Eltrombopag Sandoz

Leaflet accompanying the packaging: information for the user

Eltrombopag Sandoz, 12.5 mg, film-coated tablets

Eltrombopag Sandoz, 25 mg, film-coated tablets

Eltrombopag Sandoz, 50 mg, film-coated tablets

Eltrombopag Sandoz, 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 you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• 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 Sandoz and what is it used for
• 2. Important information before taking Eltrombopag Sandoz
• 3. How to take Eltrombopag Sandoz
• 4. Possible side effects
• 5. How to store Eltrombopag Sandoz
• 6. Contents of the packaging and other information

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

Eltrombopag Sandoz 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 Sandoz is used to treat a bleeding disorder called primary immune thrombocytopenia (ITP) in patients over 1 year of age who have 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 prone to bleeding. 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 Sandoz 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 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 certain antiviral drugs used to treat it. Taking Eltrombopag Sandoz may help patients complete full antiviral treatment (peginterferon and ribavirin).

2. Important information before taking Eltrombopag Sandoz

When not to take Eltrombopag Sandoz

• If the patient is allergicto eltrombopag or any of the other ingredients of this medicine (listed in section 6 under "What Eltrombopag Sandoz contains"). The patient should consult a doctor if they think this applies to them.

Warnings and precautions

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

• if the patient has liver disease. Patients with a low platelet count and advanced (long-standing) liver disease are at increased risk of side effects, including life-threatening liver damage and blood clots. If the doctor considers that the benefits of taking this medicine outweigh the risks, the patient will be closely monitored during treatment;
• if the patient is at risk of developing blood clots in the veins or arteries, or if there is a history of blood clots in the patient's family. The 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 disease The patient should inform their doctor before starting treatment if any of the above conditions apply to them. The patient should not take Eltrombopag Sandoz unless the doctor considers that the expected benefits outweigh the risk of blood clots.
• if the patient has cataracts (clouding of the lens in the eye)
• if the patient has other blood disorders, such as myelodysplastic syndrome (Myelodysplastic Syndrome, MDS). Before starting treatment with Eltrombopag Sandoz, the doctor will perform tests to rule out this disease. If the patient has MDS and takes this medicine, MDS may worsen. The patient should inform their doctor if any of the above situations apply to them.

Ophthalmological examination

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

Platelet count tests

If the patient stops taking Eltrombopag Sandoz, there is a risk 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 Sandoz for the patient to avoid excessive increases in platelet count.
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 severe chest pain or rapid heartbeat
• abdominal pain (stomach), abdominal distension, blood in the stool.

Bone marrow tests

In patients with bone marrow disorders, medicines like Eltrombopag Sandoz may worsen these conditions. 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 Sandoz.

Tests to detect gastrointestinal bleeding

If the patient is taking interferon-based treatment and Eltrombopag Sandoz for low platelet count associated with hepatitis C, they will be monitored for signs of gastrointestinal bleeding after stopping treatment with Eltrombopag Sandoz.

Heart tests

The doctor may consider it necessary to examine the patient's heart during treatment with Eltrombopag Sandoz 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 Sandoz 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.

Eltrombopag Sandoz 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.
Certain commonly used medicines interact with eltrombopag Sandoz - 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 the medicine" in section 3)
• statins, which lower cholesterol levels
• certain medicines used to treat HIV infection, such as lopinavir and (or) ritonavir
• cyclosporine used in transplants or immune system disorders
• minerals such as iron, calcium, magnesium, aluminum, selenium, and zinc, which may be components of

vitamin and mineral supplements (see also "When to take the medicine" in section 3)

• medicines such as methotrexate and topotecan, used to treat cancer.

The patient should consult their doctorif they are taking any of the above medicines. Some of them should not be taken during treatment with Eltrombopag Sandoz, 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, the doses of these medicines may be reduced or their use may be stopped during treatment with Eltrombopag Sandoz.

Taking Eltrombopag Sandoz with food and drink

Eltrombopag Sandoz 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

Eltrombopag Sandoz should not be taken during pregnancyunless the doctor has explicitly recommended it. The effect of Eltrombopag Sandoz when taken during pregnancy is unknown.

• The patient should inform their doctor if they are pregnant, think they may be pregnant, or plan to have a child.
• During treatment with Eltrombopag Sandoz, the patient should use appropriate contraception to prevent pregnancy.
• The patient should inform their doctor if they become pregnant while taking Eltrombopag Sandoz.

The patient should not breastfeed while taking Eltrombopag Sandoz. It is not known whether Eltrombopag Sandoz passes into breast milk.
The patient should inform their doctor if they are breastfeeding or plan to breastfeed.

Driving and using machines

Eltrombopag Sandoz 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 in them.

Eltrombopag Sandoz contains isomalt and sodium

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

3. How to take Eltrombopag Sandoz

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The patient should not change the dose or dosing schedule of Eltrombopag Sandoz unless their doctor or pharmacist recommends it. During treatment with Eltrombopag Sandoz, the patient will remain under the care of a doctor experienced in treating the patient's condition.

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 Sandoz per day.
Patients of East Asian/Southeast Asian descent 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 Sandoz per day.
In the case of hepatitis C
Adults - the usual starting dose for hepatitis C is one 25 mg tablet of Eltrombopag Sandoz per day. In patients of East Asian/Southeast Asian descent, treatment should be started with the same dose of 25 mg.
The onset of action of Eltrombopag Sandoz may occur within 1 to 2 weeks.
Depending on the patient's response to treatment with Eltrombopag Sandoz, the doctor may recommend changing 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 Sandoz
• and for 2 hours after taking Eltrombopag Sandoz
• they do not consume:
• 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
• vitamin and mineral supplements containing iron, calcium, magnesium, aluminum, selenium, and zinc.

If the above recommendations are not followed, Eltrombopag Sandoz may not be properly absorbed by the body.

The patient should consult their doctor for more information about suitable foods and drinks.

Taking a higher dose of Eltrombopag Sandoz than recommended

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

Missing a dose of Eltrombopag Sandoz

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

Stopping treatment with Eltrombopag Sandoz

The patient should not stop taking Eltrombopag Sandoz 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 doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Eltrombopag Sandoz can cause side effects, although not everybody gets them.

Symptoms to watch out for: the patient should see a doctor

In patients taking Eltrombopag Sandoz for primary immune thrombocytopenia or low platelet count associated with hepatitis C, the following symptoms of serious side effects may occur. It is essential to inform the doctor about these symptoms .
Increased risk of blood clots
Some patients may be at increased risk of blood clots, and medicines like Eltrombopag Sandoz may worsen this condition. 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, warmth, redness, or tenderness in one leg
• sudden shortness of breath, especially with severe chest pain or rapid heartbeat
• abdominal pain (stomach), abdominal distension, blood in the stool.

Liver disorders
Eltrombopag Sandoz 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 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

they should see their doctor immediately.

Bleeding or bruising after stopping treatment
Usually, within two weeks of stopping treatment with Eltrombopag Sandoz, the patient's platelet count will decrease to pre-treatment levels. 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 treatment with Eltrombopag Sandoz.
The patient should inform their doctor if they experience any bruising or bleeding after stopping treatment with Eltrombopag Sandoz.
In some patients, gastrointestinal bleedingmay occur after stopping treatment with peginterferon, ribavirin, and eltrombopag. Symptoms include:

• black, tarry stools (a change in stool color, which 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 following side effects have been reported in adults taking eltrombopag for primary immune thrombocytopenia:

Very commonside 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 commonside effects that may be detected in blood tests:

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

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

• flu, herpes simplex, pneumonia, sinusitis, tonsillitis, pharyngitis, bronchitis, gastritis, gum infection, sore throat, and discomfort when swallowing
• loss of appetite
• sleep disturbances, depression
• numbness, tingling, or prickling sensation, drowsiness, migraine
• eye disorders, including abnormal eye test results, dry eyes, 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, vomiting, abdominal pain, gas
• abnormal liver function
• skin changes, including excessive sweating, itchy rash, red spots, skin changes, hair loss
• muscle pain, muscle cramps, muscle weakness, bone pain
• urine abnormalities, including presence of air bubbles in the urine (signs of protein in the urine)
• heavy menstrual bleeding
• high fever, feeling hot, chest pain, and feeling unwell

Commonside effects that may be detected 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 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

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

• skin infection
• rectal or colon cancer
• allergic reaction
• loss of appetite, painful joint swelling caused by 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 hemorrhage, dry eyes
• rapid or irregular heartbeat, blue discoloration of the skin, cardiovascular disorders, which may be symptoms of heart and blood vessel disorders, interruption of blood flow to a part of the heart
• possible pain, swelling, and (or) redness around a vein, which may be symptoms of a blood clot, blood clot, redness
• shortness of breath, cough with sputum production, runny nose, sore throat, and discomfort when swallowing
• liver disorders, including liver tumor, yellowing of the skin or whites of the eyes (jaundice), liver damage caused by inflammation (see "Liver disorders" above in section 4)
• skin changes, including discoloration, peeling, redness, itching, and sweating
• 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

Uncommonside effects that may be detected in laboratory tests:

• changes in red blood cell shape, decreased red blood cell count (anemia) caused by excessive destruction of red blood cells (hemolytic anemia), increased 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 urine pH

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 commonside 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

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

• sleep disturbances (insomnia)
• nasal congestion, runny nose, or stuffy nose, sore throat, rhinitis, pharyngitis, and coughing
• 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 HCV:

Very commonside 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 commonside effects that may be detected in blood tests:

• decreased red blood cell count (anemia)

Commonside 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, and coughing
• weight loss
• sleep disturbances, drowsiness, depression, anxiety
• dizziness, balance disorders, speech and nerve disorders, mood changes, neurological disorders caused by liver damage
• vision disorders, including cataracts, dry eyes, retinal hemorrhage
• dizziness
• rapid or irregular heartbeat
• shortness of breath, cough with sputum production, runny nose, sore throat, and discomfort when swallowing
• gastrointestinal disorders, including vomiting, abdominal pain, nausea, constipation, bloating, taste disturbances, hemorrhoids, abdominal pain or discomfort, and bleeding in the esophagus
• liver disorders, including liver tumor, yellowing of the skin or whites of the eyes (jaundice), liver damage caused by inflammation (see "Liver disorders" above in section 4)
• skin changes, including rash, dry skin, eczema, redness, itching, and sweating
• joint pain, back pain, bone pain, limb pain (arms, legs, hands, or feet), muscle cramps
• irritability, general feeling of being unwell, skin reaction, such as redness or swelling and pain at the injection site, chest pain, and discomfort
• depression, anxiety, sleep disturbances, nervousness
• fever, headache

Commonside effects that may be detected 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 enzyme activity Uncommonside effects (may affect up to 1 in 100 patients):
• gastroenteritis (inflammation of the stomach and intestines), sore throat
• decreased red blood cell count (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• confusion, agitation
• mouth ulcers or mouth sores, gastritis
• blood clots in the vein that carries blood to the liver (possible liver damage and (or) digestive system damage), liver failure
• skin changes, including discoloration, peeling, redness, itching, and sweating, and 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 this leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides: 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Eltrombopag Sandoz

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 blister and carton 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Eltrombopag Sandoz contains

• The active substance of Eltrombopag Sandoz is eltrombopag olamine.

Eltrombopag Sandoz, 12.5 mg: each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg of eltrombopag.
Eltrombopag Sandoz, 25 mg: each film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.
Eltrombopag Sandoz, 50 mg: each film-coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag.
Eltrombopag Sandoz, 75 mg: each film-coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag.The other ingredients are: microcrystalline cellulose, mannitol, povidone (K29/32), isomalt, calcium silicate, sodium carboxymethylcellulose (type A), magnesium stearate (tablet core); hypromellose 2910 (5 mPas), titanium dioxide (E 171), iron oxide red (E 172), triacetin (tablet coating).
Eltrombopag Sandoz, 12.5 mg, 25 mg, and 50 mg film-coated tablets also contain iron oxide yellow (E 172).

What Eltrombopag Sandoz looks like and contents of the pack

Eltrombopag Sandoz, 12.5 mg, are orange to brown, round, biconvex film-coated tablets (tablets) with "I" embossed on one side, approximately 5.5 mm in diameter.
Eltrombopag Sandoz, 25 mg, are dark pink, round, biconvex film-coated tablets (tablets) with "II" embossed on one side, approximately 8 mm in diameter.
Eltrombopag Sandoz, 50 mg, are pink, round, biconvex film-coated tablets (tablets) with "III" embossed on one side, approximately 10 mm in diameter.
Eltrombopag Sandoz, 75 mg, are red to brown, round, biconvex film-coated tablets (tablets) with "IV" embossed on one side, approximately 12 mm in diameter.
Eltrombopag Sandoz, 12.5 mg, 25 mg, 50 mg, and 75 mg, are packaged in cardboard boxes containing 10, 14, 28, 30, or 84 film-coated tablets in blisters or cardboard boxes containing 10 x 1, 14 x 1, 28 x 1, 30 x 1, or 84 x 1 film-coated tablets in single-dose blisters or bulk packaging containing 84 film-coated tablets (3 packages of 28 film-coated tablets).
Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
Phone: 22 209 70 00

Manufacturer

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

This medicine is authorized in the Member States of the European Economic Area

Marketing authorisation holder under the following names:

Eltrombopag Sandoz, 12.5 mg
Austria
Eltrombopag Sandoz 12.5 mg – Film-coated tablets
Croatia
Eltrombopag Sandoz 12.5 mg film-coated tablets
Cyprus
Eltrombopag Sandoz
Estonia
Eltrombopag Sandoz
Germany
Eltrombopag - 1 A Pharma 12.5 mg Film-coated tablets
Greece
Eltrombopag/Sandoz
Hungary
Eltrombopag Sandoz 12.5 mg film-coated tablet
Ireland
Eltrombopag Rowex 12.5 mg film-coated tablets
Latvia
Eltrombopag Sandoz 12.5 mg film-coated tablets
Lithuania
Eltrombopag Sandoz 12.5 mg film-coated tablets
Poland
Eltrombopag Sandoz
Romania
Eltrombopag Sandoz 12.5 mg film-coated tablets
Slovenia
Eltrombopag Sandoz 12.5 mg film-coated tablets
Eltrombopag Sandoz, 25 mg
Austria
Eltrombopag Sandoz 25 mg – Film-coated tablets
Bulgaria
Eltrombopag Sandoz/Елтромбопаг Сандоз
Croatia
Eltrombopag Sandoz 25 mg film-coated tablets
Cyprus
Eltrombopag Sandoz
Czech Republic
Eltrombopag Sandoz
Estonia
Eltrombopag Sandoz
Finland
Eltrombopag Sandoz 25 mg tablet, film-coated
France
ELTROMBOPAG SANDOZ 25 mg, film-coated tablet
Germany
Eltrombopag - 1 A Pharma 25 mg Film-coated tablets
Greece
Eltrombopag/Sandoz
Hungary
Eltrombopag Sandoz 25 mg film-coated tablet
Ireland
Eltrombopag Rowex 25 mg film-coated tablets
Italy
Eltrombopag Sandoz
Latvia
Eltrombopag Sandoz 25 mg film-coated tablets
Lithuania
Eltrombopag Sandoz 25 mg film-coated tablets
Norway
Eltrombopag Sandoz
Poland
Eltrombopag Sandoz
Romania
Eltrombopag Sandoz 25 mg film-coated tablets
Slovakia
Eltrombopag Sandoz
Slovenia
Eltrombopag Sandoz 25 mg film-coated tablets
Spain
Eltrombopag Sandoz 25 mg film-coated tablets EFG
Sweden
Eltrombopag Sandoz
Eltrombopag Sandoz, 50 mg
Austria
Eltrombopag Sandoz 50 mg – Film-coated tablets
Bulgaria
Eltrombopag Sandoz/Елтромбопаг Сандоз
Croatia
Eltrombopag Sandoz 50 mg film-coated tablets
Cyprus
Eltrombopag Sandoz
Czech Republic
Eltrombopag Sandoz
Denmark
Eltrombopag Sandoz
Estonia
Eltrombopag Sandoz
Finland
Eltrombopag Sandoz 50 mg tablet, film-coated
France
ELTROMBOPAG SANDOZ 50 mg, film-coated tablet
Germany
Eltrombopag - 1 A Pharma 50 mg Film-coated tablets
Greece
Eltrombopag/Sandoz
Hungary
Eltrombopag Sandoz 50 mg film-coated tablet
Ireland
Eltrombopag Rowex 50 mg film-coated tablets
Italy
Eltrombopag Sandoz
Latvia
Eltrombopag Sandoz 50 mg film-coated tablets
Lithuania
Eltrombopag Sandoz 50 mg film-coated tablets
Norway
Eltrombopag Sandoz
Poland
Eltrombopag Sandoz
Romania
Eltrombopag Sandoz 50 mg film-coated tablets
Slovakia
Eltrombopag Sandoz
Slovenia
Eltrombopag Sandoz 50 mg film-coated tablets
Spain
Eltrombopag Sandoz 50 mg film-coated tablets EFG
Sweden
Eltrombopag Sandoz
Eltrombopag Sandoz, 75 mg
Austria
Eltrombopag Sandoz 75 mg – Film-coated tablets
Croatia
Eltrombopag Sandoz 75 mg film-coated tablets
Cyprus
Eltrombopag Sandoz
Denmark
Eltrombopag Sandoz
Estonia
Eltrombopag Sandoz
Finland
Eltrombopag Sandoz 75 mg tablet, film-coated
France
ELTROMBOPAG SANDOZ 75 mg, film-coated tablet
Germany
Eltrombopag - 1 A Pharma 75 mg Film-coated tablets
Greece
Eltrombopag/Sandoz
Hungary
Eltrombopag Sandoz 75 mg film-coated tablet
Ireland
Eltrombopag Rowex 75 mg film-coated tablets
Italy
Eltrombopag Sandoz
Latvia
Eltrombopag Sandoz 75 mg film-coated tablets
Lithuania
Eltrombopag Sandoz 75 mg film-coated tablets
Norway
Eltrombopag Sandoz
Poland
Eltrombopag Sandoz
Romania
Eltrombopag Sandoz 75 mg film-coated tablets
Slovakia
Eltrombopag Sandoz
Slovenia
Eltrombopag Sandoz 75 mg film-coated tablets
Sweden
Eltrombopag Sandoz

Date of last revision of the leaflet:

{logo of the marketing authorisation holder}