Deferasirox Sun

Package leaflet: Information for the user

Deferasirox SUN 90 mg film-coated tablets, 180 mg film-coated tablets, 360 mg film-coated tablets

Deferasirox
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Deferasirox SUN is
Deferasirox SUN contains an active substance called deferasirox. It is an iron chelator, that is, a
medicine used to remove excess iron from the body (iron overload). Deferasirox binds excess iron and removes it, primarily through the faeces.
What Deferasirox SUN is used for
In patients with various types of anaemia (for example thalassaemia, sickle cell anaemia or myelodysplastic syndromes (MDS)), repeated blood transfusions may be necessary. However, these can lead to excess iron in the body. This occurs because blood contains iron and the body has no natural way to eliminate the excess iron introduced through blood transfusions. In patients with thalassaemia syndromes who are not undergoing blood transfusion, iron overload may also develop over time, primarily due to increased dietary iron absorption in response to a low number of blood cells. 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 SUN is used to treat iron overload due to frequent blood transfusions in patients with beta-thalassaemia major aged 6 years and older.
Deferasirox SUN is also used to treat iron overload when therapy with deferoxamine is contraindicated or inadequate in patients with beta-thalassaemia major with iron overload due to infrequent blood transfusions, in patients with other forms of anaemia, and in children aged between 2 and 5 years.
Deferasirox SUN is also used when therapy with deferoxamine is contraindicated or inadequate for the treatment of patients aged 10 years and older who have iron overload associated with thalassaemia syndromes but who do not require blood transfusion.

2. What you should know before taking Deferasirox SUN

Do not take Deferasirox SUN

• if you are allergic to deferasirox or to any of the other ingredients of this medicine (listed in section 6). If this applies to you, inform your doctor before taking Deferasirox SUN. 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 chelating medicine.

Deferasirox SUN is not recommended

• if you have advanced myelodysplastic syndrome (MDS: reduced production of blood cells by the bone marrow) or advanced-stage cancer.

Warnings and precautions
Talk to your doctor or pharmacist before taking Deferasirox SUN:

• if you have kidney or liver problems.
• if you have heart problems due to iron overload.
• if you notice a marked decrease in urine output (a sign of kidney problems).
• if you develop a severe skin rash, breathing difficulties, dizziness, or swelling, particularly of the face and throat (signs of a severe allergic reaction; see also section 4 “Possible side effects”).
• if you experience any combination of the following symptoms: skin rash, red skin, blistering of 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 experience a combination of drowsiness, pain in the upper right abdomen, yellowing or increased yellowing of the skin or eyes, and dark urine (signs of liver problems).
• if you experience difficulty thinking, remembering information, or solving problems, feel less alert or aware, or feel very drowsy with low energy (signs of high blood ammonium levels, 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 experience frequent abdominal pain, especially after eating or taking Deferasirox SUN.
• if you frequently have heartburn.
• if you have low platelet or white blood cell counts in blood tests.
• if you have blurred vision.
• if you have diarrhoea or vomiting. If any of these situations apply to you, inform your doctor immediately.

Monitoring of treatment with Deferasirox SUN
During treatment, you will have regular blood and urine tests. These will monitor the amount of iron in your body (blood ferritin level) to assess how well Deferasirox SUN is working. The tests will also check kidney function (blood creatinine level, presence of protein in urine) and liver function (blood transaminase levels). Your doctor may request a kidney biopsy if significant kidney damage is suspected. To determine liver iron levels, you may also undergo magnetic resonance imaging (MRI) scans. Your doctor will evaluate these tests to determine the most appropriate dose of Deferasirox SUN for you and to decide when treatment should be stopped.
As a precautionary measure, your vision and hearing will be examined annually during treatment.

Other medicines and Deferasirox SUN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important for:

• other iron chelators, which must not be taken with Deferasirox SUN,
• antacids (medicines used to treat heartburn) containing aluminium, which should not be taken at the same time of day as Deferasirox SUN,
• ciclosporin (used to prevent rejection of 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 (e.g. aspirin, ibuprofen, corticosteroids),
• oral bisphosphonates (used to treat osteoporosis),
• anticoagulant medicines (used to prevent or treat blood clotting),
• hormonal contraceptives (medicines for birth control),
• bepridil, ergotamine (used for heart conditions 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 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),
• colestyramine (used to reduce blood cholesterol levels),
• busulfan (used as pre-transplant treatment to destroy the original bone marrow before transplantation),
• midazolam (used to relieve anxiety and/or sleep disorders).

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

Elderly (age 65 years and older)
Deferasirox SUN may be used in people aged 65 years and older at the same dose as in adults. Elderly patients may experience more side effects (particularly diarrhoea) than younger patients. They should be closely monitored by their doctor for side effects that may require dose adjustment.

Children and adolescents
Deferasirox SUN may be used in children and adolescents aged 2 years and older who receive regular blood transfusions, and in children and adolescents aged 10 years and older who do not receive regular blood transfusions. Your doctor will adjust the dose based on the patient’s growth.
Deferasirox SUN is not recommended for children under 2 years of age.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Deferasirox SUN is not recommended during pregnancy unless strictly necessary.
If you are currently using a hormonal contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. a condom), as Deferasirox SUN may reduce the effectiveness of hormonal contraceptives.
Breastfeeding is not recommended during treatment with Deferasirox SUN.

Driving and using machines
If you feel dizzy after taking Deferasirox SUN, do not drive or operate tools or machinery until you feel well again.

Deferasirox SUN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Deferasirox SUN

Treatment with Deferasirox SUN will be monitored by a doctor experienced in managing iron overload caused by blood transfusions.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

How much Deferasirox SUN to take
The dose of Deferasirox SUN is based on body weight for all patients. Your doctor will calculate the appropriate dose for you and tell you how many film-coated tablets to take each day.

• The usual daily dose of Deferasirox SUN film-coated tablets at the start of treatment for patients receiving regular blood transfusions is 14 mg per kilogram of body weight. Your doctor may recommend a higher or lower initial dose depending on your individual treatment needs.
• The usual daily dose of Deferasirox SUN film-coated tablets at the start of treatment for patients not receiving regular blood transfusions is 7 mg per kilogram of body weight.
• Depending on your response to treatment, your doctor may later adjust your dose by increasing or decreasing it.
• The maximum recommended daily dose of Deferasirox SUN film-coated tablets is:
  • 28 mg per kilogram of body weight for patients receiving regular blood transfusions,
  • 14 mg per kilogram of body weight for adults not receiving regular blood transfusions,
  • 7 mg per kilogram of body weight for children and adolescents not receiving regular blood transfusions.

In some countries, deferasirox may also be available as dispersible tablets produced by other manufacturers. If you switch from such dispersible tablets to Deferasirox SUN film-coated tablets, your dose will change. Your doctor will calculate the dose you need and inform you how many film-coated tablets to take each day.

When to take Deferasirox SUN
Take Deferasirox SUN once daily, every day, at approximately the same time each day, with water.
Take Deferasirox SUN film-coated tablets on an empty stomach or with a light meal.
Taking Deferasirox SUN at the same time every day will help you remember to take your tablets.

For patients unable to swallow the tablets whole, Deferasirox SUN film-coated tablets may be crushed and administered by mixing the full dose with soft food such as yogurt or applesauce (apple puree). The food must be consumed immediately and completely. Do not store it for later use.

How long to take Deferasirox SUN
Continue taking Deferasirox SUN every day for the duration prescribed by your doctor. This is a long-term treatment, which may last for months or years. Your doctor will monitor your condition regularly to ensure the treatment is effective (see also section 2: "Monitoring of Deferasirox SUN treatment").
If you have any questions about how long to continue taking Deferasirox SUN, speak with your doctor.

If you take more Deferasirox SUN than you should
If you have taken too much Deferasirox SUN, or if someone else has accidentally taken your tablets, contact your doctor or hospital immediately for advice. Show the doctor the tablet packaging.
Urgent medical treatment may be required. Symptoms may include abdominal pain, diarrhoea, nausea and vomiting, and kidney or liver problems, which can be serious.

If you forget to take Deferasirox SUN
If you forget to take a dose, take it as soon as you remember on the same day. Take your next dose at the usual time. Do not take a double dose the next day to make up for the missed tablet(s).

If you stop taking Deferasirox SUN
Do not stop taking Deferasirox SUN unless instructed by your doctor. If you stop taking it, excess iron will no longer be removed from your body (see also above section "How long to take Deferasirox SUN").

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them. Most side effects are mild to moderate and usually disappear after a period of treatment ranging from a few days to a few weeks.
Some side effects may 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) or not known (frequency cannot be estimated from the available data).

• If you develop a severe rash, or have difficulty breathing and dizziness or swelling, mainly of the face and throat (signs of a severe allergic reaction),
• If you experience a combination of any of the following symptoms: rash, red skin, blistering on the lips, eyes or in the mouth, skin peeling, high fever, flu-like symptoms, swollen lymph nodes (signs of severe skin reactions),
• If you notice a marked reduction in urine output (a sign 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 experience difficulty thinking, remembering information, or solving problems, if you feel less alert or aware, or feel very drowsy with low energy (signs of high blood ammonium levels, which may be associated with liver or kidney problems and may lead to changes in brain function),
• If you vomit blood and/or have black stools,
• If you experience frequent abdominal pain, particularly after eating or taking Deferasirox SUN,
• If you experience frequent heartburn,
• If you experience partial loss of vision,
• If you experience severe pain in the upper part of the abdomen (pancreatitis), stop taking this medicine and contact your doctor immediately.

Some side effects may become serious.
These side effects are uncommon.

• If you experience blurred or cloudy vision,
• If you experience hearing loss, contact your doctor as soon as possible.

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

• Changes in kidney function tests.

Common (may affect up to 1 in 10 people)

• Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain, bloating, constipation, indigestion
• Rash
• Headache
• Changes in liver function tests
• Itching
• Changes in urine test (protein in urine) If any of these effects becomes severe, inform your doctor.

Uncommon (may affect up to 1 in 100 people)

• Dizziness
• Fever
• Sore throat
• Swelling of the arms or legs
• Change in skin colour
• Anxiety
• Sleep disorders
• Tiredness If any of these effects becomes severe, inform your doctor.

Frequency not known (frequency cannot be estimated from the available data).

• A reduction in the number of cells involved in blood clotting (thrombocytopenia), in the number of red blood cells (worsening of anaemia), in the number of white blood cells (neutropenia), or in the number of all types of blood cells (pancytopenia)
• Hair loss
• Kidney stones
• Low urine production and acute kidney failure, tubulointerstitial nephritis, nephrolithiasis, renal tubular necrosis
• Tear in the wall of the stomach or intestine which may be painful and cause nausea
• Gastrointestinal perforation and severe pain in the upper part of the abdomen (pancreatitis)
• Increased acidity of the blood (metabolic acidosis)
• Hypersensitivity reactions (including anaphylactic reactions and angioedema), Stevens-Johnson syndrome, hypersensitivity vasculitis, urticaria, erythema multiforme, toxic epidermal necrolysis (TEN)
• Liver failure

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Deferasirox SUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister after Exp. and on the carton after Exp. The expiry date refers to the last day of that month.
Store below 25°C.
Do not use the pack if it is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DEFERASIROX SUN contains

• The active substance is deferasirox. Each film-coated tablet of Deferasirox SUN 90 mg contains 90 mg of deferasirox. Each film-coated tablet of Deferasirox SUN 180 mg contains 180 mg of deferasirox. Each film-coated tablet of Deferasirox SUN 360 mg contains 360 mg of deferasirox.
• The other components are microcrystalline cellulose; crospovidone; povidone; poloxamer; colloidal silicon dioxide; magnesium stearate.
• The tablet coating contains: hypromellose; titanium dioxide (E171); macrogol (4000); talc; aluminium lake containing indigo carmine (E132).

Description of the appearance of Deferasirox SUN and contents of the pack
Deferasirox SUN is supplied as film-coated tablets. The film-coated tablets are oval and biconvex.

• Deferasirox SUN 90 mg film-coated tablets are light blue in colour, marked with "90" on one side and smooth on the other.
• Deferasirox SUN 180 mg film-coated tablets are medium blue in colour, marked with "180" on one side and smooth on the other.
• Deferasirox SUN 360 mg film-coated tablets are dark blue in colour, marked with "360" on one side and smooth on the other.

Deferasirox SUN 90 mg / 180 mg film-coated tablets
Each pack contains 30 or 90 film-coated tablets in blisters. Multiple packs contain 300 (3 packs of 100) film-coated tablets.
Deferasirox SUN 360 mg film-coated tablets
Each pack contains 30 or 90 film-coated tablets in blisters. Multiple packs contain 300 (3 packs of 100) film-coated tablets.
Not all pack sizes or strengths may be marketed.

Marketing Authorization Holder
Marketing Authorization Holder:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Terapia S.A.
Strada Fabricii Nr 124
400632 Cluj-Napoca, Romania

This medicinal product is authorized in the EEA Member States under the following names
Germany: Deferasirox Basics 90 mg Filmtabletten
Deferasirox Basics 180 mg Filmtabletten
Deferasirox Basics 360 mg Filmtabletten
France: Deferasirox SUN 90 mg comprimés pelliculés
Deferasirox SUN 180 mg comprimés pelliculés
Deferasirox SUN 360 mg comprimés pelliculés
Italy: Deferasirox SUN
Spain: Deferasirox SUN EFG 90 mg comprimidos recubiertos con película
Deferasirox SUN EFG 180 mg comprimidos recubiertos con película
Deferasirox SUN EFG 360 mg comprimidos recubiertos con película
The Netherlands: Deferasirox SUN 90 mg filmomhulde tabletten
Deferasirox SUN 180 mg filmomhulde tabletten
Deferasirox SUN 360 mg filmomhulde tabletten