Eltrombopag Olpha

Leaflet accompanying the packaging: patient information

Eltrombopag Olpha, 12.5 mg, coated tablets

Eltrombopag Olpha, 25 mg, coated tablets

Eltrombopag Olpha, 50 mg, coated tablets

Eltrombopag Olpha, 75 mg, 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 their symptoms 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 Olpha and what is it used for
• 2. Important information before taking Eltrombopag Olpha
• 3. How to take Eltrombopag Olpha
• 4. Possible side effects
• 5. How to store Eltrombopag Olpha
• 6. Package contents and other information

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

Eltrombopag Olpha 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 cells that help reduce the risk of bleeding or prevent it. Eltrombopag Olpha 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. Primary immune thrombocytopenia is caused by a low platelet count (thrombocytopenia). People with primary immune thrombocytopenia are more likely to bleed. Symptoms that patients with primary immune thrombocytopenia may notice include petechiae (small, flat, red spots under the skin), bruising, nosebleeds, bleeding from the gums, and difficulty stopping bleeding in case of injury or trauma. Eltrombopag Olpha may also be used to treat low platelet count (thrombocytopenia) in adults with hepatitis C virus (HCV) infection who have had problems due to side effects during treatment with interferon. 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 some antiviral drugs used to treat it. Taking Eltrombopag Olpha may help patients complete full treatment with antiviral drugs (peginterferon and ribavirin).

2. Important information before taking Eltrombopag Olpha

When not to take Eltrombopag Olpha

Warnings and precautions

Before starting treatment with Eltrombopag Olpha, the patient should discuss the following with their doctor:

The patient should tell their doctor if any of the above situations apply to them.

Eye examination

The doctor will recommend an eye examination to detect cataracts. If the patient does not undergo regular eye examinations, the doctor should recommend regular examinations. 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 Olpha, the doctor will perform blood tests to assess the patient's blood cells, including platelets. During treatment with the medicine, these tests will be repeated at regular intervals.

Blood tests to assess liver function

Taking eltrombopag may cause changes in blood test results that indicate liver damage - increased activity of certain liver enzymes, in particular alanine aminotransferase and aspartate aminotransferase, and increased bilirubin. If the patient is taking interferon-based treatment with Eltrombopag Olpha for low platelet count associated with hepatitis C, some liver diseases may worsen. Before starting treatment with Eltrombopag Olpha and at regular intervals during treatment, the patient will undergo blood tests to assess liver function. It may be necessary to stop taking Eltrombopag Olpha if the levels of these substances increase too much or if other signs of liver damage occur. The patient should read the information in section 4 of this leaflet "Liver disorders".

Platelet count tests

If the patient stops taking Eltrombopag Olpha, there is a risk of the platelet count decreasing 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 Olpha to prevent the platelet count from becoming too high. The patient should seek immediate medical attention if they experience any of the following symptoms of a blood clot:

• swelling, pain, or tenderness in one leg,
• sudden shortness of breath, especially with sudden chest pain or rapid heartbeat,
• abdominal pain, abdominal enlargement, blood in the stool.

Bone marrow tests

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

Tests to detect gastrointestinal bleeding

If the patient is taking interferon-based treatment with Eltrombopag Olpha, they will be monitored for signs of gastrointestinal bleeding after finishing treatment with this medicine.

Heart tests

The doctor may consider it necessary to examine the patient's heart during treatment with Eltrombopag Olpha 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 taking Eltrombopag Olpha in patients aged 65 and older.

Children and adolescents

Eltrombopag is not recommended in children under 1 year of age with primary immune thrombocytopenia. The medicine is also not recommended in patients under 18 years of age with low platelet count associated with hepatitis C virus infection.

Other medicines and Eltrombopag Olpha

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 - including prescription and non-prescription medicines and mineral supplements. These include:

• antacids used to treat heartburn, acid reflux, and stomach ulcers (see also "When to take Eltrombopag Olpha" in section 3),
• statins, which lower cholesterol levels,
• certain medicines used to treat HIV infection, such as lopinavir and/or ritonavir,
• cyclosporin used in transplants or immune system diseases,
• minerals such as iron, calcium, magnesium, aluminum, selenium, and zinc, which may be components of vitamin and mineral supplements (see also "When to take Eltrombopag Olpha" in section 3),
• medicines such as methotrexate and topotecan, used to treat cancer.

The patient should consult their doctor if they are taking any of the above medicines. Some of them should not be taken with Eltrombopag Olpha, while others may require a dose adjustment or a change in the 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, the doses of these medicines may be reduced or their use stopped during treatment with Eltrombopag Olpha.

Taking Eltrombopag Olpha with food and drink

Eltrombopag Olpha 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 Eltrombopag Olpha" in section 3.

Pregnancy, breastfeeding

Eltrombopag Olpha should not be taken during pregnancy unless the doctor recommends it. The effect of eltrombopag during pregnancy is unknown.

• The patient should tell their doctor if they are pregnant, think they may be pregnant, or plan to have a baby.
• While taking Eltrombopag Olpha, the patient should use appropriate contraception to prevent pregnancy.
• The patient should tell their doctor if they become pregnant while taking Eltrombopag Olpha. The patient should not breastfeed while taking Eltrombopag Olpha. It is not known whether Eltrombopag Olpha passes into breast milk. The patient should tell their doctor if they are breastfeeding or plan to breastfeed.

Driving and using machines

Eltrombopag Olpha may cause dizziness and other side effects that reduce concentration. The patient should not drive or operate machinery unless they are sure that these symptoms do not occur.

Eltrombopag Olpha contains isomalt and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine. This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is essentially "sodium-free".

3. How to take Eltrombopag Olpha

This medicine should always be taken exactly as the doctor has told the patient. If the patient is unsure, they should ask their doctor or pharmacist. The patient should not change the dose or dosing schedule of Eltrombopag Olpha unless their doctor or pharmacist tells them to. While taking Eltrombopag Olpha, the patient will remain under the care of a doctor experienced in treating the disease they have.

How much to take

In the case of primary immune thrombocytopenia

• Adults and children (aged 6 to 17 years) - the usual starting dose for primary immune thrombocytopenia is one 50 mg tablet of Eltrombopag Olpha per day.
• Patients of East Asian/Southeast Asian origin may require a lower starting dose of 25 mg.
• Children (aged 1 to 5 years) - the usual starting dose for primary immune thrombocytopenia is one 25 mg tablet of Eltrombopag Olpha per day.

In the case of hepatitis C

• Adults - the usual starting dose for hepatitis C is one 25 mg tablet of Eltrombopag Olpha per day.
• Patients of East Asian/Southeast Asian origin should start treatment with the same dose of 25 mg.

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

How to take the tablets

The tablets should be swallowed whole with water. When to take the medicine The patient should make sure that -

• for 4 hours before taking Eltrombopag Olpha
• and for 2 hours after taking Eltrombopag Olpha the patient does not eat the following foods:
• dairy products, such as cheese, butter, yogurt, ice cream,
• milk or drinks containing milk, yogurt, or cream,
• antacids used to treat heartburn and acid reflux,
• mineral supplements containing iron, calcium, magnesium, aluminum, selenium, or zinc. If the patient does not follow these instructions, the medicine may not be properly absorbed by the body.

The patient should ask their doctor for more information about the foods and drinks to avoid.

What to do if too much Eltrombopag Olpha is taken

The patient should contact their doctor or pharmacist immediately. If possible, they should show them the medicine packaging or this leaflet. The patient's condition will be monitored for any side effects and appropriate treatment will be given as soon as possible.

What to do if a dose of Eltrombopag Olpha is missed

The patient should take the next dose at the usual time. The patient should not take more than one dose of Eltrombopag Olpha per day.

What to do if treatment with Eltrombopag Olpha is stopped

The patient should not stop taking Eltrombopag Olpha without consulting their 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 the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Eltrombopag Olpha can cause side effects, although not everybody gets them. Symptoms to look out for: the patient should see a doctor. In patients taking eltrombopag for primary immune thrombocytopenia 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 clotsSome patients may have an increased risk of blood clots, and medicines like Eltrombopag Olpha may worsen this. Sudden blockage of a blood vessel by a blood clot is an uncommon side effect and may affect up to 1 in 100 patients. The patient should seek immediate medical attention if they experience any symptoms of a blood clot, such as:

• swelling, pain, or tenderness in one leg,
• sudden shortness of breath, especially with sudden chest pain or rapid heartbeat,
• abdominal pain, abdominal enlargement, blood in the stool.

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

• yellowing of the skin or whites of the eyes (jaundice),
• dark urine,

the patient should see a doctor immediately.

Bleeding or bruising after stopping treatmentUsually, within two weeks of stopping Eltrombopag Olpha, the patient's platelet count returns to the level before starting treatment with Eltrombopag Olpha. 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 Olpha. The patient should tell their doctor if they experience any bruising or bleeding after stopping treatment with this medicine. In some patients, gastrointestinal bleeding may occur after stopping treatment with peginterferon, ribavirin, and eltrombopag. Symptoms include:

• black, tarry stools (a change in stool color is an uncommon side effect that may affect up to 1 in 100 patients),
• blood in the stool,
• vomiting blood or coffee-ground-like material. The patient should tell their doctor immediately if they experience any of these symptoms.

The following side effects have been reported in adults taking eltrombopag for primary immune thrombocytopenia:

If these side effects worsen, the patient should tell their doctor, pharmacist, or nurse. Very common side effects(may affect more than 1 in 10 patients):

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

Very common side effectsthat may be seen in blood tests:

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

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

• flu, herpes simplex, pneumonia, sinusitis, tonsillitis, bronchitis, pharyngitis, and discomfort when swallowing,
• loss of appetite,
• sleep disturbances, depression,
• numbness, tingling, or prickling sensations, drowsiness, migraine,
• eye disorders, including abnormal eye test results, dry eye, eye pain, and blurred vision,
• ear pain, dizziness,
• pain, swelling, or tenderness in one leg (usually the calf) with warmth of the skin in the affected area (symptoms of deep vein thrombosis), localized swelling filled with blood from a damaged blood vessel (hematoma), hot flashes,
• runny nose,
• mouth disorders, including dry mouth, mouth pain, tongue sensitivity, gum bleeding, mouth ulcers, toothache,
• liver function disorders,
• skin changes, including excessive sweating, rash, redness, itching, and flushing,
• muscle pain, muscle spasms, muscle weakness, bone pain,
• foamy urine (a sign of protein in the urine),
• heavy menstrual bleeding,
• high fever, feeling hot, chest pain, and feeling unwell.

Common side effectsthat 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 urea level, decreased potassium level,
• increased activity of liver enzymes (aspartate aminotransferase (AST)), increased bilirubin level in the blood,
• increased levels of certain proteins, increased creatinine level,
• increased alkaline phosphatase activity.

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

• skin infection,
• rectal or colon cancer,
• allergic reaction,
• loss of appetite, painful joint swelling due to uric acid (gout),
• lack of interest, mood changes, crying that is hard to control or occurs unexpectedly,
• balance disorders, speech and nerve disorders, tremors, paralysis of one side of the body, migraine with aura, nerve damage, vasodilation causing headache,
• eye disorders, including increased tearing, cataracts, retinal bleeding, dry eyes,
• rapid heartbeat, irregular heartbeat, blue discoloration of the skin, cardiovascular disorders (prolonged QT interval) that may be signs of heart and blood vessel disorders, interruption of blood flow to a part of the heart,
• possible pain, swelling, and/or redness in or around a vein, which may be symptoms of a blood clot, blood clot, redness,
• sudden shortness of breath, especially with sudden chest pain and/or rapid heartbeat, which may be a sign of a pulmonary embolism (see "Increased risk of blood clots" above in section 4), lung tissue damage due to blockage of a pulmonary artery, nose, throat, and sinus disorders, sleep apnea,
• mouth disorders, including dry mouth, mouth pain, tongue sensitivity, gum bleeding, mouth ulcers, blisters or ulcers in the mouth and throat, gastrointestinal disorders, including frequent diarrhea, food poisoning,
• blood in the stool, vomiting blood, rectal bleeding, change in stool color, abdominal bloating, constipation,
• yellowing of the skin and/or abdominal pain, which may be signs of bile duct obstruction, liver function disorders, liver damage due to inflammation (see "Liver disorders" above in section 4), drug-induced liver damage,
• skin changes, including discoloration, peeling, redness, itching, and sweating, night sweats,
• muscle weakness,
• kidney disorders, including kidney inflammation, excessive urination at night, kidney failure, presence of white blood cells in the urine,
• feeling hot, feeling unwell, bleeding around the catheter (if present) to the skin, redness or swelling at the injection site, general feeling of being unwell, feeling of a foreign body,
• sunburn.

Uncommon side effectsthat may be seen in laboratory tests:

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

The following additional side effects have been reported in children (aged 1 to 17 years) with ITP taking eltrombopag:

If these side effects worsen, the patient should tell their doctor, pharmacist, or nurse. Very common side effects(may affect more than 1 in 10 children):

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

Common side effects(may affect up to 1 in 10 children):

• sleep disturbances (insomnia),
• nasal congestion, runny nose, or stuffy nose, sore throat, nasal congestion, and sneezing, sore throat and discomfort when swallowing,
• toothache, mouth disorders, including dry mouth, mouth pain, tongue sensitivity, gum bleeding, mouth ulcers.

The following side effects have been reported in patients taking eltrombopag in combination with peginterferon and ribavirin for hepatitis C:

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

• loss of appetite
• headache
• cough
• nausea, diarrhea
• itching, swelling of the hands or feet, unusual hair loss
• muscle pain, muscle weakness
• fever, feeling tired, flu-like illness, weakness, chills.

Very common side effectsthat may be seen in blood tests:

• decreased red blood cell count (anemia).

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

• urinary tract infections, infection of the nose, sinuses, throat, and upper respiratory tract, common cold (upper respiratory tract infection), bronchitis, sinusitis, pharyngitis, flu-like illness, dry mouth, mouth pain or inflammation, toothache, flu, herpes simplex,
• weight loss,
• sleep disturbances, drowsiness, depression, anxiety,
• dizziness, concentration and memory disorders, mood changes, liver function disorders due to liver damage, tingling or numbness of the hands or feet,
• vision disorders, including cataracts, dry eye, retinal bleeding, yellowing of the whites of the eyes,
• dizziness,
• rapid or irregular heartbeat (palpitations),
• shortness of breath, coughing up mucus, runny nose, sore throat, and discomfort when swallowing,
• gastrointestinal disorders, including vomiting, abdominal pain, indigestion, constipation, bloating, taste disturbances, hemorrhoids, stomach pain or discomfort,
• liver problems, including liver tumors, yellowing of the whites of the eyes or skin (jaundice),
• drug-induced liver damage (see "Liver disorders" above in section 4),
• skin changes, including rash, dry skin, eczema, redness, itching,
• excessive sweating, skin growths, hair loss,
• joint pain, back pain, bone pain, limb pain (arms, legs, hands, or feet), muscle spasms,
• irritability, general feeling of being unwell, skin reaction, such as redness or swelling and pain at the injection site, chest pain, and discomfort, fluid accumulation in the body or limbs causing swelling,
• depression, anxiety, sleep disturbances, nervousness,
• fever, headache.

Common side effectsthat may be seen in blood tests:

• increased blood sugar (glucose) level, decreased white blood cell count, decreased neutrophil count, decreased albumin level in the blood, decreased hemoglobin level, increased bilirubin level in the blood, changes in blood clotting enzymes.

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

• stomach flu (gastroenteritis), sore throat,
• decreased red blood cell count (anemia) due to excessive destruction of red blood cells (hemolytic anemia),
• confusion, agitation,
• mouth blisters or ulcers, stomach inflammation,
• blood clots in the vein that carries blood to the liver (possible liver damage and/or gastrointestinal disorders), liver failure,
• skin changes, including discoloration, peeling, redness, itching, and sweating, night sweats,
• abnormal blood clotting in small blood vessels with kidney failure, pain when urinating,
• rash, bruising at the injection site, chest discomfort,
• heart rhythm disorders (prolonged QT interval).

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their 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, 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, more information can be collected on the safety of the medicine.

5. How to store Eltrombopag Olpha

The medicine should be stored out of sight and reach of children. The patient should not take 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. No special precautions. 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. Package contents and other information

What Eltrombopag Olpha contains

The active substance is eltrombopag olamine. Eltrombopag Olpha, 12.5 mg, coated tabletsEach coated tablet contains eltrombopag olamine equivalent to 12.5 mg of eltrombopag. Eltrombopag Olpha, 25 mg, coated tabletsEach coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag. Eltrombopag Olpha, 50 mg, coated tabletsEach coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag. Eltrombopag Olpha, 75 mg, coated tabletsEach coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag. The other ingredients are: Tablet core: microcrystalline cellulose, mannitol, povidone, isomalt (E 953), calcium silicate, sodium carboxymethylcellulose, magnesium stearate. Tablet coating: Eltrombopag Olpha, 12.5 mg, coated tablets:hypromellose, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), triacetin. Eltrombopag Olpha, 25 mg, coated tablets:hypromellose, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), triacetin. Eltrombopag Olpha, 50 mg, coated tablets:hypromellose, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), triacetin. Eltrombopag Olpha, 75 mg, coated tablets:hypromellose, titanium dioxide (E 171), iron oxide red (E 172), triacetin.

What Eltrombopag Olpha looks like and contents of the pack

Eltrombopag Olpha, 12.5 mg, coated tabletsOrange to brown, round, biconvex coated tablets with "I" engraved on one side and a diameter of about 5.5 mm. Eltrombopag Olpha, 25 mg, coated tabletsDark pink, round, biconvex coated tablets with "II" engraved on one side and a diameter of about 8 mm. Eltrombopag Olpha, 50 mg, coated tabletsPink, round, biconvex coated tablets with "III" engraved on one side and a diameter of about 10 mm. Eltrombopag Olpha, 75 mg, coated tabletsRed to brown, round, biconvex coated tablets with "IV" engraved on one side and a diameter of about 12 mm. Blisters of OPA/Aluminum/PVC/Aluminum foil packaged in a cardboard box containing 10, 14, 28, 30, or 84 coated tablets, and single-dose blisters packaged in a cardboard box containing 10x1, 14x1, 28x1, 30x1, or 84x1 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Olpha AS, Rupnicu iela 5, Olaine, Olaines novads, LV-2114, Latvia E-mail: [email protected]

Manufacturer

Synthon B.V., Microweg 22, 6545 CM Nijmegen, Netherlands Synthon Hispania S.L., c/ Castelló, 1, 08830 Sant Boi de Llobregat, Barcelona, Spain

Date of last revision of the leaflet: