Eltrombopag olpha

Patient Information Leaflet

Eltrombopag Olpha, 12.5 mg, film-coated tablets
Eltrombopag Olpha, 25 mg, film-coated tablets
Eltrombopag Olpha, 50 mg, film-coated tablets
Eltrombopag Olpha, 75 mg, film-coated tablets
eltrombopag
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

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

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

Eltrombopag Olpha contains the active substance eltrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists. It is used to increase the number of platelets in your blood. Platelets are blood cells that help reduce or prevent the risk of bleeding.

Eltrombopag Olpha is used to treat a blood clotting disorder called immune (idiopathic) thrombocytopenia in patients over 1 year of age who have already been treated with other medicines (corticosteroids or immunoglobulins) that were not effective.

Immune thrombocytopenia is caused by a low number of platelets (thrombocytopenia). People with immune thrombocytopenia are at increased risk of bleeding. Symptoms patients with immune thrombocytopenia may notice include petechiae (small, flat, red, round spots under the skin), bruising, nosebleeds, bleeding gums, and difficulty stopping bleeding after a cut or injury.

Eltrombopag Olpha may also be used to treat low platelet counts (thrombocytopenia) in adults with chronic hepatitis C virus (HCV) infection who have had difficulties with side effects during interferon-based therapy. Many people with hepatitis C have low platelet counts, not only due to the disease itself but also as a result of certain antiviral medicines used in treatment. Taking Eltrombopag Olpha may help patients complete full antiviral treatment (pegylated interferon and ribavirin).

2. Important information before using the medicine

When not to use Eltrombopag Olpha

• if the patient is allergic to eltrombopag or any of the other ingredients of the medicine (listed in section 6 under the heading "What Eltrombopag Olpha contains"). The patient should consult a doctor if they think they are in the condition described above.

Warnings and precautions

Before starting treatment with Eltrombopag Olpha, discuss the following with your doctor:

• if the patient has liver disease. Patients with low platelet counts and advanced (chronic) liver disease are at increased risk of adverse reactions, including life-threatening liver damage and blood clots. If the doctor determines that the benefits of taking this medicine outweigh the risks, the patient will be closely monitored during treatment.
• if the patient has a risk of blood clots in veins or arteries, or if there is a family history of blood clots. The risk of blood clots may be increased:
  • if the patient is elderly,
  • if the patient has been immobilized for a prolonged period,
  • if the patient has a malignant tumour,
  • if the patient is taking oral contraceptives or hormone replacement therapy,
  • if the patient has recently undergone surgery or suffered trauma,
  • if the patient is overweight,
  • if the patient smokes,
  • if the patient has advanced chronic liver disease.

The patient should inform the doctor before starting treatment if any of the above conditions apply. Do not take Eltrombopag Olpha unless the doctor considers that the expected benefits outweigh the risk of blood clots.

• if the patient has cataracts (clouding of the eye's lens),
• if the patient has other blood disorders, such as myelodysplastic syndrome (MDS). Before starting treatment with Eltrombopag Olpha, the doctor will perform tests to rule out this condition. If the patient has MDS and takes this medicine, MDS may worsen.

The patient should inform the doctor if any of the above situations apply.

Ophthalmological examination

The treating doctor will recommend regular check-ups to detect cataracts. If the patient does not routinely undergo ophthalmological examinations, the doctor should arrange regular examinations. Examinations may also detect any bleeding in the retina (the light-sensitive layer of cells at the back of the eye) or nearby areas.

Regular monitoring will be required

Before starting Eltrombopag Olpha, the doctor will perform blood tests to assess blood cells, including platelets. These tests will be repeated periodically during treatment.

Blood tests to assess liver function

Eltrombopag may cause blood test results indicating liver damage—increased activity of certain liver enzymes, particularly alanine aminotransferase and aspartate aminotransferase, and increased bilirubin. If the patient is receiving interferon-based treatment simultaneously with Eltrombopag Olpha for low platelet count associated with hepatitis C, some liver conditions may worsen.

Before starting Eltrombopag Olpha and periodically during treatment, blood tests assessing liver function will be performed. It may be necessary to discontinue Eltrombopag Olpha if levels of these substances rise too high or if other signs of liver damage occur.

Please refer to the information in section 4 of this leaflet, “Liver disorders”.

Monitoring platelet count

If the patient stops taking Eltrombopag Olpha, platelet count may decrease again within a few days. Platelet count will be monitored, and the treating doctor will discuss appropriate precautions with the patient.

A very high platelet count may increase the risk of blood clots. However, blood clots may also occur even when platelet count is normal or low. The treating doctor will adjust the dose of Eltrombopag Olpha to prevent excessive increase in platelet count.

Seek immediate medical help if the patient experiences any of the following symptoms of blood clots:

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

Bone marrow examinations

In patients with bone marrow disorders, medicines such as Eltrombopag Olpha may worsen these conditions. Changes in the bone marrow may manifest as abnormal blood test results. The treating doctor may recommend direct bone marrow examinations during treatment with Eltrombopag Olpha.

Tests to detect gastrointestinal bleeding

If the patient is receiving interferon-based treatment simultaneously with Eltrombopag Olpha, they will be monitored for signs of bleeding from the stomach or intestines after stopping this medicine.

Heart examinations

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

Elderly patients (65 years and older)

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

Children and adolescents

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

Other medicines and Eltrombopag Olpha

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines planned for future use. This also includes over-the-counter medicines and vitamins.

Some commonly used medicines interact with eltrombopag—including both prescription and over-the-counter medicines, as well as mineral supplements. These include:

• acid-reducing medicines used to treat indigestion, heartburn, or stomach ulcers (see also “When to take the medicine” in section 3),
• medicines called statins, which lower cholesterol levels,
• certain medicines used to treat HIV infection, such as lopinavir and (or) ritonavir,
• cyclosporine, used in transplant patients or in immune disorders,
• minerals such as iron, calcium, magnesium, aluminium, selenium, and zinc, which may be components of vitamin and mineral supplements (see also “When to take the medicine Eltrombopag Olpha” in section 3),
• medicines such as methotrexate and topotecan, used in cancer treatment.

Consult your doctor if the patient is taking any of the medicines listed above. Some of these medicines must not be taken during treatment with Eltrombopag Olpha; for others, dose adjustment or appropriate timing of administration may be required. The doctor will review all medicines the patient is taking and recommend changes in treatment if necessary.

If the patient is taking anticoagulant medicines to prevent blood clots, the risk of bleeding is increased. 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 concomitant treatment with Eltrombopag Olpha.

Taking Eltrombopag Olpha with food and drink

Eltrombopag Olpha must not be taken with dairy products or milk-based drinks, as calcium present in dairy products affects the absorption of the medicine. For further information, see “When to take Eltrombopag Olpha” in section 3.

Pregnancy, breastfeeding

Do not use Eltrombopag Olpha during pregnancy unless the doctor recommends it. The effect of eltrombopag used during pregnancy is unknown.

• Inform the doctor if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant.
• While taking Eltrombopag Olpha, an appropriate method of contraception should be used to prevent pregnancy.
• Inform the doctor if the patient becomes pregnant while taking Eltrombopag Olpha.

Do not breastfeed while taking Eltrombopag Olpha. It is not known whether Eltrombopag Olpha passes into breast milk. Inform the doctor if the patient is breastfeeding or plans to breastfeed.

Driving and operating machinery

Eltrombopag Olpha may cause dizziness and other adverse effects that reduce concentration.

Do not drive or operate machinery unless the patient is certain that these symptoms do not occur.

Eltrombopag Olpha contains isomalt and sodium

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

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

3. How to use Eltrombopag Olpha

This medicine should always be used exactly as directed by the doctor. If in doubt, consult the doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag Olpha unless instructed by the doctor or pharmacist. While taking Eltrombopag Olpha, the patient will remain under the care of a physician experienced in managing the disease from which the patient suffers.

How much medicine to take

In the case of primary immune thrombocytopenia

• Adults and children (aged 6 to 17 years) – the usual starting dose in 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 in primary immune thrombocytopenia is one 25 mg tablet of Eltrombopag Olpha per day.

In the case of hepatitis C

• Adults – the usual starting dose in hepatitis C is one 25 mg tablet of Eltrombopag Olpha per day.
• For patients of East Asian/Southeast Asian origin, treatment should be initiated at the same dose of 25 mg.

The effect of Eltrombopag Olpha may begin within 1 to 2 weeks. Depending on the patient's response to treatment with Eltrombopag Olpha, the doctor may adjust the daily dose.

How to take the tablets

The tablets should be swallowed whole with water.

When to take the medicine

Make sure that –

• for 4 hours before taking Eltrombopag Olpha
• and for 2 hours after taking Eltrombopag Olpha, the patient does not consume the following foods:
• dairy products such as cheese, butter, yoghurt, ice cream,
• milk or drinks containing milk, yoghurt or cream,
• antacids used to treat indigestion and heartburn,
• vitamin and mineral supplements containing iron, calcium, magnesium, aluminium, selenium, zinc.

Failure to follow these instructions may result in inadequate absorption of the medicine.

Consult the doctor for further advice regarding appropriate foods and drinks.

Taking more Eltrombopag Olpha than prescribed

Contact the doctor or pharmacist immediately. If possible, show them the medicine packaging or this leaflet. The patient's condition will be monitored to detect any adverse reactions and to provide appropriate treatment without delay.

Missing a dose of Eltrombopag Olpha

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

Stopping Eltrombopag Olpha treatment

Do not stop taking Eltrombopag Olpha without consulting the doctor. If the doctor advises 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 there are any further doubts about the use of this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Symptoms to be aware of: seek medical advice
In patients treated with eltrombopag for primary immune thrombocytopenia or low platelet count associated with hepatitis C, symptoms of severe adverse reactions may occur. It is important to inform your doctor if any of these symptoms appear.

Increased risk of blood clots
Some patients may have an increased risk of blood clots, and medicines such as Eltrombopag Olpha may increase this risk. Sudden blockage of a blood vessel by a clot is an uncommon side effect and may affect up to 1 in 100 patients.
Seek immediate medical attention if any of the following symptoms of blood clots occur:

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

Liver problems
Eltrombopag Olpha may cause changes detectable in blood tests, which may indicate liver damage. Liver disorders (increased liver enzyme activity in blood tests) are common and may affect up to 1 in 10 patients. Other liver-related problems are uncommon and may affect up to 1 in 100 patients.
If any of the following symptoms of liver problems occur:

• yellowing of the skin or whites of the eyes (jaundice)
• abnormally dark-coloured urine
  seek immediate medical advice.

Bleeding or bruising after stopping treatment
Usually, within two weeks of stopping Eltrombopag Olpha, the patient's platelet count returns to the level observed before starting treatment with Eltrombopag Olpha. A low platelet count may increase the risk of bleeding or bruising. Your doctor will monitor your platelet count for at least four weeks after stopping Eltrombopag Olpha.
Inform your doctor if bruising or bleeding occurs after stopping this medicine.
Some patients experience gastrointestinal bleeding after discontinuing peginterferon, ribavirin and eltrombopag. Symptoms include:

• black, tarry stools (change in stool colour is an uncommon side effect which may affect up to 1 in 100 patients)
• blood in stool
• vomiting blood or coffee-ground-like material
  Immediately inform your doctor if any of these symptoms occur.

The following adverse reactions have been reported in association with eltrombopag treatment in adult patients with primary immune thrombocytopenia:
Very common side effects (may affect more than 1 in 10 patients):

• nose, sinus, throat and upper respiratory tract infections (upper respiratory tract infection)
• cough, common cold
• nausea, diarrhoea
• back pain

Very common side effects detectable in blood tests:

• increased liver enzyme activity (alanine aminotransferase (AlAT))

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

• influenza, cold sores, pneumonia, irritation and inflammation (swelling) of sinuses, inflammation (swelling) and infection of tonsils, lung, sinus, nose and throat infections, gingivitis, sore throat and discomfort when swallowing
• loss of appetite
• sleep disturbances, depression
• reduced skin sensation, tingling, pricking or numbness commonly known as "pins and needles", drowsiness, migraine
• eye disorders including abnormal eye test results, dry eyes, eye pain and blurred vision
• ear pain, sensation of spinning (dizziness)
• pain, swelling and tenderness in one leg (usually calf) with warm skin at affected site (symptoms of deep vein thrombosis), localized swelling filled with blood from damaged blood vessel (haematoma), hot flushes
• nasal discharge
• oral disorders including dry mouth, mouth pain, tongue sensitivity, bleeding gums, mouth ulcers, toothache, vomiting, abdominal pain, bloating/gas
• abnormal liver function
• skin disorders including excessive sweating, raised itchy rash, red spots, skin appearance changes, hair loss

Common side effects detectable in blood tests:

• decreased number of red blood cells (anaemia), decreased platelet count (thrombocytopenia), decreased white blood cell count, decreased haemoglobin concentration, increased eosinophil count, increased white blood cell count (leucocytosis)
• increased uric acid concentration, decreased potassium concentration
• increased liver enzyme activity (aspartate aminotransferase (AspAT)), increased blood bilirubin concentration (a substance produced by the liver)
• increased levels of certain proteins, increased creatinine concentration
• increased alkaline phosphatase activity

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

• skin infection
• rectal and colon cancer
• allergic reaction
• loss of appetite, painful joint swelling due to uric acid (gout)
• lack of interest, mood changes, uncontrollable or unexpected crying
• balance, speech and nerve function disorders, tremors, paralysis on one side of the body, migraine with aura, nerve damage, blood vessel dilation or swelling causing headache
• eye disorders including excessive tearing, clouding of the eye lens (cataract), retinal haemorrhage, dry eyes
• rapid heartbeat, irregular heartbeat, skin cyanosis (bluish discolouration), cardiac rhythm disorders (prolonged QT interval), which may indicate heart and blood vessel problems, interruption of blood flow to part of the heart
• possible pain, swelling and (or) redness around a vein, which may indicate venous thrombosis, blood clot, redness
• sudden shortness of breath, particularly in combination with acute chest pain and (or) rapid breathing, which may indicate pulmonary embolism (see "Increased risk of blood clots" above in section 4), loss of function in part of the lung due to blockage of the pulmonary artery, nose, throat and sinus disorders, sleep breathing disorders
• oral disorders including dry or painful mouth, tongue pain, bleeding gums, oral discomfort, mouth or throat blisters or ulcers, gastrointestinal disorders including frequent bowel movements, food poisoning
• blood in stool, vomiting blood, rectal bleeding, stool colour change, abdominal bloating, constipation
• yellowing of the skin and (or) abdominal pain, which may indicate bile duct obstruction, liver disease, liver damage due to inflammation (see "Liver problems" above in section 4), drug-induced liver damage
• skin disorders including skin discolouration, peeling, redness, itching and sweating, cold sweats
• muscle weakness
• kidney disorders including: kidney inflammation, excessive urination at night, kidney failure, presence of white blood cells in urine
• hot flushes, restlessness, bleeding around catheter (if present) into the skin, redness or swelling at wound site, general malaise, sensation of foreign body
• sunburn

Uncommon side effects detectable in laboratory tests:

• changes in red blood cell shape, decreased number of red blood cells (anaemia) due to excessive destruction of red blood cells (haemolytic anaemia), increased myelocyte count, increased band neutrophil count, presence of developing white blood cells which may indicate certain diseases, increased platelet count, increased haemoglobin concentration
• decreased calcium concentration
• increased blood urea concentration, protein in urine
• increased blood albumin concentration, increased total protein concentration, decreased blood albumin concentration, increased urine pH

The following additional adverse reactions have been reported in association with eltrombopag treatment in children (aged 1 to 17 years) with ITP:
If these adverse reactions worsen, inform your doctor, pharmacist or nurse.
Very common side effects (may affect more than 1 in 10 children):

• nose, sinus, throat and upper respiratory tract infections, common cold (upper respiratory tract infection)
• cough
• nausea, diarrhoea, abdominal pain
• high body temperature

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

• difficulty falling asleep (insomnia)
• itchy nose, runny or blocked nose, sore throat, catarrh, nasal mucosa congestion and sneezing, nose and throat pain
• toothache, oral disorders including dry mouth, mouth soreness, tongue sensitivity, bleeding gums, mouth ulcers

The following adverse reactions have been reported in association with eltrombopag treatment in combination with peginterferon and ribavirin in patients with hepatitis C:
Very common side effects (may affect more than 1 in 10 patients):

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

Very common side effects detectable in blood tests:

• decreased number of red blood cells (anaemia)

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

• urinary tract infections, nose, sinus, throat and upper respiratory tract infections, common cold (upper respiratory tract infection), bronchial mucosa inflammation, nasal passage, throat and oral cavity inflammation, flu-like symptoms, dry mouth, pain or inflammation of oral cavity, toothache, influenza, cold sores
• weight loss
• sleep disorders, abnormal drowsiness, depression, anxiety
• dizziness, concentration and memory disturbances, mood changes, brain dysfunction due to liver damage, tingling or numbness in hands or feet
• vision disorders including: clouding of the eye lens (cataract), dry eye syndrome, small yellow deposits on the retina, yellowing of the whites of the eyes, retinal haemorrhage
• sensation of spinning (dizziness)
• rapid or irregular heartbeat (palpitations)
• shortness of breath, productive cough, catarrh, sore throat and discomfort when swallowing
• gastrointestinal disorders including: vomiting, abdominal pain, indigestion, constipation, bloating, taste disturbances, haemorrhoids, stomach pain or discomfort, blood vessel swelling and bleeding in the oesophagus, toothache
• liver problems including liver tumour, yellowing of the whites of the eyes or skin (jaundice)
• drug-induced liver damage (see above "Liver problems" in section 4)
• skin disorders including: rash, dry skin, skin eruptions, skin redness, itching
• excessive sweating, skin growths, hair loss
• joint pain, back pain, bone pain, limb pain (legs, arms, hands or feet), muscle cramps
• irritability, general malaise, skin reaction such as redness, swelling and pain at injection site, chest pain and discomfort, fluid accumulation in the body or limbs causing swelling
• depression, anxiety, sleep disorders, nervousness
• fever, headache

Common side effects detectable in blood tests:

• increased blood sugar (glucose) concentration, decreased white blood cell count, decreased neutrophil count, decreased blood albumin concentration, decreased haemoglobin concentration, increased blood bilirubin concentration (a substance produced by the liver), changes in enzymes controlling blood coagulation

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

• stomach flu (gastroenteritis), sore throat
• decreased number of red blood cells (anaemia) due to excessive destruction of red blood cells (haemolytic anaemia)
• confusion, agitation
• mouth blisters or ulcers, gastritis
• blood clots in the vein carrying blood to the liver (possible liver and (or) gastrointestinal damage), liver failure
• skin disorders including discolouration, peeling, redness, itching, skin lesions and night sweats
• abnormal blood clotting in small blood vessels with kidney failure, pain during urination
• rash, bruising at injection site, chest discomfort
• cardiac rhythm disorders (prolonged QT interval)

Reporting of adverse reactions
If any adverse reactions occur, including any unlisted side effects not mentioned in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C 02-222 Warsaw, Tel.: +48 22 49 21 301; fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Eltrombopag Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Eltrombopag Olpha contains
The active substance is eltrombopag olamine.
Eltrombopag Olpha 12.5 mg, film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg of eltrombopag.
Eltrombopag Olpha 25 mg, film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.
Eltrombopag Olpha 50 mg, film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag.
Eltrombopag Olpha 75 mg, film-coated tablets
Each film-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 carboxymethyl starch, magnesium stearate.
Tablet coating:
Eltrombopag Olpha 12.5 mg, film-coated tablets: hypromellose, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), triacetin.
Eltrombopag Olpha 25 mg, film-coated tablets: hypromellose, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), triacetin.
Eltrombopag Olpha 50 mg, film-coated tablets: hypromellose, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), triacetin.
Eltrombopag Olpha 75 mg, film-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, film-coated tablets
Orange to brown, round, biconvex film-coated tablets, embossed with the mark “I” on one side, approximately 5.5 mm in diameter.
Eltrombopag Olpha 25 mg, film-coated tablets
Dark pink, round, biconvex film-coated tablets, embossed with the mark “II” on one side, approximately 8 mm in diameter.
Eltrombopag Olpha 50 mg, film-coated tablets
Pink, round, biconvex film-coated tablets, embossed with the mark “III” on one side, approximately 10 mm in diameter.
Eltrombopag Olpha 75 mg, film-coated tablets
Red to brown, round, biconvex film-coated tablets, embossed with the mark “IV” on one side, approximately 12 mm in diameter.

Blisters made of OPA/Aluminium/PVC/Aluminium, packed in cardboard boxes containing 10, 14, 28, 30, or 84 film-coated tablets, and dose-divided blisters packed in cardboard boxes containing 10x1, 14x1, 28x1, 30x1 or 84x1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
The Netherlands

Synthon Hispania S.L.
c/ Castelló, 1
08830 Sant Boi de Llobregat
Barcelona
Spain