Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - exjade

Document Subject

Generated Narrative: MedicinalProductDefinition mpbd22c6cb08ec26dbc8a674d031b87df0

identifier: http://ema.europa.eu/identifier/EU/1/06/356/011

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: EXJADE 90 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-bd22c6cb08ec26dbc8a674d031b87df0

identifier: http://ema.europa.eu/identifier/EU/1/06/356/011

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - exjade

Attesters

What is in this leaflet

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

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

What EXJADE is used for Repeated blood transfusions may be necessary in patients with various types of anaemia (for example thalassaemia, sickle cell disease or myelodysplastic syndromes (MDS)). 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. In patients with non-transfusion-dependent thalassaemia syndromes, iron overload may also develop over time, mainly due to increased absorption of dietary iron in response to low blood cell counts. 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 to treat chronic iron overload 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.

EXJADE is also used when deferoxamine therapy is contraindicated or inadequate to treat patients aged 10 years or older who have iron overload associated with their thalassaemia syndromes, but who are not transfusion dependent.

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 applies to you, tell your doctor before taking EXJADE. If you think you may be allergic, ask your doctor for advice.
• if you have moderate or severe kidney disease.
• if you are currently taking any other iron chelator medicines.

EXJADE is not recommended

• if you are at an advanced stage of myelodysplastic syndrome (MDS; decreased production of blood cells by the bone marrow) or have advanced cancer.

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

• if you have a kidney or 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, see also section 4 Possible side effects ).
• if you experience a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes (signs of severe skin reaction, see also section 4 Possible side effects ).
• 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 experience difficulty thinking, remembering information, or solving problems, being less alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in your blood, which may be associated with liver or renal problems, see also section 4 Possible side effects ).
• 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 have a low level of platelets or white blood cells in your blood test.
• if you have blurred vision
• if you have diarrhoea or vomiting. If any of these apply to you, tell your doctor straight away.

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 may require you to undergo a kidney biopsy, if he/she suspects 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 consideration when deciding on the dose of EXJADE most suitable for you and will also use these tests to decide when you should stop taking EXJADE.

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

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) containing aluminium, which should not be taken at the same time of day as EXJADE,
• 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 (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 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),
• cholestyramine (used to lower cholesterol levels in the blood),
• busulfan (used as a treatment prior to transplantation in order to destroy the original bone marrow before the transplant),
• midazolam (used to relieve anxiety and/or trouble sleeping).

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 (in particular diarrhoea) than younger patients. They should be monitored closely by their doctor for side effects that may require a dose adjustment.

Children and adolescents EXJADE can be used in children and adolescents receiving regular blood transfusions aged 2 years and over and in children and adolescents not receiving regular blood transfusions aged 10 years and over. As the patient grows the doctor will adjust the dose.

EXJADE is not recommended for children aged under 2 years.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, 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 a hormonal contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom), as EXJADE may reduce the effectiveness of hormonal contraceptives.

Breast-feeding is not recommended during treatment with EXJADE.

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.

EXJADE contains sodium This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially sodium free .

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

Always take this medicine exactly as your doctor has told you. 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 for EXJADE film-coated tablets at the start of the treatment for patients receiving regular blood transfusions is 14 mg per kilogram body weight. A higher or lower starting dose may be recommended by your doctor based on your individual treatment needs.
• The usual daily dose for EXJADE film-coated tablets at the start of the treatment for patients not receiving regular blood transfusions is 7 mg per kilogram 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 for EXJADE film-coated tablets is:
• 28 mg per kilogram body weight for patients receiving regular blood transfusions,
• 14 mg per kilogram body weight for adult patients not receiving regular blood transfusions,
• 7 mg per kilogram body weight for children and adolescents not receiving regular blood transfusions.

In some countries, deferasirox may also be available as dispersible tablets, made by other manufacturers. If you are switching 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 a day, every day, at about the same time each day with some water.
• Take EXJADE film-coated tablets either 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 who are unable to swallow whole tablets, EXJADE film-coated tablets may be crushed and taken by sprinkling the full dose onto soft food such as yogurt or apple sauce (pureed apple). The food should be immediately and completely consumed. Do not store it for future use.

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 2: 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 the doctor the pack of tablets. Urgent medical treatment may be necessary. You may experience effects such as abdominal pain, diarrhoea, nausea and vomiting and kidney or liver problems that can be serious.

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, this medicine 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.

Some side effects could be serious and need 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 get a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and throat (signs of severe allergic reaction),
• If you experience a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes, (signs of severe skin reactions),
• 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 experience difficulty thinking, remembering information, or solving problems, being less alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in your blood, which may be associated with liver or renal problems and lead to a change in your 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 upper stomach pain (pancreatitis), stop taking this medicine and tell your doctor straight away.

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

• If you get blurred or cloudy eyesight,
• If you get reduced hearing, tell your doctor as soon as possible.

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

• Disturbance in kidney function tests.

Common (may affect up to 1 in 10 people)

• Gastrointestinal disorders, such as nausea, vomiting, diarrhoea, pain in the abdomen, bloating, constipation, indigestion
• Rash
• Headache
• Disturbance in liver function tests
• Itching
• Disturbance in urine test (protein in the urine) If any of these affects you severely, tell your doctor.

Uncommon (may affect up to 1 in 100 people)

• 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), in the number of red blood cells (anaemia aggravated), in the number of white blood cells (neutropenia) or in the number of all kinds of blood cells (pancytopenia)
• Hair loss
• Kidney stones
• Low urine output
• Tear in stomach or intestine wall that can be painful and cause nausea
• Severe upper stomach pain (pancreatitis)
• Abnormal level of acid in blood

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

• 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 and the carton after EXP. The expiry date refers to the last day of that month.
• Do not use any pack that is damaged or shows signs of tampering.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What EXJADE contains The active substance is deferasirox.

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

What EXJADE looks like and contents of the pack EXJADE is supplied as film-coated tablets. The film-coated tablets are ovaloid and biconvex.

• EXJADE 90 mg film-coated tablets are light blue and stamped 90 on one side and NVR on the other.
• EXJADE 180 mg film-coated tablets are medium blue and stamped 180 on one side and NVR on the other.
• EXJADE 360 mg film-coated tablets are dark blue and stamped 360 on one side and NVR
  on the other.

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

Not all pack sizes or strengths may be available in your country.

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

Manufacturer Novartis Pharma GmbH Roonstra e D-90429 Nuremberg Germany

Novartis Farmac utica SA Ronda de Santa Maria 08210 Barber del Vall s, Barcelona Spain

Sandoz S.R.L. Str. Livezeni nr. 7A 540472 Targu Mures Romania

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

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD .: +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0

Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Novartis Farmac utica, S.A. Tel: +34 93 306 42 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu Package leaflet: Information for the user

EXJADE 90 mg granules in sachet EXJADE 180 mg granules in sachet EXJADE 360 mg granules in sachet 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 may get. See the end of section 4 for 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 only for you or your child. Do not pass it on to others. It may harm them, even if their signs of illness 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.