Package Leaflet: Information for the User

EXJADE 90mg Film-Coated Tablets

EXJADE 180mg Film-Coated Tablets

EXJADE 360mg Film-Coated Tablets

deferasirox

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you get. The final part of section 4 includes information on how to report these 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 even if their symptoms are the same. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What is EXJADE and what it is used for

2.What you need to know before taking EXJADE

3.How to take EXJADE

4.Possible side effects

5.Storage of EXJADE

6.Contents of the pack and additional information

What is EXJADE

EXJADE contains an active ingredient called deferasirox. It is aniron chelatorthat 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 excreted mainly in the feces.

For what EXJADE is used

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 callediron chelatorsare used to eliminate excess iron and to reduce the risk of causing damage to organs.

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

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 2to5years.

EXJADE is also used to treat patients aged 10years 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 EXJADE

-if you are allergic to deferasirox or any of the other ingredients of this medicine (listed in section6). If this is the case, inform your doctor before takingEXJADE. 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 medication.

EXJADE is not recommended

-if you are in an advanced stage of myelodysplastic syndrome (SMD, reduction in blood cell production by the bone marrow) or have advanced cancer.

Warnings and precautions

Consult your doctor or pharmacist before starting to take EXJADE.

-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 (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 section4«Adverse reactions»).

-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 section4«Adverse reactions»).

-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 section4«Adverse reactions»).

-if you experience vomiting with blood and/or black stools.

-if you experience frequent abdominal pain, particularly after eating or taking EXJADE.

-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 EXJADE

During treatment, regular blood and urine tests will be performed. These tests will monitor the amount of iron in your body (ferritin level in the blood))to observe how EXJADE treatment is working. The tests will also monitor kidney function (creatinine level in the blood, presence of protein in the urine) and liver function (transaminase level in the blood). Your doctor may request a kidney biopsy if they suspect significant renal 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 EXJADE for you and will use these tests to decide when to stop your EXJADE treatment.

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

Other medicines and EXJADE

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 medications, which should not be taken with EXJADE,

-antacids (medicines used to treat heartburn) containing aluminum, which should not be taken at the same time of day as EXJADE,

-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 medications (e.g. aspirin, ibuprofen, corticosteroids),

-bisphosphonates (used to treat osteoporosis),

-anticoagulants (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),

-rifampicina (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),

-clozapina (used to treat psychiatric disorders such as schizophrenia),

-tizanidina (used as a muscle relaxant),

-colestiramina (used to reduce cholesterol levels in the blood).

-busulfan (used as a pre-transplant treatment to destroy the original bone marrow before the transplant),

-midazolam (used to alleviate anxiety and/or sleep disturbances).

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

Advanced age (65 years and older)

EXJADE can be used by people over 65 years of age at the same dose as other adults. Older patientsmay experience more adverse effects (especially diarrhea) than younger patients. The doctor should closely monitor any adverse effects that may require a dose adjustment.

Children and adolescents

EXJADE 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.

EXJADE is not recommended for children under 2 years of age.

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.

EXJADE treatment is not recommended during pregnancy unless clearly necessary.

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

EXJADE treatment is not recommended during breastfeeding.

Driving and operating machinery

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

EXJADE contains sodium

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

The treatment with EXJADE 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 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 per day.

• The normal daily dose of EXJADE 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 EXJADE 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 recommended maximum daily dose of EXJADE 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.

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 need to 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 light meals.

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

Patients with difficulty swallowing tablets can crush EXJADE 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 EXJADE

Continue taking EXJADE every day for the time your doctor tells you.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 EXJADE treatment").

If you have doubts about how long you should 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 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.

If you forget to take EXJADE

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 EXJADE treatment

Do not stop taking EXJADE 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 EXJADE").

Like all medicines, this medicine can 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 can be serious and require immediate medical attention.

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

• If you have a severe rash,or difficulty breathing and dizziness or swelling, especially in 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),
• Si you notice difficulty thinking, remembering information, or solving problems, or you 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 a change in brain function),
• If you experience vomiting with blood and/or black stools,
• If you experience frequent abdominal pain, particularly after eating or taking EXJADE,
• If you experience frequent heartburn,
• If you experience partial vision loss,
• If you experience intense pain inthe upper part of the stomach (pancreatitis),

Stop taking the medicine and inform your doctor immediately.

Some side effects can be serious.

These side effects are rare

• If you experience blurry vision,
• If you lose hearing ability,

Inform your doctor as soon as possible.

Other side effects

Very common (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.

Rare (may affect up to 1 in 100 people)

• Mild dizziness

• Fever
• Sore throat
• Swelling in arms and legs
• Changes in skin color
• Anxiety
• Sleep disturbances
• Fatigue

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

Unknown frequency(cannot be calculated from available data).

• Decreased number of blood cells involved in blood clotting (thrombocytopenia), red blood cells (worsening anemia), white blood cells (neutropenia), or all types of blood cells (pancytopenia)
• Loss of hair
• Kidney stones
• Decreased urine production
• Intestinal or stomach wall rupture that 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 side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly throughthe national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about 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.

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 manipulation.
• Medicines should not be disposed of through drains or in the trash. Ask your

pharmacist how to dispose of the packaging and medications that you no longer need. By

doing so, you will help protect the environment.

Composition of EXJADE

The active ingredient is deferasirox.

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

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

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

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

Appearance of EXJADE and contents of the pack

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

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

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

Possible commercialisation of only some pack sizes or doses.

Marketing authorisation holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible for manufacturing

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

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last date of revision of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .