Eltrombopag Viatris

Patient Information Leaflet

Eltrombopag Viatris 12.5 mg film-coated tablets, 25 mg film-coated tablets, 50 mg film-coated tablets, 75 mg film-coated tablets

eltrombopag
Read this leaflet carefully before you take 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. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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. It is 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 clotting disorder called immune (primary) thrombocytopenia (ITP) in patients over 1 year of age who have already been treated with other medicines (corticosteroids or immunoglobulins) that were not effective.

ITP is caused by a low number of platelets in the blood (thrombocytopenia). People with ITP have an increased risk of bleeding. Symptoms in patients with ITP may include petechiae (small, flat, red, round spots on the skin), bruising, epistaxis (nosebleeds), bleeding gums, and difficulty controlling bleeding in case of cuts or injuries.

• Eltrombopag Viatris may also be used to treat low platelet count (thrombocytopenia) in patients with hepatitis C virus (HCV) who have experienced problems with side effects during interferon therapy. Many people with hepatitis C have a low platelet count not only due to the disease itself but also because of certain antiviral medicines used to treat it. Taking Eltrombopag Viatris may make it easier for you to complete a full course of antiviral treatment (peginterferon and ribavirina).

2. What you should 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 ‘What Eltrombopag Viatris contains’ ). Check with your doctor if you think this applies to you.

Warnings and precautions
Talk to your doctor before taking Eltrombopag Viatris:

• if you have liver problems. People who have a low platelet count and advanced chronic (long-term) liver disease are at higher risk of experiencing side effects, including liver damage and life-threatening blood clots. If your doctor considers that the benefits of taking Eltrombopag Viatris outweigh the risks, you will be closely monitored during treatment.
• if you are at risk of developing blood clots in veins or arteries, or if you know that blood clotting is common in your family.
• You may be at increased risk of blood clot formation:
  • if you are elderly
  • if you have had to remain bedridden for a long time
  • if you have cancer
  • if you are taking oral contraceptives or hormone replacement therapy
  • if you have recently undergone surgery or suffered physical trauma
  • if you are very overweight (obese)
  • if you are a smoker
  • if you have advanced chronic liver disease. If any of these apply to you, inform your doctor before starting treatment. You must not take Eltrombopag Viatris unless your doctor considers that the expected benefits outweigh the risks of blood clot formation.
• if you suffer from cataracts (clouding of the eye's lens)
• if you suffer from another blood disorder, such as myelodysplastic syndrome (MDS). Your doctor will perform tests to check whether you have this blood disorder before you start taking Eltrombopag Viatris. If you have MDS and take Eltrombopag Viatris, your MDS may worsen. Inform your doctor if any of these apply to you.

Eye examination
Your doctor will recommend regular checks for cataracts. If you do not have routine eye examinations, your doctor will schedule regular eye exams. You may also be monitored for any bleeding in or around the retina (the layer of light-sensitive cells at the back of the eye).
You will need regular blood tests
Before starting Eltrombopag Viatris, your doctor will perform blood tests to monitor your blood cells, including platelets. These tests will be repeated at intervals while you are taking the medicine.
Blood tests for liver function
Eltrombopag Viatris may cause signs of liver damage to appear in blood test results—an increase in certain liver enzymes, particularly bilirubin and alanine/aspartate transaminase. If you are receiving interferon-based treatments in combination with Eltrombopag Viatris for low platelet count due to hepatitis C, some liver problems may worsen.
You will need blood tests to monitor liver function before starting Eltrombopag Viatris and during treatment. You may need to stop taking Eltrombopag Viatris if levels of these enzymes rise too high, or if other signs of liver damage appear.
Read the information ‘Liver problems’ in section 4 of this Leaflet
Blood tests for platelet count
If you stop taking Eltrombopag Viatris, your platelet count is likely to drop again within a few days. Your platelet count will be monitored, and your doctor will discuss appropriate precautions with you.
A very high platelet count may increase the risk of blood clots. However, blood clots can also occur with normal or even low platelet counts. Your doctor will adjust the dose of Eltrombopag Viatris to ensure that your platelet count does not rise too high.

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

• swelling, pain, or tenderness in one leg
• sudden onset of shortness of breath, especially along with sharp chest pain or rapid breathing
• abdominal pain, abdominal swelling, blood in stools

Tests to monitor bone marrow
In people who may have bone marrow problems, medicines such as Eltrombopag Viatris could worsen these conditions. Signs of bone marrow changes may appear as abnormalities in blood test results. Your doctor may perform tests to directly monitor your bone marrow during treatment with Eltrombopag Viatris.
Tests for gastrointestinal bleeding
If you are treated with interferon-based medicines in combination 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 it necessary to monitor your heart during treatment with Eltrombopag Viatris and may perform an electrocardiogram (ECG).
Elderly people (65 years and older)
There is limited data on the use of Eltrombopag Viatris in patients aged 65 years and older. Exercise caution when taking Eltrombopag Viatris if you are aged 65 years or older.
Children and adolescents
Eltrombopag Viatris is not recommended in children under 1 year of age with ITP. It is also not recommended in people under 18 years of age with low platelet count due to hepatitis C or severe aplastic anaemia.
Other medicines and Eltrombopag Viatris
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines taken without a prescription and vitamins.
Some common medicines interact with Eltrombopag Viatris – including prescription and over-the-counter medicines and minerals. These include:

• antacids used to treat indigestion, heartburn, or stomach ulcers (see also ‘When to take it’ in section 3)
• medicines called statins, used to lower cholesterol
• certain medicines for HIV infection, such as lopinavir and/or ritonavir
• cyclosporine used in organ transplants and immune disorders
• minerals such as iron, calcium, magnesium, aluminium, selenium, and zinc found in vitamin and mineral supplements (see also “When to take it” in section 3)
• medicines such as methotrexate and topotecan, used to treat cancer
  Inform your doctor if you are taking any of these medicines. Some of them cannot be taken with Eltrombopag Viatris, or you may need to adjust your dose, or the timing of administration may need to be changed. Your doctor will review all the medicines you are taking and, if necessary, suggest appropriate substitutions.

There is an increased risk of bleeding if you are also taking medicines to prevent blood clots. Your doctor will discuss this with you.
If you are taking corticosteroids, danazol and/or azathioprine, you may need to take a lower dose or stop taking them while on Eltrombopag Viatris.
Eltrombopag Viatris with food and drink
Do not take Eltrombopag Viatris with drinks or foods containing dairy or cheese products, as the calcium in dairy products affects the absorption of the medicine. For further information, see ‘When to take it’ in section 3.
Pregnancy and breastfeeding
Do not use Eltrombopag Viatris if you are pregnant unless specifically recommended by your doctor. The effect of Eltrombopag Viatris during pregnancy is not known.

• Inform your doctor if you are pregnant, think you might be pregnant, or are planning a pregnancy.
• Use a reliable method of contraception while taking Eltrombopag Viatris to prevent pregnancy.
• If you become pregnant during treatment with Eltrombopag Viatris, inform your doctor.

Do not breastfeed while taking Eltrombopag Viatris. It is not known 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 side effects that may reduce your attention.
Do not drive or operate machinery unless you are sure you are not affected.
Eltrombopag Viatris contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Eltrombopag Viatris

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag Viatris unless your doctor or pharmacist advises you to do so. While you are taking Eltrombopag Viatris, you will be under the care of a doctor experienced in the treatment of 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 tablet of Eltrombopag Viatris daily. If you are of East or Southeast Asian origin, you may need to start with a lower dose of 25 mg.

Children (1 to 5 years of age): the recommended starting dose for ITP is one 25 mg tablet of Eltrombopag Viatris daily.

For Hepatitis C

Adults: the recommended starting dose for hepatitis C is one 25 mg tablet of Eltrombopag Viatris daily. If you are of East or Southeast Asian origin, you will start with the same 25 mg dose.

Eltrombopag Viatris may take 1 to 2 weeks to take effect. Based on your response to Eltrombopag Viatris, your doctor may recommend adjusting the daily dose.

How to take the tablets

Swallow the tablet whole with some water.

When to take it

Make sure that:

• during the 4 hours before taking Eltrombopag Viatris
• and during the 2 hours after taking Eltrombopag Viatris

you do not consume any of the following:

• foods such as cheese, butter, yoghurt or ice cream
• milk or milk-based 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, the medicine will not be properly absorbed into your body.

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

If you take more Eltrombopag Viatris than you should

Contact your doctor or pharmacist immediately. If possible, show them the pack or this leaflet. You will be monitored for any signs or symptoms of adverse effects and treated appropriately without delay.

If you forget to take Eltrombopag Viatris

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

If you stop taking Eltrombopag Viatris

Do not stop taking Eltrombopag Viatris without speaking to your doctor. If your doctor advises you to stop treatment, your platelet count will be monitored weekly for four weeks. See also ‘Bleeding or bruising after stopping treatment’ in section 4.

If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Symptoms requiring attention: consult a doctor
People taking Eltrombopag Viatris for ITP or due to low platelet count caused by hepatitis C may develop signs of potentially serious side effects.
It is important to inform your doctor if you experience any of these symptoms.
Higher risk of blood clots
Some people may have an increased risk of blood clots, and medicines such as Eltrombopag Viatris could worsen this condition. Sudden blockage of a blood vessel by a blood clot is an uncommon side effect and may affect up to 1 in 100 people.

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

• swelling, pain, warmth, redness, or tenderness in one leg
• sudden onset of shortness of breath, especially together with sharp chest pain or rapid breathing
• abdominal pain (stomach), abdominal swelling, blood in the stool.

Liver problems
Eltrombopag Viatris may cause changes detectable in blood tests and may be signs of liver damage. Liver problems (increased liver enzymes detected 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 have any of the following signs of liver problems:

• yellowing of the skin or whites of the eyes (jaundice)
• urine that is unusually dark-colored
  Inform your doctor immediately.

Bleeding or bruising after stopping treatment
Within two weeks after stopping Eltrombopag Viatris, the platelet count usually decreases to the level it was before starting Eltrombopag Viatris. A lower platelet count may increase the risk of bleeding or bruising. Your doctor will monitor your platelet count for at least 4 weeks after you stop taking Eltrombopag Viatris.
Inform your doctor if you experience bleeding or bruising after stopping Eltrombopag Viatris.
Some people have experienced gastrointestinal bleeding after discontinuation of peginterferon, ribavirin, and Eltrombopag Viatris. Symptoms include:

• dark stools (change in stool color is an uncommon side effect that may affect up to 1 in 100 people)
• blood in the stool
• vomiting blood or material resembling coffee grounds
  Inform your doctor immediately if you experience any of these symptoms.

The following side effects have been reported in association with treatment with
Eltrombopag Viatris in adult patients with ITP:
Very common side effects
These may affect more than 1 person in 10:

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

Very common side effects that may be evident from blood tests:

• increased liver enzymes (alanine aminotransferase (ALT))

Common side effects
These may affect up to 1 person in 10:

• muscle pain, muscle cramps, muscle weakness
• bone pain
• heavy menstrual period
• sore throat and pain when swallowing
• eye problems including abnormalities in eye tests, dry eye, eye pain, blurred vision
• vomiting
• influenza
• cold sores
• pneumonia
• irritation and inflammation (swelling) of the sinuses
• inflammation (swelling) and infection of the tonsils
• infections of the lungs, sinuses, nose, and throat
• inflammation of the gum tissue
• loss of appetite
• sensation of tingling, pricking, or numbness, commonly known as "pins and needles"
• decreased skin sensitivity
• feeling of drowsiness
• earache
• pain, swelling, and tenderness in one of the legs (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 (haematoma)
• hot flushes
• mouth problems including dry mouth, painful mouth, sensitive tongue, bleeding gums, mouth ulcers
• runny nose
• toothache
• abdominal pain
• abnormalities in liver function
• skin disorders including excessive sweating, itchy irregular rash, red spots, changes in skin appearance
• hair loss
• urine appearing foamy, frothy, or fizzy (signs of protein in the urine)
• high temperature, feeling hot
• chest pain
• feeling of weakness
• sleep problems, depression
• migraine
• decreased vision
• sensation of spinning (dizziness)
• gas/bloating due to digestion

Common side effects that may be evident from blood tests:

• decreased number of red blood cells (anaemia)
• decreased number of platelets (thrombocytopenia)
• decreased number of white blood cells
• decreased haemoglobin levels
• increased number of eosinophils
• increased number of white blood cells (leucocytosis)
• increased levels of uric acid
• decreased potassium levels
• increased creatinine levels
• increased alkaline phosphatase levels
• increased liver enzymes (aspartate aminotransferase (AST))
• increased bilirubin (a substance produced by the liver) in the blood
• increased levels of certain proteins

Uncommon side effects
These may affect up to 1 person in 100:

• allergic reaction
• interruption of blood flow to part of the heart
• sudden breathing difficulty, especially if accompanied by sharp chest pain and/or rapid breathing, which may be a sign of a blood clot in the lungs (see ‘Higher risk of blood clots’ at the beginning of section 4)
• loss of function in part of the lung due to blockage of the pulmonary artery
• possible pain, swelling, and/or redness around a vein, which could be signs of blood clot formation in a vein
• yellowing of the skin and/or abdominal pain, which could be signs of bile duct obstruction, liver injury, or liver damage due to inflammation (see ‘Liver problems’ at the beginning of section 4)
• drug-induced liver injury
• increased heart rate, irregular heartbeat, bluish skin colouration, heart rhythm disorders (QT prolongation), which could be signs of a heart or blood vessel disorder
• blood clot
• redness
• painful swelling of joints due to uric acid (gout)
• lack of interest, mood changes, uncontrollable or unexpected crying
• balance problems, speech and nerve function issues, tremor
• painful or abnormal skin sensations
• paralysis on one side of the body
• migraine with aura
• nerve damage
• dilation or swelling of blood vessels causing headache
• eye problems including increased tear production, clouding of the eye lens (cataract), retinal bleeding, dry eye
• problems with nose, throat, and sinuses, breathing problems during sleep
• mouth and throat blisters/ulcers
• loss of appetite
• digestive system problems including frequent bowel movements, food poisoning, blood in stool, vomiting with blood
• bleeding from the rectum, change in stool colour, abdominal swelling, constipation
• mouth problems including dry mouth, painful mouth, painful tongue, bleeding gums, mouth discomfort
• sunburn
• feeling hot, anxiety sensation
• redness or swelling around a wound
• bleeding around a catheter (if present) in the skin
• sensation of a foreign body
• kidney problems including kidney inflammation, excessive urination at night, kidney failure, white blood cells in urine
• cold sweat
• feeling of general malaise
• skin infection
• skin changes including skin discolouration, peeling, redness, itching, and sweating
• muscle weakness
• cancer of the rectum and colon

Uncommon side effects that may be evident from laboratory tests:

• changes in the shape of red blood cells
• presence of abnormal white blood cell development, which may indicate certain diseases
• increased number of platelets
• decreased calcium levels
• decreased number of red blood cells (anaemia) caused by excessive destruction of red blood cells (haemolytic anaemia)
• increased number of myelocytes
• increased band neutrophils
• increased blood urea levels
• increased protein levels in urine
• increased albumin levels in blood
• increased total protein levels
• decreased albumin levels in blood
• increased urine pH
• increased haemoglobin levels

The following side effects have been reported in association with treatment with
Eltrombopag Viatris in paediatric patients (aged 1 to 17 years) with ITP:
If these side effects worsen, inform your doctor, pharmacist, or nurse.
Very common side effects
These may affect more than 1 child in 10:

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

Common side effects
These may affect up to 1 child in 10:

• difficulty sleeping (insomnia)
• toothache
• pain in nose and throat
• itchy nose, runny or blocked nose
• sore throat, runny nose, nasal congestion, and sneezing
• mouth problems including dry mouth, painful mouth, sensitive tongue, bleeding gums, mouth ulcers

The following side effects have been reported in association with treatment with
Eltrombopag Viatris in combination with peginterferon and ribavirin in patients with HCV:
Very common side effects
These may affect more than 1 person in 10:

• headache
• loss of appetite
• cough
• feeling unwell (nausea), diarrhoea
• muscle pain, muscle weakness
• itching
• feeling tired
• fever
• unusual hair loss
• feeling of weakness
• flu-like illness
• swelling of hands or feet
• chills

Very common side effects that may be evident from blood tests:

• decreased number of red blood cells (anaemia).

Common side effects
These may affect up to 1 person in 10:

• urinary tract infections
• inflammation of nasal passages, throat, and mouth, flu-like symptoms, dry mouth, painful or inflamed mouth, toothache
• weight loss
• sleep disturbances, abnormal drowsiness, depression, anxiety
• dizziness, problems with concentration and memory, mood changes
• decreased brain function due to liver damage
• tingling or numbness in hands or feet
• fever, headache
• eye problems including clouding of the eye lens (cataract), dry eye, small yellow deposits in the retina, yellowing of the white of the eye
• retinal bleeding
• sensation of spinning (dizziness)
• fast or irregular heartbeat (palpitations), shortness of breath
• productive cough, runny nose, influenza, cold sores, sore throat, and discomfort when swallowing
• digestive system problems, including vomiting, stomach ache, indigestion, constipation, stomach bloating, taste disturbances, haemorrhoids, stomach pain/discomfort, dilated blood vessels and bleeding in the oesophagus
• toothache
• liver problems, including liver tumour, yellowing of the whites of the eyes or skin (jaundice), drug-induced liver injury (see ‘Liver problems’ at the beginning of section 4)
• skin changes, including rash, dry skin, eczema, skin redness, itching, excessive sweating, unusual skin growths, hair loss
• joint pain, back pain, bone pain, pain in extremities (arms, legs, hands, or feet), muscle cramps
• irritability, general feeling of malaise, skin reaction such as redness or swelling and pain at injection site, chest pain and discomfort, fluid accumulation in the body or extremities causing swelling
• infection of the nose, sinuses, throat, and upper airways, common cold (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi
• depression, anxiety, sleep disturbances, nervousness

Common side effects that may be evident from blood tests:

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

Uncommon side effects
These may affect up to 1 person in 100:

• pain during urination
• heart rhythm disorders (QT interval prolongation)
• stomach flu (gastroenteritis), sore throat
• blisters/ulcers in mouth, stomach inflammation
• skin changes including colour changes, peeling, redness, itching, lesions, and night sweats
• blood clots in a liver vein (possible liver and/or digestive system damage)
• abnormal blood clotting in small blood vessels with kidney failure
• rash, bruising at injection site, chest discomfort
• decreased number of red blood cells (anaemia) caused by excessive destruction of red blood cells (haemolytic anaemia)
• confusion, agitation
• liver failure

The following side effects have been reported in association with treatment with
Eltrombopag Viatris in patients with severe aplastic anaemia (SAA):
If these side effects worsen, inform your doctor, pharmacist, or nurse.
Very common side effects
These may affect up to 1 person in 10:

• cough
• headache
• mouth and throat pain
• diarrhoea
• feeling unwell (nausea)
• joint pain (arthralgia)
• pain in extremities (arms, legs, hands, and feet)
• dizziness
• feeling very tired
• fever
• chills
• itchy eyes
• mouth blisters
• bleeding gums
• abdominal pain
• muscle cramps

Very common side effects that may be evident from blood tests:

• abnormal changes in cells in the bone marrow
• increased levels of liver enzymes (aspartate aminotransferase (AST))

Common side effects
These may affect up to 1 person in 10:

• anxiety
• depression
• feeling cold
• general feeling of malaise
• eye problems including vision problems, blurred vision, clouding of the eye lens (cataract), spots or deposits in the eye (vitreous floaters), dry eye, itchy eye, yellowing of the skin or whites of the eyes
• nosebleeds
• digestive system problems including difficulty swallowing, mouth pain, swollen tongue, vomiting, loss of appetite, stomach ache/discomfort, stomach bloating, gas during digestion, constipation, intestinal motility disorder that may cause constipation, bloating, diarrhoea, and/or the above-mentioned symptoms, change in stool colour
• fainting
• skin problems including small 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 lower limbs due to fluid accumulation
• urine with abnormal colour
• interruption of blood supply to the spleen (splenic infarction)
• runny nose

Common side effects that may be evident from blood tests:

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

Side effects with unknown frequency
Frequency cannot be estimated from the available data:

• skin discolouration
• dark skin
• drug-induced liver injury

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eltrombopag Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Eltrombopag Viatris contains
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 ingredients are: hypromellose (E464), macrogol 3350 (E1521), magnesium stearate, mannitol (E421), microcrystalline cellulose (E463), povidone, sodium starch glycolate, titanium dioxide (E171), hydroxypropylcellulose (E553b).
Eltrombopag Viatris 50 mg film-coated tablets also contain red iron oxide (E172ii), yellow iron oxide (E172iii), and indigo carmine (E132).
Eltrombopag Viatris 75 mg film-coated tablets also contain red iron oxide (E172ii) and indigo carmine (E132).

Description of the appearance of Eltrombopag Viatris and contents of the pack
The film-coated tablets (tablets) of Eltrombopag Viatris 12.5 mg are white, round, biconvex, with 'L' engraved on one side.
The film-coated tablets (tablets) of Eltrombopag Viatris 25 mg are white, round, biconvex, with '25' engraved on one side.
The film-coated tablets (tablets) of Eltrombopag Viatris 50 mg are brown, round, biconvex, with '50' engraved on one side.
The film-coated tablets (tablets) of Eltrombopag Viatris 75 mg are pink, round, biconvex, with '75' engraved on one side.

The tablets are supplied in aluminium blisters within a pack containing 14, 28 or 84 film-coated tablets, and a multiple pack containing 84 tablets (3 packs of 28) film-coated tablets.
Not all pack sizes may be marketed in your country.

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:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: +32 (0)658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: +36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf.: +45 28 11 69 32 Tel: +356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: +372 6363 052 Tlf: +47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390

España Polska
Viatris Pharmaceuticals S.L. Viatris Healthcare Sp. z o.o.
Tel: +34 900 102 712 Tel.: +48 22 456 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: +351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: +386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: +39 (0) 2 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/