Eltrombopag Vipharm

Leaflet accompanying the packaging: information for the user

Eltrombopag Vipharm, 12.5 mg, coated tablets

Eltrombopag Vipharm, 25 mg, coated tablets

Eltrombopag Vipharm, 50 mg, coated tablets

Eltrombopag Vipharm, 75 mg, coated tablets

Eltrombopag

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 Eltrombopag Vipharm and what is it used for
• 2. Important information before taking Eltrombopag Vipharm
• 3. How to take Eltrombopag Vipharm
• 4. Possible side effects
• 5. How to store Eltrombopag Vipharm
• 6. Contents of the packaging and other information

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

Eltrombopag Vipharm 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.
Platelets are blood components that help reduce the risk of bleeding or prevent it.

• Eltrombopag Vipharm is used to treat a blood clotting 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 in whom these medicines have not worked.

Immune thrombocytopenia is caused by a low number of platelets (thrombocytopenia).
People with immune thrombocytopenia are more prone to bleeding. Symptoms that patients with immune thrombocytopenia may notice include petechiae (pinpoint, flat, red spots under the skin), purpura, nosebleeds, gum bleeding, and an inability to stop bleeding in the event of a cut or injury.

• Eltrombopag Vipharm may also be used to treat a low number of platelets (thrombocytopenia) in adults with hepatitis C virus (HCV) infection who have had difficulties 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 in treatment. Taking Eltrombopag Vipharm may help patients complete a full course of antiviral treatment (peginterferon and ribavirin).
• Eltrombopag Vipharm can also be used to treat adult patients with a low number of blood cells caused by severe aplastic anemia (severe aplastic anemia, SAA). Severe aplastic anemia is a disease in which the bone marrow is

damaged, resulting in a lack of red blood cells (anemia), white blood cells (leukopenia), and platelets (thrombocytopenia).

2. Important information before taking Eltrombopag Vipharm

When not to take Eltrombopag Vipharm

• If the patient is allergicto eltrombopag or any of the other ingredients of this medicine (listed in section 6). → Consult a doctorif the patient thinks they have this condition.

Warnings and precautions

Before starting treatment with Eltrombopag Vipharm, the patient should discuss it with their doctor:

• if the patient has liver disease. People with a low number of platelets, as well as advanced (long-standing) 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 Vipharm outweigh the risk, the patient will be closely monitored during treatment;
• if the patient has a risk of blood clots in the veins or arteries, or if there have been cases of blood clots in their family.

Risk of blood clots may be increased:

• if the patient is elderly
• if the patient has been immobilized 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 had an injury
• if the patient is overweight
• if the patient smokes
• if the patient has advanced chronic liver diseaseInform your doctorbefore starting treatment if any of the above conditions apply to the patient. Do not take Eltrombopag Vipharm unless the doctor considers that the expected benefits outweigh the risk of blood clots.
• if the patient has cataracts(clouding of the lens of the eye)
• if the patient has other blood diseases, such as myelodysplastic syndrome (Myelodysplastic Syndrome, MDS). Before starting treatment with Eltrombopag Vipharm, the doctor will perform tests to rule out this disease. If the patient has MDS and takes Eltrombopag Vipharm, MDS may worsen. Inform your doctorif any of the above situations apply to the patient.

Ophthalmological examination

The doctor will recommend an examination to detect cataracts. If the patient does not undergo routine eye exams, the doctor should recommend regular exams. The occurrence of any bleeding in the retina (the 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 Vipharm, 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 Vipharm may cause changes in blood test results that may indicate liver damage - increased activity of certain liver enzymes, in particular bilirubin and transaminases. If the patient is taking interferon-based treatment with Eltrombopag Vipharm for low platelet count associated with hepatitis C, some liver diseases may worsen.
Before starting treatment with Eltrombopag Vipharm and at regular intervals during treatment, the patient will undergo blood tests to assess liver function. It may be necessary to discontinue Eltrombopag Vipharm if the levels of these substances increase too much or if other symptoms of liver damage occur.
See the information in section 4 of this leaflet, "Liver disorders".

Blood test to assess platelets

If the patient stops taking Eltrombopag Vipharm, there is a likelihood that the platelet count will decrease again within a few days. The platelet count will be monitored, and the 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 doctor will adjust the dose of Eltrombopag Vipharm for the patient to avoid excessive increases in platelet count.

Seek immediate medical attentionif the patient experiences any of the following symptoms of a blood clot:

• swelling, painor tenderness of one leg
• sudden shortness of breath, especially with sudden chest pain or rapid breathing
• abdominal pain (stomach), abdominal distension, blood in stool

Tests to assess bone marrow

In people with bone marrow disorders, medicines like Eltrombopag Vipharm 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 Vipharm.

Tests to detect gastrointestinal bleeding

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

Heart tests

The doctor may consider the need for a heart test for the patient during treatment with Eltrombopag Vipharm and perform an electrocardiogram (ECG).

Elderly patients (65 years and older)

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

Children and adolescents

Eltrombopag Vipharm is not recommended for children under 1 year of age with immune thrombocytopenia.
It is also not recommended for patients under 18 years of age with low platelet count associated with hepatitis C virus infection or severe aplastic anemia.

Eltrombopag Vipharm 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 includes medicines obtained without a prescription and vitamins.
Some commonly used medicines interact with Eltrombopag Vipharm- including both prescription and over-the-counter medicines and mineral supplements. These include:

• medicines that neutralize stomach acid used to treat indigestion, heartburn, stomach ulcers
• stomach(see also “When to take the medicine”in section 3)
• medicines called statins, lowering cholesterol levels
• certain medicines used to treat HIV infection, such as lopinavir and (or) ritonavir
• cyclosporine used in transplantsor in immune system diseases
• mineral products, 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 cancerTell your doctorif you are taking any of the above medicines. Some of them should not be taken during treatment with Eltrombopag Vipharm, while others may require a dose adjustment or appropriate timing of administration. The doctor will review the medicines taken by the patient and recommend changes to treatment 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, the doses of these medicines may be reduced or their use discontinued during concurrent use of Eltrombopag Vipharm.

Taking Eltrombopag Vipharm with food and drink

Eltrombopag Vipharm should not be taken with dairy products or drinks, as the calcium in dairy products affects the absorption of the medicine. For more information, see “When to take the medicine”in section 3.

Pregnancy and breastfeeding

Do not take Eltrombopag Vipharm during pregnancy, unless the doctor recommends it.
The effect of eltrombopag during pregnancy is unknown.

• Tell your doctorif you are pregnant, think you may be pregnant, or plan to have a baby.
• Use appropriate contraceptionwhile taking Eltrombopag Vipharm to prevent pregnancy.
• Tell your doctorif you become pregnant while taking Eltrombopag Vipharm.

Do not breastfeed while taking Eltrombopag Vipharm. It is not known whether eltrombopag passes into breast milk.
Tell your doctorif you are breastfeeding or plan to breastfeed.

Driving and using machines

Eltrombopag Vipharm may cause dizzinessand other side effects that reduce attention.
Do not drive or operate machineryunless you are sure that these symptoms do not occur.

Eltrombopag Vipharm contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Eltrombopag Vipharm

This medicine should always be taken exactly as prescribed by the doctor. If you have any doubts, consult your doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag Vipharm unless your doctor or pharmacist tells you to. While taking Eltrombopag Vipharm, the patient will remain under the care of a doctor with experience in treating the disease.

How much medicine to take

Primary immune thrombocytopenia
Adults and children(aged 6 to 17 years) - the usual starting dose for primary immune thrombocytopenia is one 50 mg tabletof Eltrombopag Vipharm 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 primary immune thrombocytopenia is one 25 mg tabletof Eltrombopag Vipharm per day.
Other pharmaceutical forms may be more suitable for this group of patients.
Hepatitis C
Adults- the usual starting dose for hepatitis C is one 25 mg tabletof Eltrombopag Vipharm per day. For patients of East Asian/Southeast Asian descent, it may be necessary to start treatment with the same dose of 25 mg.
Severe aplastic anemia
Adults- the usual starting dose for SAA is one 50 mg tabletof Eltrombopag Vipharm per day. Patients of East Asian/Southeast Asian descent may need to start treatment with a lower dose of 25 mg.

How to take the tablets

Swallow the tablets whole with water.

When to take the medicine

Make sure that:
→
within 4 hours beforetaking Eltrombopag Vipharm
→
and within 2 hours aftertaking Eltrombopag Vipharm
the patient will notconsume the following foods:

• dairy products, such as cheese, butter, yogurt, ice cream
• milkor drinks containing milk, yogurt, or cream
• medicines that neutralize stomach acid, used to treat indigestion and heartburn
• vitamin and mineral supplementscontaining iron, calcium, magnesium, aluminum, selenium, and zinc

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

Talk to your doctor to get more advice on suitable foods and drinks.

Taking a higher dose of Eltrombopag Vipharm than recommended

If a higher dose of Eltrombopag Vipharm than recommended is taken, you should

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

Missing a dose of Eltrombopag Vipharm

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

Stopping treatment with Eltrombopag Vipharm

Do not stop taking Eltrombopag Vipharm without consulting your doctor first. 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 doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Symptoms to watch out for: see a doctor

In patients taking Eltrombopag Vipharm for primary immune thrombocytopenia or low platelet count associated with hepatitis C, symptoms of 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 Vipharm may worsen this. Sudden blockage of a blood vessel by a blood clot is an uncommon side effect and may occur in up to 1 in 100 patients.

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

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

Liver disorders

Eltrombopag Vipharm may cause changes in blood test results that may indicate liver damage. Liver disorders (increased enzyme activity in blood test results) are common and may occur in up to 1 in 10 patients. Other liver problems are uncommon and may occur in up to 1 in 100 patients.
If any of the following symptoms of liver disorders occur:

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

Inform your doctor immediately.

Bleeding or bruising after stopping treatment

Usually, within two weeks of stopping Eltrombopag Vipharm, the patient's platelet count decreases to the level before starting Eltrombopag Vipharm. 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 Vipharm.
Inform your doctorif the patient experiences bruising or bleeding after stopping Eltrombopag Vipharm.
In some patients, gastrointestinal bleedingmay occur after stopping peginterferon, ribavirin, and eltrombopag. Symptoms include:

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

The following side effects have been reported in association with eltrombopag treatment in adult patients with primary immune thrombocytopenia:

Very common side effects

May occur in more than 1 in 10patients:

• 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 up to 1 in 10patients:

• muscle pain, muscle spasms, muscle weakness
• bone pain
• heavy menstrual bleeding
• throat pain and discomfort when swallowing
• eye disorders, including abnormal eye test results, dry eyes, eye pain, and blurred vision
• vomiting
• flu
• cold sore
• 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 of one leg (usually the calf with skin thickening in the affected area, symptoms of deep vein thrombosis)
• localized swelling filled with blood from a damaged blood vessel (hematoma)
• hot flashes
• disorders of the mouth, including dry mouth, mouth pain, tongue sensitivity, gum bleeding, mouth ulcers
• runny nose
• toothache
• abdominal pain
• abnormal liver function
• skin changes, including excessive sweating, hives, red spots, skin changes
• hair loss
• foamy urine with the presence of air bubbles (symptoms of protein in the urine)
• high fever, feeling of heat
• chest pain
• feeling of weakness
• difficulty sleeping, depression
• migraine
• blurred vision
• feeling of spinning (dizziness)
• wind

Common side effects that may be seen in blood tests:

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

Uncommon side effects

May occur in up to 1 in 100patients:

• allergic reaction
• interruption of blood flow to a part of the heart
• sudden shortness of breath, especially with sudden chest pain and (or) rapid breathing, which may be a symptom of a pulmonary embolism (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 disorders”above in section 4)
• liver damage caused by the medicine
• rapid heartbeat, irregular heartbeat, blue discoloration of the skin, heart rhythm disorders (prolonged QT interval), which may be symptoms of a heart and blood vessel disorder
• blood clot
• redness
• painful swelling of the joints caused by uric acid (gout), lack of interest, mood changes, crying that is hard 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
• infections of the nose, throat, and sinuses, respiratory disorders
• 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, feeling of restlessness
• 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
• increase in platelet count
• decrease in calcium level
• decrease in red blood cell count (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• increase in myelocytes
• increase in band neutrophils
• increase in urea level in the blood
• increase in protein level in urine
• increase in albumin level in the blood
• increase in total protein level
• decrease in albumin level in the blood
• increase in pH of urine
• increase in 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 side effects not listed in this leaflet, tell your doctor, 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
PL-02 222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Eltrombopag Vipharm

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. The expiry date refers to the last day of the month.
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.
Eltrombopag Vipharm 12.5 mg and 25 mg coated tablets do not require any special storage conditions.
Eltrombopag Vipharm 50 mg and 75 mg coated tablets do not require any special storage conditions; store in the original packaging to protect from light.

6. Contents of the packaging and other information

What Eltrombopag Vipharm contains

The active substance of Eltrombopag Vipharm is eltrombopag.

12.5 mg coated tablets

Each coated tablet contains eltrombopag olamine equivalent to 12.5 mg of eltrombopag.

25 mg coated tablets

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

50 mg coated tablets

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

75 mg coated tablets

Each coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag.
The other ingredients are: mannitol (E421), microcrystalline cellulose, povidone, sodium carboxymethyl starch, magnesium stearate, titanium dioxide (E171), hypromellose (E464), macrogol (E1521).
Eltrombopag Vipharm 12.5 mg and 25 mg coated tablets also contain polysorbate 80 (E433).
Eltrombopag Vipharm 50 mg coated tablets also contain red iron oxide (E 172) and yellow iron oxide (E 172).
Eltrombopag Vipharm 75 mg coated tablets also contain red iron oxide (E 172) and black iron oxide (E 172).

What Eltrombopag Vipharm looks like and what the pack contains

Eltrombopag Vipharm 12.5 mg coated tablets are white, round, biconvex coated tablets with the inscription "12.5" on one side and smooth on the other side.
Eltrombopag Vipharm 25 mg coated tablets are white, round, biconvex with the inscription "25" on one side and smooth on the other side.
Eltrombopag Vipharm 50 mg coated tablets are brown, round, biconvex with the inscription "50" on one side and smooth on the other side.
Eltrombopag Vipharm 75 mg coated tablets are pink, round, biconvex with the inscription "75" on one side and smooth on the other side.
The tablets are provided in aluminum blisters packaged in a cardboard box containing 14, 28 or 48 coated tablets.
Not all pack sizes may be marketed in each country.

Marketing Authorisation Holder

Vipharm S.A.
A. and F. Radziwiłłów 9 Street
05-850 Ożarów Mazowiecki
Poland
e-mail: vipharm@vipharm.com.pl

Manufacturer

Genepharm S.A.
18th km Marathonos Avenue,
153 51 Pallini
Greece

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

Denmark:
Eltrombopag Vipharm
Czech Republic:
Eltrombopag Vipharm
Hungary:
Eltrombopag Vipharm 12.5 mg, 25 mg, 50 mg, 75 mg film-coated tablet
Poland:
Eltrombopag Vipharm
Slovakia:
Eltrombopag Vipharm 12.5 mg, 25 mg, 50 mg, 75 mg film-coated tablets

Date of last revision of the leaflet: