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 as 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• 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) thrombocytopenic purpura (ITP) in patients over 1 year of age who have already been treated with other medicines (corticosteroids or immunoglobulins) that were ineffective.

Immune thrombocytopenic purpura is caused by a low number of platelets (thrombocytopenia). People with ITP are at increased risk of bleeding. Symptoms patients with ITP may notice include petechiae (small, flat, red, round spots under the skin), bruising, nosebleeds, bleeding gums, and difficulty stopping bleeding after cuts 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 difficulties with antiviral treatment due to side effects. Many people with chronic hepatitis C have low platelet counts, not only because of the disease itself but also due to side effects 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”). Please consult a doctor if the patient thinks they 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 advanced (chronic) liver disease are at increased risk of adverse reactions, 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 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 immobile 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.

Inform the doctor before starting treatment if any of the above conditions apply. Do not take Eltrombopag Olpha unless the doctor determines that the expected benefits outweigh the risk of blood clots.

• if the patient has cataracts (clouding of the eye 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.

Inform the doctor if any of the above situations apply to the patient.

Ophthalmological examination

The treating doctor will recommend regular eye examinations to detect cataracts. If the patient does not routinely undergo ophthalmological examinations, the doctor should prescribe regular checks. These may also include monitoring for any bleeding in or near the retina (the light-sensitive layer at the back of the eye).

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.

Liver function blood tests

Taking eltrombopag may lead to 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 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, the patient will undergo blood tests to assess liver function. 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 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 when platelet counts are normal or low. The 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 sharp chest pain or rapid breathing,
• 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 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 stomach or intestinal bleeding after stopping this medicine.

Heart examinations

The doctor may decide that heart monitoring is necessary 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 obtained without a prescription 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-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 should not be taken during treatment with Eltrombopag Olpha; for others, dose adjustments or changes in timing of administration may be required. The doctor will review all medicines the patient is taking and recommend changes to the treatment regimen if necessary.

If the patient is taking anticoagulant medicines to prevent blood clots, the risk of bleeding may be 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

Do not take Eltrombopag Olpha with dairy products or dairy-containing beverages, as the calcium in these 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 specifically advised by a doctor. 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, use an effective method of contraception to prevent pregnancy.
• Inform the doctor immediately 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 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 a 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 take Eltrombopag Olpha

This medicine should always be taken exactly as prescribed by your doctor. If you are in any doubt,
you should 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 remain under the care of a doctor experienced in treating the condition you have.

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 or 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 or Southeast Asian origin, treatment should be started 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 recommend adjusting the daily dose.

How to take the tablets

The tablets should be swallowed whole with water.

When to take the medicine

Make sure that

• within 4 hours before taking Eltrombopag Olpha
• and within 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 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.

You should consult your doctor for further information regarding suitable foods and drinks.

Taking more Eltrombopag Olpha than prescribed

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

If you miss a dose of Eltrombopag Olpha

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

Stopping Eltrombopag Olpha

Do not stop taking Eltrombopag Olpha without consulting your doctor. If your 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 you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Symptoms to be aware of: consult a doctor
In patients taking eltrombopag for the treatment of 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 occur.

Increased risk of thrombosis
Some patients may have an increased risk of thrombosis, and medicines such as Eltrombopag
Olpha may increase this risk. Sudden blockage of a blood vessel by a blood clot is an uncommon
adverse reaction and may occur in up to 1 in 100 patients.
Seek immediate medical help if the patient experiences any symptoms of thrombosis such as:

• 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 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
seen 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 colour is an uncommon adverse reaction, which may affect up to 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 reactions have been reported in association with eltrombopag treatment
in adult patients with primary immune thrombocytopenia:
Very common adverse reactions (may occur in 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 reactions detectable in blood tests:

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

Common adverse reactions (may occur in 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 in the affected area (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/wind,
• abnormal liver function,
• skin disorders 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 heat, chest pain, feeling of weakness.

Common adverse reactions 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 reactions (may occur in up to 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, tremor, 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 (prolongation of QT interval), which may be signs of 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 sharp chest pain and (or) rapid breathing, which may indicate pulmonary embolism (see "Increased risk of thrombosis" above in section 4), loss of function in part of the lung due to blockage of the pulmonary artery, nose, throat and sinus disorders, breathing disorders during sleep,
• oral disorders including dry or painful mouth, tongue pain, bleeding gums, oral discomfort, blisters or ulcers in mouth and throat, gastrointestinal disorders including frequent bowel movements, food poisoning,
• blood in stool, vomiting blood, rectal bleeding, change in stool colour, abdominal distension, constipation,
• yellowing of skin and (or) abdominal pain, which may indicate biliary obstruction, liver disease, liver damage due to inflammation (see "Liver problems" above in section 4), drug-induced liver damage,
• skin disorders 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 heat, restlessness, bleeding around catheter (if present) into the skin, redness or swelling at wound site, general malaise, sensation of foreign body,
• sunburn.

Uncommon adverse reactions 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 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 adverse reactions (may occur in 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 reactions (may occur in up to 1 in 10 children):

• difficulty falling asleep (insomnia),
• itchy nose, runny or blocked nose, sore throat, cold, nasal mucosal congestion and sneezing, nasal and throat pain,
• toothache, oral disorders including dry mouth, mouth pain, 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 adverse reactions (may occur in 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 reactions detectable in blood tests:

• decreased number of red blood cells (anaemia).

Common adverse reactions (may occur in up to 1 in 10 patients):

• urinary tract infections, infection of nose, sinuses, throat and upper respiratory tract, common cold (upper respiratory tract infection), inflammation of mucous lining of bronchi, nasal passage inflammation, throat, oral cavity inflammation, flu-like symptoms, dry mouth, pain or inflammation of oral cavity, toothache, influenza, cold sores,
• weight loss,
• sleep disturbances, abnormal drowsiness, depression, anxiety,
• dizziness, concentration and memory problems, mood changes, brain function disorder due to liver damage, tingling or numbness in hands or feet,
• vision disorders including: clouding of eye lens (cataract), dry eye syndrome, small yellow deposits on retina, yellowing of whites of eyes, retinal haemorrhage,
• sensation of spinning (dizziness),
• rapid or irregular heartbeat (palpitations),
• shortness of breath, cough with sputum, runny nose, sore throat and discomfort when swallowing,
• gastrointestinal disorders including: vomiting, abdominal pain, indigestion, constipation, abdominal bloating, taste disturbances, haemorrhoids, stomach pain or discomfort, blood vessel swelling and bleeding in oesophagus, toothache,
• liver problems including liver tumour, yellowing of whites of eyes or skin (jaundice),
• drug-induced liver damage (see above "Liver problems" in section 4),
• skin disorders including: rash, dry skin, skin eruption, 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 body or limbs causing swelling,
• depression, anxiety, sleep disturbances, nervousness,
• fever, headache.

Common adverse reactions 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 clotting.

Uncommon adverse reactions (may occur in 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,
• blisters or ulcers in mouth, stomach inflammation,
• blood clots in the vein bringing blood to the liver (possible liver and/or gastrointestinal damage), liver failure,
• skin disorders including colour changes, 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 (prolongation of QT interval).

Reporting of adverse reactions
If any adverse reactions occur, including any unmentioned side effects not listed 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 authorisation holder.
Reporting adverse reactions helps 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 after "EXP".
The expiry date refers to the last day of the stated month.
No special storage requirements.
Medicines must not be disposed of via the sewage system 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.

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), red iron oxide (E 172), yellow iron oxide (E 172), triacetin.
Eltrombopag Olpha 25 mg, film-coated tablets: hypromellose, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), triacetin.
Eltrombopag Olpha 50 mg, film-coated tablets: hypromellose, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), triacetin.
Eltrombopag Olpha 75 mg, film-coated tablets: hypromellose, titanium dioxide (E 171), red iron oxide (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, with the engraved 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, with the engraved mark “II” on one side, approximately 8 mm in diameter.
Eltrombopag Olpha 50 mg, film-coated tablets
Pink, round, biconvex film-coated tablets, with the engraved 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, with the engraved mark “IV” on one side, approximately 12 mm in diameter.

Blister packs 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