Deferasirox Aurobindo: detailed information

Patient Information Leaflet: Information for the User

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

Generic Medicine
Please read all of this leaflet carefully before you or your child starts taking this medicine, as 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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Deferasirox Aurobindo is and what it is used for
What you need to know before taking Deferasirox Aurobindo
How to take Deferasirox Aurobindo
Possible side effects
How to store Deferasirox Aurobindo
Contents of the pack and other information

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

What Deferasirox Aurobindo is
Deferasirox Aurobindo contains an active substance called deferasirox. It is an iron chelator, that is,
a medicine used to remove excess iron from the body (also known as iron overload). It binds to excess
iron and removes it, primarily through the faeces.
What Deferasirox Aurobindo is used for
Patients with various forms of anaemia (for example, thalassaemia, sickle cell anaemia or myelodysplastic
syndromes (MDS)) may require repeated blood transfusions. 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 by blood transfusions. In patients with thalassaemia syndromes who are not receiving blood
transfusions, 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 Aurobindo is used to treat chronic iron overload due to frequent blood transfusions in patients
with beta-thalassaemia major aged 6 years and older.
Deferasirox Aurobindo is also used to treat chronic 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 Aurobindo 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 transfusions.

2. What you need to know before taking Deferasirox Aurobindo

Do not take Deferasirox Aurobindo

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 Aurobindo. 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 Aurobindo 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 Aurobindo:

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 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 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, 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 Aurobindo.
if you frequently suffer from heartburn.
if blood tests show low platelet or white blood cell counts.
if you have blurred vision.
if you have diarrhoea or vomiting.

If any of these situations apply to you, inform your doctor immediately.
Monitoring during treatment with Deferasirox Aurobindo
During treatment, you will undergo regular blood and urine tests. These will monitor the amount of iron in your body (blood ferritin levels) to assess how well Deferasirox Aurobindo is working. The tests will also check kidney function (blood creatinine levels, 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 MRI (magnetic resonance imaging) scans. Your doctor will use these tests to determine the most appropriate dose of Deferasirox Aurobindo 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 Aurobindo
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 Aurobindo,
antacids (medicines used to treat heartburn) containing aluminium, which must not be taken at the same time of day as Deferasirox Aurobindo,
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 (birth control medicines),
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 patients (aged 65 years or older)
Deferasirox Aurobindo can be used in patients aged 65 years or 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 the doctor for side effects that may require dose adjustment.
Children and adolescents
Deferasirox Aurobindo can 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 according to the patient's growth.
Deferasirox Aurobindo is not recommended for children under 2 years of age.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Deferasirox Aurobindo is not recommended during pregnancy unless strictly necessary.
If you are currently using a hormonal contraceptive to prevent pregnancy, you must use an additional or different type of contraception (e.g. a condom), as deferasirox may reduce the effectiveness of hormonal contraceptives.
Breastfeeding is not recommended during treatment with Deferasirox Aurobindo.
Driving and using machines
If you feel dizzy after taking Deferasirox Aurobindo, do not drive or operate tools or machinery until the dizziness resolves.

3. How to take Deferasirox Aurobindo

Treatment with Deferasirox Aurobindo will be monitored by a doctor experienced in the treatment of iron overload caused by blood transfusions.
Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.

How much Deferasirox Aurobindo to take

The dose of Deferasirox Aurobindo is based on 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 starting daily dose of Deferasirox Aurobindo film-coated tablets for patients receiving regular blood transfusions is 14 mg per kilogram of body weight. Your doctor may recommend a higher or lower starting dose depending on the need for individualized treatment.
The usual starting daily dose of Deferasirox Aurobindo film-coated tablets 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, either increasing or decreasing it.
The maximum recommended daily dose of Deferasirox Aurobindo film-coated tablets is:
– 28 mg per kilogram of body weight for patients receiving regular blood transfusions, or
– 14 mg per kilogram of body weight for adults not receiving regular blood transfusions, or
– 7 mg per kilogram of body weight for children and adolescents not receiving regular blood transfusions.

Deferasirox Aurobindo is not available in the form of "dispersible" tablets. For dispersible tablets, other deferasirox-containing medicines must be used.
If you are switching from such dispersible tablets to Deferasirox Aurobindo 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 Aurobindo

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

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

How long to take Deferasirox Aurobindo

Continue taking Deferasirox Aurobindo 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 that the treatment is effective (see also section 2: "Monitoring of treatment with Deferasirox Aurobindo").
If you have any questions about how long to take Deferasirox Aurobindo, speak with your doctor.

If you take more Deferasirox Aurobindo than you should

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

If you forget to take Deferasirox Aurobindo

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 forgotten tablet(s).

If you stop taking Deferasirox Aurobindo

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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).

If you develop a severe skin 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: skin rash, red skin, blistering of the lips, eyes or 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 (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 have difficulty thinking, remembering information, or solving problems, feel less alert or aware, or feel very drowsy and lack energy (signs of high blood ammonia 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 Aurobindo,
If you frequently have 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 immediately and contact your doctor right away.

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

If you have blurred or cloudy vision,
If you have a decrease in hearing, 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
Fatigue 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 output
A tear in the wall of the stomach or intestine, which may be painful and cause nausea
Severe pain in the upper part of the abdomen (pancreatitis)
Increased acidity of the blood (metabolic acidosis).

Reporting of side effects
If you get any side effects, including ones 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 Aurobindo

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.
This medicine does not require any special storage conditions.
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 Aurobindo contains:

The active substance is deferasirox.
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.

Tablet core: Microcrystalline cellulose (grades 101 and 102), Crospovidone (type A), Poloxamer (type 188), Povidone (K 30), Anhydrous colloidal silica, and Magnesium stearate.
Tablet coating: Hypromellose 2910 (6 mPas), Titanium dioxide, Macrogol 6000, Talc,
Indigo carmine Al (3% - 5%), and Indigo carmine aluminium lake (11% - 14%).

Description of the appearance of Deferasirox Aurobindo and package contents
Film-coated tablet.

Deferasirox Aurobindo 90 mg film-coated tablets
Blue, oval, biconvex, film-coated tablet with bevelled edges, marked "DF" on one side and "90" on the other.

Deferasirox Aurobindo 180 mg film-coated tablets
Medium blue, oval, biconvex, film-coated tablet with bevelled edges, marked "DF" on one side and "180" on the other.

Deferasirox Aurobindo 360 mg film-coated tablets
Dark blue, oval, biconvex, film-coated tablet with bevelled edges, marked "DF" on one side and "360" on the other.

Deferasirox Aurobindo film-coated tablets are available in PVC transparent/PVdC – aluminium foil blisters, and PVC transparent – aluminium foil blisters containing 30, 90 and 300 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102 – 21047 Saronno (VA), Italy

Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta

Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

Arrow Génériques
26 avenue Tony Garnier
Lyon, 69007
France

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium Deferasirox AB 90 mg/180 mg/360 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten
France Deferasirox Arrow 90 mg / 180 mg / 360 mg, comprimé pelliculé
Germany DeferasiPUREN 90 mg/180 mg/360 mg Filmtabletten
Italy Deferasirox Aurobindo
Netherlands Deferasirox Aurobindo 90 mg/180 mg/360 mg filmomhulde tabletten
Portugal Deferasirox Generis
Spain Deferasirox Aurovitas 90 mg / 360 mg comprimidos recubiertos con película EFG