Eltrombopag krka

Patient Information Leaflet

Eltrombopag Krka, 25 mg, film-coated tablets
Eltrombopag Krka, 50 mg, film-coated tablets
Eltrombopag Krka, 75 mg, film-coated tablets
eltrombopagum
Please read this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents

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

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

Eltrombopag Krka contains the active substance eltrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists. It is used to increase the number of platelets in your blood. Platelets are blood components that help reduce or prevent the risk of bleeding.

• Eltrombopag Krka is used to treat a blood disorder called immune (primary) thrombocytopenia in patients over 1 year of age who have previously been treated with other medicines (corticosteroids or immunoglobulins) that were ineffective.

Immune thrombocytopenia is caused by a low number of platelets (thrombocytopenia). People with immune thrombocytopenia are at increased risk of bleeding. Symptoms patients with immune thrombocytopenia may notice include petechiae (small, flat, red, round spots under the skin), subcutaneous bruising, nosebleeds, bleeding gums, and difficulty stopping bleeding after a cut or injury.

• Eltrombopag Krka may also be used to treat low platelet counts (thrombocytopenia) in adults with chronic hepatitis C virus (HCV) infection who have difficulties due to side effects during interferon-based therapy. Many people with hepatitis C have low platelet counts, not only because of the disease itself but also due to certain antiviral medicines used in treatment. Taking Eltrombopag Krka may help patients complete a full course of antiviral therapy (pegylated interferon and ribavirin).

2. Important information before using Eltrombopag Krka

When not to use Eltrombopag Krka

• if the patient is allergic to eltrombopag or any of the other ingredients of this medicine (listed in section 6 under “What Eltrombopag Krka contains”). ➔ Consult a doctor if the patient thinks they may have the condition described above.

Warnings and precautions
Before starting treatment with Eltrombopag Krka, discuss the following with your doctor:

• if the patient has liver function disorders. Patients with low platelet counts, as well as those with advanced (chronic) liver disease, are at increased risk of adverse reactions, including life-threatening liver damage and blood clots. If the doctor considers that the benefits of taking Eltrombopag Krka outweigh the risks, the patient will be closely monitored during treatment.
• if the patient is at risk of venous or arterial thrombosis, or if there is a family history of blood clots. The risk of thrombosis may be increased:
• if the patient is elderly
• if the patient has been immobilized for a prolonged period
• if the patient has malignant tumour
• if the patient is taking oral contraceptives or hormone replacement therapy
• if the patient has recently undergone surgery or experienced trauma
• if the patient is overweight
• if the patient smokes
• if the patient has advanced chronic liver disease ➔ Inform the doctor before starting treatment if any of the above conditions apply to the patient. Do not take Eltrombopag Krka unless the doctor considers that the expected benefits outweigh the risk of thrombosis.
• if the patient has cataracts (clouding of the eye lens)
• if the patient has other blood disorders, such as myelodysplastic syndrome (MDS). Before starting Eltrombopag Krka, the doctor will perform tests to rule out this condition. If the patient has MDS, treatment with Eltrombopag Krka may worsen the condition. ➔ Inform the doctor if any of the above situations apply to the patient.

Ophthalmological examination
The treating doctor will recommend regular check-ups to detect cataracts. If the patient does not undergo routine ophthalmological examinations, the doctor should schedule regular eye exams. These may also include checking for any retinal haemorrhages (in the layer of light-sensitive cells at the back of the eye) or nearby areas.
Regular blood tests will be necessary
Before starting Eltrombopag Krka, the doctor will perform blood tests to evaluate blood cells, including platelets. These tests will be repeated periodically during treatment.
Blood tests for liver function
Eltrombopag Krka may cause blood test results indicating liver damage – increased activity of certain liver enzymes, particularly bilirubin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST). If the patient is receiving interferon-based therapy simultaneously with Eltrombopag Krka for low platelet count associated with hepatitis C, certain liver conditions may worsen.
Before starting Eltrombopag Krka and periodically during treatment, blood tests assessing liver function will be performed. It may be necessary to discontinue Eltrombopag Krka if levels of these substances rise too high or if other signs of liver damage occur.
➔ Refer to the information in section 4 of this leaflet “ Liver disorders ”.
Monitoring platelet count
If the patient stops taking Eltrombopag Krka, low platelet count may recur within a few days. Platelet count will be monitored, and the treating doctor will discuss appropriate precautions with the patient.
Very high platelet counts may increase the risk of thrombosis. However, thrombosis may also occur when platelet counts are normal or low. The treating doctor will adjust the dose of Eltrombopag Krka to prevent excessive increases in platelet count.

Seek immediate medical help if the patient experiences any of the following symptoms of thrombosis:

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

Bone marrow examinations
In patients with bone marrow disorders, drugs such as Eltrombopag Krka may worsen these conditions. Changes in the bone marrow may manifest as abnormal blood test results. The treating doctor may recommend direct bone marrow examinations during treatment with Eltrombopag Krka.
Tests to detect gastrointestinal bleeding
If the patient is receiving interferon-based therapy together with Eltrombopag Krka, they will be monitored for signs of bleeding from the stomach or intestines after stopping Eltrombopag Krka treatment.
Heart examinations
The treating doctor may consider it necessary to monitor the patient’s heart during treatment with Eltrombopag Krka and may perform an electrocardiogram (ECG).
Elderly patients (65 years and older)
There is limited data on the use of Eltrombopag Krka in patients aged 65 years and older. Caution should be exercised when using Eltrombopag Krka in patients aged 65 years and older.
Children and adolescents
Eltrombopag Krka is not recommended for children under 1 year of age with immune thrombocytopenia. It is also not recommended for patients under 18 years of age with low platelet count due to hepatitis C virus.
Eltrombopag Krka and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those taken without a prescription and vitamins.
Some commonly used medicines interact with Eltrombopag Krka – including both prescription and over-the-counter medicines, as well as mineral supplements. These include:

• acid-reducing agents used to treat indigestion, heartburn, stomach ulcers (see also “ When to take the medicine ” in section 3)
• statins, used to lower cholesterol levels
• certain medicines used to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine, used in organ transplantation or in autoimmune diseases
• mineral products such as iron, calcium, magnesium, aluminium, selenium, and zinc, which may be components of vitamin and mineral supplements (see also “ When to take the medicine ” in section 3)
• medicines such as methotrexate and topotecan, used in cancer treatment ➔ Consult a doctor if the patient is taking any of the medicines listed above. Some of these medicines should not be used during treatment with Eltrombopag Krka; others may require dose adjustments or appropriate timing of administration. The treating doctor will review all medications the patient is taking and recommend changes if necessary.

If the patient is taking anticoagulant medicines, the risk of bleeding may be increased. The treating doctor will discuss this with the patient.
If the patient is taking corticosteroids, danazol, and/or azathioprine, doses of these medicines may be reduced or their use discontinued during concomitant treatment with Eltrombopag Krka.
Taking Eltrombopag Krka with food and drink
Eltrombopag Krka must not be taken with dairy products or dairy-based beverages, as the calcium present in dairy products affects the absorption of the medicine. For further information, see “ When to take the medicine ” in section 3.
Pregnancy and breastfeeding
Do not use Eltrombopag Krka during pregnancy, unless specifically advised by a doctor.
The effect of Eltrombopag Krka during pregnancy is unknown.

• Inform the doctor if the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant.
• An appropriate method of contraception must be used during treatment with Eltrombopag Krka to prevent pregnancy.
• Inform the doctor if the patient becomes pregnant while taking Eltrombopag Krka.

Do not breastfeed while taking Eltrombopag Krka. It is not known whether Eltrombopag Krka passes into breast milk.
➔ Inform the doctor if the patient is breastfeeding or planning to breastfeed.
Driving and using machines
Eltrombopag Krka may cause dizziness and other adverse effects that may impair attention.
➔ Do not drive or operate machinery unless the patient is certain that these symptoms do not occur.
Eltrombopag Krka contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered “sodium-free”.

3. How to use Eltrombopag Krka

This medicine should always be used exactly as directed by the doctor. If in doubt, consult
your doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag Krka
unless instructed by your doctor or pharmacist. While taking Eltrombopag Krka,
the patient will remain under the care of a doctor experienced in treating the condition the patient has.
How much medicine to take
In the case of primary immune thrombocytopenia
Adults and children (aged 6 to 17 years) – the usual starting dose in primary
immune thrombocytopenia is one 50 mg tablet of Eltrombopag Krka once daily.
Patients of East Asian or Southeast Asian origin may require a lower starting dose of 25 mg.
Children (aged 1 to 5 years) – the usual starting dose in primary
immune thrombocytopenia is one 25 mg tablet of Eltrombopag Krka once daily.
In the case of chronic hepatitis C
Adults – the usual starting dose in chronic hepatitis C is one 25 mg tablet
of Eltrombopag Krka once daily. For patients of East Asian or Southeast Asian
origin, treatment should be initiated with the same 25 mg dose.
The effect of Eltrombopag Krka may begin after 1 to 2 weeks. Depending on the
patient's response to treatment with Eltrombopag Krka, the doctor may adjust the daily dose.
How to take the tablets
Swallow the tablets whole with water.
When to take the medicine
Ensure that:

• within 4 hours before taking Eltrombopag Krka
• and within 2 hours after taking Eltrombopag Krka

the patient does not consume the following foods:

• dairy products, such as cheese, butter, yoghurt, ice cream
• milk or beverages containing milk, yoghurt, or cream
• antacids used to treat indigestion and heartburn
• vitamin and mineral supplements containing iron, calcium, magnesium, aluminium, selenium, or zinc

Failure to follow these instructions may result in inadequate absorption of Eltrombopag Krka.

Consult your doctor for further information regarding suitable foods and drinks.
Taking more than the recommended dose of Eltrombopag Krka
Contact your doctor or pharmacist immediately. If possible, show them the medicine’s packaging or this leaflet. The patient’s condition will be monitored for any adverse reactions, and appropriate treatment will be initiated promptly.
Missing a dose of Eltrombopag Krka
Take the next dose at the usual time. Do not take more than one dose of Eltrombopag Krka per day.
Stopping treatment with Eltrombopag Krka
Do not stop taking Eltrombopag Krka without consulting your doctor. If your doctor advises stopping treatment, the patient’s platelet count 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Symptoms to watch for: seek medical advice
In patients taking Eltrombopag Krka for the treatment of primary immune thrombocytopenia or low platelet count associated with hepatitis C, symptoms of severe adverse effects may occur. It is important to inform your doctor if any of these symptoms occur.
Increased risk of blood clots
Some patients may have an increased risk of blood clots, and medicines such as Eltrombopag Krka may increase this risk. Sudden blockage of a blood vessel by a clot is an uncommon adverse effect and may occur in up to 1 in 100 patients.

Seek immediate medical help if the patient experiences any of the following symptoms of a blood clot:

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

Liver problems
Eltrombopag Krka may cause changes detectable in blood tests, which may indicate liver damage. Liver disorders (increased liver enzyme activity in blood tests) are common and may affect up to 1 in 10 patients. Other liver problems are uncommon and may affect up to 1 in 100 patients.
If any of the following symptoms of liver problems occur:

• yellowing of the skin or whites of the eyes (jaundice)
• abnormally dark-coloured urine ➔ tell your doctor immediately.

Bleeding or bruising after stopping treatment
Usually within two weeks of stopping Eltrombopag Krka, the patient's platelet count decreases to the level observed before starting Eltrombopag Krka. A low platelet count may increase the risk of bleeding or bruising. Your doctor will monitor your platelet count for at least four weeks after stopping Eltrombopag Krka.
➔ Inform your doctor if bruising or bleeding occurs after stopping Eltrombopag Krka.
Some patients may experience gastrointestinal bleeding after discontinuing peginterferon, ribavirin, and Eltrombopag Krka. Symptoms include:

• black, tarry stools (a change in stool colour is an uncommon adverse effect, affecting up to 1 in 100 patients)
• blood in stool
• vomiting blood or material resembling coffee grounds ➔ Tell your doctor immediately if any of these symptoms occur.

The following adverse effects have been reported in association with treatment with Eltrombopag Krka in adult patients with primary immune thrombocytopenia:
Very common adverse effects
May occur in more than 1 in 10 patients:

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

Very common adverse effects detectable in blood tests:

• increased liver enzyme activity (alanine aminotransferase (AlAT))

Common adverse effects
May occur in up to 1 in 10 patients:

• muscle pain, muscle cramps
• bone pain
• heavy menstrual bleeding
• sore throat and discomfort when swallowing
• eye disorders, including abnormal eye test results, dry eyes, eye pain, and blurred vision
• vomiting
• influenza
• cold sores
• pneumonia
• sinus irritation and inflammation (swelling)
• inflammation (swelling) and infection of the tonsils
• infection of the lungs, sinuses, nose, and throat
• gingivitis
• loss of appetite
• tingling, pricking, or numbness sensations
• reduced skin sensation
• drowsiness
• ear pain
• pain, swelling, and tenderness in one leg (usually calf), with warm skin at the affected site (symptoms of deep vein thrombosis)
• localized swelling filled with blood from a damaged blood vessel (haematoma)
• hot flushes
• oral disorders, including dry mouth, mouth pain, tongue sensitivity, bleeding gums, mouth ulcers
• watery nasal discharge
• toothache
• abdominal pain
• abnormal liver function
• skin changes including: excessive sweating, raised itchy rash, red spots, skin appearance changes
• hair loss
• foamy urine with bubbles (symptoms of protein in urine)
• high body temperature, feeling of warmth
• chest pain
• feeling of weakness
• difficulty sleeping, depression
• migraine
• impaired vision
• sensation of spinning (dizziness)
• flatulence

Common adverse effects detectable in blood tests:

• decreased number of red blood cells (anaemia)
• decreased platelet count (thrombocytopenia)
• decreased number of white blood cells
• decreased haemoglobin concentration
• increased eosinophil count
• increased number of white blood cells (leukocytosis)
• increased uric acid concentration
• decreased potassium concentration
• increased creatinine concentration
• increased alkaline phosphatase activity
• increased liver enzyme activity (aspartate aminotransferase (AspAT))
• increased bilirubin concentration in blood (a substance produced by the liver)
• increased concentration of certain proteins

Uncommon adverse effects
May occur in up to 1 in 100 patients:

• allergic reaction
• interruption of blood supply to part of the heart
• sudden shortness of breath, especially combined with acute chest pain and (or) rapid breathing, which may indicate a pulmonary embolism (see "Increased risk of blood clots" above in 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 may indicate a blood clot
• yellowing of the skin and (or) abdominal pain, which may indicate bile duct obstruction, liver disease, or liver damage due to inflammation (see "Liver problems" above in section 4)
• drug-induced liver damage
• rapid heartbeat, irregular heartbeat, bluish skin discoloration, cardiac rhythm disorders (QT interval prolongation), which may indicate heart and blood vessel disorders
• blood clot
• redness
• painful joint swelling due to uric acid (gout)
• lack of interest, mood changes, uncontrollable or unexpected crying
• balance, speech, and nerve function disorders, tremors
• 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 disorders, including excessive tearing, lens opacification (cataract), retinal haemorrhage, dry eyes
• nose, throat, and sinus disorders, sleep breathing disorders
• blisters or ulcers in the mouth and throat
• loss of appetite
• gastrointestinal disorders including frequent defecation, food poisoning, blood in stool, bloody vomiting
• bleeding from the anus, change in stool colour, abdominal bloating, constipation
• oral disorders, including dryness or pain in the mouth, tongue pain, bleeding gums, oral discomfort
• sunburn
• feeling of warmth, feeling of restlessness
• redness or swelling around a wound
• bleeding around a catheter (if present) through the skin
• sensation of a foreign body
• kidney disorders including: kidney inflammation, excessive urination at night, kidney failure, presence of white blood cells in urine
• cold sweats
• general malaise
• skin infection
• skin changes, including skin discoloration, peeling, redness, itching, and sweating
• muscle weakness
• cancer of the rectum and colon

Uncommon adverse effects detectable in laboratory tests:

• changes in the shape of red blood cells
• presence of developing white blood cells, which may indicate certain diseases
• increased platelet count
• decreased calcium concentration
• decreased number of red blood cells (anaemia) due to excessive destruction of red blood cells (haemolytic anaemia)
• increased myelocyte count
• increased band neutrophil count
• increased blood urea concentration
• increased protein concentration in urine
• increased albumin concentration in blood
• increased total protein concentration
• decreased albumin concentration in blood
• increased urine pH
• increased haemoglobin concentration

The following additional adverse effects have been reported in association with treatment with Eltrombopag Krka in children (aged 1 to 17 years) with ITP:
If these adverse effects worsen, inform your doctor, pharmacist, or nurse.
Very common adverse effects
May occur in more than 1 in 10 children:

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

Common adverse effects
May occur in up to 1 in 10 children:

• difficulty falling asleep (insomnia)
• toothache
• nasal and throat pain
• itchy nose, runny nose, or nasal congestion
• sore throat, runny nose, nasal mucosal congestion, sneezing
• oral disorders, including dry mouth, mouth pain, tongue sensitivity, bleeding gums, mouth ulcers

The following adverse effects have been reported in association with treatment with Eltrombopag Krka in combination with peginterferon and ribavirin in patients with hepatitis C:
Very common adverse effects
May occur in more than 1 in 10 patients:

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

Very common adverse effects detectable in blood tests:

• decreased number of red blood cells (anaemia)

Common adverse effects
May occur in up to 1 in 10 patients:

• urinary tract infections
• nasal, throat, and oral cavity inflammation, flu-like symptoms, dry mouth, pain or inflammation in the mouth, toothache
• weight loss
• sleep disorders, abnormal drowsiness, depression, anxiety
• dizziness, concentration and memory disturbances, mood changes
• impaired brain function due to liver damage
• tingling or numbness in hands or feet
• fever, headache
• visual disturbances, including: lens opacification (cataract), dry eye syndrome, small yellow deposits on the retina, yellowing of the whites of the eyes
• retinal haemorrhage
• sensation of spinning (dizziness)
• rapid or irregular heartbeat (palpitations), shortness of breath
• productive cough, runny nose, flu, cold sores, sore throat, and discomfort when swallowing
• gastrointestinal disorders including: vomiting, abdominal pain, indigestion, constipation, bloating, taste disturbances, haemorrhoids, stomach pain or discomfort, blood vessel swelling and bleeding in the oesophagus
• toothache
• liver function disorders including liver tumour, yellowing of the whites of the eyes or skin (jaundice), drug-induced liver damage (see above "Liver problems" in section 4)
• skin changes, including: rash, dry skin, skin eruptions, redness, itching, excessive sweating, skin growths, hair loss
• joint pain, back pain, bone pain, limb pain (legs, arms, hands, or feet), muscle cramps
• irritability, general malaise, skin reaction such as redness or swelling and pain at the injection site, chest pain and discomfort, fluid accumulation in the body or limbs causing swelling
• infection of the nose, sinuses, throat, and upper respiratory tract, cold (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi
• depression, anxiety, sleep disorders, nervousness

Common adverse effects detectable in blood tests:

• increased blood glucose (sugar) concentration
• decreased number of white blood cells
• decreased neutrophil count
• decreased albumin concentration in blood
• decreased haemoglobin concentration
• increased bilirubin concentration in blood (a substance produced by the liver)
• changes in enzymes controlling blood coagulation

Uncommon adverse effects
May occur in up to 1 in 100 patients:

• pain during urination
• cardiac rhythm disorders (QT interval prolongation)
• gastroenteritis (stomach flu), sore throat
• blisters or ulcers in the mouth, gastritis
• skin changes, including discolouration, peeling, redness, itching, skin lesions, and night sweats
• blood clots in the vein bringing blood to the liver (possible liver and (or) gastrointestinal damage)
• abnormal blood clotting in small blood vessels with kidney failure
• rash, bruising at the injection site, chest discomfort
• decreased number of red blood cells (anaemia) due to excessive destruction of red blood cells (haemolytic anaemia)
• confusion, agitation
• liver failure

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Eltrombopag Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton after "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the wastewater system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Eltrombopag Krka contains

• The active substance is eltrombopag. Eltrombopag Krka 25 mg film-coated tablets: Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag. Eltrombopag Krka 50 mg film-coated tablets: Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag. Eltrombopag Krka 75 mg film-coated tablets: Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag.
• The other ingredients are: tablet core: povidone, microcrystalline cellulose, mannitol, hydroxypropylcellulose, sodium carboxymethyl starch (type A), magnesium stearate. tablet coating: hypromellose, macrogol, talc, titanium dioxide (E 171), iron oxide red (E 172) (only for 50 mg and 75 mg), iron oxide yellow (E 172) (only for 50 mg), and indigo carmine (E 132) (only for 50 mg and 75 mg). See section 2 "Eltrombopag Krka contains sodium".

What Eltrombopag Krka looks like and contents of the pack
Eltrombopag Krka 25 mg film-coated tablets are round, biconvex, white, with engraved "25" on one side.
Eltrombopag Krka 50 mg film-coated tablets are round, biconvex, brown, with engraved "50" on one side.
Eltrombopag Krka 75 mg film-coated tablets are round, biconvex, pink, with engraved "75" on one side.
Eltrombopag Krka is available in a cardboard box containing 14, 28, 56 or 84 film-coated tablets in calendar blisters, and in multipacks containing 84 film-coated tablets (3 packs of 28) in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Manufacturer
Elpen Pharmaceutical Co. Inc.
95 Marathonos Ave.
19009 Pikermi, Attiki
Greece
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
TAD Pharma GmbH
Heinz-Lohmann-Strasse 5
27472 Cuxhaven
Germany

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

For further detailed information about this medicinal product, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warszawa
Poland
Tel. 22 57 37 500