Deferasirox Stada 360 mg Film-Coated Tablets

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 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

What is deferasirox

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

What deferasirox is used for

Repeated blood transfusions may be necessary in patients with various types of anemia (e.g., thalassemia, sickle cell anemia, or myelodysplastic syndromes (MDS)). However, repeated blood transfusions can cause an accumulation of excess iron. This is because blood contains iron, and the body does not have a natural way to remove excess iron obtained from blood transfusions. In patients with non-transfusion-dependent thalassemia syndromes, iron overload may also occur over time, mainly due to increased absorption of iron from the diet in response to low blood cell counts. Over time, excess iron can damage important organs such as the liver and heart. Medicines called 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 thalassemia 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 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 and older who have iron overload associated with non-transfusion-dependent thalassemia syndromes, when treatment with deferoxamine is contraindicated or not suitable.

2. What you need to know before you take Deferasirox Stada

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, tell 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 chelator medicine.

Deferasirox is not recommended

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

Warnings and precautions

Consult your doctor or pharmacist before starting deferasirox.

• if you have a kidney or liver problem.
• if you have a heart problem due to iron overload.
• if you notice a pronounced decrease in the amount of urine you pass (sign of a kidney problem).
• 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, redness of the skin, 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, pain in the upper right abdomen, yellowing of the 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 suffer from vomiting blood and/or black stools.
• if you suffer from frequent abdominal pain, particularly after eating or taking deferasirox.
• if you suffer from 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, you will have regular blood and urine tests. These tests will monitor the amount of iron in your body (ferritin level in the blood) to see how well the treatment with deferasirox is working. The tests will also monitor kidney function (creatinine level in the blood, protein in the urine) and liver function (transaminase level in the blood). Your doctor may ask you to have a kidney biopsy if they suspect significant kidney damage. They may also perform MRI (magnetic resonance imaging) tests 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 also use these tests to decide when to stop your treatment with deferasirox.

Every year, your vision and hearing will be checked during treatment as a precaution.

Other medicines and deferasirox

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

• other iron chelators, which must not be taken with deferasirox,
• antacids (medicines used to treat heartburn) containing aluminum, which must not be taken at the same time of day as deferasirox,
• cyclosporine (used to prevent organ rejection or for other diseases 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),
• colestiramine (used to lower cholesterol levels in the blood),
• busulfan (used as pre-transplant treatment to destroy the original bone marrow before transplantation).

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

Elderly (65 years and over)

Deferasirox can be used by people over 65 years at the same dose as other adults. Elderly patients 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 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 have a baby, ask your doctor for advice before taking this medicine.

Treatment with deferasirox is not recommended during pregnancy unless clearly necessary.

If you are currently using an oral or patch contraceptive to prevent pregnancy, you should use an additional or different contraceptive (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 machines until you feel normal again.

3. How to take Deferasirox Stada

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

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, 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 each day.

• the usual daily dose of deferasirox film-coated tablets at the start of treatment for patients who receive 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 who do not receive regular 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 regular blood transfusions,
• 14 mg per kilogram of body weight for adult patients who do not receive regular blood transfusions,
• 7 mg per kilogram of body weight for children and adolescents who do not receive regular blood transfusions.

Deferasirox is also available in "dispersible" tablets. If you switch from dispersible tablets to these film-coated tablets, you will need a dose adjustment.

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 a light meal.

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

Patients with 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). The entire dose should be consumed immediately, without saving any for later.

How long to take deferasirox

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

If you are unsure how long to 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 a hospital immediately. Show the doctor the pack of 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 can 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. Telephone 915 620 420, indicating the medicine and the amount used. You may need medical treatment.

If you forget to take deferasirox

If you have missed a dose, take it as soon as you remember on the same day. Take the next dose according to your normal 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 your doctor tells you to. If you stop taking it, the 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 all people suffer from them. Most adverse effects are mild or moderate and usually disappear after a few days or weeks of treatment.

Some adverse effects can be serious and require immediate medical attention.

These adverse effects are rare (may affect up to 1 in 100 people) or very rare (may affect up to 1 in 1,000 people)

stop taking the medicine and inform your doctor immediately.

Some adverse effects can be serious.

These adverse effects are rare

inform your doctor as soon as possible.

Other Adverse Effects

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

• changes in kidney function tests.

Common (may affect up to 1 in 10 people)

• gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, bloating, constipation, indigestion.
• rash
• headache
• changes in liver function tests
• itching
• changes in urine tests (protein in the urine)

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

Rare (may affect up to 1 in 100 people)

• dizziness
• fever
• throat pain
• swelling in arms and legs
• changes in skin color
• anxiety
• sleep disturbance
• fatigue

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

Frequency Not Known(cannot be calculated from available data).

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

Reporting Adverse Effects

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

5. Storage of Deferasirox Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine 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 medicine does not require special storage conditions.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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:

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); aluminum indigo lacquer (E132).

Appearance of the Product and Package Contents

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 are marked with "90" on one side and smooth on the other.
• Deferasirox 180 mg are film-coated tablets, blue in color, and are marked with "180" on one side and smooth on the other.
• Deferasirox 360 mg are film-coated tablets, dark blue in color, and are 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/Aluminum blisters. The blister consists of a base layer of PVC/PE/PVDC sealed with an aluminum layer.

Blister containing 30 film-coated tablets

Blister containing 90 film-coated tablets

Single-dose blister containing 30 x 1 film-coated tablets

Single-dose blister containing 90 x 1 film-coated tablets

Multiples packages containing 300 (10 packages of 30) film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory 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 Last Revision of this Prospectus:February 2021

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