleep disturbances
• fatigue

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

Frequency not known (cannot be estimated from the 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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which appears on the blister and outer packaging after 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 packaging that is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Deferasirox Stada

The active substance is deferasirox.

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

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

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

The other components are:

Tablet core: Crospovidone (E1202); povidone (E1201); microcrystalline cellulose (E460); magnesium stearate (E470b); poloxamer; and anhydrous colloidal silica (E551).

Tablet coating: Hypromellose (E464); titanium dioxide (E171); macrogol (E1521); talc (E553b); indigo carmine aluminium lake (E132).

Appearance of the product and pack contents

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

• Deferasirox 90 mg are light blue film-coated tablets marked with “90” on one side and smooth on the other.
• Deferasirox 180 mg are blue film-coated tablets marked with “180” on one side and smooth on the other.
• Deferasirox 360 mg are dark blue film-coated tablets marked with “360” on one side and smooth on the other.

Deferasirox 90 mg, 180 mg, and 360 mg film-coated tablets are available in PVC/PE/PVDC/Aluminium blisters. The blister consists of a base film made of PVC/PE/PVDC sealed with an aluminium foil.

Blisters containing 30 film-coated tablets

Blisters containing 90 film-coated tablets

Unit dose blisters containing 30 x 1 film-coated tablets

Unit dose blisters containing 90 x 1 film-coated tablets

Multiple packs containing 300 tablets (10 packs of 30) film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

PharOS MT Ltd.

HF62X, Hal-Far Industrial Estate

Birzebbugia BBG 3000

Malta

Date of the most recent revision of this leaflet: February 2021

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