Eltrombopag Viatris 50 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Eltrombopag Viatris 12.5 mg film-coated tablets EFG

Eltrombopag Viatris 25 mg film-coated tablets EFG

Eltrombopag Viatris 50 mg film-coated tablets EFG

Eltrombopag Viatris 75 mg film-coated tablets EFG

eltrombopag

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• The information in this leaflet is intended for you or your child, even though the text refers to "you".

Leaflet Contents

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

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

Eltrombopag Viatris 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 blood cells that help reduce or prevent bleeding.

• Eltrombopag Viatris is used to treat a blood disorder called immune (primary) thrombocytopenia (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 experience include petechiae (small, round, flat, red spots under the skin), bruising, nosebleeds, bleeding gums, and difficulty controlling bleeding if they are cut or injured.

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

2. What you need to know before taking Eltrombopag Viatris

Do not take Eltrombopag Viatris

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

→ Consult your doctor if you think this may affect you.

Warnings and precautions

Talk to your doctor before starting to take Eltrombopag Viatris:

• if you have liver problems. People who have low platelet counts as well as advanced chronic liver disease (long-standing) are at higher risk of adverse reactions, liver damage (which may be fatal), and blood clots. If your doctor considers that the benefit of Eltrombopag Viatris outweighs the risks, you will be closely monitored during treatment.
• if you are at risk of developing a blood clot in 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 been bedridden for a long time
• if you have cancer
• if you are taking contraceptive pills or hormone replacement therapy
• if you have recently undergone surgery or suffered physical injury
• if you are significantly overweight (obesity)
• 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 Viatris 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 Viatris, your doctor will perform tests to ensure you do not have this condition. If you have MDS and take Eltrombopag Viatris, 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 have routine eye examinations, your doctor will ask you to have them. Your retina (the light-sensitive layer at the back of the eye) should also be examined to detect any bleeding in or around the retina.

You will need regular blood tests

Before you start taking Eltrombopag Viatris, 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 check liver function

Eltrombopag Viatris 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 as part of your standard treatment along with Eltrombopag Viatris for low platelet counts due to hepatitis C, some liver problems may worsen.

You will have blood tests before starting Eltrombopag Viatris and regularly during treatment to monitor your liver function. You may need to stop treatment with Eltrombopag Viatris if levels of these markers increase too much or if you show any other signs of liver damage.

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

Blood tests for platelet count (levels)

If you stop treatment with Eltrombopag Viatris, your platelet levels are likely to drop again within a few days (thrombocytopenia). Your platelet levels will be monitored, and your doctor will advise you on the necessary precautions.

Very high platelet levels may increase the risk of blood clots. However, blood clots can also form with normal or even low platelet levels. Your doctor will adjust the dose of Eltrombopag Viatris 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 difficulty breathing, exceptionally 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 Viatris may worsen these conditions. Signs of bone marrow changes may appear as abnormal results in your blood tests. Your doctor may also perform tests to directly assess your bone marrow during treatment with Eltrombopag Viatris.

Monitoring for gastrointestinal bleeding

If you are taking interferon as part of your standard treatment along with Eltrombopag Viatris, you will be monitored for any signs of bleeding in your stomach or intestines after stopping Eltrombopag Viatris.

Heart monitoring

Your doctor may consider, if necessary, monitoring your heart during treatment with Eltrombopag Viatris using an electrocardiogram.

Elderly people (65 years and older)

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

Children and adolescents

The use of Eltrombopag Viatris is not recommended 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 or severe aplastic anemia.

Other medicines and Eltrombopag Viatris

Tell 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 Viatris (including prescription, over-the-counter 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 transplants or immunological disorders
• 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 Viatris; dose adjustments may be needed, or the timing of administration may need to be changed. Your doctor will review your current medications 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 along with Eltrombopag Viatris, it may be necessary to reduce the dose or discontinue treatment with these medicines.

Taking Eltrombopag Viatris with food and drinks

Do not take Eltrombopag Viatris with food or dairy drinks, 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 Viatris if you are pregnant unless specifically advised by your doctor. The effect of Eltrombopag Viatris 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 Viatris.
• If you become pregnant during treatment with Eltrombopag Viatris, inform your doctor.

Do not breastfeed while taking Eltrombopag Viatris. It is unknown whether Eltrombopag Viatris passes into breast milk.

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

Driving and using machines

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

→ Do not drive or operate machinery unless you are certain that Eltrombopag Viatris does not affect you.

Eltrombopag Viatris contains sodium

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

3. How to take Eltrombopag Viatris

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. Do not change the dose or treatment schedule of Eltrombopag Viatris unless advised by your doctor or pharmacist. While taking Eltrombopag Viatris, you will be under the supervision of a specialist doctor experienced in treating your condition.

How much to take

For ITP

Adults and children (aged 6 to 17 years): the usual starting dose for ITP is one 50 mg tablet of Eltrombopag Viatris 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 (aged 1 to 5 years): the usual starting dose for ITP is one 25 mg tablet of Eltrombopag Viatris per day.

For Hepatitis C

Adults: the usual starting dose for hepatitis C is one 25 mg tablet of Eltrombopag Viatris per day. If you are of East or Southeast Asian ancestry, start treatment with the same 25 mg dose.

Eltrombopag Viatris may take 1 to 2 weeks to take effect. Depending on your response to Eltrombopag Viatris, your doctor may recommend adjusting 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 Viatris
• and in the 2 hours after taking Eltrombopag Viatris

you do not consume any of the following:

• dairy foods such as cheese, butter, yoghurt, or ice cream
• milk or milkshakes, drinks made with 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, your body will not properly absorb the medicine.

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

If you take more Eltrombopag Viatris 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.

If you forget to take Eltrombopag Viatris

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

If you stop taking Eltrombopag Viatris

Do not stop taking Eltrombopag Viatris without first consulting your doctor. If your doctor advises stopping 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 will experience them.

Symptoms you should pay attention to: consult your doctor

Patients taking Eltrombopag Viatris for either ITP or low platelet counts associated with hepatitis C may experience signs related to potentially serious adverse effects. It is important that you inform your doctor if you develop any of these symptoms.

Increased risk of thrombosis

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

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

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

Liver problems

Eltrombopag Viatris 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 white part 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 Viatris, your platelet levels will usually drop to levels similar to those before starting Eltrombopag Viatris. A decrease in platelet levels may increase the risk of bleeding or bruising. Your doctor will monitor your platelet levels for at least 4 weeks after stopping treatment with Eltrombopag Viatris.

→ Contact your doctor if you experience bleeding or bruising after stopping Eltrombopag Viatris.

Some people may experience gastrointestinal bleeding after discontinuing peginterferon, ribavirin, and Eltrombopag Viatris. Symptoms include:

• black, tarry stools (discoloration of stools is an uncommon adverse effect, affecting 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 Viatris treatment in adult patients with ITP

Very common adverse effects

May affect more than 1 in 10 people

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

Very common adverse effects detectable in blood tests

• increase in the liver enzyme alanine aminotransferase (ALT)

Common adverse effects

May affect up to 1 in 10 people

• muscle pain, muscle spasms, muscle weakness
• bone pain
• heavy menstrual bleeding
• throat irritation and discomfort when swallowing
• eye problems including abnormal eye test results, dry eyes, eye pain, and blurred vision
• vomiting
• flu
• cold sores
• pneumonia
• sinus irritation and inflammation (swelling)
• swelling and infection of the tonsils
• infection of the lungs, sinuses, nose, and throat
• gum inflammation
• loss of appetite
• tingling, itching, or numbness sensation
• decreased skin sensitivity
• drowsiness
• ear pain
• pain, swelling, and tenderness 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 due to rupture of a 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 the urine)
• elevated temperature, feeling of warmth
• chest pain
• feeling of weakness
• sleep problems, depression
• migraine
• decreased vision
• sensation of spinning (vertigo)
• flatulence

Common adverse effects detectable in blood tests:

• decrease in the number of red blood cells (anemia)
• decrease in the number of platelets (thrombocytopenia)
• decrease in the number of white blood cells
• decrease in hemoglobin levels
• increase in eosinophils
• increase in the number of white blood cells (leukocytosis)
• increase in uric acid levels
• decrease in potassium levels
• increase in creatinine levels
• increase in alkaline phosphatase levels
• increase in the liver enzyme aspartate aminotransferase (AST)
• increase in bilirubin in blood (a substance produced by the liver)
• increase in 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 indicate a blood clot in the lungs (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 indicate blood clots in a vein
• yellowish skin and/or abdominal pain, which could indicate 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 (QT interval prolongation), which could indicate a disorder related to the heart and blood vessels
• 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 increased tearing, clouding of the eye lens (cataracts), retinal hemorrhage, dry eyes
• nose, throat, and sinus problems, breathing difficulties during sleep
• 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 disorders, including dryness or irritation in the mouth, tongue pain, gum bleeding, mouth discomfort
• sunburn
• feeling of warmth, anxiety sensation
• redness or swelling around wounds
• bleeding around a catheter (if present) in the skin
• sensation of a foreign body
• kidney problems including kidney inflammation, excessive urination (increased need to urinate) at night, kidney failure, white blood cells in urine
• cold sweat
• general feeling of discomfort
• 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
• increase in the number of platelets
• decrease in calcium levels
• decrease in the number of red blood cells (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• increase in myelocytes
• increase in neutrophils
• increase in blood urea levels
• increase in protein in urine
• increase in blood albumin levels
• increase in total protein levels
• decrease in blood albumin levels
• increase in urine pH
• increase in hemoglobin levels

The following adverse effects have been reported with Eltrombopag Viatris 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

• infection of the nose, sinuses, throat, and upper respiratory tract, cold (upper respiratory tract infection)
• diarrhea
• abdominal pain
• cough
• elevated temperature
• feeling of 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 Viatris 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
• feeling dizzy (nausea), diarrhea
• muscle pain, muscle weakness
• itching
• feeling of fatigue
• fever
• hair loss
• feeling of weakness
• flu-like discomfort
• swelling of hands or feet
• chills

Very common adverse effects detectable in blood tests:

• decrease in the number of red blood cells (anemia)

Common adverse effects

May affect up to 1 in 10 people:

• urinary tract infection
• inflammation of nasal passages, throat, and mouth, 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, yellowish discoloration of the white part of the eyes
• retinal bleeding
• sensation of spinning
• rapid and irregular heartbeat (palpitations), difficulty breathing
• cough with phlegm, runny nose, flu (influenza), cold sores, throat irritation and discomfort when swallowing
• digestive disorders, including vomiting, stomach pain, indigestion, constipation, bloated stomach, taste disturbances, hemorrhoids, abdominal pain/discomfort, swelling and bleeding in blood vessels of 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 spasms
• irritability, general discomfort, skin reactions such as redness or swelling and pain at injection site, chest pain and discomfort, fluid retention in the body or limbs causing swelling
• infection of nose, sinuses, throat, and respiratory tract, 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:

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

Uncommon adverse effects

May affect up to 1 in 100 people:

• pain when urinating
• changes in heart rhythm (QT interval prolongation)
• stomach flu (gastroenteritis), sore throat
• blisters/pain in the mouth, stomach inflammation
• skin changes, including color changes, peeling, skin redness, itching, skin lesions, and night sweats
• blood clots in liver veins (possible liver and/or digestive system damage)
• poor coagulation in small blood vessels with kidney failure
• itching and bruising at injection site, chest discomfort
• decrease in the 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 Viatris 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
• itchy eyes
• mouth blisters
• abdominal pain
• muscle spasms

Very common adverse effects detectable in blood tests

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

Common adverse effects

May affect up to 1 in 10 people:

• anxiety
• depression
• feeling cold
• general discomfort
• eye problems including vision problems, clouding of the eye lens (cataracts), spots or deposits in the eye (floaters), dry eyes, itchy eyes, 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/digestive gas, constipation, intestinal motility disturbances that may cause constipation, bloating, diarrhea and/or the previously mentioned 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
• gum bleeding
• back pain
• muscle pain
• bone pain
• weakness (asthenia)
• swelling of the lower limbs due to fluid accumulation
• abnormal urine color
• interruption of blood flow to the spleen (splenic infarction)
• runny nose

Common adverse effects detectable in blood tests

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

Adverse effects of unknown frequency

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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Eltrombopag Viatris

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

Do not use this medicine after the expiry date stated on the packaging and blister after CAD or EXP.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. 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 Viatris

The active substance in Eltrombopag Viatris is eltrombopag.

12.5 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg of 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: hypromellose (E464), polyethylene glycol 3350 (E1521), magnesium stearate, mannitol (E421), microcrystalline cellulose (E463), povidone, sodium carboxymethyl starch, titanium dioxide (E171), hydroxypropylcellulose, talc (E553b).

Eltrombopag Viatris 50 mg film-coated tablets also contain: red iron oxide (E172ii), yellow iron oxide (E172iii) and indigotine (E132).

Eltrombopag Viatris 75 mg film-coated tablets also contain: red iron oxide (E172ii) and indigotine (E132).

Appearance of the product and contents of the pack

Eltrombopag Viatris 12.5 mg film-coated tablets (tablets) are round, biconvex, white to off-white in colour and marked with ‘L’ on one side.

Eltrombopag Viatris 25 mg film-coated tablets (tablets) are round, biconvex, white to off-white in colour and marked with ‘25’ on one side.

Eltrombopag Viatris 50 mg film-coated tablets (tablets) are round, biconvex, brown in colour and marked with ‘50’ on one side.

Eltrombopag Viatris 75 mg film-coated tablets (tablets) are round, biconvex, pink in colour and marked with ‘75’ on one side.

The tablets are supplied in aluminium blisters within a carton pack containing 14, 28 or 84 film-coated tablets, multiple packs containing 84 film-coated tablets (3 packs of 28), or single-dose aluminium blisters in a carton pack containing 14 x 1 or 28 x 1 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Viatris Limited
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturer(s)

ELPEN Pharmaceutical Co. Inc.
Marathonos Ave. 95, Pikermi, Attiki, 19009, Greece

Mylan Germany GmbH
Zweigniederlassung Bad Homburg v.d. Hohe, Benzstrasse 1, 61352 Bad Homburg v. d. Hohe,
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgium Viatris Tel/Tel: +32 (0)2 658 61 00	Lithuania Viatris UAB Tel: +370 5 205 1288
	Luxembourg/Luxembourg Viatris Tel/Tel: +32 (0)2 658 61 00 (Belgium/Belgium)
Czech Republic Viatris CZ s.r.o. Tel: +420 222 004 400	Hungary Viatris Healthcare Kft. Tel.: +36 1 465 2100
Denmark Viatris ApS Tlf.: +45 28 11 69 32	Malta V.J. Salomone Pharma Ltd Tel: +356 21 22 01 74
Germany Viatris Healthcare GmbH Tel: +49 800 0700 800	Netherlands Mylan BV Tel: +31 (0)20 426 3300
Estonia Viatris OÜ Tel: +372 6363 052	Norway Viatris AS Tlf: +47 66 75 33 00
Greece Viatris Hellas Ltd Tel: +30 2100 100 002	Austria Viatris Austria GmbH Tel: +43 1 86390
Spain Viatris Pharmaceuticals, S.L. Tel: +34 900 102 712	Poland Viatris Healthcare Sp. z o.o. Tel.: +48 22 546 64 00
France Viatris Santé Tél: +33 4 37 25 75 00	Portugal Mylan, Lda. Tel: +351 214 127 200
Croatia Viatris Hrvatska d.o.o. Tel. +385 1 23 50 599	Romania BGP Products SRL Tel: +40 372 579 000
Ireland Viatris Limited Tel: +353 1 8711600	Slovenia Viatris d.o.o. Tel: +386 1 23 63 180
Iceland Icepharma hf. Tel: +354 540 8000	Slovakia Viatris Slovakia s.r.o. Tel: +421 2 32 199 100
Italy Viatris Italia S.r.l. Tel: +39 (0) 2 612 46921	Finland Viatris Oy Tel/Puh: +358 20 720 9555
Cyprus CPO Pharmaceuticals Limited Tel: +357 22863100	Sweden Viatris AB Tel: +46 (0)8 630 19 00
Latvia Viatris SIA Tel: +371 678 055 80

Date of the most recent revision of this leaflet: [MM/YYYY]

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

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