Deferasirox Msn

Leaflet accompanying the packaging: information for the user

Deferasirox MSN, 90 mg, film-coated tablets

Deferasirox MSN, 180 mg, film-coated tablets

Deferasirox MSN, 360 mg, film-coated tablets

Deferasirox

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for an adult or child. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Deferasirox MSN and what is it used for
• 2. Important information before taking Deferasirox MSN
• 3. How to take Deferasirox MSN
• 4. Possible side effects
• 5. How to store Deferasirox MSN
• 6. Contents of the packaging and other information

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

What is Deferasirox MSN

Deferasirox MSN contains the active substance deferasirox. It is an iron-chelating substance, i.e., a medicine used to remove excess iron (so-called iron overload) from the body. Deferasirox MSN captures and removes excess iron, which is then mainly excreted in the stool.

What is Deferasirox MSN used for

Repeated blood transfusions may be necessary for patients with various types of anemia (e.g., thalassemia, sickle cell anemia, or myelodysplastic syndromes). However, repeated blood transfusions can cause excessive iron accumulation. This happens because blood contains iron, and the body does not have natural methods to remove excess iron received during transfusions. In patients with thalassemia who are not dependent on blood transfusions, iron overload may also develop over time, mainly due to increased iron absorption from food, caused by a low number of red blood cells. Over time, excess iron can cause damage to important organs, such as the liver and heart. To remove excess iron and reduce the risk of organ damage, so-called iron-chelating medicines are used. Deferasirox MSN is used to treat chronic iron overload due to frequent blood transfusions in patients with severe beta-thalassemia aged 6 years and older. Deferasirox MSN is also used to treat chronic iron overload when treatment with deferoxamine is contraindicated or inappropriate, in patients with severe beta-thalassemia with iron overload due to infrequent blood transfusions, in patients with other types of anemia, and in children aged 2 to 5 years. Deferasirox MSN is also used when deferoxamine therapy is contraindicated or insufficient in the treatment of patients aged 10 years and older with iron overload in the course of thalassemia syndromes independent of blood transfusions.

2. Important information before taking Deferasirox MSN

When not to take Deferasirox MSN

• if the patient is allergic to deferasirox or any of the other ingredients of this medicine (listed in section 6). If the patient has such an allergy, they must inform their doctor before taking Deferasirox MSN. If the patient suspects they may be allergic, they should consult their doctor;
• if the patient has moderate or severe kidney impairment;
• if the patient is currently taking any other iron-chelating medicines.

Deferasirox MSN is not recommended

• if the patient has advanced myelodysplastic syndrome (reduced production of blood cells by the bone marrow) or advanced cancer.

Warnings and precautions

Before starting treatment with Deferasirox MSN, the patient should discuss it with their doctor or pharmacist:

• if the patient has kidney or liver disease;
• if the patient has heart problems caused by iron overload;
• if the patient notices a significant decrease in the amount of urine produced (a sign of kidney disease);
• if the patient experiences a severe rash, or breathing difficulties and dizziness or swelling mainly of the face and throat (symptoms of a severe allergic reaction, see also section 4: "Possible side effects");
• if the patient experiences any of the following symptoms: rash, red skin, blisters on the lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, swollen lymph nodes (symptoms of severe skin reactions, see also section 4: "Possible side effects");
• if the patient experiences drowsiness, pain in the upper right part of the abdomen, yellowing or darkening of the skin or eyes, and dark urine (symptoms of liver disease);
• if the patient has difficulty thinking, remembering information, or solving problems, becomes less alert or aware, or feels drowsy with a lack of energy (symptoms of high ammonia levels in the blood, which may be related to liver or kidney disorders and may lead to changes in brain function);
• if the patient vomits blood and/or passes black stools;
• if the patient frequently experiences abdominal pain, especially after eating or taking Deferasirox MSN;
• if the patient frequently experiences heartburn;
• if the patient's blood test shows a decreased number of platelets or white blood cells;
• if the patient has blurred vision;
• if the patient has diarrhea or vomiting. If any of these conditions or situations occur, the patient should immediately inform their doctor.

Monitoring treatment with Deferasirox MSN

During treatment, the patient will undergo regular blood and urine tests. Their purpose is to monitor the amount of iron in the body (ferritin levels in the blood) to check how deferasirox is working. Blood tests also allow monitoring of kidney function (creatinine levels in the blood, protein in the urine) and liver function (increased activity of aminotransferases in the blood). The doctor may order a kidney biopsy if they suspect significant kidney damage. The patient may also undergo an MRI (magnetic resonance imaging) to determine the amount of iron in the liver. The doctor will take into account the results of these tests when determining the optimal dose of deferasirox for the patient and when deciding when to stop taking deferasirox. As a precaution, annual vision and hearing tests will be performed during treatment.

Deferasirox MSN and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is especially important for:

• other iron-chelating medicines, which should not be taken with Deferasirox MSN;
• antacids (medicines used to treat heartburn) containing aluminum, which should not be taken at the same time of day as Deferasirox MSN;
• cyclosporine (used to prevent organ rejection or treat other diseases such as rheumatoid arthritis or atopic dermatitis);
• simvastatin (used to lower cholesterol levels);
• pain or anti-inflammatory medicines (e.g., aspirin, ibuprofen, corticosteroids);
• oral bisphosphonates (used to treat osteoporosis);
• anticoagulant medicines (used to prevent or treat excessive blood clotting);
• hormonal contraceptives (birth control methods);
• bepridil, ergotamine (used to treat heart diseases or 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 to treat cancer);
• theophylline (used to treat respiratory diseases such as asthma);
• clozapine (used to treat mental disorders such as schizophrenia);
• tizanidine (used as a muscle relaxant);
• cholestyramine (used to lower cholesterol levels in the blood);
• busulfan (used before receiving a transplant to destroy the existing bone marrow before the transplant);
• midazolam (used to relieve anxiety and/or sleep problems).

The doctor may order additional tests to monitor the levels of some of these medicines in the blood.

Elderly patients (65 years and older)

Deferasirox MSN can be used in patients aged 65 years and older at the same doses as in other adult patients. In elderly patients, more side effects may occur (especially diarrhea) than in younger patients. Patients in this age group should be closely monitored by their doctor to detect possible side effects that may require dose adjustment.

Children and adolescents

Deferasirox MSN 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. As the patient grows, the doctor will adjust the dose of the medicine. This medicine is not recommended for children under 2 years of age.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. This medicine is not recommended during pregnancy unless there is a clear need for treatment. If the patient is using a hormonal contraceptive method to prevent pregnancy, they should use additional or alternative contraception (e.g., condoms), as Deferasirox MSN may reduce the effectiveness of hormonal contraceptives. Breastfeeding is not recommended during treatment with deferasirox.

Driving and using machines

If the patient experiences dizziness while taking deferasirox, they should not drive or operate machines until they feel better.

Deferasirox MSN contains lactose and sodium

Lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially sodium-free.

3. How to take Deferasirox MSN

Treatment with Deferasirox MSN will be supervised by a doctor with experience in treating patients with iron overload due to blood transfusions. This medicine should always be taken according to the doctor's instructions. If the patient has any doubts, they should consult their doctor or pharmacist.

How much Deferasirox MSN to take

In all patients, the dose of deferasirox is based on body weight. The doctor will calculate the required dose and tell the patient how many tablets to take per day.

• Usually, the initial daily dose of deferasirox for patients receiving regular blood transfusions is 14 mg per kilogram of body weight. Depending on individual needs, the doctor may recommend a higher or lower initial dose.
• In patients not receiving regular blood transfusions, the initial daily dose of Deferasirox MSN is usually 7 mg per kilogram of body weight.
• Depending on the response to treatment, the doctor may adjust the dose later, increasing or decreasing it.
• The maximum recommended daily dose of deferasirox is:
• 28 mg per kilogram of body weight in patients receiving regular blood transfusions,
• 14 mg per kilogram of body weight in adult patients not receiving regular blood transfusions,
• 7 mg per kilogram of body weight in children and adolescents not receiving regular blood transfusions.

In some countries, deferasirox may also be available in the form of tablets for preparing an oral suspension, manufactured by other manufacturers. If the patient switches from such tablets for preparing an oral suspension to Deferasirox MSN film-coated tablets, the dose will change. The doctor will calculate the required dose and tell the patient how many film-coated tablets to take daily.

When to take Deferasirox MSN

• Deferasirox MSN should be taken once a day, every day, at approximately the same time each day, with a small amount of water.
• Deferasirox MSN film-coated tablets should be taken either on an empty stomach or with a light meal.
• Taking Deferasirox MSN at the same time every day will also help the patient remember to take the medicine.

In the case of patients who cannot swallow tablets whole, the film-coated tablets of deferasirox can be crushed and the entire dose can be added to a semi-liquid food, such as yogurt or apple sauce. The patient should consume the entire dose immediately with the food and not store it for future use.

How long to take Deferasirox MSN

The patient should continue to take deferasirox daily for as long as their doctor recommends.This is a long-term treatment that may last several months or years. The doctor will regularly monitor the patient's health to check if the treatment is working (see also section 2: "Monitoring treatment with Deferasirox MSN"). If the patient has any questions about the duration of treatment with Deferasirox MSN, they should consult their doctor.

Taking more Deferasirox MSN than recommended

If the patient takes more Deferasirox MSN than recommended or if someone else accidentally takes the tablets, they should immediately consult their doctor or go to the nearest hospital. The patient should show the doctor the packaging of the medicine. Immediate treatment may be necessary. The patient may experience symptoms such as abdominal pain, diarrhea, nausea, and vomiting, as well as kidney or liver problems, which can be serious.

Missing a dose of Deferasirox MSN

If the patient misses a dose, they should take it as soon as possible on the same day. The next dose should be taken at the usual time. The patient should not take a double dose the next day to make up for the missed tablet (tablets).

Stopping treatment with Deferasirox MSN

The patient should not stop taking deferasirox unless their doctor decides to. After stopping treatment, excess iron will no longer be removed from the body (see also the section "How long to take Deferasirox MSN").

4. Possible side effects

Like all medicines, Deferasirox MSN can cause side effects, although not everybody gets 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 occur uncommonly (may affect up to 1 in 100 patients) or rarely (may affect up to 1 in 1,000 patients).

• if the patient experiences a severe rash or breathing difficulties and dizziness, or

swelling, mainly of the face and throat (symptoms of a severe allergic reaction);

• if the patient experiences any of the following symptoms: rash, red skin, blisters on the lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, swollen lymph nodes (symptoms of severe skin reactions);
• if the patient notices a significant decrease in the amount of urine produced (a sign of kidney disease);
• if the patient experiences drowsiness, pain in the upper right part of the abdomen, yellowing or darkening of the skin or eyes, and dark urine (symptoms of liver disease);
• if the patient has difficulty thinking, remembering information, or solving problems, becomes less alert or aware, or feels drowsy with a lack of energy (symptoms of high ammonia levels in the blood, which may be related to liver or kidney disorders and may lead to changes in brain function);
• if the patient vomits blood and/or passes black stools;
• if the patient frequently experiences abdominal pain, especially after eating or taking Deferasirox MSN;
• if the patient frequently experiences heartburn;
• if the patient's blood test shows a decreased number of platelets or white blood cells;
• if the patient has blurred vision;
• if the patient experiences acute pain in the upper part of the abdomen (pancreatitis); the patient should stop taking the medicine and immediately tell their doctor.

Some side effects may become serious.

These side effects occur uncommonly.

• if the patient experiences blurred or cloudy vision,
• if the patient experiences hearing loss, they should inform their doctor as soon as possible.

Other side effects

Very common (may affect more than 1 in 10 patients):

• abnormal kidney function test results.

Common (may affect up to 1 in 10 patients):

• gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, bloating, constipation, indigestion;
• rash;
• headache;
• abnormal liver function test results;
• itching;
• abnormal urine test results (protein in the urine). If any of these symptoms are severe, the patient should inform their doctor.

Uncommon (may affect up to 1 in 100 patients):

• dizziness;
• fever;
• sore throat;
• swelling of the arms and legs;
• skin discoloration;
• anxiety;
• sleep disorders;
• fatigue. If any of these symptoms are severe, the patient should tell their doctor.

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

• decreased number of blood cells involved in blood clotting (thrombocytopenia), decreased number of red blood cells (aggravation of anemia), number of white blood cells (neutropenia), or decreased number of all types of blood cells (pancytopenia);
• hair loss;
• kidney stones;
• low urine output;
• rupture of the stomach or intestine, which can cause pain and nausea;
• acute pain in the upper part of the abdomen (pancreatitis);
• abnormal blood acidity.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder.

5. How to store Deferasirox MSN

The medicine should be stored out of sight and reach of children. This medicine does not require special storage conditions. Do not use this medicine after the expiry date stated on the blister and carton after the abbreviation used to describe it (EXP). The expiry date refers to the last day of the specified month. Do not use this medicine if the packaging is damaged or shows signs of opening or damage. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Deferasirox MSN contains

The active substance of the medicine is deferasirox. Each Deferasirox MSN 90 mg film-coated tablet contains 90 mg of deferasirox. Each Deferasirox MSN 180 mg film-coated tablet contains 180 mg of deferasirox. Each Deferasirox MSN 360 mg film-coated tablet contains 360 mg of deferasirox. The other ingredients are: microcrystalline cellulose, sodium croscarmellose, low-substituted hydroxypropylcellulose (E 463), poloxamer 188, povidone K30, lactose monohydrate, colloidal silica anhydrous, sodium stearyl fumarate, hydrogenated castor oil. Coating ingredients:Opadry yellow 03H520019 (HPMC 2910): hypromellose 6mPas, titanium dioxide (E 171), propylene glycol, talc, yellow iron oxide (E 172).

What Deferasirox MSN looks like and contents of the pack

• Deferasirox MSN 90 mg film-coated tablets: Yellow, oval (approximately 11 mm x 4 mm), biconvex film-coated tablets with beveled edges, with the imprint "D" on one side and "90" on the other side of the tablet.
• Deferasirox MSN 180 mg film-coated tablets: Yellow, oval (approximately 14 mm x 5.5 mm), biconvex film-coated tablets with beveled edges, with the imprint "D" on one side and "180" on the other side of the tablet.
• Deferasirox MSN 360 mg film-coated tablets: Yellow, oval (approximately 17 mm x 7 mm), biconvex film-coated tablets with beveled edges, with the imprint "D" on one side and "360" on the other side of the tablet.

Each pack contains 30 or 90 film-coated tablets packaged in blisters. Not all pack sizes or strengths may be marketed.

Marketing authorization holder:

Vivanta Generics s.r.o. Třtinová 260/1, Čakovice 196 00 Prague 9 Czech Republic

Manufacturer:

Pharmadox Healthcare Limited KW20A, Kordin Industrial Park Paola, PLA3000 Malta MSN Labs Europe Limited KW20A, Corradino Park Paola, PLA3000 Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands:

Deferasirox MSN 90 mg / 180 mg / 360 mg

Czech Republic:

Deferasirox MSN

Hungary:

Deferasirox MSN 90 mg / 180 mg / 360 mg

Poland:

Deferasirox MSN

Romania:

Deferasirox MSN Laboratories 90 mg film-coated tablets Deferasirox MSN Laboratories 180 mg film-coated tablets Deferasirox MSN Laboratories 360 mg film-coated tablets

Slovakia:

Deferasirox MSN 90 mg / 180 mg / 360 mg

Cyprus:

Deferasirox MSN

Date of last revision of the leaflet: 11/2022