DEFERASIROX 90 mg Film-Coated Tablets

Зміст інструкції

1. Deferasirox Abdi 90 mg film-coated tablets, 180 mg film-coated tablets, 360 mg film-coated tablets
   1. What is Deferasirox Abdi and what it is used for
   2. What you need to know before you take Deferasirox Abdi
   3. How to take Deferasirox Abdi
   4. Possible side effects
   5. How to store Deferasirox Abdi
   6. Package contents and other information

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

Deferasirox

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

What is Deferasirox Abdi
Deferasirox Abdi contains an active substance called deferasirox. It is an iron chelator, i.e. a
medicinal product used to remove excess iron from the body (also known as iron overload). Deferasirox binds to excess iron and removes it, eliminating it mainly with the faeces.

What is Deferasirox Abdi used for
In patients with various forms of anaemia (for example thalassemia, sickle cell anaemia or myelodysplastic
syndromes (MDS)), repeated blood transfusions may be necessary. However, these can
cause an excess of iron in the body. This happens because blood contains iron and
the body does not have a natural way to remove the excess iron introduced with the
blood transfusions. In patients with thalassaemic syndromes who are not undergoing blood
transfusion, iron overload can also develop over time, mainly due to an
increased absorption of iron with the diet 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 chelatorsare used to eliminate excess iron and reduce the risk
that this may damage some organs.
Deferasirox Abdi is used for the treatment of iron overload due to frequent blood
transfusions in patients with beta thalassemia major aged 6 years and over.
Deferasirox Abdi is also used for the treatment of iron overload when deferoxamine therapy is contraindicated or inadequate in patients with beta thalassemia 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 Abdi is also used when deferoxamine therapy is contraindicated or inadequate
for the treatment of patients aged 10 years and over who have iron overload
associated with thalassaemic syndromes, but who do not require blood transfusion.

2. What you need to know before you take Deferasirox Abdi

Do not take Deferasirox Abdi

• 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, tell your doctor before takingDeferasirox Abdi. 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-chelating medicine.

Deferasirox Abdi is not recommended

• if you are in an advanced stage of myelodysplastic syndrome (MDS: decreased production of blood cells by the bone marrow) or have an advanced stage cancer.

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

• if you have a kidney or liver problem.
• if you have a heart problem due to iron overload.
• if you notice a marked reduction in urine output (a sign of kidney problems).
• if you have a severe skin rash, or difficulty breathing and 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, reddened skin, blistering of the lips, eyes or mouth, peeling skin, 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 on the right side of the upper 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 if you feel very sleepy with little energy (signs of a high level of ammonia 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 have black stools.
• if you experience frequent abdominal pain, especially after eating or taking Deferasirox Abdi.
• if you experience frequent heartburn.
• if you have low levels of platelets or white blood cells in your blood tests.
• if you have blurred vision.
• if you have diarrhoea or vomiting. If any of these situations apply to you, tell your doctor immediately.

Monitoring of treatment with Deferasirox Abdi
During treatment, you will be regularly subjected to blood and urine tests.
These will check the amount of iron in your body (ferritinlevel in the blood) to verify
how Deferasirox Abdi is working. The tests will also check kidney function (creatinine level
in the blood, presence of protein in the urine) and liver function (transaminase level
in the blood). Your doctor may ask you to undergo a kidney biopsy if they suspect significant
kidney damage. To determine the amount of iron in the liver, you may also undergo
magnetic resonance imaging (MRI) scans. The doctor will evaluate these tests
to decide what is the most appropriate dose of Deferasirox Abdi for you and will also use these tests to
decide when you should stop taking Deferasirox Abdi.
As a precaution, your vision and hearing will be examined every year during treatment.

Other medicines and Deferasirox Abdi
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This applies particularly to:

• other iron chelators, which must not be taken with Deferasirox Abdi,
• antacids (medicines used to treat heartburn) containing aluminium, which must not be taken at the same time of day as Deferasirox Abdi,
• cyclosporine (used to prevent organ rejection after a transplant or for other conditions such as rheumatoid arthritis or atopic dermatitis),
• simvastatin (used to lower cholesterol),
• some painkillers or anti-inflammatory drugs (e.g. aspirin, ibuprofen, corticosteroids),
• oral bisphosphonates (used to treat osteoporosis),
• anticoagulant medicines (used to prevent or treat blood clots),
• hormonal contraceptives (birth control pills),
• 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 in the treatment of 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),
• cholestyramine (used to lower cholesterol levels in the blood),
• busulfan (used as a treatment before transplantation to destroy the original bone marrow before the transplant),
• midazolam (used to relieve anxiety and/or sleep disorders).

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

Elderly (age 65 years or older)
Deferasirox Abdi can be used by people aged 65 years or older at the same dose
used in adults. Elderly patients may experience more side effects (particularly
diarrhoea) than younger patients. They should be carefully monitored by the doctor
for side effects that may require a dose adjustment.

Children and adolescents
Deferasirox Abdi can be used in children and adolescents receiving regular blood transfusions
aged 2 years or older and in children and adolescents not receiving regular
blood transfusions aged 10 years or older. The doctor will adjust the dose according to the patient’s growth.
Deferasirox Abdi is not recommended for children under 2 years of age.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor for advice before taking this medicine.
Deferasirox Abdi is not recommended during pregnancy unless it is 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 Abdi may reduce the effectiveness of hormonal contraceptives.
Breastfeeding is not recommended during treatment with Deferasirox Abdi.

Driving and using machines
If you feel dizzy after taking Deferasirox Abdi, do not drive or use tools or
machinery until you feel normal.

Deferasirox Abdi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.

3. How to take Deferasirox Abdi

Treatment with Deferasirox Abdi will be monitored by a doctor experienced in the treatment of
iron overload caused by blood transfusions.
Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

How much Deferasirox Abdi to take
The dose of Deferasirox Abdi is related to body weight for all patients. The doctor will calculate the dose
you need and tell you how many tablets to take each day.

• The usual daily dose of Deferasirox Abdi film-coated tablets at the beginning of treatment for patients receiving regular blood transfusions is 14 mg per kilogram of body weight. The doctor may recommend a higher or lower initial dose based on the need for personalized treatment.
• The usual daily dose of Deferasirox Abdi film-coated tablets at the beginning of treatment for patients who are not receiving regular blood transfusions is 7 mg per kilogram of body weight.
• Depending on how you respond to treatment, the doctor may subsequently modify the treatment by increasing or decreasing the dose.
• The maximum recommended daily dose of Deferasirox Abdi 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 adult patients who are not receiving regular blood transfusions,
• 7 mg per kilogram of body weight for children and adolescents who are not receiving regular blood transfusions.

Deferasirox is also available in the form of “dispersible” tablets. If you switch from dispersible tablets
to these film-coated tablets, a dose adjustment will be necessary.

When to take Deferasirox Abdi

• Take Deferasirox Abdi once a day, every day, at about the same time each day with a little water.
• Take the deferasirox film-coated tablets on an empty stomach or with a light meal.
• Taking Deferasirox Abdi every day at the same time will also help you remember when to take the tablets.

For patients who cannot swallow the tablets whole, the film-coated tablets of
Deferasirox Abdi can be crushed and administered by sprinkling the entire dose on soft food such as yogurt or applesauce (pureed apples). The food must be consumed immediately
and completely. Do not store it for future use.

How long to take Deferasirox Abdi
Continue to take Deferasirox Abdievery day for the duration that your doctor has told you.This is
a long-term treatment, which can last for months or years. Your condition will be
regularly monitored by your doctor to verify that the treatment is effective (see also section 2: “Monitoring treatment with Deferasirox Abdi”).
If you have questions about how long to take Deferasirox Abdi, talk to your doctor.

If you take more Deferasirox Abdi than you should
If you have taken too much Deferasirox Abdi, or if someone else has accidentally taken your
tablets, contact your doctor or hospital immediately for advice. Show them the
pack of tablets. Medical treatment may be necessary. Effects such as abdominal pain, diarrhea, nausea and vomiting, and kidney or liver problems that may
be serious may occur.

If you forget to take Deferasirox Abdi
If you forget to take a dose, take it as soon as you remember during that day. Take the next dose as scheduled. Do not take a double dose the next day to make up for the
missed dose(s).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Most side effects are mild to moderate and usually disappear after a period of treatment lasting 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 have a severe rash, or 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, reddened skin, blistering on the lips, eyes or in the mouth, peeling skin, high fever, flu-like symptoms, swollen lymph nodes (signs of severe skin reactions),
• If you notice a marked decrease in urine output (sign of kidney problems),
• If you experience a combination of drowsiness, pain on the right side of the upper 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 sleepy with little energy (signs of a high level of ammonia in the blood, which may be associated with liver or kidney problems and lead to a change in brain function),
• If you vomit blood and/or have black stools,
• If you experience frequent abdominal pain, especially after eating or taking Deferasirox Abdi,
• If you experience frequent heartburn,
• If you experience partial loss of vision,
• If you experience severe pain in the upper abdomen (pancreatitis), stop taking this medicine and inform your doctor immediately.

Some side effects could become serious.

These side effects are uncommon.

• If you have blurred or hazy vision,
• If you have a decrease in hearing, inform 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, diarrhea, abdominal pain, bloating, constipation, indigestion
• Rash
• Headache
• Changes in liver function tests
• Itching
• Changes in urine tests (protein in urine) If any of these effects occur severely, inform your doctor.

Uncommon (may affect up to 1 in 100 people)

• Dizziness
• Fever
• Sore throat
• Swelling of the arms or legs
• Changes in skin color
• Anxiety
• Sleep disorders
• Fatigue If any of these effects occur severely, inform your doctor.

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

• A reduction in the number of cells involved in blood clotting (thrombocytopenia), red blood cells (worsening of anemia), white blood cells (neutropenia) or all types of cells in the blood (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 abdomen (pancreatitis)
• Increased acidity of the blood.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 Abdi

• 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 package after Exp. The expiry date refers to the last day of that month.
• Do not use the package if it is damaged or shows signs of tampering.
• This medicine does not require any particular storage conditions.
• Do not dispose of any medicine in 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 Abdi contains
The active ingredient is deferasirox.

• Each film-coated tablet of Deferasirox Abdi 90 mg contains 90 mg of deferasirox.
• Each film-coated tablet of Deferasirox Abdi 180 mg contains 180 mg of deferasirox.
• Each film-coated tablet of Deferasirox Abdi 360 mg contains 360 mg of deferasirox. The other components are microcrystalline cellulose (Type 101), crospovidone (Type A), Poloxamer 188 (micronized), povidone (K30), microcrystalline cellulose (Type 102), silica (colloidal anhydrous), magnesium stearate. The tablet coating material contains: HPMC/hypromellose, titanium dioxide (E171), macrogol/PEG, talc, indigotine aluminium lake (E132)

Description of the appearance of Deferasirox Abdi and package contents
Deferasirox Abdi is provided in the form of film-coated tablets. The film-coated tablets
are oval and biconvex.

• Deferasirox Abdi 90 mg film-coated tablets of light grey colour, with “D1” imprinted on one side and smooth on the other side.
• Deferasirox Abdi 180 mg film-coated tablets of blue colour, with “D2” imprinted on one side and smooth on the other side.
• Deferasirox Abdi 360 mg film-coated tablets of dark blue colour, with “D3” imprinted on one side and smooth on the other side.

Packs:
For all dosages unit packs containing30 or 90 film-coated tablets.
Also, for Deferasirox Abdi 360 mg multipacks containing 300 (10 packs of 30)

film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
ABDI FARMA GmbH
Donnersbergstraβe 4
64646 Heppenheim
Germany

Manufacturer
Interpharma Services Ltd.
43A Cherni Vrach Blvd.,
1407 Sofia, Bulgaria
Interpharma Services Ltd.
11, Rusalijski prohod Str., fl. 3, ap. 8
1407 Sofia, Bulgaria
Flavine Pharma France
3 Voie d’Allermagne, Vitrolles,
13127 France

This medicinal product is authorised in the Member States of the European Economic Area
United Kingdom (Northern Ireland)> with the following denominations:



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