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
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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific adult or child. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Deferasirox MSN is and what it is used for
2. What you need to know before taking 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 a substance called deferasirox. It is an iron chelating agent, i.e. a medicine used to remove excess iron (so-called iron overload) from the body. Deferasirox MSN binds and removes excess iron, which is then mainly excreted in the faeces.

What Deferasirox MSN is used for
Frequent blood transfusions may be necessary in patients with various types of anaemia (e.g. thalassaemia, sickle cell anaemia or myelodysplastic syndromes). However, repeated blood transfusions can lead to excessive accumulation of iron. This occurs because blood contains iron, and the body has no natural way of eliminating excess iron received during transfusions. In patients with non-transfusion-dependent thalassaemia syndromes, iron overload may also develop over time, primarily due to increased iron absorption from food caused by low red blood cell count. Over time, excess iron may damage important organs such as the liver and heart. To remove excess iron and reduce the risk of organ damage, so-called iron chelating agents are used.

Deferasirox MSN is used in the treatment of chronic iron overload due to frequent blood transfusions in patients with severe beta-thalassaemia aged 6 years and older.

Deferasirox MSN is also used in the treatment of chronic iron overload when deferoxamine therapy is contraindicated or inappropriate, in patients with severe beta-thalassaemia with iron overload due to infrequent blood transfusions, in patients with other types of anaemia, and in children aged 2 to 5 years.

Deferasirox MSN is also used when deferoxamine therapy is contraindicated or insufficient in treating patients aged 10 years and older with iron overload associated with non-transfusion-dependent thalassaemia syndromes.

2. Important information before taking Deferasirox MSN

When not to use Deferasirox MSN

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

Use of Deferasirox MSN is not recommended

• if the patient has advanced myelodysplastic syndrome (reduced blood cell production by the bone marrow) or advanced malignant neoplasm.

Warnings and precautions
Before starting treatment with Deferasirox MSN, discuss the following with a 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 urine output (a sign of kidney disease);
• if the patient develops a severe rash, breathing difficulties, 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 develops any combination of the following symptoms: rash, red skin, blistering of 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 the patient experiences drowsiness, pain in the upper right part of the abdomen, yellowing or worsening yellow discoloration of the skin or eyes, and dark-colored urine (symptoms of liver disease);
• if the patient has difficulty thinking, remembering information, or solving problems, becomes less alert or conscious, or feels drowsy along with lack of energy (symptoms of high blood ammonia levels, which may be related to liver or kidney disorders; see also section 4: "Possible side effects");
• if the patient vomits blood and/or passes black stools;
• if the patient frequently has abdominal pain, especially after eating or taking Deferasirox MSN;
• if the patient frequently has heartburn;
• if blood tests show the patient has low platelet or white blood cell counts;
• if the patient has blurred vision;
• if the patient has diarrhoea or vomiting. If any of these conditions occur, the patient must inform their doctor immediately.

Monitoring of treatment with Deferasirox MSN
During treatment, the patient will undergo regular blood and urine tests. These are intended to monitor iron levels in the body (serum ferritin concentration) to assess how deferasirox is working. Blood tests also allow monitoring of kidney function (serum creatinine levels, presence of protein in urine) and liver function (increased blood aminotransferase activity). The treating doctor may order a kidney biopsy if significant kidney damage is suspected. The patient may also undergo MRI (magnetic resonance imaging) to determine iron levels in the liver. The treating doctor will consider the results of these tests when determining the optimal deferasirox dose for the individual patient and when deciding whether treatment should be discontinued.
As a precaution, annual hearing and vision tests will be performed during treatment.

Deferasirox MSN and other medicines
The patient must inform their doctor or pharmacist about all medicines currently or recently taken, as well as any medicines they plan to take. This is especially important for:

• other iron-chelating medicines, which must not be taken together with Deferasirox MSN;
• antacids containing aluminium, which should not be taken at the same time of day as Deferasirox MSN;
• cyclosporine (used to prevent organ transplant rejection or to treat other conditions such as rheumatoid arthritis or atopic dermatitis);
• simvastatin (used to reduce 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 for heart conditions or migraine);
• 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 psychiatric disorders such as schizophrenia);
• tizanidine (used as a muscle relaxant);
• cholestyramine (used to reduce blood cholesterol levels);
• busulfan (used before receiving a transplant, to destroy existing bone marrow prior to transplantation);
• midazolam (used to relieve anxiety and/or sleep problems).

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

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. Elderly patients may experience more side effects (especially diarrhoea) than younger patients. Patients in this age group should be closely monitored by their treating 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. The doctor will adjust the dose as the patient grows.
This medicine is not recommended for children under 2 years of age.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
This medicine is not recommended during pregnancy unless there is a strong medical need for treatment.
If the patient uses hormonal contraception to prevent pregnancy, it is necessary to 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 operating machinery
If the patient experiences dizziness while taking deferasirox, they should not drive or operate machinery until they feel well again.

Deferasirox MSN contains lactose and sodium

Lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

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

3. How to use Deferasirox MSN

Treatment with Deferasirox MSN will be supervised by a physician experienced in managing patients with iron overload due to blood transfusions.
This medicine should always be used exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

How much Deferasirox MSN to take

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

• The usual starting daily dose of deferasirox in patients receiving regular blood transfusions is generally 14 mg per kilogram of body weight. Depending on individual needs, your doctor may prescribe a higher or lower initial dose.
• In patients not receiving regular blood transfusions, the usual starting daily dose of Deferasirox MSN, film-coated tablets, is generally 7 mg per kilogram of body weight.
• Depending on the response to treatment, your doctor may later adjust the dose, either 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 adults 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 oral dispersible tablets manufactured by other companies. If a patient switches treatment from such oral dispersible tablets to the film-coated tablets of Deferasirox MSN, the dose will change. Your treating physician will calculate the required dose and inform you how many film-coated tablets to take daily.

When to take Deferasirox MSN

• Deferasirox MSN should be taken once daily, every day, approximately at 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 approximately the same time each day will help you remember to take your dose.

For patients who cannot swallow the tablets whole, the film-coated deferasirox tablets may be crushed and mixed with a soft food, such as yogurt or apple puree (applesauce). The entire dose should be consumed immediately together with the food and should not be stored for later use.

How long to take Deferasirox MSN

You should continue taking deferasirox daily for as long as your doctor recommends. This is a long-term treatment that may last for several months or years. Your doctor will regularly monitor your health to assess whether the treatment is achieving the desired effects (see also section 2: "Monitoring of treatment with Deferasirox MSN").

If you have any questions regarding the duration of treatment with Deferasirox MSN, please contact your doctor.

Taking more than the prescribed dose of Deferasirox MSN

If you take more than the prescribed dose of Deferasirox MSN, or if someone else accidentally takes the tablets, seek medical advice immediately by contacting a doctor or going to the nearest hospital. Bring the medicine packaging with you. Immediate medical treatment may be necessary. Symptoms such as abdominal pain, diarrhoea, nausea and vomiting, as well as kidney or liver problems, which may be serious, could occur.

Missed dose of Deferasirox MSN

If you miss a dose, take it as soon as possible 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).

Stopping Deferasirox MSN

Do not stop taking deferasirox unless your doctor advises you to do so. If treatment is stopped, excess iron will no longer be removed from the body (see also section "How long to take Deferasirox MSN").

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Most adverse reactions are mild to moderate in severity and usually resolve within a few days or weeks of treatment.
Some adverse reactions may be serious and require immediate medical attention.
These adverse reactions occur uncommonly (may occur in up to 1 in 100 patients) or rarely (may occur in up to 1 in 1,000 patients).

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

• if the patient develops any combination of the following symptoms: rash, red skin, blistering of the lips, eyes or mouth, peeling of the skin, 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 passed (symptom of kidney disease);

• if the patient experiences simultaneously drowsiness, pain in the upper right part of the abdomen, yellowing or worsening yellow discoloration of the skin or eyes, and dark-colored urine (symptoms of liver disease);

• if the patient has difficulty thinking, remembering information, or solving problems, becomes less alert or conscious, or feels drowsy along with lack of energy (symptoms of high blood ammonia levels, 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 has abdominal pain, especially after eating or taking Deferasirox MSN;

• if the patient frequently experiences heartburn;

• if the patient experiences partial loss of vision;

• if the patient develops sudden severe pain in the upper abdomen (pancreatitis); the medicine should be discontinued immediately and the doctor must be informed without delay.

Some adverse reactions may become severe.
These adverse reactions occur uncommonly.

• if blurred or hazy vision occurs,
• if hearing impairment occurs, the doctor should be informed as soon as possible.

Other adverse reactions
Very common (may occur in more than 1 in 10 patients):

• abnormal kidney function test results.

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

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

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

• dizziness;
• fever;
• sore throat;
• swelling of arms and legs;
• change in skin pigmentation;
• restlessness;
• sleep disorders;
• fatigue. If any of these symptoms are severe, the doctor should be informed.

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

• decreased number of platelets involved in blood clotting (thrombocytopenia), decreased number of red blood cells (worsening of anaemia), decreased number of white blood cells (neutropenia), or decreased number of all types of blood cells (pancytopenia);
• hair loss;
• kidney stones;
• low volume of urine output;
• perforation of the stomach or intestinal wall, which may cause pain and nausea;
• sudden severe pain in the upper abdomen (pancreatitis);
• abnormal blood pH.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the responsible entity.

5. How to store Deferasirox MSN

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister pack and outer carton after "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 having been opened or tampered with.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Deferasirox MSN contains
The active substance 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
anhydrous silica, sodium stearyl fumarate, hydrogenated castor oil.
Coating ingredients: Opadry yellow 03H520019 (HPMC 2910): hypromellose 6mPas, titanium
dioxide (E 171), propylene glycol, talc, iron oxide yellow (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 bevelled edges, embossed with the mark "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 bevelled edges, embossed with the mark "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 bevelled edges, embossed with the mark "D" on one side and "360" on the other side of the tablet.

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

Marketing Authorisation 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 medicinal product is authorised in 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