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, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, 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. Important information 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 clotting 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 that patients with immune thrombocytopenia may notice include petechiae (small, flat, red, round spots under the skin), bruising, nosebleeds, bleeding gums, and difficulty stopping bleeding after cuts or injuries.

• Eltrombopag Krka may also be used to treat low platelet counts (thrombocytopenia) in adult patients with chronic hepatitis C virus (HCV) infection who have difficulties due to adverse reactions during interferon-based therapy. Many patients with hepatitis C have low platelet counts, not only due to the disease itself but also as a result of 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 higher risk of experiencing 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 blood clots, or if there is a family history of blood clots. The risk of blood clots 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 determines that the expected benefits outweigh the risk of blood clots.
• if the patient has cataracts (clouding of the eye lens)
• if the patient has other blood disorders, such as myelodysplastic syndrome (MDS). Before starting treatment with Eltrombopag Krka, the doctor will perform tests to rule out this condition. If the patient has MDS, treatment with Eltrombopag Krka may worsen the disease. ➔ 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 routinely undergo ophthalmological examinations, the doctor should schedule regular eye exams. These may also detect any bleeding in or around the retina (the light-sensitive layer at the back of the eye).
Regular monitoring will be required
Before starting treatment with Eltrombopag Krka, the doctor will perform blood tests to assess 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 and alanine aminotransferase and aspartate aminotransferase. If the patient is receiving interferon-based therapy concurrently with Eltrombopag Krka for low platelet count associated with hepatitis C, some liver conditions may worsen.
Before starting treatment with Eltrombopag Krka and periodically during therapy, 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 information in section 4 of this leaflet “ Liver disorders ”.
Monitoring platelet count
If the patient stops taking Eltrombopag Krka, there is a likelihood that low platelet count will recur within a few days. Platelet count will be monitored, and the treating doctor will discuss appropriate precautions with the patient.
Very high platelet count may increase the risk of blood clots. However, blood clots may also occur even when platelet count is normal or low. The treating doctor will adjust the dose of Eltrombopag Krka to prevent excessive increase in platelet count.

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

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

Bone marrow examinations
In patients with bone marrow disorders, medicines such as Eltrombopag Krka may worsen these conditions. Changes in 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 concurrently 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 perform heart examinations during treatment with Eltrombopag Krka, including electrocardiography (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 chronic hepatitis C.
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 medicines used to treat indigestion, heartburn, stomach ulcers (see also “ When to take the medicine ” in section 3)
• medicines known as 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 the treatment of cancer ➔ Consult your doctor if the patient is taking any of the medicines listed above. Some of these 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 medicines the patient is taking and recommend changes if necessary.

If the patient is taking anticoagulant medicines, there is an increased risk of bleeding. 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 drinks, as 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 the doctor specifically recommends it.
The effect of Eltrombopag Krka when used 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 operating machinery
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 take Eltrombopag Krka

This medicine should always be taken as prescribed by your 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 physician experienced in managing the disease 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 per day.
Patients of East/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 per day.
In the case of hepatitis C
Adults – the usual starting dose in hepatitis C is one 25 mg tablet of Eltrombopag Krka per day.
Patients of East/Southeast Asian origin should start treatment with the same 25 mg dose.
The effect of Eltrombopag Krka may begin within 1 to 2 weeks. Depending on the patient's
response to treatment with Eltrombopag Krka, the doctor may recommend adjusting 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, zinc

Failure to follow these instructions may result in improper absorption of Eltrombopag Krka by the body.

Consult your doctor for further advice regarding suitable foods and drinks.
Taking more Eltrombopag Krka than prescribed
Contact your doctor or pharmacist immediately. If possible, show them the medicine’s packaging
or this leaflet. The patient’s condition will be monitored to detect any adverse effects and to provide
appropriate treatment without delay.
If a dose of Eltrombopag Krka is missed
Take the next dose at the usual time. Do not take more than one dose of Eltrombopag Krka per day.
Stopping Eltrombopag Krka treatment
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 using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Symptoms to watch for: seek medical advice
Severe adverse reactions may occur in patients treated with Eltrombopag Krka for primary immune
thrombocytopenia or thrombocytopenia associated with hepatitis C. 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, which may be worsened by medicines such as
Eltrombopag Krka. Sudden blockage of a blood vessel by a blood clot is an uncommon adverse reaction 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), abdominal swelling, blood in stool.

Liver problems
Eltrombopag Krka may cause changes detectable in blood tests, which may indicate liver damage.
Liver problems (increased liver enzyme activity in blood tests) are common and may affect up to 1 in 10 patients.
Other liver-related 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 treatment with Eltrombopag Krka. Low platelet count may increase the risk of bleeding or bruising. Your doctor will monitor your platelet count for at least 4 weeks after stopping Eltrombopag Krka.
➔ Inform your doctor if the patient develops bruising or bleeding after stopping Eltrombopag Krka.
Some patients may experience gastrointestinal bleeding after discontinuing peginterferon, ribavirin, and Eltrombopag Krka. Symptoms include:

• black, tarry stools (change in stool colour is an uncommon adverse reaction, which may affect up to 1 in 100 patients)
• blood in stool
• vomiting blood or coffee-ground-like material ➔ Tell your doctor immediately if any of these symptoms occur.

The following adverse reactions have been reported in association with treatment with
Eltrombopag Krka in adult patients with primary immune thrombocytopenia:
Very common adverse reactions
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 reactions detectable in blood tests:

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

Common adverse reactions
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, 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 (inflammation of the gums)
• 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 presence of air bubbles (symptoms of protein in urine)
• high body temperature, feeling of heat
• chest pain
• feeling of weakness
• difficulty sleeping, depression
• migraine
• impaired vision
• sensation of spinning (dizziness)
• flatulence

Common adverse reactions detectable in blood tests:

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

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

• allergic reaction
• interruption of blood flow to part of the heart
• sudden shortness of breath, especially combined with acute chest pain and (or) rapid breathing, which may indicate 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 venous thrombosis
• yellowing of the skin and (or) abdominal pain, which may indicate bile duct obstruction, liver disease or drug-induced liver injury (see "Liver problems" above in section 4)
• drug-induced liver injury
• rapid heartbeat, irregular heartbeat, bluish skin colour, cardiac arrhythmias (prolonged QT interval), 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 opacity (cataract), retinal haemorrhage, dry eyes
• nose, throat and sinus disorders, breathing disorders during sleep
• blisters or ulcers in the mouth and throat
• loss of appetite
• gastrointestinal disorders including frequent bowel movements, food poisoning, blood in stool, bloody vomiting
• bleeding from the rectum, change in stool colour, abdominal distension, constipation
• oral disorders, including dry or painful mouth, tongue pain, bleeding gums, oral discomfort
• sunburn
• feeling of heat, 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 discolouration, peeling, redness, itching and sweating
• muscle weakness
• rectal and colon cancer

Uncommon adverse reactions detectable in laboratory tests:

• changes in 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 number of neutrophilic band granulocytes
• 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 reactions have been reported in association with treatment with
Eltrombopag Krka in children (aged 1 to 17 years) with ITP:
If these adverse reactions worsen, tell your doctor, pharmacist or nurse.
Very common adverse reactions
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 reactions
May occur in up to 1 in 10 children:

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

The following adverse reactions have been reported in association with treatment with
Eltrombopag Krka in combination with peginterferon and ribavirin in patients with hepatitis C:
Very common adverse reactions
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
• unusual hair loss
• weakness
• flu-like illness
• swelling of hands or feet
• chills

Very common adverse reactions detectable in blood tests:

• decreased number of red blood cells (anaemia)

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

• urinary tract infections
• inflammation of nasal passages, throat, oral cavity, flu-like symptoms, dry mouth, pain or inflammation of the mouth, toothache
• weight loss
• sleep disorders, abnormal drowsiness, depression, anxiety
• dizziness, concentration and memory disturbances, mood changes
• brain dysfunction due to liver damage
• tingling or numbness in hands or feet
• fever, headache
• visual disturbances, including: lens opacity (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, abdominal distension, 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 injury (see above "Liver problems" in section 4)
• skin changes, including: rash, dry skin, skin eruptions, skin 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 reactions detectable in blood tests:

• increased blood glucose (sugar) concentration
• decreased white blood cell count
• 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 reactions
May occur in up to 1 in 100 patients:

• pain during urination
• cardiac arrhythmias (prolonged QT interval)
• 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 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 reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Eltrombopag Krka

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and 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 wastewater 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.
• Other ingredients are: Tablet core: povidone, microcrystalline cellulose, mannitol, hydroxypropylcellulose, sodium carboxymethyl starch (type A), magnesium stearate. Tablet coating: hypromellose, polyethylene glycol, 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 the imprint "25" on one side.
Eltrombopag Krka 50 mg, film-coated tablets are round, biconvex, brown, with the imprint "50" on one side.
Eltrombopag Krka 75 mg, film-coated tablets are round, biconvex, pink, with the imprint "75" on one side.
Eltrombopag Krka is available in cardboard boxes containing 14, 28, 56 or 84 film-coated tablets in calendar blister packs, 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 for marketing in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

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