EXJADE 500 mg dispersible tablets

What EXJADE is

EXJADE contains an active substance called deferasirox. It is an iron chelator which is a medicine used to remove the excess iron from the body (also called iron overload).

What EXJADE is used for

EXJADE is used to treat iron overload caused by blood transfusions.

Repeated blood transfusions may be necessary in patients with various types of anaemia (for example thalassaemia, sickle cell disease or myelodysplastic syndromes). However, repeated blood transfusions can cause a build-up of excess iron. This is because blood contains iron and your body does not have a natural way to remove the excess iron you get with your blood transfusions. Over time, the excess iron can damage important organs such as the liver and heart. Medicines called iron chelators are used to remove the excess iron and reduce the risk of it causing organ damage.

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

EXJADE is also used when deferoxamine therapy is contraindicated or inadequate in patients with beta thalassaemia major with iron overload caused by infrequent blood transfusions, in patients with other types of anaemias, and in children aged 2 to 5 years.

How EXJADE works

EXJADE traps and removes excess iron which is then excreted mainly in the stools.

Monitoring your EXJADE treatment

You will have regular blood and urine tests during treatment. These will monitor the amount of iron in your body (blood level of ferritin) to see how well EXJADE is working. The tests will also monitor your kidney function (blood level of creatinine, presence of protein in the urine) and liver function (blood level of transaminases). Your doctor will take these tests into consideration when deciding on the dose of EXJADE most suitable for you.

You will get a booklet from your doctor which will help you to track your response to EXJADE. Your doctor will write your blood tests in this booklet at each visit. Keep the booklet safe and bring it with you each time you visit your doctor.

Your eyesight and hearing will be tested each year during treatment as a precautionary measure.

If you have any questions about how EXJADE works or why this medicine has been prescribed for you, ask your doctor.

Follow all the doctor?s instructions carefully. They may differ from the general information in this leaflet.

Do not take EXJADE

• if you are allergic (hypersensitive) to deferasirox or any of the other ingredients of EXJADE listed in section 6 of this leaflet. If this applies to you, tell your doctor before taking EXJADE. If you think you may be allergic, ask your doctor for advice.
• if you have kidney disease.
• if you are currently taking another iron chelator medication.

EXJADE is not recommended

• if you are at an advanced stage of myelodysplastic syndrome (MDS) or have advanced cancer.

Take special care with EXJADE

• if you have a liver problem.
• if you have a cardiac problem due to iron overload.
• if you notice a marked decrease in your urine output (sign of kidney problem).
• if you develop a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and throat (signs of severe allergic reaction).
• if you develop a rash, reddening of the skin, blistering of lips, eyes or mouth, skin peeling, sore throat (signs of severe skin reaction).
• if you experience a combination of drowsiness, upper right abdominal pain, yellowing or increased yellowing of your skin or eyes and dark urine (signs of liver problems).
• 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 are taking or have recently taken certain painkillers, anti-inflammatory medicines or oral bisphosphonates (see ?Taking other medicines?).
• if you are taking or have recently taken anticoagulant medication (see ?Taking other medicines?).
• if you have a low level of platelets in your blood test. If any of these apply to you, tell your doctor straight away.

Taking other medicines

Antacids (medicines used to treat heartburn) containing aluminium should not be taken at the same time of day as EXJADE.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes in particular:

• ciclosporin (used to prevent the body rejecting a transplanted organ or for other conditions, such as rheumatoid arthritis or atopic dermatitis),
• simvastatin (used to lower cholesterol),
• 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 clotting),
• hormonal contraceptive agents (birth control medicines),
• bepridil, ergotamine,
• repaglinide (used to treat diabetes),
• rifampicin (used to treat tuberculosis),
• phenytoin, phenobarbital, carbamazepine (used to treat epilepsy),
• ritonavir (used in the treatment of 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).

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

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

Children and adolescents (age 2 years to 17 years)

EXJADE can be used in adolescents and children aged 2 years and over. As the patient grows the doctor will adjust the dose.

Pregnancy and breast-feeding

EXJADE is not recommended during pregnancy unless clearly necessary. If you are pregnant or think that you may be, tell your doctor who will discuss with you whether you can take EXJADE during your pregnancy.

Breast-feeding is not recommended during treatment with EXJADE. Tell your doctor if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
If you feel dizzy after taking EXJADE, do not drive or operate any tools or machines until you are feeling normal again.

Important information about some of the ingredients of EXJADE

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take EXJADE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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 at the start of the treatment is 20 mg per kilogram body weight. A higher or lower starting dose may be recommended by your doctor based on your individual treatment needs.
- 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 is 40 mg per kilogram body weight.

When to take EXJADE

- Take EXJADE once a day, every day, at about the same time each day.
- Take the tablets on an empty stomach.
- Then wait at least 30 minutes before eating any food.
Taking EXJADE at the same time each day will help you remember when to take your tablets.

How to take EXJADE Drop the tablets into a glass of water, or apple or orange juice 100 to 200 ml. Stir until the tablets dissolve completely. The liquid in the glass will look cloudy. Drink everything in the glass. Then add a little water or juice to what is left in the glass and drink that too. Do not dissolve the tablets in fizzy drinks or milk. Do not chew, break or crush the tablets. Do not swallow the tablets whole.

How long to take EXJADE
Continue taking EXJADE every day for as long as your doctor tells you. This is a long-term treatment, possibly lasting for months or years. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect (see also section 1: ?Monitoring your EXJADE treatment?).

If you have questions about how long to take EXJADE, talk to 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 hospital for advice straight away. Show them the pack of tablets. Medical treatment may be necessary.

If you forget to take EXJADE
If you miss a dose, take it as soon as you remember on that day. Take your next dose as scheduled. Do not take a double dose on the next day to make up for the forgotten tablet(s).

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

Like all medicines, EXJADE can cause side effects, although not everybody gets them. Most of the side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Some side effects could be serious and need immediate medical attention. These side effects are uncommon or rare. If you get a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and throat signs of severe allergic reaction, If you notice a marked decrease in your urine output sign of kidney problem, If you experience a combination of drowsiness, upper right abdominal pain, yellowing or increased yellowing of your skin or eyes and dark urine signs of liver problems, If you vomit blood andor 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, tell your doctor straight away.

Some side effects could become serious.

These side effects are uncommon, that is they may affect less than 1 in every 100 patients. - If you get blurred or cloudy eyesight,
- If you get reduced hearing,
tell your doctor as soon as possible.

Some side effects are very common.

These side effects may affect more than 1 in every 10 patients.
- Disturbance in renal function tests.

Some side effects are common.

These side effects may affect between 1 and 10 in every 100 patients.
- Gastrointestinal disorders, such as nausea, vomiting, diarrhoea, pain in the abdomen, bloating, constipation, indigestion
- Rash
- Headache
If any of these affects you severely, tell your doctor.

Other side effects are uncommon. These side effects may affect less than 1 in every 100 patients. Dizziness Fever Sore throat Swelling of arms or legs Change in the colour of the skin Anxiety Sleep disorder Tiredness If any of these affects you severely, tell your doctor.

Frequency not known (cannot be estimated from the available data).
- A decrease in the number of cells involved in blood clotting (thrombocytopenia), or in all kinds of blood cells (pancytopenia)
- Hair loss
- Rash, reddening of the skin, blistering of lips, eyes or mouth, skin peeling, sore throat (signs of severe skin reaction)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children. Do not use EXJADE after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month. Store in the original package in order to protect from moisture. Do not use any pack that is damaged or shows signs of tampering.

What EXJADE contains

The active substance is deferasirox.
Each tablet of EXJADE 125 mg contains 125 mg deferasirox.
Each tablet of EXJADE 250 mg contains 250 mg deferasirox.
Each tablet of EXJADE 500 mg contains 500 mg deferasirox.
The other ingredients are lactose monohydrate, crospovidone type A, povidone, sodium lauryl sulphate, microcrystalline cellulose, colloidal anhydrous silica and magnesium stearate.

What EXJADE looks like and contents of the pack

EXJADE is supplied as dispersible tablets. The tablets are off-white, round and flat. Each tablet contains 125 mg, 250 mg or 500 mg deferasirox:
- EXJADE 125 mg tablets are stamped on each tablet with ?J 125?.
- EXJADE 250 mg tabletsare stamped on each tablet with ?J 250?.
- EXJADE 500 mg tablets are stamped on each tablet with ?J 500?.

Each blister pack contains 28, 84 or 252 dispersible tablets.
Not all pack sizes or strengths may be available in your country.

Marketing Authorisation Holder

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Manufacturer

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma GmbH TélTel 49 911 273 0

Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00

eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217

Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111

Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00

Eesti Novartis Pharma Services Inc. Tel 372 66 30 810 Österreich Novartis Pharma GmbH Tel 43 1 86 6570

Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888

España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600

France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. Tel 40 21 31299 01

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

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

Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Novartis Finland Oy PuhTel 358 010 6133 200

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

Latvija Novartis Pharma Services Inc. Tel 371 67 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370

Lietuva
Novartis Pharma Services Inc.
Tel: +370 5 269 16 50

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