Package Leaflet: Information for the User

Deferasirox Stada 90 mg Film-Coated Tablets

Deferasirox Stada 180 mg Film-Coated Tablets

Deferasirox Stada 360 mg Film-Coated TabletsEFG

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, talk to your doctor, pharmacist, even if they are not listed in this leaflet. See section 4.

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. Storage of Deferasirox Stada

6. Contents of the pack and additional information

What is deferasirox

This medication contains an active ingredient called deferasirox. It is an iron chelator, which is a medication used to eliminate excess iron from the body (also known as iron overload). It captures and eliminates excess iron, which is then mainly excreted in the feces.

For what it is used deferasirox

Repeated blood transfusions may be necessary in patients with various types of anemia (for example, thalassemia, sickle cell anemia, or myelodysplastic syndromes (MDS)). However, repeated blood transfusions can cause an accumulation of excess iron. This is because the blood contains iron and the body does not have a natural way to eliminate excess iron obtained with blood transfusions. In patients with non-transfusion-dependent thalassemic syndromes, iron overload can also appear over time, mainly due to an increase in iron absorption from the diet in response to low blood cell counts. Over time, excess iron can damage important organs such as the liver and heart. Medications called iron chelators are used to eliminate excess iron and to reduce the risk of causing damage to organs.

Deferasirox is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta-thalassemia major, aged 6 years or 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 or older who have iron overload associated with thalassemic syndromes, but who are not dependent on transfusions, when treatment with deferoxamine is contraindicated or not suitable.

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 is the case, inform your doctor before taking this medicine.Inform your doctor before taking this medicine if you think you may be allergic.
• if you have moderate or severe kidney disease.
• if you are currently taking any other iron chelating medicine.

Deferasirox is not recommended

• if you are in an advanced stage of myelodysplastic syndrome (MDS, a decrease in blood cell production by the bone marrow) or have advanced cancer.

Warnings and precautions

Consult your doctor or pharmacist before starting to take deferasirox.

• if you have a kidney or liver problem.
• if you have a heart problem due to iron overload.
• if you notice a significant decrease in the amount of urine you eliminate (a sign of kidney problems).
• 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, upper right abdominal pain, yellow or more yellow 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 experience vomiting with blood and/or black stools.
• if you experience frequent abdominal pain, particularly after eating or taking deferasirox.
• if you experience 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

During treatment, regular blood and urine tests will be performed. These tests will control the amount of iron in your body (iron level in the blood, measured by ferritin) to observe how the treatment with deferasirox is working. The tests will also control kidney function (creatinine level in the blood, presence of protein in the urine) and liver function (transaminase levels in the blood). Your doctor may request a kidney biopsy if they suspect significant kidney damage. They may also perform MRI scans 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 use these tests to decide when to stop your treatment with deferasirox.

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

Other medicines and deferasirox

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

• other iron chelating medicines, which should not be taken with deferasirox.
• antacids (medicines used to treat heartburn) containing aluminum, which should not be taken at the same time of day as deferasirox.
• ciclosporin (used to prevent organ transplant rejection or for other diseases such as rheumatoid arthritis or atopic dermatitis).
• simvastatin (used to lower cholesterol levels).
• some analgesics or anti-inflammatory medicines (e.g. aspirin, ibuprofen, corticosteroids).
• oral bisphosphonates (used to treat osteoporosis).
• blood thinners (used to prevent or treat blood clots).
• hormonal contraceptives (medicines for birth control).
• bepridilo, ergotamine (used for heart problems and migraines).
• repaglinida (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).
• colestiramine (used to reduce cholesterol levels in the blood).
• busulfan (used as a pre-transplant treatment to destroy the original bone marrow before transplant).

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

Older adults (65 years and older)

Deferasirox can be used by people over 65 years old at the same dose as other adults. Older adults 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 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.

Deferasirox is not recommended for children under 2 years old.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Deferasirox treatment is not recommended during pregnancy unless clearly necessary.

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

Deferasirox treatment is not recommended during breastfeeding.

Driving and operating machinery

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

The treatment with deferasirox will be supervised by a doctor with experience in treating iron overload caused by blood transfusions.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, 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 per day.

• The normal 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 normal 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 can also be found in "dispersible" tablets. If you switch from dispersible tablets to these film-coated tablets, you will need to adjust your dose.

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 light meals.

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

Patients who have difficulty swallowing tablets can crush deferasirox film-coated tablets and take the powder with a soft food, such as yogurt or apple sauce (apple puree). You must consume the entire dose immediately, without saving any for later.

How long to take deferasirox

Continue taking deferasirox every day for the time your doctor tells you to.This is a long-term treatment, which may last for months or years. Your doctor will monitor your situation periodically to check that the treatment is having the desired effect (see also section 2: "Monitoring your deferasirox treatment").

If you have 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 has taken your tablets by mistake, contact your doctor or go to the hospital immediately. Show the doctor the packaging of the 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 could be serious.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, go to the hospital immediately, or call the Toxicology Information Service. Phone 915 620 420, indicating the medication and the amount used. You may need medical treatment.

If you forget to take deferasirox

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

If you interrupt the treatment with deferasirox

Do not stop taking deferasirox unless your doctor tells you to. If you stop taking it, the excess iron will not be eliminated from your body (see also the previous section "How long to take deferasirox").

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

Some side effects may be serious and require immediate medical attention.

These side effects are infrequent (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 kidney problems),
• if you notice a combination of drowsiness, upper right abdominal pain, yellow or darker 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 and cause changes in brain function),
• if you experience vomiting with blood and/or black stools,
• if you experience frequent abdominal pain, particularly after eating or taking deferasirox,
• if you experience frequent heartburn,
• if you experience partial loss of vision,
• if you experience intense pain in the upper abdomen (pancreatitis),

Stop taking the medicine and inform your doctor immediately.

Some side effects may be severe.

These side effects are infrequent

• if you have blurred vision,
• if you lose hearing ability,

Inform your doctor as soon as possible.

Other side effects

Frequent (may affect more than 1 in 10 people)

• alterations in kidney function tests.

Common (may affect up to 1 in 10 people)

• gastrointestinal changes, such as nausea, vomiting, diarrhea, abdominal pain, swelling, constipation, poor digestion.
• rashes
• headaches
• alterations in liver function tests
• itching
• alterations in urine tests (protein in urine)

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

Infrequent (may affect up to 1 in 100 people)

• dizziness
• fever
• sore throat
• swelling in arms and legs
• skin color changes
• anxiety
• sleep disturbances
• fatigue

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

Unknown frequency(cannot be calculated from available data).

• decrease in the number of cells involved in blood clotting (thrombocytopenia), the number of red blood cells (worsening of anemia), the number of white blood cells (neutropenia) or the number of all types of blood cells (pancytopenia)
• hair loss
• kidney stones
• low urine production
• rupture of the stomach or intestine wall that may be painful and cause nausea
• severe pain in the upper abdomen (pancreatitis)
• abnormal levels of acid in the blood

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es . By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use any packaging that is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Deferasirox Stada

The active ingredient is deferasirox.

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

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

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

The other components are:

Core of the tablet: Crospovidone (E1202); povidone (E1201); microcrystalline cellulose (E460); magnesium stearate (E470b); poloxamer and anhydrous colloidal silica (E551).

Tablet coating:Hydroxypropyl methylcellulose (E464); titanium dioxide (E171); macrogol (E1521); talc (E553b); aluminium lake of indigo (E132).

Appearance of the product and contents of the package

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

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

Deferasirox 90 mg; 180 mg; 360 mg film-coated tablets are presented in PVC/PE/PVDC/Aluminium blisters. The blister consists of a PVC/PE/PVDC base sheet sealed with an aluminium sheet.

Blister containing 30 film-coated tablets

Blister containing 90 film-coated tablets

Unit blister containing 30 x 1 film-coated tablets

Unit blister containing 90 x 1 film-coated tablets

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

PharOS MT Ltd.

HF62X, Hal-Far Industrial Estate

Birzebbugia BBG 3000

Malta

Last review date of this leaflet:February 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/