EXJADE 125 mg dispersible tablets
EXJADE 250 mg dispersible tablets
EXJADE 500 mg dispersible tablets
Deferasirox

1. What EXJADE is and what it is used for

What EXJADE is

EXJADE contains an active substance called deferasirox. It is an iron chelate complexing agent which is a drug used to remove an excess of iron from the body (also called increased iron storage). It catches and removes the excess iron, which is then mainly excreted in the feces.

What EXJADE is used for

Repeated blood transfusions may be necessary for patients with different types of anemia (eg thalassemia, sickle cell anemia, or myelodysplastic syndrome (MDS)). Repeated blood transfusions can, however, give rise to an accumulation of excess iron. This is because blood contains iron and your body has no natural way to remove the excess iron you get through your blood transfusions. In patients with non-transfusion-dependent thalassemia syndrome, excess iron may develop over time, mainly due to increased iron uptake at food intake and an effect of low blood cell count. are. Over time, excess iron can damage important organs, e.g. liver and heart. Medicines called iron chelate complexing agents are used to remove excess iron and reduce the risk of organ damage.

EXJADE is used to treat chronic iron overload caused by repeated blood transfusions in patients with beta-lacinia from the age of 6 years and up.

EXJADE can also be used to treat chronically increased iron storage when deferoxamine treatment cannot be used or is inappropriate for patients with a beta-iron deficiency with excess iron transfusions, in patients with other types of anemia, and for children aged 2 to 5 years.

EXJADE can also be used when deferoxamine treatment is contraindicated or insufficient to treat patients aged 10 years and older with increased iron storage related to their thalassemia syndrome, but who are not transfusion dependent.

2. What you need to know before taking EXJADE

Do not use this medicine

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, consult your doctor.
  • if you have moderate or severe kidney disease
  • if you are taking other medicines for excess iron at the same time.

EXJADE is not recommended

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

Warnings and cautions

Talk to your doctor or pharmacist before taking EXJADE :

  • if you have kidney or liver disease.
  • if you have heart disease caused by increased iron storage.
  • if you notice a marked decrease in your urine output (signs of kidney problems).
  • if you have a severe rash, or have difficulty breathing and dizziness or swelling mainly in the face or 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: rash, red skin, blistering of the lips, eyes, or mouth, scaly skin, 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, 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, remember information, or solve problems, are less alert or experience decreased consciousness, feel very sleepy with low energy (signs of high levels of ammonia in the blood, 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 often get abdominal pain, especially after eating or taking EXJADE.
  • if you often get heartburn.
  • if you have low levels of platelets or white blood cells in your blood test.
  • if you have blurred vision.
  • if you have diarrhea or vomiting.

If any of these apply to you, tell your doctor straight away.

Control of your EXJADE treatment

You will be given blood and urine samples at regular intervals during the course of treatment. With the help of these, you will be able to check the amount of iron in your body (the level of ferritin in the blood) to see how well EXJADE works. The blood tests also allow you to monitor your kidney function (the level of creatinine in the blood, if there is a protein in the urine) and liver function (the level of transaminases in the blood). Your doctor may require you to have a kidney biopsy if hehe/suspects significant kidney damage. You will have MRI scans (Magnetic Resonance Imaging Examinations) to determine the amount of iron in your liver. Your doctor will weigh the results of these blood tests in determining the doseone of EXJADE that is most suitable for you and to decide when to stop taking EXJADE.

Your vision and hearing will be tested every year during treatment as a precaution.

Other medicines and EXJADE

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. These include in particular:

  • other iron chelate complexing agents that must not be taken with EXJADE.
  • antacids (medicines used to treat heartburn) that contain aluminum which should not be taken at the same time of day as EXJADE.
  • ciclosporin (used to prevent the body from 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 drugs (eg acetylsalicylic acid, ibuprofen, corticosteroids )
  • oral bisphosphonates (used to treat osteoporosis),
  • blood thinners (used to prevent or treat blood clots),
  • hormonal contraceptives (birth control medicines),
  • bepridil, ergotamine (used to treat 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 in the treatment of respiratory diseases such as asthma ),
  • clozapine (used to treat mental illnesses such as schizophrenia),
  • tizanidine (used as a muscle relaxant),
  • cholestyramine (used to lower blood cholesterol levels).
  • busulfan (used as a pre-transplant treatment to destroy the original bone marrow before the transplant).

When using any of these drugs, additional tests may be needed to monitor blood levels.

Elderly people (from 65 years and up)

EXJADE can be used by people over 65 years and in the same dosage as for other adults. Elderly patients may experience more side effects (especially diarrhea) than younger patients. They should be carefully monitored by their doctor for side effects that may require dose adjustment.

Children and young people

EXJADE can be used by adolescents and children 2 years of age and older who receive regular blood transfusions and by adolescents and children 10 years of age and older who do not receive regular blood transfusions . s the patient grows, the doctor will adjust the dose one.

EXJADE is not recommended for children younger than 2 years.

Pregnancy and breastfeeding

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 recommended during pregnancy only when necessary.

If you are currently using birth control pills or a contraceptive patch to prevent getting pregnant, you should use another contraceptive or another type of contraceptive (eg a condom), as EXJADE may reduce the effect of birth control pills and contraceptive patches.

Breastfeeding is not recommended during treatment with EXJADE.

Driving and using machines

If you feel dizzy after taking EXJADE, do not drive or use any tools or machines until you feel normal again.

EXJADE contains lactose

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

3. How to take EXJADE

Treatment with EXJADE will be supervised by a doctor who has experience in the treatment of increased iron storage caused by blood transfusions .

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

How much EXJADE you should take

Dose an EXJADE is related to the individual patient’s weight. Your doctor will calculate the dose you need and tell you how many tablets to take each day.

  • The usual daily dose of EXJADE dispersible tablets at the beginning of treatment for patients receiving regular blood transfusions is 20 mg per kg body weight. A higher or lower starting dose may be recommended by your doctor based on the treatment needs in your particular case.
  • The usual daily dose of EXJADE dispersible tablets at the beginning of treatment for patients who do not receive regular blood transfusions is 10 mg per kg body weight.
  • Depending on how you respond to treatment, your doctor may later adjust your treatment to a higher or lower dose.
  • The recommended daily maximum dose for EXJADE dispersible tablets is 40 mg per kg bodyweight for patients receiving regular blood transfusions, 20 mg per kg bobodyweightor adult patients not receiving regular blood transfusions, and 10 mg per kg nobody weight or children and adolescents not receiving regular blood. blood transfusion is.

Deferasirox is also available as “film-coated” tablets and granules. If you are switching from film-coated tablets or granules to these dispersible tablets, dose one needs to be adjusted.

When to take EXJADE

  • Take EXJADE once a day, every day, at about the same time each day.
  • Take EXJADE dispersible tablets on an empty stomach.
  • Then wait at least 30 minutes before eating any food.

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

How to take EXJADE:
Put the tablet (s) in a glass of water, alternatively apple or orange juice (100 to 200 ml).
Stir until the tablet (s) have completely dissolved. The liquid in the glass gets a cloudy appearance.
Drink everything in the glass. Then add some water or juice to what is left in the glass, mix in the liquid and drink it up as well.
Do not dissolve the tablets in carbonated beverages or milk. The tablets must not be chewed, broken, or crushed. Do not swallow the tablets whole.

How long to take EXJADE

Continue to take EXJADE every day for as long as your doctor prescribes. This is a long-term treatment that may need to continue for months or years. Your doctor will periodically check your condition to see if the treatment has the intended effect (see also section 2: “Checking your EXJADE treatment”).

If you have any further questions on the use of EXJADE, talk to your doctor.

If you take more EXJADE than you should

If you have taken too much EXJADE, or if someone else has accidentally swallowed your tablets, contact a doctor or hospital immediately for advice. Show the medicine pack to the doctor. You may need immediate medical attention. You may have symptoms such as abdominal pain, diarrhea, nausea, and vomiting, or kidney or liver damage that can be severe.

If you forget to take EXJADE

If you miss a dose, take it as soon as you arrive on the same day. Take the next dose as planned. Do not take a double dose the next day to make up for a forgotten tablet/tablet.

If you stop taking EXJADE

Do not stop taking EXJADE unless your doctor tells you to. If you stop taking the tablets, the excess iron will no longer be removed from your body (see also the 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 generally disappear after a few days to a few weeks of treatment.

Some side effects can 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 rash, or difficulty breathing, dizziness, or swelling, especially on the face and throat (signs of a severe allergic reaction ).
  • If you experience a combination of any of the following symptoms: skin rash, red skin, blistering on the lips, eyes, or mouth, scaly skin, high fever, flu-like symptoms, enlarged lymph nodes (signs of severe skin reactions),
  • If you notice a marked decrease in your urine output (signs of kidney problems),
  • 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, remember information, or solve problems, are less alert or experience decreased consciousness, feel very sleepy with low energy (signs of high levels of ammonia in the blood, which can be associated with liver or kidney problems and lead to a change in your brain function),
  • If you vomit blood anand/grave black stools,
  • If you often have abdominal pain, especially after eating or taking EXJADE,
  • If you often get heartburn,
  • If you experience visual disturbances,
  • If you experience severe pain in the upper abdomen ( inflammation of the pancreas),

Stop taking this medicine and tell your doctor immediately.

Some side effects can develop into serious ones.

These side effects are less common.

  • If you get blurred or blurred vision,
  • If you start hearing worse,

Tell your doctor as soon as possible.

Other side effects are

Very common (may affect more than 1 user in 10).

  • Affects kidney function tests.

Common (may affect up to 1 in 10 people).

  • Problems from the gastrointestinal tract, e.g. nausea, vomiting, diarrhea, abdominal pain, flatulence, constipation, indigestion
  • Rash
  • Headache
  • Affected liver function tests
  • Itching
  • Affected urine samples ( protein in the urine)

If you get any of these side effects, talk to your doctor.

Uncommon (may affect up to 1 in 100 people).

  • Dizziness
  • Fever
  • Sore throat
  • Swollen arms or legs
  • Color changes in the skin
  • Concern
  • Sleep disturbance
  • Fatigue

If you get any of these side effects, talk to your doctor.

Has been reported (occurs in an unknown number of users).

  • A decrease in the number of cells involved in blood coagulation ( thrombocytopenia ), in the number of red blood cells (worsening anemia ), in the number of white blood cells ( neutropenia ), or the number of all types of blood cells (pancytopenia)
  • Hair loss
  • Kidney stone
  • Low urine production
  • Gastric ulcers or ulcers in the intestine that can be painful and cause nausea
  • Severe pain in the upper abdomen ( pancreatitis )
  • Abnormal levels of acid in the blood

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 and carton after EXP. The expiration date is the last day of the specified month.
  • Store in the original package. Moisture sensitive.
  • Do not use packaging that is damaged or appears to have been opened earlier.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is deferasirox.

Each EXJADE 125 mg dispersible tablet contains 125 mg of deferasirox.

Each dispersible tablet of EXJADE 250 mg contains 250 mg of deferasirox.

Each EXJADE 500 mg dispersible tablet contains 500 mg of deferasirox.

The other ingredients are lactose, crospovidone, povidone, sodium lauryl sulfate, microcrystalline cellulose, silica ( colloidal, anhydrous), and magnesium stearate.

What the medicine looks like and the contents of the pack

EXJADE is supplied as dispersible tablets. The tablets are white to pale yellow, round, and flat.

  • EXJADE 125 mg tablet is marked with “J 125” on one side and with “NVR” on the other side.
  • EXJADE 250 mg tablet is marked with “J 250” on one side and with “NVR” on the other side.
  • EXJADE 500 mg tablet is marked with “J 500” on one side and with “NVR” on the other side.

EXJADE 125 mg, 250 mg, and 500 mg dispersible tablets are available in packs containing 28, 84, or 252 dispersible tablets.

EXJADE 500 mg dispersible tablets are also available in multipacks containing 294 (3 packs of 98) dispersible tablets.

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

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Farma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 LithuaniaNovartis Pharma Services Inc.Tel: +370 5 269 16 50
BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11
Czech RepublicNovartis sroTel: +420 225 775 111 HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00
DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
GermanyNovartis Pharma GmbHTel: +49 911 273 0 The NetherlandsNovartis Pharma BVTel: +31 26 37 82 555
EestiNovartis Pharma Services Inc.Tel: +372 66 30 810 NorwayNovartis Norge ASTel: +47 23 05 20 00
GreeceNovartis (Hellas) Α.Ε.Β.Ε.:Ηλ: +30 210 281 17 12 AustriaNovartis Pharma GmbHTel: +43 1 86 6570
SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
FranceNovartis Pharma SASTel: +33 1 55 47 66 00 PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600
CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439
ItalyNovartis Farma SpATel: +39 02 96 54 1 Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
LatviaSIA “Novartis Baltics”Tel: +371 67 887 070 United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370

This leaflet was last modified

2019-07-19

Muhammad Nadeem

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