Eltrombopag Msn

Leaflet accompanying the packaging: patient information

Eltrombopag MSN, 25 mg, film-coated tablets

Eltrombopag MSN, 50 mg, film-coated tablets

Eltrombopag MSN, 75 mg, film-coated tablets

Eltrombopag

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

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

Table of contents of the leaflet

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

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

Eltrombopag MSN contains eltrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists. The medicine is used to increase the number of platelets in the patient's blood.

• Eltrombopag MSN is used to treat a bleeding disorder called primary immune thrombocytopenia (ITP) in patients over 1 year of age who have already been treated with other medicines (corticosteroids or immunoglobulins) and have not responded to them.

ITP is caused by a low platelet count (thrombocytopenia). People with ITP are more prone to bleeding. Symptoms that patients with ITP may notice include petechiae (small, flat, red spots on the skin), bruising, nosebleeds, gum bleeding, and difficulty stopping bleeding in case of injury or trauma.

• Eltrombopag MSN may also be used to treat a low platelet count (thrombocytopenia) in adults with hepatitis C virus (HCV) infection who have had difficulty due to side effects during interferon treatment. Many people with hepatitis C have a low platelet count, not only due to the disease but also as a result of the action of certain antiviral drugs used to treat it. Taking Eltrombopag MSN may help patients complete a full course of antiviral treatment (peginterferon and ribavirin).

2. Important information before taking Eltrombopag MSN

When not to take Eltrombopag MSN

• If the patient is allergicto eltrombopag or any of the other ingredients of this medicine (listed in section 6 "What Eltrombopag MSN contains"). Consult a doctorif the patient thinks this situation applies to them.

Warnings and precautions

Before starting treatment with Eltrombopag MSN, discuss it with a doctor or pharmacist.

• If the patient has liver disease. People with a low platelet count and advanced (long-term) liver disease are at higher risk of side effects, including life-threatening liver damage and blood clots. If the doctor considers that the benefits of taking Eltrombopag MSN outweigh the risks, the patient will be closely monitored during treatment.
• If the patient is at risk of blood clots in the veins or arteries, or if there have been cases of blood clots in the family.

Risk of blood clots may be increased:

• If the patient is elderly
• If the patient has been immobile for a long time
• If the patient has cancer
• If the patient is taking oral contraceptives or hormone replacement therapy
• If the patient has recently undergone surgery or trauma
• If the patient is overweight
• If the patient smokes
• If the patient has advanced chronic liver diseaseIt is necessary to inform the doctorbefore starting treatment if any of the above situations apply to the patient. Do not take Eltrombopag MSN unless the doctor considers that the expected benefits outweigh the risk of blood clots.
• If the patient has cataracts
• If the patient has other blood diseases, such as myelodysplastic syndrome (MDS). Before starting treatment with Eltrombopag MSN, the doctor will perform tests to rule out this disease. If the patient has MDS and takes Eltrombopag MSN, MDS may worsen. It is necessary to inform the doctorif any of the above situations apply to the patient.

Ophthalmological examination

The attending doctor will recommend an examination to detect cataracts. If the patient does not undergo routine eye examinations, the doctor should recommend regular examinations. The occurrence of any bleeding in the retina (layer of light-sensitive cells at the back of the eye) or near it may also be examined.

Regular tests will be necessary

Before starting treatment with Eltrombopag MSN, the doctor will perform blood tests to assess blood cells, including platelets. During treatment, these tests will be repeated at regular intervals.

Blood tests to assess liver function

Eltrombopag MSN may cause changes in blood test results that may indicate liver damage - increased activity of certain liver enzymes, particularly alanine aminotransferase and aspartate aminotransferase, and bilirubin levels. If the patient is taking interferon-based treatment with Eltrombopag MSN for low platelet count associated with hepatitis C, some liver diseases may worsen.

Before starting treatment with Eltrombopag MSN and at regular intervals during treatment, the patient will undergo blood tests to assess liver function. It may be necessary to discontinue Eltrombopag MSN if these substances increase to very high values or if other symptoms of liver damage occur.

Refer to the information in section 4 of this leaflet "Liver function disorders".

Blood tests to assess platelet count

If the patient stops taking Eltrombopag MSN, there is a likelihood of a relapse of low platelet count within a few days. The platelet count will be monitored, and the attending doctor will discuss appropriate precautions with the patient.

A very high platelet count may increase the risk of blood clots. However, blood clots can also occur when the platelet count is normal or too low. The attending doctor will adjust the dose of Eltrombopag MSN for the patient to avoid excessive increase in platelet count.

Seek immediate medical attentionif the patient experiences symptoms of a blood clotsuch as:

• swelling, painor tenderness in one leg
• sudden shortness of breath, especially with severe chest pain or rapid breathing
• abdominal pain, abdominal enlargement, blood in stool

Examinations to assess bone marrow

In people with bone marrow disorders, medicines like Eltrombopag MSN may worsen these disorders. Changes in bone marrow may be indicated by abnormal blood test results. The doctor may order direct bone marrow tests during treatment with Eltrombopag MSN.

Examinations to detect gastrointestinal bleeding

If the patient is taking interferon-based treatment with Eltrombopag MSN, they will be monitored for symptoms of gastrointestinal bleeding after stopping Eltrombopag MSN.

Heart examinations

The doctor may consider it necessary to monitor the patient's heart function during treatment with Eltrombopag MSN and perform an electrocardiogram (ECG).

Elderly patients (65 years and older)

There is limited data on the use of Eltrombopag MSN in patients aged 65 and older. Caution should be exercised when using Eltrombopag MSN in patients aged 65 and older.

Children and adolescents

Eltrombopag MSN is not recommended for children under 1 year of age with ITP. The medicine is also not recommended for people under 18 years of age with low platelet count associated with hepatitis C virus infection or severe aplastic anemia.

Eltrombopag MSN and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription and vitamins.

Some commonly used medicines interact with Eltrombopag MSN- including both prescription and over-the-counter medicines and mineral supplements. These include:

• antacids used to treat heartburn, acid reflux, and stomach ulcers (see also "When to take the medicine" in section 3)
• statins, cholesterol-lowering medicines
• certain HIV medicinessuch as lopinavir and (or) ritonavir
• cyclosporine used for transplantsor immune system diseases
• mineral supplements, such as iron, calcium, magnesium, aluminum, selenium, and zinc, which may be ingredients in vitamin and mineral supplements(see also "When to take the medicine" in section 3)
• medicines such as methotrexate and topotecan, used to treat cancerIt is necessary to consult a doctorif the patient is taking any of the above medicines. Some of them should not be taken during treatment with Eltrombopag MSN, while others may require dose adjustment or appropriate timing of administration. The doctor will review the patient's medicines and recommend changes if necessary.

If the patient is taking medicines to prevent blood clots, there is an increased risk of bleeding. The doctor will discuss this with the patient.

If the patient is taking corticosteroids, danazol, and (or) azathioprine, it may be necessary to reduce the doses of these medicines or discontinue them during concurrent use of Eltrombopag MSN.

Taking Eltrombopag MSN with food and drink

Eltrombopag MSN should not be taken with dairy products or drinks, as the calcium in dairy products affects the absorption of the medicine. See "When to take the medicine" in section 3 for more information.

Pregnancy and breastfeeding

Do not take Eltrombopag MSN during pregnancyunless the doctor recommends it. The effect of taking Eltrombopag MSN during pregnancy is unknown.

• Tell the doctor if the patient is pregnant, thinks they may be pregnant, or plans to have a baby.
• During treatment with Eltrombopag MSN, use appropriate contraceptionto prevent pregnancy.
• Tell the doctor if the patient becomes pregnantwhile taking Eltrombopag MSN.

Do not breastfeed while taking Eltrombopag MSN. It is not known whether Eltrombopag MSN passes into breast milk.

Tell the doctor if the patient is breastfeedingor plans to breastfeed.

Driving and using machines

Eltrombopag MSN may cause dizzinessand other side effects that reduce attention.

Do not drive or operate machineryunless the patient is sure that these symptoms do not occur.

Eltrombopag MSN contains sodium

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

3. How to take Eltrombopag MSN

Always take this medicine exactly as the doctor has told you. If you are not sure, ask your doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag MSN unless your doctor or pharmacist tells you to. During treatment with Eltrombopag MSN, the patient will remain under the care of a doctor experienced in treating the disease.

How much to take

Primary immune thrombocytopenia (ITP) Adults and children (aged 6 to 17 years) - the usual starting dose for ITP is one

50 mg tabletof Eltrombopag MSN per day. For patients of East Asian/Southeast Asian descent, it may be necessary to start treatment with a lower dose of 25 mg.

Children (aged 1 to 5 years) - the usual starting dose for ITP is one

25 mg tabletof Eltrombopag MSN per day.

Hepatitis C Adults - the usual starting dose for hepatitis C is one

25 mg tabletof Eltrombopag MSN per day. For patients of East Asian/Southeast Asian descent, treatment should be started with the same dose of 25 mg.

The effect of Eltrombopag MSN may occur within 1 to 2 weeks. Depending on the patient's response to treatment with Eltrombopag MSN, the doctor may recommend a change in the daily dose.

How to take the tablets

Swallow the tablets whole with water.

When to take the medicine

Make sure that -

• 4 hours beforetaking Eltrombopag MSN
• and 2 hours aftertaking Eltrombopag MSN

the patient will notconsume the following foods:

• dairy products, such as cheese, butter, yogurt, ice cream
• milk or milkshakes, milk-based drinks, yogurt, or cream
• antacids, used to treat heartburn and acid reflux
• certain vitamin and mineral supplementscontaining iron, calcium, magnesium, aluminum, selenium, and zinc

If these recommendations are not followed, Eltrombopag MSN will not be properly absorbed by the body.

Taking Eltrombopag MSN

Talk to the doctor to get more information about the right foods and drinks.

What to do if too much Eltrombopag MSN is taken

Contact a doctor or pharmacist immediately. If possible, show them the packaging or this leaflet. The patient's condition will be monitored for any side effects and appropriate treatment will be applied promptly.

What to do if a dose of Eltrombopag MSN is missed

Take the next dose at the usual time. Do not take more than one dose of Eltrombopag MSN per day.

What to do if treatment with Eltrombopag MSN is stopped

Do not stop taking Eltrombopag MSN without consulting a doctor. If the doctor recommends stopping treatment, the patient's platelet count will be monitored weekly for four weeks. See also "Bleeding or bruising after stopping treatment" in section 4.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Symptoms to look out for: see a doctor

In patients taking Eltrombopag MSN for ITP or low platelet count associated with hepatitis C, severe side effects may occur.

It is essential to inform the doctor about these symptoms.

Increased risk of blood clots

In some patients, there may be an increased risk of blood clots, and medicines like Eltrombopag MSN may worsen this condition. Sudden blockage of a blood vessel by a blood clot is an uncommon side effect and may occur in less than 1 in 100 people.

Seek immediate medical attention if the patient experiences symptoms of a blood clot such as:

• swelling, pain, feeling of heat, rednessor tenderness in one leg
• sudden shortness of breath, especially with severe chest pain or rapid breathing
• abdominal pain, abdominal enlargement, blood in stool

Liver function disorders

Eltrombopag MSN may cause changes in blood test results that may indicate liver damage. Liver function disorders (increased enzyme activity in blood test results) are common and may occur in less than 1 in 10 people. Other liver problems are uncommon and may occur in less than 1 in 100 people.

If any of the following symptoms of liver function disorders occur:

• yellowingof the skin or whites of the eyes (jaundice)
• abnormally dark urine

Tell the doctor immediately.

Bleeding or bruising after stopping treatment

Usually, within two weeks of stopping Eltrombopag MSN, the patient's platelet count returns to the level before starting Eltrombopag MSN.

A low platelet count may increase the risk of bleeding or bruising. The doctor will monitor the patient's platelet count for at least 4 weeks after stopping Eltrombopag MSN.

Tell the doctor immediatelyif the patient experiences bruising or bleeding after stopping Eltrombopag MSN.

In some patients, gastrointestinal bleedingmay occur after stopping peginterferon, ribavirin, and Eltrombopag MSN. Symptoms include:

• black, tarry stools (a change in stool color that is an uncommon side effect, which may occur in less than 1 in 100 people)
• blood in stool
• vomiting blood or coffee ground-like material Tell the doctor immediatelyif any of these symptoms occur.

The following side effects have been reported in association with Eltrombopag MSN treatment

In adult patients with ITP:

Very common side effects

May occur in more than 1 in 10 people:

• common cold
• nausea
• diarrhea
• cough
• infection of the nose, sinuses, throat, and upper respiratory tract (upper respiratory tract infection)
• back pain

Very common side effects that may be seen in blood tests:

• increased activity of liver enzymes (alanine aminotransferase (ALT))

Common side effects

May occur in less than 1 in 10 people:

• muscle pain, muscle spasms, muscle weakness
• bone pain
• heavy menstrual bleeding
• sore throat and discomfort when swallowing
• eye disorders, including abnormal eye test results, dry eyes, eye pain, and blurred vision
• vomiting
• flu
• cold sores
• pneumonia
• sinusitis
• tonsillitis
• infection of the lungs, sinuses, nose, and throat
• gum inflammation
• loss of appetite
• tingling, numbness, or prickling sensations
• reduced skin sensation
• drowsiness
• ear pain
• pain, swelling, and tenderness in one leg (usually the calf with skin warming in the affected area, symptoms of deep vein thrombosis)
• localized swelling filled with blood from a damaged blood vessel (hematoma)
• hot flashes
• oral disorders, including dry mouth, mouth pain, tongue sensitivity, gum bleeding, mouth ulcers
• runny nose
• toothache
• abdominal pain
• liver function disorders
• skin changes, including excessive sweating, hives, red spots, skin changes
• hair loss
• foamy urine
• high fever
• chest pain
• feeling of weakness
• difficulty sleeping, depression
• migraine
• blurred vision
• dizziness
• gas

Common side effects that may be seen in blood tests:

• decreased red blood cell count (anemia)
• decreased platelet count (thrombocytopenia)
• decreased white blood cell count
• decreased hemoglobin level
• increased eosinophil count
• increased white blood cell count (leukocytosis)
• increased uric acid level
• decreased potassium level
• increased creatinine level
• increased alkaline phosphatase activity
• increased liver enzyme activity (aspartate aminotransferase (AST))
• increased bilirubin level in the blood (a substance produced by the liver)
• increased protein levels

Uncommon side effects

May occur in less than 1 in 100 people:

• allergic reaction
• heart attack
• sudden shortness of breath, especially with severe chest pain and (or) rapid breathing, which may be a symptom of a blood clot in the lungs (see "Increased risk of blood clots" above in section 4)
• loss of lung function due to blockage of a pulmonary artery
• possible pain, swelling, and (or) redness in the area of a vein, which may be symptoms of a blood clot in a vein
• yellowing of the skin or whites of the eyes (jaundice) or abdominal pain, which may be symptoms of bile duct obstruction, liver disease, or liver damage (see "Liver function disorders" above in section 4)
• liver damage caused by the medicine
• rapid heartbeat, irregular heartbeat, blue discoloration of the skin, heart rhythm disorders (QT interval prolongation), which may be symptoms of heart and blood vessel disorders
• blood clot
• redness
• painful swelling of the joints due to uric acid (gout)
• lack of interest, mood changes, crying, which is difficult to control or occurs unexpectedly
• balance disorders, speech disorders, and nerve function disorders, tremors
• painful or abnormal skin sensations
• paralysis of one side of the body
• migraine with aura
• nerve damage
• expansion or swelling of blood vessels causing headache
• eye disorders, including increased tearing, cataracts, retinal bleeding, dry eyes
• disorders of the nose, throat, and sinuses, sleep apnea
• blisters or ulcers in the mouth and throat
• loss of appetite
• gastrointestinal disorders, including frequent bowel movements, food poisoning, blood in stool, vomiting blood or coffee ground-like material
• blood in stool
• disorders of the mouth, including dry mouth, mouth pain, tongue sensitivity, gum bleeding, mouth ulcers
• sunburn
• feeling of heat
• redness or swelling in the area of a wound
• bleeding around a catheter (if present) into the skin
• feeling of a foreign body
• kidney disorders, including kidney inflammation, excessive urination at night, kidney failure, presence of white blood cells in urine
• cold sweats
• general poor health
• skin infection
• skin changes, including skin discoloration, peeling, redness, itching, and sweating
• muscle weakness
• rectal or colon cancer

Uncommon side effects that may be seen in laboratory tests:

• changes in the shape of red blood cells
• presence of developing white blood cells, which may indicate certain diseases
• increased platelet count
• decreased calcium level
• decreased red blood cell count (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• increased myelocyte count
• increased neutrophil count
• increased urea level in the blood
• increased protein level in urine
• increased albumin level in the blood
• increased total protein level in the blood
• decreased albumin level in the blood
• increased urine pH
• increased hemoglobin level

Side effects with unknown frequency

Frequency cannot be estimated from the available data

• skin discoloration
• darkening of the skin
• liver damage caused by the medicine

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eltrombopag MSN

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month stated.

There are no special storage instructions for the medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Eltrombopag MSN contains

The active substance is eltrombopag.

Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.

Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag.

Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag.

The other ingredients are:

Tablet core: mannitol (E 421), povidone (E 1201), microcrystalline cellulose (E 460(i)), carboxymethylcellulose sodium, magnesium stearate (E 470b).

Coating:

• [25 mg]: hypromellose (E 464), titanium dioxide (E 171), macrogol (E 1521), yellow iron oxide (E 172), red iron oxide (E 172). [50 mg]: hypromellose (E 464), titanium dioxide (E 171), macrogol (E 1521), aluminum lake of indigo carmine (E 132), yellow iron oxide (E 172). [75 mg]: hypromellose (E 464), red iron oxide (E 172), macrogol (E 1521), titanium dioxide (E 171), black iron oxide (E 172), yellow iron oxide (E 172).

How the Eltrombopag MSN medicine looks like and what the packaging contains

The Eltrombopag MSN medicine, 25 mg, coated tablets are light orange to orange,
round, biconvex coated tablets with a diameter of about 7 mm, with the embossing
"ME" on one side and "13" on the other side.
The Eltrombopag MSN medicine, 50 mg, coated tablets are light blue to blue, round,
biconvex coated tablets with a diameter of about 9 mm, with the embossing "ME"
on one side and "14" on the other side.
The Eltrombopag MSN medicine, 75 mg, coated tablets are brown, round, biconvex
coated tablets with a diameter of about 10 mm, with the embossing "ME" on one side and "15"
on the other side.
The coated tablets are supplied in aluminum blisters in a cardboard box containing 14
or 28 coated tablets, and in bulk packs containing 84 coated tablets (3 packs of 28 coated
tablets).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer

Marketing Authorisation Holder:

MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
tel.: (+48) 699 711 147
(logo of the Marketing Authorisation Holder)

Importer:

Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Countries:

Czech Republic:
Eltrombopag MSN
Croatia:
Eltrombopag MSN 25 mg film-coated tablets
Eltrombopag MSN 50 mg film-coated tablets
Eltrombopag MSN 75 mg film-coated tablets
Slovenia:
Eltrombopag MSN 25 mg film-coated tablets
Eltrombopag MSN 50 mg film-coated tablets
Eltrombopag MSN 75 mg film-coated tablets
Romania:
Eltrombopag MSN 25 mg film-coated tablets
Eltrombopag MSN 50 mg film-coated tablets
Eltrombopag MSN 75 mg film-coated tablets
Poland:
Eltrombopag MSN
Bulgaria:
Елтромбопаг MSN 25 mg филмирани таблетки
Елтромбопаг MSN 50 mg филмирани таблетки
Елтромбопаг MSN 75 mg филмирани таблетки
Estonia:
Eltrombopag MSN
Hungary:
Eltrombopag MSN 25 mg filmtabletta
Eltrombopag MSN 50 mg filmtabletta
Eltrombopag MSN 75 mg filmtabletta
Lithuania:
Eltrombopag MSN 25 mg plėvele dengtos tabletės
Eltrombopag MSN 50 mg plėvele dengtos tabletės
Eltrombopag MSN 75 mg plėvele dengtos tabletės
Slovakia:
Eltrombopag MSN

Date of last revision of the leaflet: