Eltrombopag Olpha

Package leaflet: Information for the patient

Eltrombopag Olpha 12.5 mg film-coated tablets, 25 mg film-coated tablets, 50 mg film-coated tablets, 75 mg film-coated tablets

Eltrombopag
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

• Eltrombopag Olpha is used to treat a blood clotting disorder called immune (primary) thrombocytopenia (ITP) in patients (over 1 year of age) who have previously taken other medicines (corticosteroids or immunoglobulins) that were not effective.

ITP is caused by a low number of platelets in the blood (thrombocytopenia). People with ITP have an increased risk of bleeding. Symptoms in patients with ITP may include petechiae (small flat red round spots on the skin), bruising, epistaxis (nosebleeds), bleeding gums, and difficulty controlling bleeding from cuts or injuries.

• Eltrombopag Olpha may also be used to treat low platelet counts ( thrombocytopenia ) in patients with hepatitis C virus (HCV) infection, if they have experienced problems due to adverse reactions while using interferon. Many people with hepatitis C have a low platelet count not only as a result of the disease itself but also due to some antiviral medicines used in its treatment. Taking Eltrombopag Olpha may make it easier for you to complete a full course of antiviral therapy (peginterferon and ribavirin).

2. What you need to know before taking Eltrombopag Olpha

Do not take Eltrombopag Olpha

• if you are allergic to eltrombopag or to any of the other ingredients of this medicine (listed in section 6 under 'What Eltrombopag Olpha contains').

Check with your doctor if you think this applies to you.
Warnings and precautions
Talk to your doctor before taking Eltrombopag Olpha:

• if you have liver problems. People who have a low platelet count and also advanced chronic (long-term) liver disease are at higher risk of experiencing side effects, including liver damage and life-threatening blood clots. If your doctor considers that the benefits of taking this medicine outweigh the risks, you will be closely monitored during treatment.
• if you are at risk of developing blood clots in your veins or arteries, or if you know that blood clots are common in your family. You may be at increased risk of developing blood clots:
• if you are elderly
• if you have had to stay in bed for a long time
• if you have a tumour
• if you are taking the contraceptive pill for birth control or hormone replacement therapy
• if you have recently had surgery or suffered physical trauma
• if you are very overweight (obese)
• if you are a smoker
• if you have advanced chronic liver disease If any of these apply to you, inform your doctor before starting treatment. You must not take Eltrombopag Olpha unless your doctor considers that the expected benefits outweigh the risks of blood clot formation.
• if you suffer from cataracts (clouding of the eye's lens)
• if you suffer from another blood disorder such as myelodysplastic syndrome (MDS). Your doctor will carry out tests to check that you do not have this blood disorder before you start taking Eltrombopag Olpha. If you have MDS and take this medicine, your MDS may worsen.

Inform your doctor if any of these apply to you.
Eye examination
Your doctor will recommend regular checks for cataracts. If you do not have routine eye examinations, your doctor will schedule regular eye exams. You may also be monitored for any bleeding in the retina or around the retina (the layer of light-sensitive cells at the back of the eye).
You will need regular tests
Before starting Eltrombopag Olpha, your doctor will perform blood tests to monitor your blood cells, including platelets. These tests will be repeated at intervals while you are taking the medicine.
Blood tests for liver function
Eltrombopag may alter blood test results that could indicate liver damage – an increase in certain liver enzymes, particularly bilirubin and alanine/aspartate transaminase. If you are receiving interferon-based treatments in combination with Eltrombopag Olpha for the treatment of low platelet count due to hepatitis C, some liver problems may worsen.
You will need blood tests to monitor liver function before starting Eltrombopag Olpha and during treatment. You may need to stop taking Eltrombopag Olpha if levels of these enzymes rise too much, or if physical signs of liver damage appear.
Read the information on ‘Liver problems’ in section 4 of this Patient Information Leaflet
Blood tests for platelet count
If you stop taking Eltrombopag Olpha, your platelet count is likely to decrease again within a few days. Your platelet count will be monitored and your doctor will discuss appropriate precautions with you.
A very high platelet count may increase the risk of blood clots. However, blood clots can also form when platelet count is normal or even low. Your doctor will adjust the dose of Eltrombopag Olpha to ensure that your platelet count does not increase too much.
Seek immediate medical help if you experience any of the following signs indicating a blood clot:

• swelling, pain or tenderness in one leg
• sudden onset of breathlessness, especially together with sharp chest pain or rapid breathing
• abdominal (stomach) pain, abdominal swelling, blood in the stools

Tests to monitor bone marrow
In people who may have bone marrow problems, medicines such as Eltrombopag Olpha could worsen these problems. Signs of bone marrow abnormalities may appear as abnormal results in blood tests. Your doctor may perform tests to directly monitor your bone marrow during treatment with Eltrombopag Olpha.
Tests for gastrointestinal bleeding
If you are treated with interferon-containing medicines in combination with Eltrombopag Olpha, you will be monitored for any signs of bleeding in your stomach or intestines after stopping this medicine.
Heart monitoring
Your doctor may consider it necessary to monitor your heart during treatment with Eltrombopag Olpha and may perform an electrocardiogram (ECG).
Elderly patients (65 years and over)
There is limited data on the use of eltrombopag in patients aged 65 years and over. Exercise caution when taking Eltrombopag Olpha if you are aged 65 years or older.
Children and adolescents
Eltrombopag is not recommended in children under 1 year of age with ITP. It is also not recommended in people under 18 years of age with low platelet count due to hepatitis C or severe aplastic anaemia.
Other medicines and Eltrombopag Olpha
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines used without a prescription and vitamins.
Some common medicines interact with eltrombopag – including prescription and over-the-counter medicines and minerals. These include:

• antacid medicines used to treat indigestion, heartburn or stomach ulcers (see also ‘When to take it’ in section 3)
• medicines called statins, used to lower cholesterol
• some medicines used to treat HIV infection, such as lopinavir and/or ritonavir
• ciclosporin, used in transplants and immune disorders
• minerals such as iron, calcium, magnesium, aluminium, selenium and zinc, which may be found in vitamin and mineral supplements (see also “When to take it” in section 3)
• medicines such as methotrexate and topotecan, used to treat cancer

Inform your doctor if you are taking any of these medicines. Some of them cannot be taken with Eltrombopag Olpha, or you may need to have your dose adjusted, or the timing of administration may need to be changed. Your doctor will review all the medicines you are taking and, if necessary, suggest appropriate substitutions.
There is an increased risk of bleeding if you are also taking medicines to prevent blood clots. Your doctor will discuss this with you.
If you are taking corticosteroids, danazol and/or azathioprine, you may need to take a lower dose or stop taking them while on Eltrombopag Olpha.
Eltrombopag Olpha with food and drink
Do not take Eltrombopag Olpha with beverages or products made from milk and cheese, as the calcium in dairy products affects the absorption of the medicine. For further information, see ‘When to take it’ in section 3.
Pregnancy and breastfeeding
Do not use Eltrombopag Olpha during pregnancy unless specifically recommended by your doctor. The effect of eltrombopag during pregnancy is not known.

• Inform your doctor if you are pregnant, think you may be pregnant, or are planning a pregnancy.
• Use a reliable method of contraception while taking Eltrombopag Olpha to prevent pregnancy.
• If you become pregnant while being treated with Eltrombopag Olpha, inform your doctor.

Do not breastfeed while taking Eltrombopag Olpha. It is not known whether eltrombopag passes into breast milk.
If you are breastfeeding or planning to breastfeed, inform your doctor.
Driving and using machines
Eltrombopag Olpha may cause dizziness and other side effects that may reduce your attention. Do not drive or operate machinery unless you are sure you are not affected.
Eltrombopag Olpha contains isomalt and sodium
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially ‘sodium-free’.

3. How to take Eltrombopag Olpha

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag Olpha unless your doctor or pharmacist advises you to do so. While taking Eltrombopag Olpha, you will be under the care of a doctor experienced in treating your condition.

How much to take

For ITP
Adults and children (6 to 17 years of age): The recommended starting dose for ITP is one 50 mg tablet of Eltrombopag Olpha daily. If you are of East or Southeast Asian origin, you may need to start with a lower dose of 25 mg.
Children (1 to 5 years of age): The recommended starting dose for ITP is one 25 mg tablet of Eltrombopag Olpha daily.

For Hepatitis C
Adults: The recommended starting dose for hepatitis C is one 25 mg tablet of Eltrombopag Olpha daily. If you are of East or Southeast Asian origin, you will start with the same dose of 25 mg.

Eltrombopag Olpha may take 1 to 2 weeks to work. Based on your response to Eltrombopag Olpha, your doctor may recommend adjusting the daily dose.

How to take the tablets
Swallow the tablet whole with some water.

When to take it
Make sure that

• in the 4 hours before taking Eltrombopag Olpha
• and in the 2 hours after taking Eltrombopag Olpha

you do not consume any of the following:

• foods such as cheese, butter, yoghurt, or ice cream
• milk or milk-based shakes, milk-containing drinks, yoghurt, or cream
• antacids, a type of medicine used for indigestion and heartburn
• certain vitamin and mineral supplements including iron, calcium, magnesium, aluminium, selenium, and zinc.

If you do, the medicine will not be properly absorbed into your body.

For further advice on suitable foods and drinks, consult your doctor.

If you take more Eltrombopag Olpha than you should
Contact your doctor or pharmacist immediately. If possible, show them the pack or this leaflet. You will be monitored for any signs or symptoms of adverse effects and treated appropriately without delay.

If you forget to take Eltrombopag Olpha
Take the next dose at your usual time. Do not take more than one dose of Eltrombopag Olpha in a day.

If you stop taking Eltrombopag Olpha
Do not stop taking Eltrombopag Olpha without talking to your doctor. If your doctor advises you to stop treatment, your platelet count will be monitored weekly for four weeks.
See also ‘Bleeding or bruising after stopping treatment’ in section 4.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Symptoms requiring attention: consult a doctor
People who take eltrombopag for ITP or low platelet count due to hepatitis C may develop signs of potentially serious side effects. It is important to inform your doctor if you experience any of these symptoms.
Increased risk of blood clots
Some people may have an increased risk of blood clots, and medicines such as Eltrombopag Olpha could worsen this problem. Sudden blockage of a blood vessel by a blood clot is an uncommon side effect and may affect up to 1 in 100 people.
Seek immediate medical help if you experience signs and symptoms of a blood clot, such as:

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

Liver problems
Eltrombopag Olpha may cause changes detectable in blood tests that could indicate liver damage. Liver problems (increased liver enzymes detected in blood tests) are common and may affect up to 1 in 10 people. Other liver problems are uncommon and may affect up to 1 in 100 people.
If you experience any of the following signs of liver problems:

• yellowing of the skin or whites of the eyes (jaundice)
• unusually dark-coloured urine

Inform your doctor immediately.

Bleeding or bruising after stopping treatment
Within two weeks after stopping Eltrombopag Olpha, platelet counts usually decrease to the level they were before starting treatment. A lower platelet count may increase the risk of bleeding or bruising. Your doctor will monitor your platelet count for at least 4 weeks after you stop taking this medicine.
Inform your doctor if you experience bleeding or bruising after stopping Eltrombopag Olpha.
Some people have gastrointestinal bleeding after stopping treatment with

• dark stools, change in stool colour is an uncommon side effect which may affect up to 1 in 100 people
• blood in the stools
• vomiting blood or material resembling coffee grounds

Inform your doctor immediately if you experience any of these symptoms.

The following side effects have been reported in association with eltrombopag treatment in
adults with ITP:
Very common side effects (may affect more than 1 in 10 people):

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

Very common side effects detectable by blood tests:

• increased liver enzymes (alanine aminotransferase, ALT)

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

• influenza, herpes labialis, pneumonia, irritation and inflammation (swelling) of the sinuses, inflammation (swelling) and infection of the tonsils, infections of the lungs, sinuses, nose and throat, inflammation of the gum tissue, sore throat and pain on swallowing
• loss of appetite
• sleep problems, depression
• decreased skin sensitivity, tingling, pricking or numbness sensation, commonly known as "pins and needles", drowsiness, headache
• eye problems including abnormalities in eye tests, dry eye, eye pain and blurred vision
• earache, sensation of spinning (dizziness)
• pain, swelling and tenderness in one of the legs (usually calf) with warm skin in the affected area (signs of a blood clot in a deep vein), hot flushes
• runny nose
• mouth problems including dry mouth, sore mouth, sensitive tongue, bleeding gums, mouth ulcers, toothache, vomiting, abdominal pain, gas due to digestion
• abnormalities in liver function
• skin changes including excessive sweating, irregular itchy rash, red spots, changes in skin appearance, hair loss
• muscle pain, muscle spasms, muscle weakness, bone pain
• foamy, frothy or fizzy-looking urine (signs of protein in the urine)
• heavy menstrual period
• high temperature, feeling of warmth, chest pain, feeling of weakness

Common side effects detectable by blood tests:

• decrease in red blood cell count (anaemia), decrease in platelet count (thrombocytopenia)
• decrease in white blood cell count, decrease in haemoglobin level, increase in eosinophils, increase in white blood cell count (leucocytosis)
• increased uric acid levels, decreased potassium levels
• increased liver enzymes (aspartate aminotransferase, AST), increased blood bilirubin (a substance produced by the liver)
• increased levels of certain proteins, increased creatinine levels
• increased alkaline phosphatase levels

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

• 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 problems, language and nervous system problems, tremor, paralysis on one side of the body, migraine with aura, nerve damage, dilation or swelling of blood vessels causing headache
• eye problems including increased tear production, clouding of the eye's lens (cataract), retinal bleeding, dry eye
• increased heart rate, irregular heartbeat, bluish skin colouration, heart and blood vessel rhythm disorders (QT prolongation) which could be signs of heart problems, sudden interruption of blood flow to part of the heart
• possible pain, swelling and/or redness around a vein which could be signs of blood clot formation in a vein, blood clot, redness
• sudden breathing failure, especially if accompanied by sharp chest pain and/or rapid breathing, which may be a sign of a blood clot in the lungs (see 'Increased risk of blood clots' at the beginning of section 4), loss of function in part of the lung due to blockage of the pulmonary artery, problems with nose, throat and sinuses, breathing problems during sleep
• mouth problems including dry mouth, sore mouth, painful tongue, bleeding gums, mouth discomfort, mouth and throat blisters/ulcers, digestive system problems including frequent bowel movements, food poisoning, blood in stools, vomiting blood, rectal bleeding, change in stool colour, abdominal swelling, constipation
• yellowing of the skin and/or abdominal pain which could be signs of bile duct obstruction, liver injury, liver damage due to inflammation (see 'Liver problems' at the beginning of section 4), drug-induced liver damage
• painful or abnormal skin sensations, skin changes including skin discolouration, peeling, redness, itching and sweating, cold sweats
• muscle weakness
• kidney problems including kidney inflammation, excessive urination at night, kidney failure, white blood cells in urine
• feeling hot, anxiety, bleeding around a catheter (if present) in the skin, redness or swelling around a wound, general feeling of discomfort, sensation of foreign body
• sunburn

Uncommon side effects detectable by laboratory tests:

• changes in red blood cell shape, decrease in red blood cell count (anaemia) caused by excessive destruction of red blood cells (haemolytic anaemia), increased myelocytes, increased band neutrophils, presence of immature white blood cells which may indicate certain diseases, increased platelet count, increased haemoglobin level

• decreased calcium levels

• increased blood urea, increased protein levels in urine

• increased albumin levels in blood, increased total protein levels, decreased albumin levels in blood, increased urine pH

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

• infection of the nose, sinuses, throat and upper airways, common cold (upper respiratory tract infection)
• cough
• feeling unwell (nausea), diarrhoea, abdominal pain
• high temperature

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

• difficulty sleeping (insomnia)
• itchy nose, runny or blocked nose, sore throat, runny nose, nasal congestion and sneezing, pain in nose and throat
• toothache, mouth problems including dry mouth, sore mouth, sensitive tongue, bleeding gums, mouth ulcers

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

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

Very common side effects detectable by blood tests:

• decrease in red blood cell count (anaemia)

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

• urinary tract infections, infection of the nose, sinuses, throat and upper airways, common cold (upper respiratory tract infection), inflammation of the mucous lining of the bronchi, nasal, throat and mouth inflammation, flu-like symptoms, dry mouth, sore or inflamed mouth, toothache, influenza, herpes labialis
• weight loss
• sleep disorders, abnormal drowsiness, depression, anxiety
• dizziness, problems with concentration and memory, mood changes, decreased brain function due to liver damage, tingling or numbness in hands or feet
• eye problems including clouding of the eye's lens (cataract), dry eye, small yellow deposits in the retina, yellowing of the whites of the eyes, retinal bleeding
• sensation of spinning (dizziness)
• fast or irregular heartbeat (palpitations)
• shortness of breath, productive cough, runny nose, influenza, sore throat and swallowing discomfort
• digestive system problems including vomiting, stomach ache, indigestion, constipation, abdominal bloating, taste disturbances, haemorrhoids, stomach pain/discomfort, dilated blood vessels 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 'Liver problems' at the beginning of section 4)
• skin changes including rash, dry skin, eczema, skin redness, itching, excessive sweating, unusual skin growths, hair loss
• joint pain, back pain, bone pain, limb pain (in arms, legs, hands or feet), muscle spasms
• irritability, general feeling of discomfort, 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 by blood tests:

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

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

• stomach flu (gastroenteritis), sore throat
• decrease in red blood cell count (anaemia) caused by excessive destruction of red blood cells (haemolytic anaemia)
• confusion, agitation
• mouth blisters/ulcers, stomach inflammation
• blood clots in a liver vein (possible liver and/or digestive system damage), liver failure
• skin changes including colour changes, peeling, redness, itching, lesions and night sweats
• abnormal blood clotting in small blood vessels with kidney failure, pain during urination
• rash, bruising at injection site, chest discomfort
• heart rhythm disorders (QT interval prolongation)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help 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 blister and carton after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Eltrombopag Olpha contains
The active substance in Eltrombopag Olpha is eltrombopag olamine.
12.5 mg film-coated tablets
25 mg film-coated tablets
50 mg film-coated tablets
75 mg film-coated tablets
The other ingredients are: microcrystalline cellulose, mannitol, povidone, isomalt (E 953), calcium silicate, sodium starch glycolate, magnesium stearate (tablet core); hypromellose, titanium dioxide (E 171), red iron oxide (E 172), triacetin (tablet coating).
Eltrombopag Olpha 12.5 mg, 25 mg and 50 mg film-coated tablets also contain yellow iron oxide (E 172).

Description of the appearance of Eltrombopag Olpha and contents of the pack
Eltrombopag Olpha 12.5 mg film-coated tablets are orange to brown in colour, round, biconvex, with "I" engraved on one side and approximately 5.5 mm in diameter.
Eltrombopag Olpha 25 mg film-coated tablets are dark pink in colour, round, biconvex, with "II" engraved on one side and approximately 8 mm in diameter.
Eltrombopag Olpha 50 mg film-coated tablets are pink in colour, round, biconvex, with "III" engraved on one side and approximately 10 mm in diameter.
Eltrombopag Olpha 75 mg film-coated tablets are red to brown in colour, round, biconvex, with "IV" engraved on one side and approximately 12 mm in diameter.
Eltrombopag Olpha 12.5 mg, 25 mg, 50 mg and 75 mg is available in blisters in cartons containing 10, 14, 28, 30 or 84 film-coated tablets, or in unit dose blisters in cartons containing 10x1, 14x1, 28x1, 30x1 or 84x1 film-coated tablet(s).
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

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

This medicinal product is authorised in the European Economic Area Member States under the following names:
Czech Republic, Estonia: Eltrombopag Olpha
Italy, Poland: Eltrombopag Olpha
France: Eltrombopag Olpha 12.5 mg, 25 mg, 50 mg, 75 mg comprimés pelliculés
Latvia: Eltrombopag Olpha 12.5 mg, 25 mg, 50 mg, 75 mg apvalkotās tabletes
Lithuania: Eltrombopag Olpha 12.5 mg, 25 mg, 50 mg, 75 mg plėvele dengtos tabletės
The Netherlands: Eltrombopag Olpha 12.5 mg, 25 mg, 50 mg, 75 mg filmomhulde tabletten
Slovakia: Eltrombopag Olpha 12.5 mg, 25 mg, 50 mg, 75 mg filmom obalené tablety
Spain: Eltrombopag Olpha 12.5 mg, 25 mg, 50 mg, 75 mg comprimidos recubiertos con película EFG
Germany: Eltrombopag Olpha 12.5 mg, 25 mg, 50 mg, 75 mg Filmtabletten