EXJADE 360 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

EXJADE 90mg film-coated tablets

EXJADE 180mg film-coated tablets

EXJADE 360mg film-coated tablets

deferasirox

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

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

1. What is EXJADE and what is it used for

What is EXJADE

EXJADE 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 EXJADE 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 has no 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 dietary iron 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.

EXJADE is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta-thalassemia major, aged 6 years and above.

EXJADE 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.

EXJADE is also used to treat patients aged 10 years and above with 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 EXJADE

Do not take EXJADE

• 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 EXJADE. 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.

EXJADE 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 treatment with EXJADE.

• 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 (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, 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 vomit blood and/or black stools.
• if you have frequent abdominal pain, particularly after eating or taking EXJADE.
• if you have 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 EXJADE

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 EXJADE 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. You may also have 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 EXJADE for you and will also use these tests to decide when to stop your treatment with EXJADE.

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

Other medicines and EXJADE

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 EXJADE,
• antacids (medicines used to treat heartburn) that contain aluminum, which must not be taken at the same time of day as EXJADE,
• cyclosporine (used to prevent organ rejection after a transplant 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),
• cholestyramine (used to lower cholesterol levels in the blood).
• busulfan (used as pre-transplant treatment to destroy the original bone marrow before transplantation),
• midazolam (used to relieve anxiety and/or sleep disturbances).

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

Elderly (65 years and over)

EXJADE can be used in 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

EXJADE can be used in children and adolescents aged 2 years and above who receive regular blood transfusions and in children and adolescents aged 10 years and above who do not receive regular blood transfusions. As the patient grows, the doctor will adjust the dose.

EXJADE 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.

EXJADE is not recommended during pregnancy unless clearly necessary.

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

Breastfeeding is not recommended during treatment with EXJADE.

Driving and using machines

If you feel dizzy after taking EXJADE, do not drive or use tools or machines until you feel normal again.

EXJADE contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

3. How to take EXJADE

Treatment with EXJADE will be supervised by a doctor with experience in the treatment of iron overload caused by blood transfusions.

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist.

How much EXJADE to take

The dose of EXJADE 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 EXJADE 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 EXJADE 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 EXJADE 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.

In some countries, deferasirox may also be available as dispersible tablets, manufactured by other manufacturers. If you are switching from these dispersible tablets to EXJADE film-coated tablets, the dose you take will change. Your doctor will calculate the dose you need and inform you about how many film-coated tablets to take each day.

When to take EXJADE

• Take EXJADE once a day, every day, at the same time with some water.
• Take EXJADE film-coated tablets on an empty stomach or with a light meal

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

Patients with difficulty swallowing tablets may crush EXJADE 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 EXJADE

Continue taking EXJADE 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 working (see also section 2: "Monitoring your treatment with EXJADE").

If you are unsure how long to take EXJADE, consult your doctor.

If you take more EXJADE than you should

If you have taken too much EXJADE, or if someone else has taken your tablets, 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.

If you forget to take EXJADE

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

If you stop taking EXJADE

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

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 uncommon (may affect up to 1 in 100people) or rare (may affect up to 1 in1000people)

• 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 a kidney problem),
• If you notice a combination of drowsiness, pain in the upper right abdomen, yellowish or more yellowish 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 can be associated with liver or kidney problems and cause a change in brain function),
• If you suffer from vomiting with blood and/or black stools,
• If you suffer from frequent abdominal pain, particularly after eating or taking EXJADE,
• If you suffer from frequent heartburn,
• If you have partial loss of vision,
• If you have severe pain in the upper abdomen (pancreatitis),

Stop taking the medicine and inform your doctor immediately.

Some adverse effects can be serious.

These adverse effects are uncommon

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

inform your doctor as soon as possible.

Other Adverse Effects

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

• Alterations in kidney function tests.

Common (may affect up to 1 in 10people)

• Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain,

swelling, constipation, indigestion.

• Rashes
• Headache
• Alterations in liver function tests
• Itching
• Alterations in urine tests (protein in urine)

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

Uncommon (may affect up to 1 in 100people)

• Dizziness

• Fever
• Sore throat
• 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 coagulation (thrombocytopenia), in the number of red blood cells (worsening of anemia), 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 production
• Rupture of the stomach or intestine wall that can be painful and cause nausea
• Severe pain in the upper abdomen (pancreatitis)

Abnormal acid levels in the blood

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of EXJADE

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiration date that appears on the blister

after EXP and on the packaging after CAD. The expiration date is the last day of the

month indicated.

• Do not use any packaging that is damaged or shows signs of tampering.
• Medicines should not be thrown down the drain or into the trash. Ask your

pharmacist how to dispose of packaging and medicines that are no longer needed. This

way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of EXJADE

The active ingredient is deferasirox.

• Each EXJADE 90 mg film-coated tablet contains 90 mg of deferasirox.
• Each EXJADE 180 mg film-coated tablet contains 180 mg of deferasirox.
• Each EXJADE 360 mg film-coated tablet contains 360 mg of deferasirox.

The other components are microcrystalline cellulose; crospovidone; povidone; magnesium stearate; anhydrous colloidal silica; poloxamer. The tablet coating contains: hypromellose; titanium dioxide (E171); macrogol (4000); talc; aluminum lake of indigo carmine (E132).

Appearance of EXJADE and Package Contents

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

• EXJADE 90 mg film-coated tablets are light blue and marked with «J 90» on one side and «NVR» on the other.
• EXJADE 180 mg film-coated tablets are blue and marked with «J 180» on one side and «NVR» on the other.
• EXJADE 360 mg film-coated tablets are dark blue and marked with «J 360» on one side and «NVR» on the other.

Each blister pack contains 30 or 90 film-coated tablets. Multiple packs containing 300 film-coated tablets (10 packs of 30).

Possible marketing of only some package sizes or some doses.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Germany

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes 764

08013 Barcelona

Spain

Sandoz S.R.L.

Str. Livezeni nr. 7A

540472 Targu Mures

Romania

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of the last revisionof this prospectus:

Other Sources of Information

Detailed information about this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.