Exjade: detailed information

Patient Information Leaflet: Information for the User

EXJADE 90 mg film-coated tablets, 180 mg film-coated tablets, 360 mg film-coated tablets

deferasirox
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What EXJADE is and what it is used for
What you need to know before taking EXJADE
How to take EXJADE
Possible side effects
How to store EXJADE
Contents of the pack and other information

1. What EXJADE is and what it is used for

What EXJADE is
EXJADE contains an active substance called deferasirox. It is an iron chelator, that is a
medicine used to remove excess iron from the body (iron overload).
Deferasirox binds excess iron and removes it, primarily eliminating it through the faeces.
What EXJADE is used for
In patients with various forms of anaemia (for example thalassaemia, sickle cell anaemia or myelodysplastic syndromes (MDS)), repeated blood transfusions may be necessary.
However, these can cause an excess of iron in the body. This occurs because blood contains iron, and the body does not have a natural way to remove the excess iron introduced through blood transfusions.
In patients with thalassaemic syndromes who are not receiving blood transfusions, iron overload may also develop over time, primarily due to increased dietary iron absorption in response to a low number of blood cells.
Over time, excess iron can damage important organs such as the liver and heart.
Medicines called iron chelators are used to eliminate excess iron and reduce the risk of organ damage.
EXJADE is used to treat iron overload due to frequent blood transfusions in patients with beta-thalassaemia major aged 6 years and older.
EXJADE is also used to treat iron overload when deferoxamine therapy is contraindicated or inadequate in patients with beta-thalassaemia major with iron overload due to infrequent blood transfusions, in patients with other forms of anaemia, and in children aged between 2 and 5 years.
EXJADE is also used, when deferoxamine therapy is contraindicated or inadequate, to treat patients aged 10 years and older who have iron overload associated with thalassaemic syndromes but who do not require blood transfusions.

2. What you should know before taking EXJADE

Do not take EXJADE

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 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 chelating medicine.

EXJADE is not recommended

if you have advanced myelodysplastic syndrome (MDS: reduced production of blood cells by the bone marrow) or advanced-stage cancer.

Warnings and precautions
Talk to your doctor or pharmacist before taking EXJADE:

if you have kidney or liver problems.
if you have heart problems due to iron overload.
if you notice a marked decrease in urine output (a sign of kidney problems).
if you develop a severe skin rash, or experience breathing difficulties, dizziness, or swelling, particularly of the face and throat (signs of a severe allergic reaction; see also section 4, "Possible side effects").
if you develop any combination of the following symptoms: skin rash, flushed skin, 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 experience a combination of drowsiness, pain in the upper right part of the abdomen, yellowing or increased yellowing of the skin or eyes, and dark urine (signs of liver problems).
if you experience difficulty thinking, remembering information, or solving problems, feel less alert or aware, or feel very drowsy with low energy (signs of high blood ammonium levels, which may be associated with liver or kidney problems; see also section 4, "Possible side effects").
if you vomit blood and/or have black stools.
if you experience frequent abdominal pain, especially after eating or taking EXJADE.
if you frequently have heartburn.
if blood tests show low platelet or white blood cell counts.
if you have blurred vision.
if you have diarrhoea or vomiting. If any of these situations apply to you, inform your doctor immediately.

Monitoring of EXJADE treatment
During treatment, you will have regular blood and urine tests. These will monitor the amount of iron in your body (blood ferritin level) to assess how well EXJADE is working. The tests will also check kidney function (blood creatinine level, presence of protein in urine) and liver function (blood transaminase levels). Your doctor may request a kidney biopsy if significant kidney damage is suspected. To determine the amount of iron in your liver, you may also undergo magnetic resonance imaging (MRI) scans. Your doctor will use these tests to determine the most appropriate EXJADE dose for you and to decide when EXJADE should be discontinued.
As a precautionary measure, your vision and hearing will be checked annually during treatment.

Other medicines and EXJADE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important for:

other iron chelators, which must not be taken with EXJADE,
antacids (medicines used to treat heartburn) containing aluminium, which must not be taken at the same time of day as EXJADE,
cyclosporine (used to prevent rejection of a transplanted organ or for other conditions such as rheumatoid arthritis or atopic dermatitis),
simvastatin (used to lower cholesterol),
certain painkillers or anti-inflammatory drugs (e.g. aspirin, ibuprofen, corticosteroids),
oral bisphosphonates (used to treat osteoporosis),
anticoagulant medicines (used to prevent or treat blood clotting),
hormonal contraceptives (birth control medicines),
bepridil, ergotamine (used for heart conditions 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 in 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 a pre-transplant treatment to destroy the original bone marrow before transplantation),
midazolam (used to relieve anxiety and/or sleep disorders).

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

Elderly (age 65 years and older)
EXJADE can be used in patients aged 65 years and older at the same dose as in adults. Elderly patients may experience more side effects (particularly diarrhoea) than younger patients. They should be closely monitored by their doctor for side effects that may require 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. Your doctor will adjust the dose according to the patient's growth.
EXJADE is not recommended for children under 2 years of age.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
EXJADE is not recommended during pregnancy unless strictly necessary.
If you are currently using a hormonal contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. a 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 operate tools or machinery until the dizziness resolves.

EXJADE contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially 'sodium-free'.

3. How to take EXJADE

Treatment with EXJADE will be supervised by a doctor experienced in managing iron overload due to blood transfusions.
Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

How much EXJADE to take
The dose of EXJADE is based on 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 starting daily dose of EXJADE film-coated tablets for patients receiving regular blood transfusions is 14 mg per kilogram of body weight. Your doctor may recommend a higher or lower initial dose depending on your individual treatment needs.
The usual starting daily dose of EXJADE film-coated tablets for patients not receiving regular blood transfusions is 7 mg per kilogram of body weight.
Depending on your response to treatment, your doctor may later adjust your dose upward or downward.
The maximum recommended daily dose of EXJADE 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 adults not receiving regular blood transfusions,
- 7 mg per kilogram of body weight for children and adolescents not receiving regular blood transfusions.

In some countries, deferasirox may also be available as dispersible tablets produced by other manufacturers. If you switch from such dispersible tablets to EXJADE film-coated tablets, your dose will change. Your doctor will calculate the dose you need and tell you how many film-coated tablets to take each day.

When to take EXJADE

Take EXJADE once daily, every day, at approximately the same time each day, with a glass of water.
Take EXJADE film-coated tablets on an empty stomach or with a light meal. Taking EXJADE at the same time each day will also help you remember when to take your tablets.

For patients unable to swallow the tablets whole, EXJADE film-coated tablets may be crushed and administered by mixing the full dose with soft food such as yogurt or applesauce. The food should be consumed immediately and completely. Do not store it for later use.

How long to take EXJADE
Continue taking EXJADE every day for the duration prescribed by your doctor. This is a long-term treatment that may last for months or years. Your doctor will monitor your condition regularly to ensure the treatment is effective (see also section 2: “Monitoring treatment with EXJADE”).
If you have any questions about how long you should take EXJADE, speak with your doctor.

If you take more EXJADE than you should
If you have taken too much EXJADE, or if someone else has accidentally taken your tablets, contact your doctor or hospital immediately for advice. Show the tablet packaging to the doctor. Medical treatment may be urgently required. Symptoms may include abdominal pain, diarrhoea, nausea and vomiting, and kidney or liver problems, which may be serious.

If you forget to take EXJADE
If you forget to take a dose, take it as soon as you remember during that day. Take your next dose at the usual time. Do not take a double dose the next day to make up for the missed tablet(s).

If you stop taking EXJADE
Do not stop taking EXJADE unless your doctor tells you to. If you stop, excess iron will no longer be removed from your body (see also above section “How long to take EXJADE”).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Most of the side effects are mild to moderate and usually disappear after a few days to a few weeks of treatment.
Some side effects may be serious and require immediate medical attention.
These side 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 skin rash, or have difficulty breathing and dizziness or swelling, mainly of the face and throat (signs of a severe allergic reaction),
If you develop a combination of any of the following symptoms: skin rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, swollen lymph nodes (signs of severe skin reactions),
If you notice a marked reduction in urine output (sign of kidney problems),
If you experience a combination of drowsiness, pain on the right side in the upper abdomen, yellowing or increased yellowing of the skin or eyes, and dark urine (signs of liver problems),
If you have difficulty thinking, remembering information, or solving problems, if you feel less alert or aware, or feel very drowsy with little energy (signs of high blood ammonium levels, which may be associated with liver or kidney problems and may lead to changes in brain function),
If you vomit blood and/or have black stools,
If you have frequent abdominal pain, particularly after eating or taking EXJADE,
If you have frequent heartburn,
If you experience partial loss of vision,
If you have severe pain in the upper abdomen (pancreatitis), stop taking this medicine and contact your doctor immediately.

Some side effects could become serious.
These side effects are uncommon.

If you have blurred or cloudy vision,
If you have a decrease in hearing, contact your doctor as soon as possible.

Other side 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, diarrhoea, abdominal pain, bloating, constipation, indigestion
Rash
Headache
Changes in liver function tests
Itching
Changes in urine test (protein in urine). If any of these effects becomes severe, inform your doctor.

Uncommon (may affect up to 1 in 100 people)

Dizziness
Fever
Sore throat
Swelling of the arms or legs
Change in skin colour
Anxiety
Sleep disorders
Tiredness. If any of these effects becomes severe, inform your doctor.

Frequency not known (frequency cannot be estimated from the available data).

A reduction in the number of cells involved in blood clotting (thrombocytopenia), in the number of red blood cells (worsening of anaemia), 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
Tear in the wall of the stomach or intestine, which may be painful and cause nausea
Severe pain in the upper abdomen (pancreatitis)
Increased acidity of the blood (metabolic acidosis).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store EXJADE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister after EXP and on the carton after Exp.. The expiry date refers to the last day of that month.
Do not use the pack if it is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What EXJADE contains
The active substance is deferasirox.
Each film-coated tablet of EXJADE 90 mg contains 90 mg of deferasirox.
Each film-coated tablet of EXJADE 180 mg contains 180 mg of deferasirox.
Each film-coated tablet of EXJADE 360 mg contains 360 mg of deferasirox.
The other components are microcrystalline cellulose; crospovidone; povidone; magnesium stearate; anhydrous colloidal silica; and poloxamer. The tablet coating contains: hypromellose; titanium dioxide (E171); macrogol (4000); talc; aluminium lake containing indigo carmine (E132).

Description of the appearance of EXJADE and package contents
EXJADE is supplied as film-coated tablets. The film-coated tablets are oval and biconvex.

EXJADE 90 mg film-coated tablets are blue in colour and are marked “90” on one side and “NVR” on the other.
EXJADE 180 mg film-coated tablets are medium blue in colour and are marked “180” on one side and “NVR” on the other.
EXJADE 360 mg film-coated tablets are dark blue in colour and are marked “360” on one side and “NVR” on the other.

Each pack contains 30 or 90 film-coated tablets in blisters. Multipacks contain 300 tablets (10 packs of 30) film-coated tablets.
It is possible that not all pack sizes or strengths are marketed in your country.

Marketing Authorization Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes 764
08013 Barcelona
Spain
Novartis Pharmaceuticals S.R.L.
Str. Livezeni nr. 7A
540472 Targu Mures
Romania
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf.: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor ehf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

Patient Information Leaflet: Information for the User

EXJADE 90 mg granules in sachet, 180 mg granules in sachet, 360 mg granules in sachet

deferasirox
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What EXJADE is and what it is used for
What you need to know before taking EXJADE
How to take EXJADE
Possible side effects
How to store EXJADE
Contents of the pack and other information

1. What EXJADE is and what it is used for

What EXJADE is used for
In patients with various forms of anaemia (for example thalassaemia, sickle cell anaemia or
myelodysplastic syndromes (MDS)), repeated blood transfusions may be necessary.
However, these can cause excess iron in the body. This occurs because blood contains iron and
the body has no natural way to remove the excess iron introduced through blood transfusions.
In patients with thalassaemic syndromes who are not receiving blood transfusions, iron overload can
also develop over time, primarily due to increased dietary iron absorption 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 eliminate excess iron and reduce the risk of organ damage.

EXJADE is used to treat iron overload due to frequent blood transfusions in patients with beta-thalassaemia major aged 6 years and older.

EXJADE is also used to treat iron overload when therapy with deferoxamine is contraindicated or inadequate in patients with beta-thalassaemia major with iron overload due to infrequent blood transfusions, in patients with other forms of anaemia, and in children aged between 2 and 5 years.

EXJADE is also used when therapy with deferoxamine is contraindicated or inadequate for the treatment of patients aged 10 years and older who have iron overload associated with thalassaemic syndromes but who do not require blood transfusions.

2. What you need to know before taking EXJADE

Do not take EXJADE

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 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 chelating medicine.

EXJADE is not recommended

if you have advanced myelodysplastic syndrome (MDS: reduced production of blood cells by the bone marrow) or advanced-stage cancer.

Warnings and precautions
Talk to your doctor or pharmacist before taking EXJADE:

if you have kidney or liver problems.
if you have heart problems due to iron overload.
if you notice a marked decrease in urine output (a sign of kidney problems).
if you develop a severe skin rash, or have difficulty breathing, dizziness, or swelling, particularly 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: skin rash, red skin, 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 experience a combination of drowsiness, pain in the upper right part of the abdomen, yellowing or increased yellowing of the skin or eyes, and dark urine (signs of liver problems).
if you have difficulty thinking, remembering information, or solving problems, if you feel less alert or aware, or feel very drowsy and lack energy (signs of high blood ammonium levels, which may be associated with liver or kidney problems; see also section 4 “Possible side effects”).
if you vomit blood and/or have black stools.
if you experience frequent abdominal pain, especially after eating or taking EXJADE.
if you frequently have heartburn.
if you have low platelet or white blood cell counts in blood tests.
if you have blurred vision.
if you have diarrhoea or vomiting. If any of these situations apply to you, inform your doctor immediately.

Monitoring during EXJADE treatment
During treatment, you will have regular blood and urine tests. These will monitor the amount of iron in your body (blood ferritin level) to assess how well EXJADE is working. The tests will also check kidney function (blood creatinine level, presence of protein in urine) and liver function (blood transaminase levels). Your doctor may request a kidney biopsy if significant kidney damage is suspected. To determine the amount of iron in the liver, you may also undergo magnetic resonance imaging (MRI) scans. Your doctor will use the results of these tests to determine the most appropriate EXJADE dose for you and to decide when you should stop taking EXJADE.
As a precautionary measure, your vision and hearing will be examined annually during treatment.

Other medicines and EXJADE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important for:

other iron chelators, which must not be taken with EXJADE,
antacids (medicines used to treat heartburn) containing aluminium, which must not be taken at the same time of day as EXJADE,
cyclosporine (used to prevent organ transplant rejection or for other conditions such as rheumatoid arthritis or atopic dermatitis),
simvastatin (used to lower cholesterol),
certain painkillers or anti-inflammatory drugs (e.g. aspirin, ibuprofen, corticosteroids),
oral bisphosphonates (used to treat osteoporosis),
anticoagulant medicines (used to prevent or treat blood clotting),
hormonal contraceptives (birth control medicines),
bepridil, ergotamine (used for heart conditions 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 in 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 pre-transplant treatment to destroy the original bone marrow before transplantation),
midazolam (used to relieve anxiety and/or sleep disorders).

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

Elderly (age 65 years and older)
EXJADE can be used in people aged 65 years and older at the same dose as in adults. Elderly patients may experience more side effects (particularly diarrhoea) than younger patients. They should be closely monitored by their doctor for side effects that may require dose adjustment.

Driving and using machines
If you feel dizzy after taking EXJADE, do not drive or operate tools or machinery until the dizziness has resolved.

EXJADE contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e., essentially ‘sodium-free’.

3. How to take EXJADE

Treatment with EXJADE will be monitored by a doctor experienced in managing iron overload due to blood transfusions.
Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.

How much EXJADE to take
The dose of EXJADE is based on body weight for all patients. Your doctor will calculate the dose you need and tell you how many sachets to take each day.

The usual starting daily dose of EXJADE granules for patients receiving regular blood transfusions is 14 mg per kilogram of body weight. Your doctor may recommend a higher or lower initial dose depending on your individual treatment needs.
The usual starting daily dose of EXJADE granules for patients not receiving regular blood transfusions is 7 mg per kilogram of body weight.
Depending on your response to treatment, your doctor may later adjust your dose by increasing or decreasing it.
The maximum recommended daily dose of EXJADE granules is:
- 28 mg per kilogram of body weight for patients receiving regular blood transfusions,
- 14 mg per kilogram of body weight for adults not receiving regular blood transfusions,
- 7 mg per kilogram of body weight for children and adolescents not receiving regular blood transfusions.

In some countries, deferasirox may also be available as dispersible tablets produced by other manufacturers. If switching from such dispersible tablets to EXJADE granules, your dose will change. Your doctor will calculate the dose you need and tell you how many granule sachets to take each day.

When to take EXJADE

Take EXJADE once daily, every day, at approximately the same time each day.
EXJADE granules may be taken with or without a light meal. Taking EXJADE at the same time each day will help you remember to take your medicine.

EXJADE granules must be administered by sprinkling the full dose onto soft food such as yogurt or applesauce (apple puree). The food must be consumed immediately and completely. Do not store it for later use.

How long to take EXJADE
Continue taking EXJADE every day for the duration prescribed by your doctor. This is a long-term treatment, which may last for months or years. Your doctor will monitor your condition regularly to ensure the treatment is effective (see also section 2: "Monitoring of EXJADE treatment").
If you have any questions about how long you should take EXJADE, speak with your doctor.

If you take more EXJADE than you should
If you have taken too much EXJADE, or if someone else has accidentally taken your granules, contact your doctor or hospital immediately for advice. Show the granule packaging to the doctor. Urgent medical treatment may be necessary. Symptoms may include abdominal pain, diarrhoea, nausea and vomiting, and kidney or liver problems, which may be serious.

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

If you stop taking EXJADE
Do not stop taking EXJADE unless instructed by your doctor. If you stop taking it, excess iron will no longer be removed from your body (see also above section "How long to take EXJADE").

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate and usually disappear after a period of treatment ranging from a few days to a few weeks.
Some side effects may be serious and require immediate medical attention.
These side 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 skin rash, or have difficulty breathing and dizziness or swelling mainly of the face and throat (signs of a severe allergic reaction),
If you develop a combination of any of the following symptoms: skin rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, swollen lymph nodes (signs of severe skin reactions),
If you notice a marked reduction in urine output (sign of kidney problem),
If you experience a combination of drowsiness, pain in the upper right part of the abdomen, yellowing or increased yellowing of the skin or eyes, and dark urine (signs of liver problems),
If you experience difficulty thinking, remembering information, or solving problems, if you feel less alert or aware, or feel very drowsy with little energy (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 vomit blood and/or have black stools,
If you experience frequent abdominal pain, particularly after eating or taking EXJADE,
If you experience frequent heartburn,
If you experience partial loss of vision,
If you experience severe pain in the upper part of the abdomen (pancreatitis), stop taking this medicine and inform your doctor immediately.

Some side effects could become serious.
These side effects are uncommon.

If you have blurred or cloudy vision,
If you have decreased hearing, inform your doctor as soon as possible.

Other side 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, diarrhoea, abdominal pain, bloating, constipation, indigestion
Rash
Headache
Changes in liver function tests
Itching
Changes in urine test (protein in urine). If any of these effects become severe, inform your doctor.

Uncommon (may affect up to 1 in 100 people)

Dizziness
Fever
Sore throat
Swelling of the arms or legs
Change in skin colour
Anxiety
Sleep disorders
Tiredness. If any of these effects become severe, inform your doctor.

Frequency not known (frequency cannot be estimated from the available data).

A reduction in the number of cells involved in blood clotting (thrombocytopenia), in the number of red blood cells (worsening of anaemia), 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 output
Tear in the wall of the stomach or intestine, which may be painful and cause nausea
Severe pain in the upper part of the abdomen (pancreatitis)
Increased acidity of the blood (metabolic acidosis).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store EXJADE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the sachet after EXP and on the carton after Exp.. The expiry date refers to the last day of that month.
Do not use the pack if it is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What EXJADE contains
The active substance is deferasirox.

Each sachet of EXJADE 90 mg granules contains deferasirox 90 mg.
Each sachet of EXJADE 180 mg granules contains deferasirox 180 mg.
Each sachet of EXJADE 360 mg granules contains deferasirox 360 mg.
The other components are microcrystalline cellulose; crospovidone; povidone; magnesium stearate; anhydrous colloidal silica; and poloxamer.

Description of the appearance of EXJADE and contents of the pack
EXJADE granules are supplied as white to almost white granules in sachets.
Each pack contains 30 sachets.
It is possible that not all strengths are marketed in your country.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V
Tel.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf.: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Tel: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel: +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor ehf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Tel: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Further sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu