ELTROMBOPAG 25 mg Film-Coated Tablets

Contents of the leaflet

1. Introduction
2. What is Eltrombopag Sala and what is it used for
3. What you need to know before you take Eltrombopag Sala
4. Warning
5. Eye Exams
6. You will need to have regular blood tests
7. Blood tests to check liver function
8. Blood tests for platelet count
9. Tests to examine your bone marrow
10. Review of gastrointestinal bleeding
11. Heart monitoring
12. Elderly (65 years and over)
13. Children and adolescents
14. Other medicines and Eltrombopag Sala
15. Taking Eltrombopag Sala with food and drinks
16. Pregnancy and breastfeeding
17. Driving and using machines
18. Eltrombopag Sala contains sodium
19. How to take Eltrombopag Sala
20. How much to take
21. For PTI
22. For Hepatitis C
23. How to take the tablets
24. When to take it
25. For more information on what foods and drinks are suitable, consult your doctor.
26. If you forget to take Eltrombopag Sala
27. If you stop taking Eltrombopag Sala
28. Possible side effects
29. Symptoms to which you need to pay attention: consult your doctor
30. Increased risk of blood clots
31. Seek medical help immediately if you have signs or symptoms of a blood clot, such as:
32. Liver problems
33. What to Expect
34. The following adverse reactions have been reported with eltrombopag treatment in adult patients with ITP
35. Very Common Adverse Reactions that may appear in Blood Tests:
36. Common Adverse Reactions
37. Common Adverse Reactions that may appear in Blood Tests:
38. Uncommon Adverse Reactions
39. Uncommon Adverse Reactions that may appear in Blood Tests:
40. The following adverse reactions have been reported with eltrombopag treatment in children (1 to 17 years) with ITP
41. Very Common Adverse Reactions
42. Common Adverse Reactions
43. The following adverse reactions have been reported with eltrombopag treatment in combination with peginterferon and ribavirin in patients with HCV
44. Very Common Adverse Reactions that may appear in Blood Tests:
45. Common Adverse Reactions
46. Common Adverse Reactions that may appear in Blood Tests:
47. Uncommon Adverse Reactions
48. The following adverse reactions have been observed with eltrombopag treatment in patients with severe aplastic anemia (SAA)
49. Very Common Adverse Reactions
50. Very Common Adverse Reactions that may appear in Blood Tests
51. Common Adverse Reactions that may appear in Blood Tests
52. Adverse Reactions of Unknown Frequency
53. Reporting of Adverse Reactions
54. Storage of Eltrombopag Sala
55. Package Contents and Additional Information
56. Composition of Eltrombopag Sala
57. 25 mg Film-Coated Tablets
58. 50 mg Film-Coated Tablets
59. Appearance and Packaging of the Product
60. Marketing Authorization Holder
61. Manufacturer
63. Date of Last Revision of this Leaflet: April 2025

Introduction

Package Leaflet: Information for the Patient

Eltrombopag Sala 25 mg film-coated tablets EFG

Eltrombopag Sala 50 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 Sala and what is it used for
2. What you need to know before you take Eltrombopag Sala
3. How to take Eltrombopag Sala
4. Possible side effects
5. Storing Eltrombopag Sala
6. Contents of the pack and other information

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

Eltrombopag Sala 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 prevent or stop bleeding.

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

PTI is caused by a low platelet count (thrombocytopenia). People with PTI have a higher risk of bleeding. Symptoms that patients with PTI may notice include petechiae (small, round, flat red spots the size of a pinhead, under the skin), bruises, nosebleeds, bleeding gums, and inability to stop bleeding if cut or injured.

• 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 Sala

Do not takeEltrombopag Sala

• to eltrombopag or any of the other ingredients of this medicine (listed in section 6 under the heading “Composition of Eltrombopag Sala”).

Consult your doctorif you think this may affect you.

Warning

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 (long-standing) have a higher risk of side effects, liver damage that can be fatal, and blood clots. If your doctor considers that the benefit of eltrombopag outweighs the risks, you will be closely monitored during treatment.
• if you have a risk of blood clotsin veins or arteries, or if you know that blood clots are common in your family.

The risk of blood clots may be higherin the following circumstances:

• if you are elderly
• if you have been bedridden for a long time
• if you have cancer
• if you are taking birth control pills 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, tell your doctorbefore starting treatment. You should not take eltrombopag unless your doctor considers that the expected benefit outweighs the risk of blood clots.

• if you have cataracts(clouding of the lens in the eye).
• 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 eltrombopag, MDS may worsen.

Tell your doctorif 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. Your retina (the light-sensitive layer of cells at the back of the eye) should also be examined to check for 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 blood test results that indicate liver damage - an increase in certain 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 on “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, blood 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 immediatelyif you have any of these signs of a blood clot:

• swelling, painor tenderness in one leg
• sudden difficulty breathing, exceptionally accompanied by severe chest pain

or rapid breathing

• abdominal pain(stomach), enlarged abdomen, blood in your stools.

Tests to examine your bone marrow

In people with bone marrow problems, medicines like eltrombopag may worsen the problems. 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 eltrombopag.

Heart monitoring

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

Elderly (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 PTI. It is also not recommended in children under 18 years of age with low platelet counts due to hepatitis C or severe aplastic anemia.

Other medicines and Eltrombopag Sala

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 common medicines may interact with Eltrombopag Sala(including prescription medicines, over-the-counter 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 transplantsor 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 doctorif 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 azathioprinealong with Eltrombopag Sala, it may be necessary to reduce the dose or interrupt treatment with these medicines.

Taking Eltrombopag Sala 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 eltrombopagif you are pregnantunless your doctor specifically recommends it. The effect of eltrombopag during pregnancy is not known.

• Tell your doctor if you are pregnant,think you may be pregnant, or plan to become pregnant.
• Use a reliable contraceptive methodto prevent pregnancy while taking eltrombopag.
• If you become pregnant during treatmentwith eltrombopag, tell your doctor.

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

If you are breastfeedingor plan to breastfeed, tell your doctor.

Driving and using machines

Eltrombopagmay cause dizzinessand have other side effects that may make you less alert.

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

Eltrombopag Sala contains sodium

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

3. How to take Eltrombopag Sala

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist again. 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 condition.

How much to take

For PTI

Adults and children(6 to 17 years) - the usual initial dose for PTI is one 50 mg tabletof eltrombopag 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 PTI is one 25 mg tabletof eltrombopag per day.

For Hepatitis C

Adults- the usual initial dose for hepatitis C is one 25 mg tabletof eltrombopag 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 beforetaking eltrombopag
• and in the 2 hours aftertaking eltrombopag

do notconsume any of the following:

• dairy productssuch as cheese, butter, yogurt, or ice cream
• milk or milkshakes, drinks made with milk, yogurt, or cream
• antacids, a type of medicine for indigestion and heartburn
• some 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 what foods and drinks are suitable, consult your doctor.

If you take more Eltrombopag Sala 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 will receive immediate treatment if necessary.

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

If you forget to take Eltrombopag Sala

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

If you stop taking Eltrombopag Sala

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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

People taking eltrombopag for both PTI and low platelet counts associated with hepatitis C may have signs related to possible serious side effects. It is important that you inform your doctor if you develop these symptoms.

Increased risk of blood clots

Some people may have a higher risk of blood clots, and medicines like eltrombopag may worsen this problem. The sudden blockage of a blood vessel by a blood clot is a rare but serious side effect that can affect up to 1 in 100 people.

Seek medical help immediately if you have signs or symptoms of a blood clot, such as:

• swelling, pain, warmth, redness, ortenderness in one leg
• sudden difficulty breathing, exceptionally accompanied by severe chest pain
• abdominal pain(stomach), enlarged abdomen, blood in your stools.

Liver problems

Eltrombopag may cause changes in blood test results that indicate liver damage. Liver problems (increased liver enzymes in blood tests) are common 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:

• yellowing of the skinor the white part of the eyes (jaundice)
• unusually dark-colored urine

What to Expect

Bleeding or Bruising After Stopping Treatment

Two weeks after stopping 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 stopping treatment with eltrombopag.

Contact your doctorif you experience bleeding or bruising when stopping eltrombopag.

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

• black, tarry stools (a rare side effect that can affect up to 1 in 100 people).
• blood in stools
• vomiting blood or something that looks like coffee grounds

Contact your doctor immediatelyif you experience any of these symptoms.

The following adverse reactions have been reported with eltrombopag treatment in adult patients with ITP

Very Common Adverse Reactions

May affect more than 1 in 10people

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

Very Common Adverse Reactions that may appear in Blood Tests:

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

Common Adverse Reactions

May affect up to 1 in 10people

• muscle pain, muscle spasms, muscle weakness
• bone pain
• heavy menstrual bleeding
• irritation of the throat and difficulty swallowing
• eye problems including abnormal eye tests, dry eyes, eye pain, and blurred vision
• vomiting
• flu
• cold sores
• pneumonia
• irritation and inflammation (swelling) of the breasts
• inflammation (swelling) and infection of the tonsils
• infection of the lungs, sinuses, nose, and throat
• inflammation of the gums
• loss of appetite
• tingling, itching, or numbness
• decreased sensitivity in the skin
• drowsiness
• ear pain
• pain, swelling, and sensitivity in one leg (usually the calf) with warm skin in the affected area (signs of a blood clot in a deep vein)
• localized swelling filled with blood from a broken blood vessel (hematoma)
• hot flashes
• alterations in the mouth including dryness or irritation in the mouth, sensitivity in the tongue, bleeding gums, mouth ulcers
• runny nose
• toothache
• abdominal pain
• abnormal liver function
• skin changes including excessive sweating, itchy rash, red spots, changes in skin appearance
• hair loss
• foamy or bubbly urine (signs of protein in the urine)
• high temperature, feeling of heat
• chest pain
• feeling of weakness
• sleep problems, depression
• migraine
• decreased vision
• feeling of dizziness (vertigo)
• gas

Common Adverse Reactions that 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 creatinine levels
• increase in alkaline phosphatase levels
• increase in liver enzymes (aspartate aminotransferase (AST))
• increase in blood bilirubin (a substance produced by the liver)
• increase in some protein levels

Uncommon Adverse Reactions

May affect up to 1 in 100people:

• allergic reaction
• disruption of blood supply to parts of the heart
• sudden difficulty breathing, especially when accompanied by acute chest pain and/or agitated breathing, which could be signs of a blood clot in the lungs (see “Increased Risk of Blood Clots” earlier in Section 4)
• partial loss of lung function due to a blockage in the pulmonary artery
• possible pain, swelling, and/or redness around a vein that could be signs of blood clots in a vein
• yellowish skin and/or abdominal pain that could be signs of a blockage of a bile duct, liver injury, liver damage due to inflammation (see “Liver Problems” earlier in Section 4)
• liver damage due to medication
• rapid or irregular heartbeat, blue discoloration of the skin, alterations in heart rhythm (prolonged QT interval) that could be a sign of a heart and blood vessel disorder.
• blood clots
• hot flashes
• joint pain and swelling due to uric acid (gout)
• lack of interest, mood changes, uncontrolled crying
• balance problems, speech and nervous system problems, tremors
• pain or abnormal sensations in the skin
• paralysis of one side of the body
• migraine with aura
• nerve pain
• expansion or swelling of blood vessels that cause headaches
• eye problems, including increased tearing, clouding of the eye lens (cataracts), bleeding in the retina, dry eyes
• nose, throat, and sinus problems, breathing problems while sleeping
• blisters/pain in mouth and throat
• loss of appetite
• digestive problems, including frequent bowel movements, food poisoning, blood in stools, vomiting blood
• rectal bleeding, changes in stool color, abdominal swelling, constipation
• mouth problems, including dryness or irritation in the mouth, tongue pain, gum bleeding, mouth sores
• sunburn
• feeling hot, feeling anxious
• redness or swelling around wounds
• bleeding around a catheter (if you have one) in the skin
• feeling of a foreign body
• kidney problems, including kidney inflammation, frequent urination at night, kidney failure, white blood cells in urine
• cold sweats
• feeling of general discomfort
• skin infection
• skin changes, including skin discoloration, peeling, redness, itching, and sweating
• muscle weakness
• rectal and colon cancer

Uncommon Adverse Reactions that may appear in Blood Tests:

• changes in the shape of white blood cells
• presence of immature white blood cells that may indicate certain diseases
• increase in platelet count
• decrease in calcium levels
• decrease in red blood cell count (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• increase in myelocytes
• increase in neutrophils
• increase in blood urea
• increase in protein in urine
• increase in albumin levels in blood
• increase in total protein levels
• decrease in albumin levels in blood
• increase in urine pH
• increase in hemoglobin levels

The following adverse reactions have been reported with eltrombopag treatment in children (1 to 17 years) with ITP

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

Very Common Adverse Reactions

May affect more than 1 in 10children

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

Common Adverse Reactions

May affect up to 1 in 10children

• difficulty sleeping (insomnia)
• toothache
• sore throat and nose
• itching, runny nose, or stuffiness
• irritation of the throat, runny nose, nasal congestion, and sneezing
• mouth problems, including dryness, irritation in the mouth, sensitivity in the tongue, gum bleeding, mouth ulcers

The following adverse reactions have been reported with eltrombopag treatment in combination with peginterferon and ribavirin in patients with HCV

Very Common Adverse Reactions

May affect more than 1 in 10people:

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

Very Common Adverse Reactions that may appear in Blood Tests:

• decrease in red blood cell count (anemia)

Common Adverse Reactions

May affect up to 1 in 10people:

• urinary tract infection
• inflammation of the nasal passages, throat, and mouth, flu-like symptoms, dryness, irritation, or inflammation of the mouth, toothache
• weight loss
• sleep disorders, excessive drowsiness, depression, anxiety
• dizziness, attention and memory problems, mood changes
• decreased brain function due to liver damage
• tingling or numbness in hands and feet
• fever, headache
• eye problems, including clouding of the eye lens (cataracts), dry eyes, small yellow deposits in the retina, yellowish color in the white of the eyes
• retinal bleeding
• feeling of dizziness
• rapid or irregular heartbeat (palpitations), difficulty breathing
• cough with phlegm, runny nose, flu (influenza), cold sores, throat irritation and difficulty swallowing
• digestive problems, including vomiting, stomach pain, indigestion, constipation, abdominal swelling, changes in taste, hemorrhoids (piles), abdominal pain/discomfort, bloating, gas, changes in bowel movements
• toothache
• liver problems, including liver tumor, yellowing of the whites of the eyes or skin (jaundice), liver damage due to medication (see “Liver Problems” earlier in Section 4)
• skin changes, including rash, dry skin, eczema, redness of the skin, itching, excessive sweating, unusual skin growth, hair loss
• joint pain, back pain, bone pain, pain in the limbs (arms, legs, hands, and feet), muscle spasms
• irritability, feeling of general discomfort, skin reactions such as redness or swelling and pain at the injection site, chest pain and discomfort, fluid retention in the body or limbs that causes swelling
• nose, throat, and sinus problems, cold (upper respiratory tract infection), bronchial inflammation
• depression, anxiety, sleep problems, nervousness

Common Adverse Reactions that may appear in Blood Tests:

• increase in blood sugar (glucose) levels
• decrease in white blood cell count
• decrease in neutrophil count
• decrease in albumin levels in blood
• decrease in hemoglobin levels
• increase in blood bilirubin levels (a substance produced by the liver)
• changes in enzymes that control blood clotting

Uncommon Adverse Reactions

May affect up to 1 in 100people:

• pain when urinating
• alterations in heart rhythm (prolonged QT interval)
• stomach flu (gastroenteritis), sore throat
• blisters/pain in the mouth, stomach inflammation
• skin changes, including changes in color, peeling, redness of the skin, itching, and sweating at night
• blood clots in the liver veins (possible liver damage and/or digestive system damage)
• poor blood clotting in small blood vessels with kidney failure
• itching and bruising at the injection site, chest discomfort
• decrease in red blood cell count (anemia) caused by massive destruction of red blood cells (hemolytic anemia)
• confusion, agitation
• liver failure

The following adverse reactions have been observed with eltrombopag treatment in patients with severe aplastic anemia (SAA)

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

Very Common Adverse Reactions

May affect more than 1 in 10people:

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

Very Common Adverse Reactions that may appear in Blood Tests

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

Common Adverse Reactions

May affect up to 1 in 10people:

• anxiety
• depression
• feeling cold
• feeling of general discomfort
• eye problems, including vision problems, clouding of the eye lens (cataracts), floaters in the eye, dry eyes, eye itching, yellowing of the whites of the eyes or skin
• nosebleeds
• digestive problems, including difficulty swallowing, mouth pain, tongue swelling, vomiting, loss of appetite, stomach pain/discomfort, bloating, gas, changes in bowel movements
• fainting
• skin problems, including red spots or purple spots due to bleeding under the skin (petechiae), rash, itching, hives, skin lesions
• back pain
• muscle pain
• bone pain
• weakness (asthenia)
• swelling of the lower limbs due to fluid accumulation
• abnormal urine color
• disruption of blood flow to the spleen (splenic infarction)
• runny nose

Common Adverse Reactions that may appear in Blood Tests

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

Adverse Reactions of Unknown Frequency

Cannot be estimated from the available data

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

Reporting of Adverse Reactions

If you experience any adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Eltrombopag Sala

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

Do not use this medicine after the expiration date stated on the packaging and blister.

Eltrombopag Sala 25 mg film-coated tablets EFG do not require special storage conditions.

Eltrombopag Sala 50 mg film-coated tablets EFG do not require any special storage temperature; store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE point at the pharmacy. If in doubt, 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 Sala

The active ingredient of Eltrombopag Sala is eltrombopag.

25 mg Film-Coated Tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.

50 mg Film-Coated Tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag.

The other ingredients are: mannitol (E421), microcrystalline cellulose, povidone, sodium carboxymethyl starch, magnesium stearate, titanium dioxide (E171), hypromellose (E464), macrogol (E1521).

Eltrombopag Sala 25 mg film-coated tablets EFG also contain polysorbate 80 (E433).

Eltrombopag Sala 50 mg film-coated tablets EFG also contain red iron oxide (E172) and yellow iron oxide (E172).

Appearance and Packaging of the Product

The Eltrombopag Sala 25 mg film-coated tablets are white, round, biconvex, engraved with '25' on one side and smooth on the other.

The Eltrombopag Sala 50 mg film-coated tablets are brown, round, biconvex, engraved with '50' on one side and smooth on the other.

They are supplied in aluminum blisters in a carton containing 14, 28 or 84 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Laboratorio Reig Jofre, S.A.

C/Gran Capitán 10,

08970 Sant Joan Despí

Barcelona (Spain)

Manufacturer

Genepharm S.A.

18th km Marathonos Avenue,

Pallini, 153 51,

Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of Last Revision of this Leaflet: April 2025

Other Sources of Information

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