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 share it with others. It may harm them, 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. Important information 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 increase the number of platelets in your blood. Platelets are blood cells that help reduce the risk of bleeding or prevent it.

Eltrombopag Olpha is used to treat a blood clotting disorder called immune (primary) thrombocytopenia in patients over 1 year of age who have previously been treated with other medicines (corticosteroids or immunoglobulins) that were ineffective.

Immune thrombocytopenia is caused by a low number of platelets (thrombocytopenia). People with immune thrombocytopenia are at increased risk of bleeding. Symptoms that patients with immune thrombocytopenia may notice include petechiae (small, flat, red, pinpoint 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 hepatitis C virus (HCV) infection who have experienced difficulties due to side effects during interferon treatment. 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 (peginterferon and ribavirin).

2. 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 this medicine (listed in section 6 under the heading “What Eltrombopag Olpha contains”). Please consult your doctor if you think you may have 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/or advanced (chronic) liver disease are at increased risk of adverse reactions, including life-threatening liver damage and blood clots. If your doctor considers that the benefits of taking this medicine outweigh the risks, you will be closely monitored during treatment.
• if the patient is at 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 immobile for a prolonged period,
  • if the patient has malignant cancer,
  • if the patient is taking oral contraceptives or hormone replacement therapy,
  • if the patient has recently undergone surgery or experienced trauma,
  • if the patient is overweight,
  • if the patient smokes,
  • if the patient has advanced chronic liver disease.

Inform your doctor before starting treatment if any of the above conditions apply to you. Do not take Eltrombopag Olpha unless your doctor determines 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 Eltrombopag Olpha, your doctor will perform tests to rule out this condition. If the patient has MDS and takes this medicine, MDS may worsen.

Inform your doctor if any of the above situations apply to you.

Ophthalmological examination

Your treating doctor will recommend regular monitoring to detect cataracts. If the patient does not routinely undergo eye examinations, the doctor should arrange regular check-ups. Monitoring may also include detection of any retinal haemorrhages (in the light-sensitive layer at the back of the eye) or haemorrhages nearby.

Regular tests will be required

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

Blood tests to monitor 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 levels. If the patient is receiving interferon-based treatment concurrently with Eltrombopag Olpha for low platelet count associated with hepatitis C, certain liver conditions may worsen.

Before starting Eltrombopag Olpha and periodically during treatment, blood tests to assess 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 counts may decrease again within a few days. Platelet counts will be monitored, and your treating doctor will discuss appropriate precautions with you.

A very high platelet count may increase the risk of blood clots. However, blood clots may also occur even when platelet counts are normal or low. Your treating doctor will adjust the dose of Eltrombopag Olpha to prevent excessive increases 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,
• stomach (abdominal) 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 be indicated by abnormal blood test results. Your 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 concurrently with Eltrombopag Olpha, they will be monitored for signs of bleeding from the stomach or intestines after stopping this medicine.

Heart examinations

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

Elderly patients (aged 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.

Other medicines and Eltrombopag Olpha

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This 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:

• antacids used to treat indigestion, heartburn, or 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 transplant patients or in autoimmune diseases,
• 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” 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; others may require dose adjustments or appropriate timing of administration. Your 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, there is an increased risk of bleeding. Your doctor will discuss this with you.

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 dairy drinks, as the calcium in dairy products affects the absorption of the medicine. For further information, see “When to take Eltrombopag Olpha” in section 3.

Pregnancy and breastfeeding

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

• Inform your doctor if the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant.
• An appropriate method of contraception should be used during treatment with Eltrombopag Olpha to prevent pregnancy.
• Inform your 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 your doctor if the patient is breastfeeding or planning to breastfeed.

Driving and operating machinery

Eltrombopag Olpha may cause dizziness and other adverse effects that may impair 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. In case of 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 doctor experienced in treating the condition 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.
• In patients of East Asian/Southeast Asian origin, treatment should be initiated at the same 25 mg dose.

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 the patient does not consume any of the following foods:

• 4 hours before taking Eltrombopag Olpha

• and 2 hours after taking Eltrombopag Olpha:

• dairy products such as cheese, butter, yoghurt, ice cream,

• milk or milk-containing drinks, yoghurts 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 information regarding suitable 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 effects and appropriate treatment will be initiated promptly.

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 concerning the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Symptoms to be aware of: consult a doctor
In patients treated with eltrombopag for primary immune thrombocytopenia or low platelet count associated with hepatitis C, symptoms of severe adverse effects may occur. It is important to inform your doctor if any of these symptoms appear.

Increased risk of thrombosis
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 adverse effect and may occur in no more than 1 in 100 patients.
Seek immediate medical help if the patient experiences any of the following symptoms of thrombosis:

• swelling, pain, warmth, redness or tenderness in one leg
• sudden shortness of breath, especially with sharp chest pain or rapid breathing
• abdominal pain (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 no more than 1 in 10 patients. Other liver-related problems are uncommon and may affect no more than 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 urine

seek immediate medical advice.

Bleeding or bruising after stopping treatment
Usually, within two weeks of stopping Eltrombopag Olpha, the patient's platelet count decreases 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 the patient's platelet count for at least 4 weeks after stopping Eltrombopag Olpha.
Inform your doctor if bruising or bleeding occurs after stopping this medicine.
Some patients may experience gastrointestinal bleeding after discontinuing peginterferon, ribavirin and eltrombopag. Symptoms include:

• black, tarry stools (change in stool color is an uncommon adverse effect, which may affect no more than 1 in 100 patients)
• blood in stool
• vomiting blood or coffee-ground-like material

Inform your doctor immediately if any of these symptoms occur.

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

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

Very common adverse effects detectable in blood tests:

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

Common adverse effects (may affect no more than 1 in 10 patients):

• influenza, cold sores, pneumonia, irritation and inflammation (swelling) of sinuses, inflammation (swelling) and infection of tonsils, infection of lungs, sinuses, nose and throat, 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 the affected site (symptoms of deep vein thrombosis), localized swelling filled with blood from a 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 changes including excessive sweating, raised itchy rash, red spots, skin appearance changes, hair loss
• muscle pain, muscle cramps, muscle weakness, bone pain
• passing foamy urine with presence of air bubbles (symptoms of protein in urine)
• heavy menstrual bleeding
• high body temperature, feeling of warmth, chest pain, feeling of weakness

Common adverse effects detectable in blood tests:

• decreased number of red blood cells (anaemia), decreased number of platelets (thrombocytopenia), decreased number of white blood cells, decreased haemoglobin concentration, increased eosinophil count, increased number of white blood cells (leukocytosis)
• 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 concentration of certain proteins, increased creatinine concentration
• increased alkaline phosphatase activity

Uncommon adverse effects (may affect no more than 1 in 100 patients):

• skin infection
• cancer of rectum and colon
• 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, dilation or swelling of blood vessels causing headache
• eye disorders including excessive tearing, clouding of the eye lens (cataract), retinal haemorrhage, dry eyes
• rapid heartbeat, irregular heartbeat, bluish skin discoloration, heart rhythm disorders (QT interval prolongation), 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, especially combined with acute chest pain and (or) rapid breathing, which may indicate pulmonary embolism (see "Increased risk of thrombosis" above in section 4), loss of function of part of the lung due to blockage of the pulmonary artery, nose, throat and sinus disorders, sleep breathing disorders
• oral disorders including dryness or pain in the mouth, tongue pain, bleeding gums, oral discomfort, blisters or ulcers in mouth and throat; gastrointestinal disorders including frequent defecation, food poisoning
• presence of blood in stool, bloody vomiting, bleeding from rectum, change in stool color, abdominal distension, 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 injury
• skin changes including skin discoloration, 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
• feeling of warmth, restlessness, bleeding around catheter (if present) into the skin, redness or swelling at wound site, general malaise, sensation of foreign body
• sunburn

Uncommon adverse effects detectable in laboratory tests:

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

The following additional adverse effects have been reported in association with eltrombopag treatment in children (aged 1 to 17 years) with ITP:
If these adverse effects worsen, inform your doctor, pharmacist or nurse.

Very common adverse effects (may affect more than 1 in 10 children):

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

Common adverse effects (may affect no more than 1 in 10 children):

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

The following adverse effects have been reported in association with eltrombopag treatment in combination with peginterferon and ribavirin in patients with hepatitis C:
Very common adverse 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 adverse effects detectable in blood tests:

• decreased number of red blood cells (anaemia)

Common adverse effects (may affect no more than 1 in 10 patients):

• urinary tract infections, infection of nose, sinuses, throat and upper respiratory tract, common cold (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi, nasal passage inflammation, throat, oral cavity inflammation, flu-like symptoms, dry mouth, pain or inflammation of the oral cavity, toothache, influenza, cold sores
• weight loss
• sleep disturbances, abnormal drowsiness, depression, anxiety
• dizziness, concentration and memory problems, 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, cough with sputum, 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 injury (see above "Liver problems" in section 4)
• skin changes including: rash, dry skin, skin eruption, 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 disturbances, nervousness
• fever, headache

Common adverse effects detectable in blood tests:

• increased blood sugar (glucose) concentration, decreased number of white blood cells, decreased number of neutrophils, decreased blood albumin concentration, decreased haemoglobin concentration, increased blood bilirubin concentration (a substance produced by the liver), changes in enzymes controlling blood coagulation

Uncommon adverse effects (may affect no more than 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 bringing blood to the liver (possible liver and/or gastrointestinal damage), liver failure
• skin changes including discoloration, 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
• heart rhythm disorders (QT interval prolongation)

Reporting of adverse effects
If any adverse effects occur, including any unlisted symptoms not mentioned in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects 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 4921301; fax: +48 22 4921309; website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Eltrombopag Olpha

Keep this medicine out of 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This 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, engraved 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, engraved 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, engraved 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, engraved 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