ELTROMBOPAG OLPHA 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Eltrombopag Olpha 12.5 mg film-coated tablets EFG

Eltrombopag Olpha 25 mg film-coated tablets EFG

Eltrombopag Olpha 50 mg film-coated tablets EFG

Eltrombopag Olpha 75 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

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

ITP is caused by a low platelet count (thrombocytopenia). People with ITP have a higher risk of bleeding. Symptoms that patients with ITP may notice are petechiae (small, round, flat red spots under the skin), bruises, nosebleeds, bleeding gums, and inability to control bleeding if they cut or injure themselves.

Eltrombopag may also be used to treat low platelet counts (thrombocytopenia) in adults with hepatitis C virus (HCV) infection, in case they have had problems with the side effects of interferon treatment. Many people with hepatitis C have low platelet counts, not only due to the disease but also due to the antiviral treatments used to treat it. Taking Eltrombopag may help you complete the cycle with antivirals (peginterferon and ribavirin).

2. What you need to know before you take Eltrombopag Olpha

Do not take Eltrombopag Olpha

• if you are allergic to eltrombopag or any of the other ingredients of this medicine

(listed in section 6 under the heading “Composition of Eltrombopag Olpha”).

Consult your doctor if you think this may affect you.

Warnings and precautions

Consult your doctor before starting to take Eltrombopag:

• if you have liver problems. People who have a low platelet count, as well as advanced chronic liver disease, are at higher risk of side effects, liver damage that can be fatal, and blood clots. If your doctor considers that the benefit of taking this medicine outweighs the risks, they will closely monitor you during treatment.
• if you are at risk of having a blood clot in your veins or arteries, or if you know that the occurrence of clots is common in your family.

The risk of having a blood clot may be higher in the following circumstances:

• if you are elderly
• if you have been bedridden for a long time
• if you have cancer
• if you are taking the contraceptive pill or hormone replacement therapy
• if you have recently undergone surgery or have suffered physical trauma
• if you are severely overweight (obese)
• if you are a smoker
• if you have advanced chronic liver disease.

If you are in any of these situations, inform your doctor before starting treatment. You should not take eltrombopag unless your doctor considers that the expected benefit outweighs the risk of having clots.

• if you have cataracts (the lens of the eye becomes cloudy).
• if you have another blood disorder, such as myelodysplastic syndrome (MDS). Before starting to take eltrombopag, your doctor will perform tests to check that you do not have this disease. If you have MDS and take this medicine, MDS may worsen.

Tell your doctor if you are in any of these situations.

Eye exams

Your doctor will recommend that you have an eye exam to check for cataracts. If you do not have regular eye exams, your doctor will ask you to have them. They should also examine your retina (the light-sensitive layer at the back of the eye) to see if there is bleeding in the retina or around it.

You will need to have regular blood tests

Before you start taking eltrombopag, your doctor will perform a blood test to check your blood cells, including platelets. These tests will be repeated frequently while you are taking the medicine.

Blood tests to check liver function

Eltrombopag may cause changes in your blood test results that indicate liver damage - an increase in some liver enzymes, especially bilirubin and alanine/aspartate transaminase. If you are taking interferon, basic treatment along with eltrombopag to treat low platelet counts due to hepatitis C, some liver problems may worsen.

You will have blood tests before starting to take eltrombopag and frequently while taking it to check your liver function. It may be necessary to interrupt treatment with eltrombopag if the levels of these markers increase too much or if you have any other sign of liver damage.

Read the information “Liver problems” in section 4 of this leaflet.

Blood tests for platelet count

If you stop taking eltrombopag, it is likely that, within a few days, you will again have low platelet counts (thrombocytopenia). Your platelet counts will be monitored and your doctor will tell you what precautions to take.

Very high platelet counts may increase the risk of blood clots. However, clots can also form with normal or even low platelet counts. Your doctor will adjust the dose of eltrombopag to ensure that your platelet count does not become too high.

Seek medical help immediately if you have any of these signs of a blood clot:

• swelling, pain, or tenderness in one leg
• sudden difficulty breathing, exceptionally accompanied by sharp chest pain or rapid breathing
• abdominal pain (stomach), enlarged abdomen, blood in the stool.

Tests to examine your bone marrow

In people with bone marrow disorders, medicines like eltrombopag may worsen the disorders. Signs of changes in the bone marrow may appear as abnormal results in your blood tests. Your doctor may also perform tests to directly check your bone marrow during treatment with eltrombopag.

Review of gastrointestinal bleeding

If you are taking interferon, basic treatment along with eltrombopag, you will be monitored for any signs of bleeding in your stomach or intestine after you stop taking this medicine.

Heart monitoring

Your doctor may consider monitoring your heart while you are taking eltrombopag using an electrocardiogram (ECG) if necessary.

Elderly people (65 years and over)

There is limited data on the use of eltrombopag in patients 65 years of age or older. If you are 65 or older, you should be cautious when using eltrombopag.

Children and adolescents

Eltrombopag is not recommended for use in children under 1 year of age with ITP. It is also not recommended in children under 18 years of age with low platelet counts due to hepatitis C.

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 obtained without a prescription and vitamins.

Some commonly used medicines may interact with eltrombopag (including prescription medicines, non-prescription medicines, and minerals). These include:

• antacids for indigestion, heartburn, or stomach ulcers (see also section 3 “When to take it”).
• statins to lower cholesterol
• certain medicines to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine, used in transplants or immune system diseases
• minerals such as iron, calcium, magnesium, aluminum, selenium, and zinc, which may be present in vitamin and mineral supplements (see also section 3 “When to take it”).
• medicines such as methotrexate and topotecan, used to treat cancer.

Consult your doctor if you are taking any of these medicines. Some should not be taken with eltrombopag; it may be necessary to adjust the dose or change the times when you take them. Your doctor will review the medicines you are taking and recommend alternatives if necessary.

If you are also taking medicines to prevent blood clots, there is a higher risk of bleeding. Your doctor will discuss this with you.

If you are taking corticosteroids, danazol, and/or azathioprine along with eltrombopag, it may be necessary to reduce the dose or interrupt treatment with these medicines.

Taking Eltrombopag Olpha with food and drinks

Do not take eltrombopag with food or dairy products, as the calcium in dairy products affects the absorption of the medicine. For more information, see section 3, “When to take it”.

Pregnancy and breastfeeding

Do not take eltrombopag if you are pregnant unless your doctor specifically recommends it. The effect of eltrombopag during pregnancy is not known.

• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
• Use a reliable contraceptive method to prevent pregnancy while taking eltrombopag.
• If you become pregnant during treatment with eltrombopag, inform your doctor.

Do not breastfeed while taking eltrombopag. It is not known whether eltrombopag passes into breast milk.

If you are breastfeeding or plan to breastfeed, inform your doctor.

Driving and using machines

Eltrombopag may cause dizziness and have other side effects that may make you less alert.

Do not drive or use machines unless you are sure that eltrombopag does not affect you.

Eltrombopag Olpha contains isomalt and sodium

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Eltrombopag Olpha

Follow exactly the instructions for administration of this medicine given by your doctor. In case of doubt, ask your doctor or pharmacist. Do not change the dose or treatment schedule with eltrombopag unless your doctor or pharmacist advises you to do so. While taking eltrombopag, you will be under the supervision of a specialist doctor with experience in treating your disease.

How much to take

For ITP

Adults and children (6 to 17 years) - the usual initial dose for ITP is one 50 mg eltrombopag tablet per day.

If you are of East or Southeast Asian descent, you may need to start treatment with a lower dose of 25 mg.

Children (1 to 5 years) - the usual initial dose for ITP is one 25 mg eltrombopag tablet per day.

For Hepatitis C

Adults - the usual initial dose for hepatitis C is one 25 mg eltrombopag tablet per day. If you are of East or Southeast Asian descent, start treatment with the same dose of 25 mg.

Eltrombopag may take 1 to 2 weeks to take effect. Depending on your response to eltrombopag, your doctor may recommend changing your daily dose.

How to take the tablets

Swallow the tablet whole, with water

When to take it

Make sure that

• in the 4 hours before taking eltrombopag
• and in the 2 hours after taking eltrombopag

you do not consume any of the following:

• dairy products such as cheese, butter, yogurt, or ice cream
• milk or milkshakes, milk-based drinks, yogurt, or cream
• antacids, a type of medicine for indigestion and heartburn
• certain vitamin and mineral supplements, including iron, calcium, magnesium, aluminum, selenium, and zinc.

If you do, your body will not absorb the medicine properly.

For more information on which foods and drinks are suitable, consult your doctor.

If you take more Eltrombopag Olpha than you should

Consult your doctor or pharmacist immediately. If possible, show them the pack or this leaflet. You will be monitored for signs or symptoms of side effects and given the appropriate treatment immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20.

If you forget to take Eltrombopag Olpha

Take the next dose at the usual time. Do not take more than one dose of eltrombopag in a day.

If you stop taking Eltrombopag Olpha

Do not stop taking eltrombopag without first consulting your doctor. If your doctor advises you to stop treatment, your platelet counts will be monitored every week for four weeks. See also “Bleeding or bruising after stopping treatment” in section 4.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Symptoms to which you need to pay attention: consult your doctor

People taking eltrombopag for both ITP and low platelet counts associated with hepatitis C may exhibit signs related to potential serious adverse effects.

It is essential that you inform your doctor if you develop symptoms.

Increased risk of thrombosis

Some people may have an increased risk of having a thrombus, and medications like eltrombopag may worsen this problem. The sudden blockage of a blood vessel by a thrombus is a rare adverse effect that can affect up to 1 in 100 people.

Seek immediate medical attention if you experience signs or symptoms of a thrombus, such as:

• swelling, pain, heat, redness, or sensitivity in one leg
• sudden difficulty breathing, exceptionally accompanied by acute chest pain or agitated breathing.
• abdominal pain (stomach), enlarged abdomen, blood in your stool.

Liver problems

Eltrombopag may cause changes that appear in blood tests, which can be signs of liver damage. Liver problems (elevated liver enzymes in blood tests) are frequent and can affect up to 1 in 10 people. Other liver problems are rare and can affect up to 1 in 100 people.

If you have any signs of liver problems:

• yellowish color in the skin or the white area of the eyes (jaundice)
• unusually dark-colored urine

contact your doctor immediately.

Bleeding or bruising after treatment interruption

Two weeks after interrupting treatment with eltrombopag, your platelet levels will normally drop to levels similar to those before starting eltrombopag. A decrease in platelet levels can increase the risk of bleeding or bruising. Your doctor will check your platelet levels for at least 4 weeks after interrupting treatment with eltrombopag.

Contact your doctor if you experience bleeding or bruising when stopping eltrombopag.

Some people have bleeding in the digestive system after stopping peginterferon, ribavirin, and eltrombopag. Symptoms include:

• black, tar-like stools (stool discoloration is a rare adverse effect that can affect up to 1 in 100 people).
• blood in the stool
• vomiting blood or something that looks like coffee grounds

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

The following adverse effects have been reported in relation to treatment with eltrombopag in adult patients with ITP

Adverse effects very common(may affect more than 1 in 10 people)

• nose, sinus, throat, and upper respiratory tract infection (upper respiratory tract infection)
• cough, common cold
• feeling unwell (nausea), diarrhea
• back pain

Adverse effects very commonthat may appear in blood tests:

• increase in liver enzymes (alanine aminotransferase (ALT))

Adverse effects common(may affect up to 1 in 10 people)

• flu, herpes labialis, pneumonia, irritation and inflammation (swelling) of the paranasal sinuses, inflammation (swelling) and infection in the tonsils, lung infection, paranasal sinuses, nose, and throat infection, gum tissue inflammation, sore throat, and swallowing difficulties
• loss of appetite
• sleeping problems, depression
• decreased skin sensitivity, tingling, itching, or numbness, commonly called "tingling", drowsiness, migraine
• eye problems including abnormal eye tests, dry eye, eye pain, and blurred vision, decreased vision
• ear pain, feeling of spinning (vertigo)
• pain, swelling, and sensitivity in one leg (usually the calf) with hot skin in the affected area (signs of a blood clot in a deep vein), localized swelling filled with blood due to a ruptured blood vessel (hematoma), hot flashes
• runny nose
• mouth alterations including dryness, mouth pain, tongue sensitivity, bleeding gums, mouth ulcers, toothache, vomiting, abdominal pain, flatulence/digestive gases
• abnormal liver function
• skin changes, including excessive sweating, itching, rash with bumps, red spots, changes in skin appearance, hair loss
• muscle pain, muscle spasm, muscle weakness, bone pain
• foamy or bubbly urine (signs of protein in the urine)
• heavy menstruation
• high temperature, feeling of heat, chest pain, feeling of weakness

Adverse effects commonthat may appear in blood tests:

• decrease in red blood cell count (anemia), decrease in platelet count (thrombocytopenia),
• decrease in white blood cell count, decrease in hemoglobin levels, increase in eosinophil count, increase in white blood cell count (leukocytosis)
• increase in uric acid levels, decrease in potassium levels
• increase in liver enzymes (aspartate aminotransferase (AST)), increase in blood bilirubin (a substance produced by the liver)
• increase in some protein levels, increase in creatinine levels
• increase in alkaline phosphatase levels

Adverse effects uncommon(may affect up to 1 in 100 people)

• skin infection
• rectal and colon cancer
• allergic reaction
• loss of appetite, joint pain and swelling due to uric acid (gout)
• lack of interest, mood changes, uncontrolled or unexpected crying
• balance problems, speech and nervous system alterations, tremors, paralysis on one side of the body, migraine with aura, nerve pain, dilation or swelling of blood vessels causing headache
• eye problems, including increased tearing, cataracts, retinal hemorrhage, dry eye
• rapid or irregular heartbeat, blue discoloration of the skin, cardiac rhythm alterations (QT interval prolongation) that could be signs of a heart and blood vessel disorder, interruption of blood supply to a part of the heart
• possible pain, swelling, and/or redness around a vein that could be signs of a blood clot in a vein, blood clot, redness
• sudden shortness of breath, especially when accompanied by acute chest pain and/or rapid breathing, which could be signs of a blood clot in the lungs (see 'Increased risk of thrombosis' earlier in section 4), loss of function of a part of the lung caused by a blockage in the pulmonary artery, problems with the nose, throat, and paranasal sinuses, respiratory problems while sleeping
• mouth problems, including dry or painful mouth, tongue pain, gum bleeding, mouth discomfort, blisters/sores in the mouth and throat, digestive system problems including frequent bowel movements, food poisoning, blood in the stool, vomiting blood, rectal bleeding, change in stool color, abdominal swelling, constipation
• yellowish skin and/or abdominal pain that could be signs of a bile duct obstruction, liver injury, liver damage due to inflammation (see 'Liver problems' earlier in section 4), liver damage due to medication
• pain or abnormal sensations in the skin, skin changes, including skin discoloration, peeling, redness, itching, and sweating, cold sweat
• muscle weakness
• kidney problems, including kidney inflammation, excessive nighttime urination, kidney failure, white blood cells in the urine
• feeling of heat, feeling of anxiety, bleeding around a catheter (if you have one) in the skin, redness or inflammation around a wound, general discomfort, feeling of a foreign body
• burns

Adverse effects uncommonthat may appear in blood tests:

• changes in the shape of red blood cells, decrease in red blood cell count (anemia) caused by excessive destruction of red blood cells (hemolytic anemia), increase in myelocyte count, increase in neutrophil band, presence of developing white blood cells that may be indicative of certain diseases, increase in platelet count, increase in hemoglobin level
• decrease in calcium levels
• increase in blood urea, increase in protein levels in the urine
• increase in blood albumin levels, increase in total protein levels, decrease in blood albumin levels, increase in urine pH

The following adverse effects have been reported in relation to treatment with eltrombopag in children (1 to 17 years old) with ITP:

If these adverse effects worsen, inform your doctor, pharmacist, or nurse.

Adverse effects very common(may affect more than 1 in 10 children)

• nose, sinus, throat, and upper respiratory tract infection, common cold (upper respiratory tract infection)
• cough
• feeling unwell (nausea), diarrhea, abdominal pain
• high temperature

Adverse effects common(may affect up to 1 in 10 children)

• difficulty sleeping (insomnia)
• itching, nasal discharge, or congestion, sore throat, nasal discharge, congestion, and sneezing, throat and nasal pain
• toothache, mouth alterations including dryness, mouth irritation, tongue sensitivity, gum bleeding, mouth ulcers

The following adverse effects have been reported in relation to treatment with Eltrombopag in combination with peginterferon and ribavirin in patients with HCV

Adverse effects very common(may affect more than 1 in 10 people)

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

Adverse effects very commonthat may appear in blood tests:

• decrease in red blood cell count (anemia)

Adverse effects common(may affect up to 1 in 10 people)

• urinary tract infection, nose, sinus, throat, and upper respiratory tract infection, common cold (upper respiratory tract infection), bronchial membrane inflammation, nasal fossa, throat, and mouth inflammation, flu-like symptoms, dry mouth, mouth pain or inflammation, toothache, flu, herpes labialis
• weight loss
• sleep disorders, abnormal drowsiness, depression, anxiety
• dizziness, attention and memory problems, mood changes, decreased brain function due to liver damage, tingling or numbness in the hands or feet
• eye problems, including cataracts, dry eye, small yellow deposits in the retina, yellowish color in the white part of the eye, retinal bleeding
• feeling of spinning (vertigo)
• rapid or irregular heartbeat (palpitations)
• difficulty breathing, cough producing phlegm, nasal discharge, sore throat, and swallowing difficulties
• digestive system problems, including vomiting, stomach pain, indigestion, constipation, stomach swelling, taste alterations, hemorrhoids, stomach pain/discomfort, inflamed and bleeding blood vessels in the esophagus, toothache
• liver problems, including liver tumor, yellowish color in the white part of the eyes or skin (jaundice), liver injury due to medication (see "Liver problems" earlier in section 4)
• skin changes, including rash, dry skin, eczema, skin redness, itching, excessive sweating, unusual skin growth, hair loss
• joint pain, back pain, bone pain, pain in the limbs (arms, legs, hands, or feet), muscle spasms
• irritability, general discomfort, skin reaction such as redness or swelling and pain at the injection site, chest pain and discomfort, fluid accumulation in the body or limbs causing swelling
• depression, anxiety, sleep problems, nervousness
• fever, headache

Adverse effects commonthat may appear in blood tests:

• increase in blood sugar (glucose), decrease in white blood cell count, decrease in neutrophil count, decrease in blood albumin level, decrease in hemoglobin level, increase in blood bilirubin (a substance produced by the liver), changes in blood coagulation enzymes

Adverse effects uncommon(may affect up to 1 in 100 people)

• stomach flu (gastroenteritis), sore throat
• decrease in red blood cell count (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• confusion, agitation
• blistering/sores in the mouth, stomach inflammation
• blood clots in a liver vein (possible liver and/or digestive system damage), liver failure
• skin changes, such as skin color changes, peeling, redness, itching, and lesions, and night sweats
• abnormal blood coagulation in small blood vessels with kidney failure, painful urination
• rash, bruising at the injection site, chest discomfort
• cardiac rhythm alterations (QT interval prolongation)

The following adverse effects have been observed in relation to treatment with Eltrombopag in patients with severe aplastic anemia (SAA)

If these adverse effects worsen, please inform your doctor, pharmacist, or nurse.

Adverse effects very common(may affect more than 1 in 10 people)

• headache, dizziness
• cough, mouth and throat pain
• diarrhea, nausea, gum bleeding, abdominal pain
• joint pain (arthralgia), pain in the limbs (arms, legs, hands, and feet), muscle spasms
• feeling very tired, fever, chills
• eye itching
• mouth blisters

Adverse effects very commonthat may appear in a blood test

• abnormal changes in bone marrow cells
• increase in liver enzymes (aspartate aminotransferase (AST))

Adverse effects common(may affect up to 1 in 10 people)

• interruption of blood circulation to the spleen (splenic infarction)
• anxiety, depression
• fainting
• eye problems, including vision problems, blurred vision, cataracts, floaters in the eye (vitreous floaters), dry eye, eye itching, yellowish color in the white part of the eyes or skin
• nosebleeds, runny nose
• digestive problems, including difficulty swallowing, mouth pain, tongue swelling, vomiting, loss of appetite, stomach pain/discomfort, stomach swelling, gas, constipation, changes in intestinal motility that can cause constipation, swelling, diarrhea, and/or the aforementioned symptoms, changes in stool color
• skin problems, including red or purple spots due to bleeding under the skin (petechiae), rash, itching, hives, skin lesions
• back pain, muscle pain, bone pain
• abnormal urine color
• weakness (asthenia), swelling of the lower limbs due to fluid accumulation, general discomfort, feeling cold

Adverse effects commonthat may appear in a blood test:

• decrease in white blood cell count
• iron accumulation in the body (iron overload), decrease in sugar levels (hypoglycemia)
• increase in blood bilirubin (a substance produced by the liver)
• increase in some enzymes due to muscle breakdown (creatine phosphokinase)

Adverse effects of unknown frequency(frequency cannot be estimated from available data)

• liver damage due to medication
• skin discoloration, skin darkening

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Eltrombopag Olpha

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after “EXP”. The expiry date refers to the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Eltrombopag Olpha

• The active substance is eltrombopag olamine.

Eltrombopag Olpha 12.5 mg: each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg of eltrombopag.

Eltrombopag Olpha 25 mg: each film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.

Eltrombopag Olpha 50 mg: each film-coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag.

Eltrombopag Olpha 75 mg: each film-coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag.

• The other ingredients are: microcrystalline cellulose, mannitol, povidone, isomalt (E 953), calcium silicate, sodium carboxymethyl starch type A (potato), 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).

Appearance and Package Contents

Eltrombopag Olpha 12.5 mg film-coated tablets EFG are film-coated tablets, orange to brown in color, round, biconvex, with an “I” engraved on one face and a diameter of approximately 5.5 mm.

Eltrombopag Olpha 25 mg film-coated tablets EFG are film-coated tablets, dark pink in color, round, biconvex, with “II” engraved on one face and a diameter of approximately 8 mm.

Eltrombopag Olpha 50 mg film-coated tablets EFG are film-coated tablets, pink in color, round, biconvex, engraved with ‘III’ and a diameter of approximately 10 mm.

Eltrombopag Olpha 75 mg film-coated tablets EFG are film-coated tablets, red to brown in color, round, biconvex, engraved with ‘IV’ on one face and an approximate diameter of 12 mm.

Eltrombopag Olpha 12.5 mg, 25 mg, 50 mg, and 75 mg are available in boxes containing 10, 14, 28, 30, or 84 film-coated tablets in blisters, or in boxes containing 10, 14, 28, 30, or 84 film-coated tablets in unit-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Olpha AS,

Rupnicu iela 5,

Olaine, Olaines novads, LV-2114,

Latvia

Manufacturer

Synthon B.V.

Microweg 22

6545 CM Nijmegen

Netherlands

Synthon Hispania S.L.

c/ Castelló, 1

08830 Sant Boi de Llobregat

Barcelona

Spain

Date of Last Revision of this Leaflet:June 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es