Eltrombopag Teva 50 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Eltrombopag Teva 25 mg film-coated tablets EFG

Eltrombopag Teva 50 mg film-coated tablets EFG

Eltrombopag Teva 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

• Eltrombopag is used to treat a blood disorder called immune (primary) thrombocytopenia (ITP) in patients aged 1 year and older who have already received other treatments (corticosteroids or immunoglobulins) that were ineffective.

ITP is caused by a low platelet count (thrombocytopenia). People with ITP have an increased risk of bleeding. Symptoms that patients with ITP may experience include petechiae (small, round, flat, red spots the size of a pinprick located under the skin), bruising, nosebleeds, bleeding gums, and difficulty controlling bleeding if they are cut or injured.

• Eltrombopag may also be used to treat low platelet levels (thrombocytopenia) in adults with hepatitis C virus (HCV) infection who have had problems with adverse effects from interferon-based treatment. Many people with hepatitis C have low platelet counts, not only due to the disease itself but also because of the antiviral treatments used to treat it. Taking eltrombopag may help them complete their antiviral therapy (peginterferon and ribavirina).

2. What you need to know before taking Eltrombopag Teva

Do not take Eltrombopag Teva

• if you are allergic to eltrombopag or to any of the other ingredients of this medicine (listed in section 6).
  • Consult your doctor if you think this may affect you.

Warnings and precautions

Talk to your doctor or pharmacist before taking eltrombopag:

• if you have liver problems. People who have low platelet counts and also advanced chronic liver disease (long-standing) have an increased risk of adverse reactions, liver damage (which may be fatal), and blood clots. If your doctor considers that the benefit of taking this medicine outweighs the risks, you will be closely monitored during treatment.
• if you are at risk of developing a blood clot in the veins or arteries, or if you know that blood clots are common in your family.

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

• if you are elderly
• if you have had to remain in bed for a long period of time
• if you have cancer
• if you are taking oral contraceptives or hormone replacement therapy
• if you have recently undergone surgery or suffered physical injury
• if you are significantly overweight (obesity)
• if you smoke
• 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 developing blood clots.

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

? Inform your doctor if you are in any of these situations.

Eye examinations

Your doctor will recommend that you have an eye examination to check for cataracts. If you do not routinely have regular eye examinations, your doctor will ask you to have them. Your retina (the layer of light-sensitive cells at the back of the eye) should also be examined to check for bleeding in or around the retina.

Regular blood tests are required

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

Blood tests to monitor liver function

Eltrombopag may cause blood test results indicating liver damage—an increase in certain liver enzymes, especially bilirubin and alanine/aspartate aminotransferase. If you are taking interferon-based treatments along with eltrombopag to treat low platelet counts due to hepatitis C, some liver problems may worsen.

Blood tests will be performed before starting eltrombopag and regularly during treatment to monitor your liver function. You may need to stop treatment with eltrombopag if levels of these markers increase too much or if you develop any other signs of liver damage.

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

Blood tests to monitor platelet count

If you stop treatment with eltrombopag, your platelet levels are likely to drop again within a few days. Your platelet levels will be monitored, and your doctor will advise you on the precautions you should take. Very high platelet counts may increase the risk of blood clots. However, blood clots can also form when platelet counts are normal or even low. Your doctor will adjust the dose of eltrombopag to ensure that the platelet count does not become too high.

Seek immediate medical help if you experience any of the following signs of a blood clot:

• swelling, pain or tenderness in one leg

• sudden shortness of breath, occasionally accompanied by sharp chest pain or rapid breathing

• abdominal pain, enlarged abdomen, blood in stools.

Bone marrow examination

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

Monitoring for gastrointestinal bleeding

If you are taking interferon-based treatments together with eltrombopag, you will be monitored for any signs of bleeding in the stomach or intestines after stopping this medicine.

Heart monitoring

Your doctor may consider it necessary to monitor your heart during treatment with eltrombopag and may perform an electrocardiogram (ECG).

Elderly people (65 years and older)

There is limited data on the use of eltrombopag in patients aged 65 years or older. Caution should be exercised when using eltrombopag in patients aged 65 or older.

Children and adolescents

The use of eltrombopag is not recommended in children under 1 year of age with ITP (immune thrombocytopenia). It is also not recommended in children under 18 years of age with low platelet counts due to hepatitis C.

Other medicines and Eltrombopag Teva

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription and vitamins.

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

• antacids used to treat indigestion, heartburn, or stomach ulcers (see also section 3 “When to take it”)
• statins, used to lower cholesterol
• certain medicines used to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine, used in organ transplantation or immunological disorders
• minerals such as iron, calcium, magnesium, aluminium, 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; dose adjustments may be needed, or you may need to 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 an increased risk of bleeding. Your doctor will discuss this with you.

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

Taking Eltrombopag Teva with food and drinks

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

Pregnancy and breastfeeding

Do not take eltrombopag if you are pregnant unless specifically advised by your doctor. The effect of eltrombopag during pregnancy is unknown.

• Inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant.
• Use a reliable method of contraception 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 planning to breastfeed, inform your doctor.

Driving and using machines

Eltrombopag may cause dizziness and other adverse effects that may reduce your alertness.

• Do not drive or operate machinery unless you are certain that eltrombopag does not affect you.

Eltrombopag Teva contains sodium

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

3. How to take Eltrombopag Teva

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. Do not change the dose or treatment regimen of eltrombopag unless your doctor or pharmacist advises you to do so. While taking eltrombopag, you will be under the supervision of a specialist doctor experienced in treating your condition.

How much to take

For ITP

Adults and children (6 to 17 years of age) – the recommended starting dose for ITP is one 50 mg eltrombopag tablet per day. If you are of East or Southeast Asian ancestry, you may need to start treatment with a lower dose of 25 mg.

Children (1 to 5 years of age) – the recommended starting dose for ITP is one 25 mg eltrombopag tablet per day.

For hepatitis C

Adults – the recommended starting dose for hepatitis C is one 25 mg eltrombopag tablet per day. If you are of East or Southeast Asian ancestry, you should start treatment with the same 25 mg dose.

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

How to take the tablets

Swallow the tablet whole with water.

Eltrombopag Teva 25 mg film-coated tablets may be divided into equal doses.

Eltrombopag Teva 50 mg film-coated tablets may be divided into equal doses.

When to take it

Make sure that

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

you do not consume any of the following:

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

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

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

If you take more Eltrombopag Teva than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Eltrombopag Teva

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

If you stop taking Eltrombopag Teva

Do not stop taking eltrombopag without first consulting your doctor. If your doctor advises you to stop treatment, your platelet levels 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 using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Symptoms to pay attention to: consult your doctor

Patients taking eltrombopag, both for ITP and for low platelet count associated with hepatitis C, may develop signs related to potentially serious adverse effects. It is important that you inform your doctor if you experience any of these symptoms.

Increased risk of thrombosis

Some people may have an increased risk of developing a blood clot, and medicines such as eltrombopag may worsen this problem. Sudden blockage of a blood vessel by a clot is an uncommon adverse effect that may affect up to 1 in 100 people.

Seek immediate medical help if you experience signs or symptoms of thrombosis, such as:

• swelling, pain, warmth, redness, or tenderness in one leg.
• sudden shortness of breath, occasionally accompanied by sharp chest pain or rapid breathing.
• abdominal pain (stomach), enlarged abdomen, blood in your stools.

Liver problems

Eltrombopag may cause changes detectable in blood tests, which could indicate liver damage. Liver problems (elevated liver enzymes in blood tests) are common and may affect up to 1 in 10 people. Other liver problems are uncommon and may affect up to 1 in 100 people.

If you experience any signs of liver problems:

• yellowing of the skin or the whites of the eyes (jaundice)

• unusually dark-colored urine

• contact your doctor immediately

Bleeding or bruising after stopping treatment

Within two weeks after stopping treatment with eltrombopag, your platelet levels will usually fall to levels similar to those before starting treatment with this medicine. A decrease in platelet levels may increase the risk of bleeding or bruising. Your doctor will monitor your platelet levels for at least four weeks after stopping eltrombopag treatment.

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

Some patients experience gastrointestinal bleeding after stopping peginterferon, ribavirin, and eltrombopag. Symptoms include:

• black, tar-like stools (discoloration of stools is an uncommon adverse effect that may affect up to 1 in 100 people).

• blood in the stools

• vomiting blood or material resembling coffee grounds

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

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

Very common adverse effects

May affect more than 1 in 10 people

• cold
• dizziness (nausea)
• diarrhea
• cough
• nasal, sinus, throat, or respiratory tract infection (upper respiratory tract infection)
• back pain

Very common adverse effects detectable in blood tests

• increased liver enzymes (alanine aminotransferase [ALT])

Common adverse effects

May affect up to 1 in 10 people

• muscle pain, muscle cramps, muscle weakness
• bone pain
• heavy menstrual bleeding
• throat irritation and difficulty swallowing
• eye problems including abnormal eye test results, dry eyes, eye pain, blurred vision
• vomiting
• flu
• cold sores
• pneumonia
• sinus irritation and inflammation (swelling)
• swelling (inflammation) and infection of the tonsils
• lung, sinus, nose, and throat infections
• gum inflammation
• loss of appetite
• tingling, itching, or numbness
• decreased skin sensitivity
• drowsiness
• ear pain
• pain, swelling, and tenderness in one leg (usually calf) with warm skin in the affected area (signs of a deep vein thrombosis)
• localized swelling filled with blood due to a ruptured blood vessel (hematoma)
• hot flushes
• mouth disorders including dryness or irritation in the mouth, tongue sensitivity, gum bleeding, 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 urine)
• elevated temperature, feeling hot
• chest pain
• feeling weak
• trouble sleeping, depression
• migraine
• decreased vision
• sensation of spinning (vertigo)
• gas (flatulence)

Common adverse effects detectable in blood tests:

• decreased number of red blood cells (anemia)
• decreased number of platelets (thrombocytopenia)
• decreased number of white blood cells
• decreased hemoglobin levels
• increased eosinophils
• increased number of white blood cells (leukocytosis)
• increased uric acid levels
• decreased potassium levels
• increased creatinine levels
• increased alkaline phosphatase levels
• increased liver enzymes (aspartate aminotransferase [AST])
• increased blood bilirubin levels (a substance produced by the liver)
• increased levels of certain proteins

Uncommon adverse effects

May affect up to 1 in 100 people:

• allergic reaction

• interruption of blood supply to parts of the heart

• sudden difficulty breathing, especially when accompanied by sharp chest pain and/or rapid breathing, which could be signs of a pulmonary embolism (see "Increased risk of thrombosis" above in section 4)

• partial loss of lung function due to blockage in the pulmonary artery

• possible pain, swelling, and/or redness around a vein, which could be signs of venous thrombosis

• yellowish skin and/or abdominal pain, which could be signs of bile duct obstruction, liver injury, or liver damage due to inflammation (see "Liver problems" above in section 4)

• drug-induced liver damage

• faster heartbeat, irregular heartbeat, bluish discoloration of the skin, heart rhythm disturbances (prolongation of QT interval), which could be signs of a heart or blood vessel disorder

• blood clots

• hot flushes

• joint pain and swelling due to uric acid (gout)

• lack of interest, mood changes, uncontrollable or unexpected crying

• balance problems, speech and nerve function disturbances, tremors

• pain or abnormal sensations in the skin

• paralysis on one side of the body

• migraine with aura

• nerve pain

• dilation or swelling of blood vessels causing headache

• eye problems including excessive tearing, clouding of the eye lens (cataracts), retinal hemorrhage, dry eyes

• nose, throat, and sinus problems, breathing difficulties during sleep

• mouth and throat blisters/pain

• loss of appetite

• digestive system problems including frequent bowel movements, food poisoning, blood in stools, vomiting blood

• rectal bleeding, changes in stool color, abdominal swelling, constipation

• mouth disorders including dryness or irritation in the mouth, tongue pain, gum bleeding, mouth discomfort

• sunburn

• feeling hot, anxiety sensation

• redness or inflammation around wounds

• bleeding around a catheter (if present) in the skin

• foreign body sensation

• kidney problems including kidney inflammation, excessive urination (increased need to urinate) at night, kidney failure, white blood cells in urine

• cold sweats

• general malaise

• skin infection

• skin changes including skin discoloration, peeling, redness, itching, and sweating

• muscle weakness

• rectal and colon cancer

Uncommon adverse effects detectable in blood tests:

• changes in the shape of white blood cells
• presence of immature white blood cells, which may indicate certain diseases
• increased number of platelets
• decreased calcium levels
• decreased number of red blood cells (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• increased number of myelocytes
• increased neutrophils
• increased blood urea levels
• increased protein in urine
• increased blood albumin levels
• increased total protein levels
• decreased blood albumin levels
• increased urine pH
• increased hemoglobin levels

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

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

Very common adverse effects

May affect more than 1 in 10 children

• nasal, sinus, throat, and upper respiratory tract infection, cold (upper respiratory tract infection)
• diarrhea
• abdominal pain
• cough
• elevated temperature
• dizziness (nausea)

Common adverse effects

May affect up to 1 in 10 children

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

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

Very common adverse effects

May affect more than 1 in 10 people:

• headache
• loss of appetite
• cough
• dizziness (nausea), diarrhea
• muscle pain, muscle weakness
• itching
• feeling tired
• fever
• hair loss
• feeling weak
• flu-like discomfort
• swelling of hands or feet
• chills

Very common adverse effects detectable in blood tests:

• decreased number of red blood cells (anemia)

Common adverse effects

May affect up to 1 in 10 people:

• urinary tract infection
• nasal, throat, and mouth inflammation, flu-like symptoms, dryness, irritation or inflammation of the mouth, toothache
• 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 hands and feet
• fever, headache
• eye problems including clouding of the eye lens (cataracts), dry eyes, small yellow deposits in the retina, yellowing of the whites of the eyes
• retinal bleeding
• sensation of spinning
• rapid or irregular heartbeats (palpitations), difficulty breathing
• cough with phlegm, runny nose, flu (influenza), cold sores, throat irritation and difficulty swallowing
• digestive system disorders including vomiting, stomach pain, indigestion, constipation, bloated stomach, taste disturbances, hemorrhoids, abdominal pain/discomfort, swelling and bleeding of blood vessels in the throat (esophagus)
• toothache
• liver problems, including liver tumor, yellowing of the whites of the eyes or skin (jaundice), drug-induced liver damage (see "Liver problems" above 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, limb pain (arms, legs, hands, feet), muscle cramps
• irritability, general malaise, skin reactions such as redness, swelling, and pain at injection site, chest pain and discomfort, fluid retention in the body or limbs causing swelling
• nasal, sinus, throat, and respiratory tract infection, cold (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi
• depression, anxiety, sleep problems, nervousness

Common adverse effects detectable in blood tests:

• increased blood sugar (glucose)
• decreased number of white blood cells
• decreased number of neutrophils
• decreased blood albumin
• decreased hemoglobin levels
• increased blood bilirubin levels (a substance produced by the liver)
• changes in enzymes controlling blood clotting

Uncommon adverse effects

May affect up to 1 in 100 people:

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

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

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

Very common adverse effects

May affect more than 1 in 10 people:

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

Very common adverse effects detectable in blood tests

• abnormal changes in bone marrow cells
• increased liver enzymes (aspartate aminotransferase [AST])

Common adverse effects

May affect up to 1 in 10 people:

• anxiety
• depression
• feeling cold
• general malaise
• eye problems including vision problems, clouding of the eye lens (cataracts), spots or deposits in the eye (vitreous floaters), 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, bloated stomach, flatulence/gas, constipation, intestinal motility disturbances that may cause constipation, bloating, diarrhea, and/or the aforementioned symptoms, changes in stool color
• fainting
• 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
• weakness (asthenia)
• swelling of the lower limbs due to fluid accumulation
• abnormal urine coloration
• interruption of blood flow to the spleen (splenic infarction)
• runny nose

Common adverse effects detectable in blood tests

• increased levels of certain enzymes due to muscle breakdown (creatine phosphokinase)
• iron accumulation in the body (iron overload)
• decreased blood sugar levels (hypoglycemia)
• increased bilirubin in blood (a substance produced by the liver)
• decreased number of white blood cells

Adverse effects of unknown frequency – Cannot be estimated from available data

• skin discoloration
• darkening of the skin
• drug-induced liver damage

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eltrombopag Teva

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 outer packaging and on the blister after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to your local pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eltrombopag Teva film-coated tablets EFG

The active substance 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.

75 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag.

The other components are: microcrystalline cellulose (PH 101) (E-460(i)), mannitol (E-421), povidone, microcrystalline cellulose (PH 102) (E-460(i)), sodium carboxymethylstarch type B (derived from potato starch), colloidal anhydrous silica, talc (E-553b), magnesium stearate.

The 25 mg film-coated tablets also contain hypromellose (E-464), titanium dioxide (E-171), Macrogol (E-1521).

The 50 mg film-coated tablets also contain hypromellose (E-464), titanium dioxide (E-171), Macrogol (E-1521), yellow iron oxide (E-172) and red iron oxide (E-172).

The 75 mg film-coated tablets also contain hypromellose (E-464), titanium dioxide (E-171), Macrogol (E-1521), red iron oxide (E-172) and black iron oxide (E-172).

Nature of the product and contents of the container

Eltrombopag Teva 25 mg film-coated tablets EFG are round, white tablets, with "25" engraved on one side and scored on the other.

Eltrombopag Teva 50 mg film-coated tablets EFG are round, light brown tablets, with "50" engraved on one side and scored on the other.

Eltrombopag Teva 75 mg film-coated tablets EFG are round, pink tablets, with "75" engraved on one side.

They are supplied in aluminium blisters in cardboard packaging containing 14, 28, 30, 84 film-coated tablets, and in single-dose aluminium blisters in cardboard packaging containing 14x1, 28x1, 30x1, 84x1 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid, Spain

Manufacturer

Actavis Ltd.,

BLB015, BLB016,

Bulebel Industrial Estate,

Zejtun, ZTN3000, Malta

Date of the most recent revision of this leaflet: December 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/)