DEFERASIROX 90 mg Film-Coated Tablets

Зміст інструкції

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

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

deferasirox

Read 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 only for you or for your child. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

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

What is Deferasirox Glenmark used for
In patients with various forms of anaemia (for example thalassemia, sickle cell disease 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 blood
transfusions. In patients with thalassaemic syndromes who are not undergoing blood
transfusion, iron overload can also develop over time, mainly due to increased
iron absorption 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 chelators are used to eliminate excess iron and reduce the risk that this may
damage some organs.
Deferasirox Glenmark is used for the treatment of chronic iron overload due to frequent
blood transfusions in patients with beta thalassemia major aged 6 years and over.
Deferasirox Glenmark is also used for the treatment of chronic 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 Glenmark 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 taking Deferasirox Glenmark

Do not take Deferasirox Glenmark

• 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 taking DeferasiroxGlenmark. 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 medicine chelating iron.

Deferasirox Glenmark 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 Glenmark:

• 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, especially 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 on 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 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 Glenmark.
• 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 Glenmark
During treatment, you will have regular blood and urine tests. These tests will
check the amount of iron in your body (serum ferritin level) to see how Deferasirox Glenmark is
working. The tests will also check kidney function (serum creatinine level, presence of protein in the urine) and liver function (serum transaminase level). Your doctor may ask you to have 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 (magnetic resonance imaging, MRI) scans. The doctor will evaluate these tests to decide what is the
most appropriate dose of Deferasirox Glenmark for you and will also use these tests to decide when you should
stop taking Deferasirox Glenmark.
As a precaution, your vision and hearing will be checked every year during treatment.

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

• other iron chelators, which should not be taken with Deferasirox Glenmark,
• antacids (medicines used to treat heartburn) containing aluminium, which should not be taken at the same time of day as Deferasirox Glenmark
• 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 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 cholesterol levels in the blood),
• busulfan (used as treatment prior to transplant to destroy the original bone marrow before the transplant),
• midazolam (used to relieve anxiety and/or sleep disorders).

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

Elderly (age 65 years or older)
Deferasirox Glenmark can be used by people aged 65 years or older at the same dose
used in adults. Elderly patients may experience more side effects (especially
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 Glenmark 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 Glenmark is not recommended for children under 2 years of age.

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

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

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

3. How to take Deferasirox Glenmark

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

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

• The usual daily dose of Deferasirox Glenmark 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 Glenmark 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 reducing the dose.
• The maximum recommended daily dose of Deferasirox Glenmark 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. In some countries, deferasirox may also be available as dispersible tablets, produced by other manufacturers. If you switch from such dispersible tablets to Deferasirox Glenmark film-coated tablets, the dose will change. The doctor will calculate the dose you need and tell you how many film-coated tablets to take each day.

When to take Deferasirox Glenmark

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

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

How long to take Deferasirox Glenmark
Continue to take Deferasirox Glenmark every 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 monitored regularly
by the doctor to verify that the treatment is effective (see also paragraph 2: “Monitoring of
treatment with Deferasirox Glenmark”).
If you have questions about how long to take Deferasirox Glenmark, talk to your doctor

If you take more Deferasirox Glenmark than you should
If you have taken too much Deferasirox Glenmark or if someone else has accidentally taken your
tablets, contact your doctor or hospital for advice immediately. Show the doctor the package of
tablets. Urgent 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 Glenmark
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 Glenmark
Do not stop taking Deferasirox Glenmark unless your doctor tells you to do so. 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 Glenmark”).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are mild to moderate in intensity and usually disappear after a period of treatment lasting from a few days to a few weeks.

Some side effects can 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 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 seem less alert or aware or feel very sleepy with little energy (signs of a high level of ammonia in the blood, which can 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 Glenmark,
• 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 may become serious.These side effects are uncommon.
• If you have blurred or cloudy vision,
• If you have a decrease in hearing inform your doctor as soon as possible.Other side effectsVery 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, bloated stomach, 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 present 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 (metabolic acidosis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at the address: 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 Glenmark

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is reported on the blister and on the package after Scad. The expiry date refers to the last day of that month.
• Do not use the package which is damaged or shows signs of tampering.
• Do not dispose of any medicine in the 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 Glenmark contains
The active ingredient is deferasirox.

• Each film-coated tablet of Deferasirox Glenmark 90 mg contains deferasirox 90 mg.
• Each film-coated tablet of Deferasirox Glenmark 180 mg contains deferasirox 180 mg.
• Each film-coated tablet of Deferasirox Glenmark 360 mg contains deferasirox 360 mg.

The other ingredients are microcrystalline cellulose; crospovidone; colloidal anhydrous silica, poloxamer;
povidone; sodium starch glycolate, magnesium stearate and isopropyl alcohol. The tablet coating
contains: hypromellose; titanium dioxide (E171); macrogol (4000); talc; aluminium lake containing
indigotine (E132).

Description of Deferasirox Glenmark and package contents
Deferasirox Glenmark is supplied in the form of film-coated tablets.

• Deferasirox Glenmark 90 mg film-coated tablets are light blue, oval, biconvex, film-coated tablets with bevelled edges, with "L" imprinted on one side and "663" on the other.
• Deferasirox Glenmark 180 mg film-coated tablets are medium blue, oval, biconvex, film-coated tablets with bevelled edges, with "L" imprinted on one side and "664" on the other.
• Deferasirox Glenmark 360 mg film-coated tablets are dark blue, oval, biconvex, film-coated tablets with bevelled edges, with "L" imprinted on one side and "665" on the other.

Blister packaging:
Each pack contains 30 or 90 film-coated tablets.
Bottle packaging:
Each bottle contains 30 film-coated tablets.
Bulk packaging:
Each bottle contains 1,000 film-coated tablets.
Not all pack sizes or strengths may be marketed in your country.

Marketing Authorisation Holder
Glenmark Arzneimittel GmbH
Industriestrasse 31, Groebenzell, 82194
Munich, Germany

Manufacturer
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park
Paola
PLA 3000
Malta
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
Vysoke Myto
566 01
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area (EEA)
with the following denominations:
Denmark: Deferasirox Glenmark
Czech Republic: Deferasirox Glenmark
Germany: Deferasirox Glenmark 90 mg Filmtabletten
Deferasirox Glenmark 180 mg Filmtabletten
Deferasirox Glenmark 360 mg Filmtabletten
Spain: Deferasirox Viso Farmacéutica 90 mg
film-coated tablets EFG
Deferasirox Viso Farmacéutica 360 mg
film-coated tablets EFG
Finland: Deferasirox Glenmark 90 mg tabletti, kalvopäällysteinen
Deferasirox Glenmark 180 mg tabletti, kalvopäällysteinen
Deferasirox Glenmark 360 mg tabletti, kalvopäällysteinen
Sweden: Deferasirox Glenmark 90 mg filmdragerad tablet
Deferasirox Glenmark 180 mg filmdragerad tablet
Deferasirox Glenmark 360 mg filmdragerad tablett
Slovakia: Deferasirox Glenmark 180 mg filmom obalené tablety
Deferasirox Glenmark 360 mg filmom obalené tablet
Italy: Deferasirox Glenmark