Deferasirox Sandoz: detailed information

Package leaflet: Information for the patient

Deferasirox Sandoz 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 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 they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

What Deferasirox Sandoz is
Deferasirox Sandoz 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 Sandoz is used for
Patients with various forms of anaemia (e.g. thalassaemia, sickle cell anaemia or myelodysplastic syndromes (MDS)) may require repeated blood transfusions.
However, these can cause an excess of iron in the body. This occurs because blood contains iron, and the body has no natural way of eliminating the excess iron introduced through 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 Sandoz is used to treat iron overload due to frequent blood transfusions in patients with beta thalassaemia major aged 6 years and older.

Deferasirox Sandoz is also used to treat iron overload when deferoxamine therapy 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 Sandoz is also used when deferoxamine therapy 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 should know before taking Deferasirox Sandoz

Do not take Deferasirox Sandoz
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 Sandoz. If you think you
might be allergic, consult your doctor.
if you have moderate or severe kidney disease.
if you are currently taking any other iron-chelating medicine.
Deferasirox Sandoz 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 Sandoz:
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, or have difficulty breathing, 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: 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 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, 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, particularly after eating or after taking Deferasirox Sandoz.
if you have frequent 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 during treatment with Deferasirox Sandoz
During treatment, you will have regular blood and urine tests. These will measure the amount of iron in your body (serum ferritin level) to monitor how well Deferasirox Sandoz 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 the amount of iron in your liver, you may also undergo magnetic resonance imaging (MRI) scans. Your doctor will use these tests to determine the most appropriate dose of Deferasirox Sandoz 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 Sandoz
Tell 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 Sandoz,
antacids (medicines used to treat heartburn) containing aluminium, which must not be taken at the same time of day as Deferasirox Sandoz,
ciclosporine (used to prevent organ transplant rejection 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 bisphosphonates (used to treat osteoporosis),
anticoagulants (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),
cholestyramine (used to lower 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 monitoring may be required to check blood levels of some of these medicines.

Elderly patients (age 65 years and older)
Deferasirox Sandoz can be used in patients 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 Sandoz 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 Sandoz is not recommended for children under 2 years of age.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Deferasirox Sandoz 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), because Deferasirox Sandoz may reduce the effectiveness of hormonal contraceptives.
Breastfeeding is not recommended during treatment with Deferasirox Sandoz.

Driving and using machines
If you feel dizzy after taking Deferasirox Sandoz, do not drive or operate tools or machinery until the dizziness has resolved.

3. How to take Deferasirox Sandoz

Treatment with Deferasirox Sandoz 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 Sandoz to take
The dose of Deferasirox Sandoz 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 initial daily dose of Deferasirox Sandoz 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 initial daily dose of Deferasirox Sandoz 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 subsequently adjust the dose upward or downward.
The maximum recommended daily dose of Deferasirox Sandoz 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

Deferasirox is also available as "dispersible" tablets. If switching from dispersible tablets to these film-coated tablets, a dose adjustment will be necessary. Your doctor will calculate the required dose and inform you how many film-coated tablets to take each day.

When to take Deferasirox Sandoz

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

Taking Deferasirox Sandoz at the same time every day will help you remember when to take the tablets.
For patients unable to swallow the tablets whole, Deferasirox Sandoz 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 should be consumed immediately and entirely. Do not store it for future use.

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

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

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

If you stop taking Deferasirox Sandoz
Do not stop taking Deferasirox Sandoz 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 Sandoz").

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. Most side effects are mild to moderate and usually disappear after a few days or weeks of treatment.
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, breathing difficulties 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 problem)
if you experience a combination of drowsiness, pain in the right upper 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 with low energy (signs of high blood ammonia levels, which may be associated with liver or kidney problems and can lead to changes in brain function)
if you vomit blood and/or have black stools
if you experience frequent abdominal pain, especially after eating or taking Deferasirox Sandoz
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 and contact your doctor immediately.
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
skin 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 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 production
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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website:
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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton, after "Exp.". The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the packaging 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 Sandoz contains

The active substance is deferasirox.

Deferasirox Sandoz 90 mg film-coated tablets
Each tablet contains 90 mg of deferasirox.
Deferasirox Sandoz 180 mg film-coated tablets
Each tablet contains 180 mg of deferasirox.
Deferasirox Sandoz 360 mg film-coated tablets
Each tablet contains 360 mg of deferasirox.
The other ingredients are – in the tablet core: microcrystalline cellulose, crospovidone, magnesium stearate, povidone, poloxamer, anhydrous colloidal silica. In the coating - Opadry blue: hypromellose, titanium dioxide (E171), macrogol, talc, indigo carmine aluminium lake (E132).

Description of the appearance of Deferasirox Sandoz and contents of the pack
Deferasirox Sandoz 90 mg film-coated tablets
Film-coated, non-scored, blue, oval, biconvex tablet with bevelled edges, marked with “NVR” on one side and “90” on a slight upward curve between two curved lines on the other side. Approximate tablet dimensions: 10.7 mm x 4.2 mm.
Deferasirox Sandoz 180 mg film-coated tablets
Film-coated, non-scored, blue, oval, biconvex tablet with bevelled edges, marked with “NVR” on one side and “180” on a slight upward curve between two curved lines on the other. Approximate tablet dimensions: 14 mm x 5.5 mm.
Deferasirox Sandoz 360 mg film-coated tablets
Film-coated, non-scored, dark blue, oval, biconvex tablet with bevelled edges, marked with “NVR” on one side and “360” on a slight upward curve between two curved lines on the other. Approximate tablet dimensions: 17 mm x 6.7 mm.
The tablets are packaged in PVC/PVDC//Aluminium or PA/AL/PVC//Aluminium blisters.
Each blister pack contains 30, 90, 100 or 300 film-coated tablets. The multi-pack carton contains 300 film-coated tablets (10 packs of 30 film-coated tablets).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Novartis Pharmaceuticals S.R.L.
7A Livezeni Street
540472 Targu Mures
Romania