Deferasirox Accord 180 mg film-coated tablets

Introduction

Package Leaflet: Information for the User

Deferasirox Accord 90 mg film-coated tablets EFG

Deferasirox Accord 180 mg film-coated tablets EFG

Deferasirox Accord 360 mg film-coated tablets EFG

deferasirox

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 not listed in this leaflet. See section 4.

Contents of the pack

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

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

What is Deferasirox Accord

Deferasirox Accord contains the active substance deferasirox. It is an iron chelator, a medicine used to remove excess iron from the body (also called iron overload). It captures and removes excess iron, which is then mainly excreted in the feces.

What is Deferasirox Accord used for

Repeated blood transfusions may be necessary in patients with various types of anemia (e.g. thalassemia, sickle cell anemia, or myelodysplastic syndromes (MDS)). However, repeated blood transfusions can cause an accumulation of excess iron. This is because blood contains iron and the body has no natural way to remove excess iron obtained from blood transfusions. In patients with non-transfusion-dependent thalassemia syndromes, iron overload may also occur over time, mainly due to increased absorption of dietary iron in response to low blood cell counts. Over time, excess iron can damage important organs such as the liver and heart. Medicines called iron chelators are used to remove excess iron and reduce the risk of organ damage.

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

Deferasirox Accord is also used to treat chronic iron overload when treatment with deferoxamine is contraindicated or not suitable in patients with beta thalassemia major with iron overload caused by infrequent blood transfusions, in patients with other types of anemia, and in children aged 2 to 5 years.

Deferasirox Accord is also used to treat patients aged 10 years and above who have iron overload associated with thalassemia syndromes but are not transfusion-dependent, when treatment with deferoxamine is contraindicated or not suitable.

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, consult your doctor.
• If you have moderate or severe kidney disease.
• If you are currently taking any other iron chelator medicine.

Deferasirox Accord is not recommended

• If you have advanced myelodysplastic syndrome (MDS, decreased production of blood cells by the bone marrow) or advanced cancer.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Deferasirox Accord.

• If you have a kidney or liver problem.
• If you have a heart problem due to iron overload.
• If you notice a marked decrease in the amount of urine you pass (sign of a kidney problem).
• If you develop a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and 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: a rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, swollen lymph nodes (signs of a severe skin reaction, see also section 4 «Possible side effects»).
• If you notice a combination of drowsiness, pain in the upper right abdomen, yellowing of the skin or eyes, and dark urine (signs of liver problems).
• • If you notice difficulty thinking, remembering information, or solving problems, or are less conscious or awake, or feel drowsy and weak (signs of high ammonia levels 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 black stools.
• If you have frequent abdominal pain, particularly after eating or taking Deferasirox Accord.
• If you have frequent heartburn.
• If you have a low platelet or white blood cell count in your blood test.
• If you have blurred vision.
• If you have diarrhea or vomiting.

If you are in any of these situations, inform your doctor immediately.

Monitoring your treatment with Deferasirox Accord

During treatment, you will have regular blood and urine tests. These tests will monitor the amount of iron in your body (ferritin level in the blood) to see how well the treatment with Deferasirox Accord is working. The tests will also monitor kidney function (creatinine level in the blood, protein in the urine) and liver function (transaminase level in the blood). Your doctor may ask you to have a kidney biopsy if they suspect significant kidney damage. They may also perform MRI (magnetic resonance imaging) tests to determine the amount of iron in your liver. Your doctor will take these tests into account to decide on the most suitable dose of Deferasirox Accord for you and will also use these tests to decide when to stop your treatment with Deferasirox Accord.

Every year, your vision and hearing will be checked during treatment as a precaution.

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) that contain aluminum, which must not be taken at the same time of day as Deferasirox Accord,
• Ciclosporin (used to prevent organ rejection after a transplant or for other diseases such as rheumatoid arthritis or atopic dermatitis),
• Simvastatin (used to lower cholesterol levels),
• 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 clots),
• Hormonal contraceptives (medicines for birth control),
• 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 to treat HIV infection),
• Paclitaxel (used to treat cancer),
• Theophylline (used to treat respiratory diseases such as asthma),
• Clozapine (used to treat psychiatric disorders such as schizophrenia),
• Tizanidine (used as a muscle relaxant),
• Colestyramine (used to lower cholesterol levels in the blood),
• Busulfan (used as pre-transplant treatment to destroy the original bone marrow before the transplant).

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

Elderly (65 years and over)

Deferasirox Accord can be used in people over 65 years at the same dose as other adults. Elderly patients may experience more side effects (especially diarrhea) than younger patients. The doctor should closely monitor side effects that may require a dose adjustment.

Children and adolescents

Deferasirox Accord can be used in children and adolescents aged 2 years and above who receive regular blood transfusions and in children and adolescents aged 10 years and above who do not receive regular blood transfusions. As the patient grows, the doctor will adjust the dose.

Deferasirox Accord is not recommended in children under 2 years of age.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, 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 an oral or patch contraceptive to prevent pregnancy, you should use an additional or different contraceptive (e.g. condom) because Deferasirox Accord may reduce the effectiveness of oral and patch contraceptives.

Breastfeeding is not recommended during treatment with Deferasirox Accord.

Driving and using machines

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

Deferasirox Accord contains lactose (a type of sugar)

You should talk to your doctor before taking this medicine if you have been told you have an intolerance to some sugars.

Deferasirox Accord contains sodium

Deferasirox Accord contains less than 1 mmol of sodium per tablet (23 mg), which means it is essentially "sodium-free".

Deferasirox Accord contains castor oil

This medicine may cause stomach upset and diarrhea.

3. How to take Deferasirox Accord

Treatment with Deferasirox Accord will be supervised by a doctor with experience in the treatment of iron overload caused by blood transfusions.

Follow the instructions for administration of this medicine exactly as told by your doctor.

If you are in doubt, consult your doctor or pharmacist again.

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 of Deferasirox Accord film-coated tablets at the start of treatment for patients who receive regular blood transfusions is 14 mg per kilogram of body weight. Your doctor may recommend a higher or lower dose depending on your individual treatment needs.
• The usual daily dose of Deferasirox Accord film-coated tablets at the start of treatment for patients who do not receive regular blood transfusions is 7 mg per kilogram of 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 of Deferasirox Accord film-coated tablets is:

• 28 mg per kilogram of body weight for patients who receive regular blood transfusions,
• 14 mg per kilogram of body weight for adult patients who do not receive regular blood transfusions,
• 7 mg per kilogram of body weight for children and adolescents who do not receive regular blood transfusions.

Deferasirox can also be found in "dispersible" tablets. If you switch from the dispersible tablets to these film-coated tablets, you will need a dose adjustment.

When to take Deferasirox Accord

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

Taking Deferasirox Accord at the same time every day will also help you remember when to take your tablets.

Patients who have difficulty swallowing tablets can crush Deferasirox Accord film-coated tablets and take the powder with a soft food, such as yogurt or apple sauce (apple puree). The entire dose should be consumed immediately, without saving any for later.

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 that may last for months or years. Your doctor will regularly check your condition to see if the treatment is having the desired effect (see also section 2: «Monitoring your treatment with Deferasirox Accord»).

If you have doubts about how long to take Deferasirox Accord, consult your doctor.

If you take more Deferasirox Accord than you should

If you have taken too much Deferasirox Accord, or if someone else has taken your tablets by mistake, contact your doctor or go to a hospital immediately. Show the doctor the pack of tablets. You may need urgent medical treatment. You may notice effects such as abdominal pain, diarrhea, nausea, and vomiting, and kidney or liver problems, which can be serious.

If you forget to take Deferasirox Accord

If you have missed a dose, take it as soon as you remember on the same day. Take the next dose according to your normal schedule. Do not take a double dose the next day to make up for the missed dose(s).

If you stop taking Deferasirox Accord

Do not stop your treatment with Deferasirox Accord unless your doctor tells you to. If you stop taking it, the excess iron will not be removed from your body (see also previous section «How long to take Deferasirox Accord»).

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Most adverse effects are mild or moderate and usually disappear after a few days or weeks of treatment.

Some adverse effects can be serious and require immediate medical attention.

These adverse 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 and 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: rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, swollen lymph nodes (signs of a severe skin reaction).
• If you notice a pronounced decrease in urine volume (sign of a kidney problem).
• If you notice a combination of drowsiness, pain in the upper right abdomen, yellowing or more yellowing of the skin or eyes, and dark urine (signs of liver problems).
• If you notice difficulty thinking, remembering information, or solving problems, or are less conscious or awake, or feel drowsy and weak (signs of high ammonia levels in the blood, which can be associated with liver or kidney problems and cause a change in brain function).
• If you vomit blood and/or have black stools.
• If you have frequent abdominal pain, particularly after eating or taking Deferasirox Accord.
• If you have frequent heartburn.
• If you have partial loss of vision.
• If you have severe pain in the upper abdomen (pancreatitis).

Stop taking the medicine and inform your doctor immediately.

Some adverse effects can be serious.

These adverse effects are uncommon

• If you have blurred vision.
• If you lose hearing ability.

Inform your doctor as soon as possible.

Other Adverse Effects

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

• Alterations in kidney function tests.

Common (may affect up to 1 in 10 people)

• Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, swelling, constipation, indigestion.
• Rashes.
• Headache.
• Alterations in liver function tests.
• Itching.
• Alterations in urine tests (protein in the urine).

If you suffer from any of these effects severely, inform your doctor.

Uncommon (may affect up to 1 in 100 people)

• Dizziness.
• Fever.
• Sore throat.
• Swelling in arms and legs.
• Changes in skin color.
• Anxiety.
• Sleep disturbance.
• Fatigue.

If you suffer from any of these effects severely, inform your doctor.

Frequency not known(cannot be calculated from available data).

• Decrease in the number of cells involved in blood coagulation (thrombocytopenia), the number of red blood cells (worsening of anemia), the number of white blood cells (neutropenia), or the number of all types of blood cells (pancytopenia).
• Hair loss.
• Kidney stones.
• Low urine production.
• Rupture of the stomach or intestinal wall, which can be painful and cause nausea.
• Severe pain in the upper abdomen (pancreatitis).

Abnormal acid levels in the blood

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Deferasirox Accord

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiration date that appears on the blister pack after CAD and on the container after CAD. The expiration date is the last day of the month indicated.
• Do not use any packaging that is damaged or shows signs of tampering.
• Medicines should not be thrown away in drains or trash. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Deferasirox Accord

The active ingredient isdeferasirox.

Each film-coated tablet contains 90 mg of deferasirox.

Each film-coated tablet contains 180 mg of deferasirox.

Each film-coated tablet contains 360 mg of deferasirox.

The other components are:

Core: microcrystalline cellulose, sodium croscarmellose, low-substituted hydroxypropylcellulose, povidone, poloxamer, lactose monohydrate, anhydrous colloidal silica, sodium stearyl fumarate, hydrogenated ricin oil (see section 2).

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

Appearance of Deferasirox Accord and Package Contents

Deferasirox Accord 90 mg are yellow, oval, biconvex film-coated tablets, with beveled edges, and engraved with a "D" on one side and "90" on the other.

Deferasirox Accord 180 mg are yellow, oval, biconvex film-coated tablets, with beveled edges, and engraved with a "D" on one side and "180" on the other.

Deferasirox Accord 360 mg are yellow, oval, biconvex film-coated tablets, with beveled edges, and engraved with a "D" on one side and "360" on the other.

Deferasirox Accord film-coated tablets are available in PVC/PE/PVdC-Aluminum blister packs, in containers containing 28 x 1, 30 x 1, 56 x 1, or 90 x 1 film-coated tablets.

Marketing Authorization 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

Date of the last revision of this prospectus: <{MM/AAAA}>

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