InfoCons Consumer Protection informs you – Deferasirox Accord – Package Leaflet

Before anything else

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 for you only. 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 no t listed in this leaflet . See section 4.

What is i n this leaflet 1. What Deferasirox Accord is and what it is used for 2. What you need to know b efore you take Deferasirox Accord 3. How to take Deferasirox Accord 4. Possible side effects 5. How to store Deferasirox Accord 6. Contents of the pack and other information

ℹ️ 1. What Deferasirox Accord is and what it is used for

What Deferasirox Accord is Deferasirox Accord 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 Defer asirox Accord 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 r educe the risk of it causing organ damage.

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

Deferasirox Accord is also used to treat chronic i ron 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.

Defer asirox Accord 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.

⚠️ 2. What you need to know before you take Deferasirox Accord

Do not take Deferasirox Accord

• 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 Accord . 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 Accord 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 Deferasirox Accord :

• if you have a kidney or liver problem.
• if you hav e 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 sev ere 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 dif ficulty 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 “Poss ible side effects”).
• if you vomit blood and/or have black stools.
• if you experience frequent abdominal pain, particularly after eating or taking Deferasirox Accord .
• if you experience frequent heartburn.
• if you have a low level of platelets or white blood c ells 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 Deferasirox Accord 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 Accord is working. The tests will also monitor your kidney function (blood level of creat inine, 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 de termine the amount of iron in your liver. Your doctor will take these tests into consideration when deciding on the dose of Deferasirox Accord most suitable for you and will also use these tests to decide when you should stop taking Deferasirox Accord .

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

Other medicines and Deferasirox Accord

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 Accord ,
• antacids (medicines used to treat heartburn) containing aluminium, which should not be taken at the same time of day as Deferasirox Accord , 40 • 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 b isphosphonates (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 trea t 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) Deferasirox Accord 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 s ide effects that may require a dose adjustment.

Children and adolescents

Deferasirox Accord 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 Accord is not recommended for children aged under 2 years.

Pregnancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnan t or are planning to have a baby, ask your doctor for advice before taking this medicine.

Deferasirox Accord 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 Accord may reduce the effectiveness of hormonal contraceptives.

Breast -feeding is not recommended during treatment with Defer asirox Accord .

Driving and using machines

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

Deferasirox Accord contains lactose (a type of sugar)

If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicin al product .

Deferasirox Accord contains sodium

41 This medicin al product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium -free’ .

Deferasirox Accord contains castor oil

This medicinal product may cause stomach upset and diarrhea.

💊 3. How to take Deferasirox Accord

Treatment with Deferasirox Accord 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 Accord to take The dose of Deferasirox Accord 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 Accord 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 Deferasirox Accord 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 d ose.
• The maximum recommended daily dose for Deferasirox Accord 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 transfu sions,
• 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 dispersibl e tablets to Deferasirox Accord 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 Deferasirox Accord

• Take Deferasirox Accord once a day, every day, at about the same time each day with some water.
• Take Deferasirox Accord film-coated tablets either on an empty stomach or with a light meal.

Taking Deferasirox Accord 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, Deferasirox Accord 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 immediatel y and completely consumed. Do not store it for future use.

How long to take Deferasirox Accord Continue taking Deferasirox Accord every day for as long as your doctor tells you. This is a long -term treatment, possibly lasting for months or years. Your doc tor will regularly monitor your condition to check that the treatment is having the desired effect (see also section 2: “Monitoring your Deferasirox Accord treatment”).

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

If you take more Deferasirox Accord than you should

42 If you have taken too much Deferasirox Accord , 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 Deferasirox Accord

If you miss a dose, take it as soon as you remem ber 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 Accord

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

❗ 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.

Some s ide effects could be serious and need i mmediate medical attention.

These s ide effects are unco mmon (may affect up to 1 in 100 peop le) or rare (may affect up to 1 in 1,000 peop le).

• 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 c ombination 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 a ware 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 f requent abdominal pain, particularly after eating or taking Deferasirox Accord ,
• 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 stra ight a way.

Some s ide effects could beco me serious.

These s ide effects are unco mmon.

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

Other s ide effects Very com mon (may affect more than 1 in 10 peop le)

• Disturbance in kidney function tests.

Common (may affect up to 1 in 10 peop le)

• Gastrointestinal disorders, such as nausea, vomiting, diarrhoea, pain in the abdomen, bloating, 43 constipation, indigestion
• Rash
• Headache
• Disturbance in live r function tests
• Itching
• Disturbance in urine test (protein in the urine) If any of these affects you severely, tell your doct or.

Uncom mon (may affect up to 1 in 100 peop le)

• 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 k nown (cannot be es timated 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 Repor ting of side effects If you get any side effect s, talk to your doc tor or pha rmacist. This includes any possible side effects not listed in this leafle t. You can a lso report side effects d irectly via the national reporting system listed in Appendix V . By reporting side effect s you can help provide more inform ation on the safety of this medicine.

🌡️ 5. How to store Deferasirox Accord

• 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 da te 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 measur es will help protect the environment.

📦 6. Contents of the pack and other information

What Deferasirox Accord contains

The active substance is deferasirox .

Each film -coated tablet (tablet) contains 90 mg deferasirox.

Each film -coated tablet (tablet) contains 180 mg deferasirox.

Each film -coated tablet (tablet) contains 360 mg deferasirox.

The other ingredients are:

44 Tablet core: cellulose, microcrystalline, croscarmellose sodium, low-substituted hydroxypropyl cellulose, povidone, poloxamer, lactose monohydrate, silica colloidal anhydrous, sodium stearyl fumarate, hydrogenated castor oil (see section 2).

Tablet coat : hypromellose (E464), propylene glycol (E1520), talc (E553b) , iron oxide yellow (E172), titanium dioxide (E171) .

What Deferasiro x Accord looks like and contents of the pack

Deferasirox Accord 90 mg are yellow colored, film coated oval, biconvex tablets with beveled edges debossed with ‘D’ on one side and ‘90’ on another side .

Deferasirox Accord 180 mg are yellow colored, film coated oval, biconvex tablets with beveled edges debossed with ‘D’ on one side and ‘180’ on another side .

Deferasirox Accord 360 mg are yellow colored, film coated oval, biconvex tablets with beveled edges debossed with ‘D’ on one side and ‘360’ on anothe r side .

Deferasirox Accord 90 mg film-coated tablets and Deferasirox Accord 180 mg film-coated tablets are available in PVC/PE/PV dC-Aluminium blisters , unit packs containing 28 x 1, 30 x 1, 56 x 1 or 90 x 1 film-coated tablet .

Deferasirox Accord 360 mg film -coated tablets are available in PVC/PE/PVdC -Aluminium blisters, unit packs conta ining 28 x 1, 30 x 1, 56 x 1, 90 x 1 or 300 x 1 film-coated tablet.

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a Planta, Barcelona, 08039 Spain

Manufacturer

Accord Healthcare Polska Sp.z.o.o.

Ul. Lutomierska 50, 96-200, Pabianice, Poland Pharmadox Healthcare Limited KW20A Kordin Industrial Park, Paola PLA 3000, Malta LABORATORI FUNDACIÓ DAU C/ C, 12 -14 Pol. Ind. Zona Franca, Barcelona, 08040 Barcelona, Spain For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE / IS / IT / LT / LV / LX / MT / NL / NO / PT / PL / RO / SE / SI / SK / ES Accord Healthcare S.L.U.

Tel: +34 93 301 00 64 EL Win Medica Pharmaceutical S.A.

Tel: +30 210 7488 821

This leaflet was last revised in {MM/YYYY}

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Deferasirox Accord (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/19/1412).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.