Exjade 360 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

EXJADE 90 mg film-coated tablets

EXJADE 180 mg film-coated tablets

EXJADE 360 mg film-coated tablets

Deferasirox

Read the entire leaflet carefully before you or your child start taking this medicine, as 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you or your child experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What EXJADE is 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. How to store EXJADE
6. 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, which is a type of medicine used to remove excess iron from the body (also known as iron overload). It binds and removes excess iron, which is then excreted mainly in the faeces.

What EXJADE is used for

Repeated blood transfusions may be necessary in patients with various types of anaemia (for example, thalassaemia, sickle cell anaemia or myelodysplastic syndromes (MDS)). However, repeated blood transfusions can lead to an accumulation of excess iron. This is because blood contains iron, and the body has no natural way of eliminating the excess iron acquired through blood transfusions. In non-transfusion-dependent thalassaemia syndromes, iron overload may also develop over time, primarily 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 known as 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-thalassaemia major who are aged 6 years and older.

EXJADE is also used to treat chronic iron overload when treatment with deferoxamine is contraindicated or not suitable in patients with beta-thalassaemia major who have iron overload due to infrequent blood transfusions, in patients with other types of anaemias, and in children aged 2 to 5 years.

EXJADE is also used to treat patients aged 10 years and older who have iron overload associated with thalassaemic syndromes but who are not transfusion-dependent, when treatment with deferoxamine is contraindicated or not suitable.

2. What you need to know before starting 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 cancer.

Warnings and precautions

• Talk to your doctor or pharmacist before starting 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 (a sign of kidney problems).
• if you develop a severe rash, or have 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, blistering of the lips, eyes or mouth, peeling of the skin, high fever, flu-like symptoms, swollen lymph nodes (signs of a serious skin reaction, see also section 4 “Possible side effects”).
• if you notice a combination of drowsiness, pain in the upper right part of the abdomen, yellowing or increased yellowing of the skin or eyes, and dark-coloured urine (signs of liver problems).
• if you notice difficulty thinking, remembering information, or solving problems, or if you are less alert or awake, or feel drowsy and weak (signs of high blood ammonia levels, which may be associated with liver or kidney problems, see also section 4 “Possible side effects”).
• if you have vomiting with 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 low platelet or white blood cell counts in your blood test.
• if you have blurred vision.
• if you have diarrhoea 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 (blood ferritin level) to assess how well EXJADE is working. The tests will also monitor 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. You may also undergo MRI (magnetic resonance imaging) tests to determine the amount of iron in your liver. Your doctor will use these test results to decide the most appropriate EXJADE dose for you and to determine when your treatment with EXJADE should be stopped.

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

Other medicines and EXJADE

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

• other iron chelators – these must not be taken with EXJADE,
• antacids (medicines used to treat heartburn) containing aluminium – these 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 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),
• colestyramine (used to reduce blood cholesterol levels),
• busulfan (used as a pre-transplant conditioning treatment to destroy the original bone marrow before transplant),
• midazolam (used to relieve anxiety and/or sleep disturbances).

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

Elderly (aged 65 years and over)

EXJADE can be used in people aged 65 years and over at the same dose as other adults. Elderly patients may experience more side effects (especially diarrhoea) than younger patients. Your doctor should closely monitor for adverse 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. As the patient grows, your doctor will adjust the dose accordingly.

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 become pregnant, consult your doctor before using this medicine.

Treatment with EXJADE 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 method (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 operate 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; essentially “sodium-free”.

3. How to take EXJADE

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

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How much EXJADE should you take

The dose of EXJADE is based on body weight for all patients. Your doctor will calculate the dose you need and will 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 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 how you respond to treatment, your doctor may later adjust your dose to a higher or lower level.
• 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 adult patients 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 manufactured by other companies. If you are switching from these dispersible tablets to EXJADE film-coated tablets, your dose will change. Your doctor will calculate the required dose and inform you how many film-coated tablets to take each day.

When to take EXJADE

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

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

Patients who have difficulty swallowing tablets may crush EXJADE film-coated tablets and mix the powder with soft food such as yoghurt or apple puree (applesauce). The entire dose should be consumed immediately; do not save 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 monitor your condition regularly to ensure the treatment is having the desired effect (see also section 2: "Monitoring your treatment with EXJADE").

If you have any 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 accidentally takes your tablets, contact your doctor or go to a hospital immediately. Show the doctor the medicine packaging. You may require urgent medical treatment. You may experience effects such as abdominal pain, diarrhoea, nausea and vomiting, and kidney or liver problems, which could 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(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 everyone will experience them. Most adverse effects are mild or moderate and usually disappear after a few days or weeks of treatment.

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

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

• If you develop a severe rash, or have difficulty breathing and dizziness or swelling, especially of 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 marked decrease in urine volume (a sign of kidney problems),
• If you notice a combination of drowsiness, pain in the upper right part of the abdomen, yellowing or increased yellowing of the skin or eyes, and dark-colored urine (signs of liver problems),
• If you experience difficulty thinking, remembering information, or solving problems, or are less alert or awake, or feel drowsy and weak (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 have vomiting with blood and/or 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 part of the stomach (pancreatitis),

Stop taking the medicine and contact your doctor immediately.

Some adverse effects may become serious.

These adverse effects are uncommon

• If you have blurred vision,
• If you experience hearing loss,

inform your doctor as soon as possible.

Other adverse effects

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

• Abnormalities in kidney function tests.

Common (may affect up to 1 in 10 people)

• Gastrointestinal disturbances, such as nausea, vomiting, diarrhea, abdominal pain, bloating, constipation, indigestion.
• Rash
• Headache
• Abnormalities in liver function tests
• Itching
• Abnormalities in urine tests (protein in urine)

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

Uncommon (may affect up to 1 in 100 people)

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

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

Frequency not known (cannot be estimated from available data)

• Decrease in the number of cells involved in blood clotting (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 output
• Rupture of the stomach or intestinal wall, which 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 CAD. The expiry date refers to the last day of the month indicated.
• Do not use any packaging that is damaged or shows signs of tampering.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of EXJADE

The active substance 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; colloidal anhydrous silica; poloxamer. The tablet coating contains: hypromellose; titanium dioxide (E171); macrogol (4000); talc; indigo carmine aluminium lake (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 contains 30 or 90 film-coated tablets. Multi-packs containing 300 film-coated tablets (10 packs of 30).

Some pack sizes or strengths may not be marketed.

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 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 Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

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