Deferasirox Msn

Package Leaflet: 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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

What Deferasirox MSN is

Deferasirox MSN contains the active substance deferasirox. It is an iron chelator, which is a medicine used to remove excess iron from the body (iron overload). Deferasirox MSN captures and removes excess iron, which is then mainly excreted in the feces.

What Deferasirox MSN is 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 lead to excessive iron accumulation. This happens because blood contains iron, and the body does not have a natural mechanism 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, iron chelators 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 inadequate 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. What you need to know before you take Deferasirox MSN

Do not take Deferasirox MSN

• if you are allergic to deferasirox or any of the other ingredients of this medicine (listed in section 6). If you have such an allergy, you must inform your doctor before taking Deferasirox MSN.If you suspect that you may be allergic, consult your doctor;
• if you have moderate or severe kidney problems;
• if you are currently taking any other iron chelators.

Deferasirox MSN is not recommended

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

Warnings and precautions

Before starting treatment with Deferasirox MSN, discuss with your doctor or pharmacist:

• if you have kidney or liver disease;
• if you have heart problems caused by iron overload;
• if you notice a significant decrease in the amount of urine you pass (a sign of kidney disease);
• if you experience a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and throat (symptoms of a severe allergic reaction, see also section 4: "Possible side effects");
• if you experience 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 a severe skin reaction, see also section 4: "Possible side effects");
• if you experience 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 you have difficulty thinking, remembering information, or solving problems, become less alert or aware, or feel drowsy with a lack of energy (symptoms of high ammonia levels in the blood, which may be related to liver or kidney problems and may lead to changes in brain function);
• if you vomit blood and/or pass black stools;
• if you frequently experience abdominal pain, especially after eating or taking Deferasirox MSN;
• if you frequently experience heartburn;
• if you have abnormal blood test results showing a low platelet count or white blood cell count;
• if you have blurred vision;
• if you have diarrhea or vomiting. If any of these conditions or situations occur, you should immediately inform your doctor.

Monitoring of Deferasirox MSN treatment

During treatment, you will undergo regular blood and urine tests. Their purpose is to monitor the amount of iron in your 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 liver enzyme activity in the blood). Your doctor may order a kidney biopsy if they suspect significant kidney damage. You may also undergo an MRI (magnetic resonance imaging) to determine the amount of iron in the liver. Your doctor will consider the results of these tests when determining the optimal dose of deferasirox for you 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, especially:

• other iron chelators, which must not be taken with Deferasirox MSN;
• antacids (medicines used to treat heartburn) containing aluminum, which must 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);
• painkillers 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 medicines);
• 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 existing bone marrow before the transplant);
• midazolam (used to relieve anxiety and/or sleep problems).

Your doctor may order additional tests to monitor the levels of some of these medicines in your 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 (especially diarrhea) may occur 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. This medicine is not recommended during pregnancy unless clearly necessary. If you are using hormonal contraception to prevent pregnancy, you should use additional or alternative contraception (e.g., condoms) because Deferasirox MSN may reduce the effectiveness of hormonal contraceptives. Breastfeeding is not recommended during treatment with deferasirox.

Driving and using machines

If you experience dizziness while taking deferasirox, do not drive or operate machinery until you feel better.

Deferasirox MSN contains lactose and sodium

Lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Sodium

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

3. How to take Deferasirox MSN

Treatment with Deferasirox MSN will be supervised by a doctor experienced in the treatment of patients with iron overload due to blood transfusions. Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

How much Deferasirox MSN to take

For all patients, the dose of deferasirox is based on body weight. Your doctor will calculate the dose you need and tell you how many tablets to take each day.

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

In some countries, deferasirox may also be available in the form of tablets for oral suspension, manufactured by other manufacturers. If you switch from such tablets for oral suspension to Deferasirox MSN film-coated tablets, the 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 MSN

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

If you are unable to swallow the tablets whole, you can crush the Deferasirox MSN film-coated tablets and mix the entire dose with a soft food such as yogurt or apple sauce. Consume the mixture immediately and do not store it for later use.

How long to take Deferasirox MSN

Continue to take Deferasirox MSN every day for as long as your doctor tells you.This is a long-term treatment that may last several months or years. Your doctor will regularly check your health to see if the treatment is working (see also section 2: "Monitoring of Deferasirox MSN treatment"). If you have any questions about the duration of treatment with Deferasirox MSN, ask your doctor.

If you take more Deferasirox MSN than you should

If you take more Deferasirox MSN than you should or if someone else takes your tablets by mistake, contact your doctor or the nearest hospital immediately. Show your doctor the package of the medicine. You may need immediate treatment. You may experience symptoms such as abdominal pain, diarrhea, nausea, and vomiting, as well as kidney or liver problems, which can be serious.

If you forget to take Deferasirox MSN

If you miss a dose, take it as soon as possible on the same day. Take the next dose at the usual time. Do not take a double dose the next day to make up for the missed tablet (tablets).

Stopping treatment with Deferasirox MSN

Do not stop taking Deferasirox MSN unless your doctor tells you to. If you stop treatment, excess iron will no longer be removed from your 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 go away after a few days or weeks of treatment.

Some side effects may be serious and require immediate medical attention.

These side effects are not common (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people).

• if you experience a severe rash or difficulty breathing and dizziness or swelling mainly of the face and throat (symptoms of a severe allergic reaction);

or

• if you experience 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 you notice a significant decrease in the amount of urine you pass (a sign of kidney disease);
• if you experience 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 you have difficulty thinking, remembering information, or solving problems, become less alert or aware, or feel drowsy with a lack of energy (symptoms of high ammonia levels in the blood, which may be related to liver or kidney problems and may lead to changes in brain function);
• if you vomit blood and/or pass black stools;
• if you frequently experience abdominal pain, especially after eating or taking Deferasirox MSN;
• if you frequently experience heartburn;
• if you have abnormal blood test results showing a low platelet count or white blood cell count;
• if you have blurred vision;
• if you experience a sudden severe pain in the upper part of the abdomen (pancreatitis); you must stop taking the medicine and immediately tell your doctor.

Some side effects may become serious.

These side effects are not common.

• if you experience blurred or cloudy vision,
• if you experience hearing loss, you must tell your doctor as soon as possible.

Other side effects

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

• abnormal kidney function test results.

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

• 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, you should tell your doctor.

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

• dizziness;
• fever;
• sore throat;
• swelling of the arms and legs;
• skin discoloration;
• restlessness;
• sleep disorders;
• fatigue. If any of these symptoms are severe, you should tell your 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 (worsening anemia), white blood cells (neutropenia), or 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;
• sudden severe pain in the upper part of the abdomen (pancreatitis);
• abnormal blood acidity.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist or nurse. Side effects can be reported to the national reporting system via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme (www.mhra.gov.uk/yellowcard). Side effects can also be reported to the marketing authorization holder.

5. How to store Deferasirox MSN

Keep this medicine out of the sight and reach of children. This medicine does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. Do not use this medicine if the packaging is damaged or shows signs of tampering. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Deferasirox MSN contains

The active substance is deferasirox. Each film-coated tablet of Deferasirox MSN 90 mg contains 90 mg of deferasirox. Each film-coated tablet of Deferasirox MSN 180 mg contains 180 mg of deferasirox. Each film-coated tablet of Deferasirox MSN 360 mg contains 360 mg of deferasirox. The other ingredients are: microcrystalline cellulose, sodium croscarmellose, hypromellose 2910 (E 464), poloxamer 188, povidone K30, lactose monohydrate, colloidal anhydrous silica, sodium stearyl fumarate, hydrogenated castor oil. Coating: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 "D" engraved on one side and "90" on the other side.
• Deferasirox MSN 180 mg film-coated tablets: Yellow, oval (approximately 14 mm x 5.5 mm), biconvex film-coated tablets with beveled edges, with "D" engraved on one side and "180" on the other side.
• Deferasirox MSN 360 mg film-coated tablets: Yellow, oval (approximately 17 mm x 7 mm), biconvex film-coated tablets with beveled edges, with "D" engraved on one side and "360" on the other side.

Each pack contains 30 or 90 film-coated tablets 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