DEFERASIROX 250 MG DISPERSIBLE TABLETS - patient leaflet, side effects, dosage

2. what you need to know before you take deferasirox dispersible tablets

Do not take Deferasirox Dispersible Tablets

• 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 Deferasirox Dispersible Tablets. 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.

Deferasirox Dispersible Tablets are 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 Deferasirox Dispersible Tablets:

• if you have a kidney or liver problem.
• if you have heart problems due to iron overload.
• if you notice you pass less urine than normal (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.
• 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 Deferasirox Dispersible Tablets.
• 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.

Elderly (age 65 years and over)

Deferasirox Dispersible Tablets 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

Deferasirox Dispersible Tablets 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.

Deferasirox Dispersible Tablets are not recommended for children aged under 2 years.

Monitoring your Deferasirox Dispersible Tablets 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 Deferasirox Dispersible Tablets are 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 Deferasirox Dispersible Tablets most suitable for you and will also use these tests to decide when you should stop taking Deferasirox Dispersible Tablets

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

Other medicines and Deferasirox Dispersible Tablets

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 Deferasirox Dispersible Tablets,
• antacids (medicines used to treat heartburn) containing aluminium, which should not be taken at the same time of day as Deferasirox Dispersible Tablets,
• 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).

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

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.

Deferasirox Dispersible Tablets are not recommended during pregnancy unless clearly necessary.

If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom), as Deferasirox Dispersible Tablets may reduce the effectiveness of oral and patch contraceptives.

Breast-feeding is not recommended during treatment with Deferasirox Dispersible Tablets.

Driving and using machines

If you feel dizzy after taking Deferasirox Dispersible Tablets, do not drive or operate any tools or machines until you are feeling normal again.

Deferasirox Dispersible Tablets contains hydrogenated castor oil

This may cause stomach upset or diarrhoea.

3. how to take deferasirox dispersible tablets

Treatment with Deferasirox Dispersible Tablets 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 Deferasirox Dispersible Tablets to take

The dose of Deferasirox Dispersible Tablets 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 Deferasirox Dispersible Tablets at the start of the treatment for patients receiving regular blood transfusions 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.
• The usual daily dose for Deferasirox Dispersible Tablets at the start of the treatment for patients not receiving regular blood transfusions is 10 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 Deferasirox Dispersible Tablets is:

• – 40 mg per kilogram body weight for patients

receiving regular blood transfusions,

• – 20 mg per kilogram body weight for adult

patients not receiving regular blood transfusions

• – 10 mg per kilogram body weight for

children and adolescents not receiving regular blood transfusions.

Deferasirox also comes as “film-coated” tablets and granules. If you are switching from the film-coated tablets or granules to these dispersible tablets, you will need an adjustment of the dose.

When to take Deferasirox Dispersible Tablets

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

How to take Deferasirox Dispersible Tablets:

• Drop the tablet(s) into a glass of water, or apple or orange juice (100 to 200 ml).
• Stir until the tablet(s) dissolve completely. The liquid in the glass will look cloudy.
• Drink everything in the glass immediately and not stored for future use. Then add a little water or juice to what is left in the glass, swirl the liquid around 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.

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 Yellow Card Scheme at:. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store deferasirox dispersible tablets

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.

This medicinal product does not require any special storage condition.

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.

6. contents of the pack and other information

What Deferasirox Dispersible Tablets contains

• The active substance is deferasirox.

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

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

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

• The other ingredients are microcrystalline cellulose, crospovidone type a, hydroxypropyl cellulose (low-substituted), colloidal silicon dioxide, hypromellose, sodium lauryl sulfate, disodium hydrogen phosphate, castor oil, hydrogenated (see section 2 ‚Deferasirox Dispersible Tablets contains hydrogenated castor oil‘), magnesium stearate.

What Deferasirox Dispersible Tablets looks like and contents of the pack

Deferasirox 125 mg Dispersible Tablets are white to off white, round, flat tablet with bevelled edge and debossed with ‚DS‘ on the one side and ‚125‘ on other side.

Deferasirox 250 mg Dispersible Tablets are white to off white, round, flat tablet with beveled edge and debossed with ‚DS‘ on the one side and ‚250‘ on other side.

Deferasirox 500 mg Dispersible Tablets are white to off white, round, flat tablet with beveled edge and debossed with ‚DS‘ on the one side and ‚500‘ on other side.

Deferasirox 125 mg, 250 mg and 500 mg Dispersible Tablets are available in HDPE bottle pack containing a canister with silica gel containing 30 dispersible tablets. They are also available in PVC-ACLAR/Alu blister pack and PVC-PE-PVDC/Alu blister pack containing 10, 14, 28, 84, 252 dispersible tablets.

• * Do not eat/swallow the canister containing silica gel.

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

Marketing Authorisation Holder

Ascend Laboratories (UK) Ltd. 5th floor, 89 New Bond Street, London, W1S 1DA, United Kingdom

Manufacturer:

Wave Pharma Limited

4th floor, Cavendish House, 369 Burnt Oak Broadway, Edgware, HA85AW United Kingdom.

This leaflet was last revised in 02/2019.

How long to take Deferasirox Dispersible Tablets Continue taking Deferasirox Dispersible Tablets 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 Deferasirox Dispersible Tablets treatment”).

If you have questions about how long to take Deferasirox Dispersible Tablets, talk to your doctor.

If you take more Deferasirox Dispersible Tablets than you should

If you have taken too much Deferasirox Dispersible Tablets, 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 Deferasirox Dispersible Tablets

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 Deferasirox Dispersible Tablets Do not stop taking Deferasirox Dispersible Tablets 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 Deferasirox Dispersible Tablets”).

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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.

Serious side effects

These side effects need immediate medical attention. Stop taking this medicine and tell your doctor straight away:

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 pass less urine than normal (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 Deferasirox Dispersible Tablets,
• if you experience frequent heartburn,
• if you experience partial loss of vision,
• if you experience severe upper stomach pain (pancreatitis).

These side effects could become serious. Tell your doctor as soon as possible:

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

• if you get blurred or cloudy vision,

• if you experience hearing problems.