The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 25258/0346 .
Deferasirox 90, 180, 360 mg film-coated tablets
Deferasirox 90 mg film-coated tablets
Deferasirox 180 mg film-coated tablets
Deferasirox 360 mg film-coated tablets
1. What Deferasirox film-coated tablets is and what it is used for
2. What you need to know before you take Deferasirox film-coated tablets
3. How to take Deferasirox film-coated tablets
4. Possible side effects
5. How to store Deferasirox film-coated tablets
6. Contents of the pack and other information
Deferasirox film-coated tablets 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.
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.
Deferasirox film-coated tablets is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta thalassaemia major aged 6 years and older.
Deferasirox film-coated tablets 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.
Deferasirox film-coated tablets 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.
Talk to your doctor or pharmacist before taking Deferasirox film-coated tablets:
If any of these apply to you, tell your doctor straight away.
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 film-coated tablets 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 Deferasirox film-coated tablets most suitable for you and will also use these tests to decide when you should stop taking Deferasirox film-coated tablets.
Your eyesight and hearing will be tested each year during treatment as a precautionary measure.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes in particular:
Additional tests may be required to monitor the blood levels of some of these medicines.
Deferasirox film-coated 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.
Deferasirox film-coated 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 film-coated tablets is not recommended for children aged under 2 years.
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 film-coated tablets 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 Deferasirox film-coated tablets may reduce the effectiveness of hormonal contraceptives.
Breast-feeding is not recommended during treatment with Deferasirox film-coated tablets.
If you feel dizzy after taking Deferasirox film-coated tablets, do not drive or operate any tools or machines until you are feeling normal again.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Treatment with Deferasirox film-coated 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.
The dose of Deferasirox film-coated 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.
Deferasirox also comes as “dispersible” tablets as generic alternatives. If you are switching from the dispersible tablets to these film-coated tablets, you will need an adjustment of the dose.
For patients who are unable to swallow whole tablets, Deferasirox 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.
Continue taking Deferasirox film-coated 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 film-coated tablets treatment”).
If you have questions about how long to take Deferasirox film-coated tablets, talk to your doctor.
If you have taken too much Deferasirox film-coated tablets, 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 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).
Do not stop taking Deferasirox film-coated 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 film-coated tablets”).
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).
stop taking this medicine and tell your doctor straight away.
Some side effects could become serious.
These side effects are uncommon.
tell your doctor as soon as possible.
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
If any of these affects you severely, tell your doctor.
Frequency not known (cannot be estimated from the available data).
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.co.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
The other ingredients are microcrystalline cellulose, crospovidone, colloidal anhydrous silica, poloxamer, povidone, sodium starch glycolate and magnesium stearate. The tablet coating material contains: hypromellose, titanium dioxide (E171), macrogol (4000), talc and indigo carmine aluminium lake (E132).
Deferasirox is supplied as film-coated tablets.
Each blister pack contains 30 or 90 film-coated tablets.
Each bottle contains 30 film-coated tablets.
Not all pack sizes may be marketed.
This leaflet was last revised in March 2023.