Eltrombopag sandoz

Package leaflet: Information for the user

Eltrombopag Sandoz, 12.5 mg, film-coated tablets
Eltrombopag Sandoz, 25 mg, film-coated tablets
Eltrombopag Sandoz, 50 mg, film-coated tablets
Eltrombopag Sandoz, 75 mg, film-coated tablets
Eltrombopagum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person only. Do not pass it on to others. It may harm other people, 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.

Contents of the leaflet:

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

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

Eltrombopag Sandoz 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 cells that help reduce or prevent the risk of bleeding.

• Eltrombopag Sandoz is used to treat a blood clotting disorder called immune (idiopathic) thrombocytopenic purpura (ITP) in patients over 1 year of age who have already been treated with other medicines (corticosteroids or immunoglobulins) that have not worked.

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

• Eltrombopag Sandoz 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 the effects of certain antiviral medicines used in treatment. Taking Eltrombopag Sandoz may help patients complete full antiviral treatment (with peginterferon and ribavirin).

2. Important information before using Eltrombopag Sandoz

When not to use Eltrombopag Sandoz

• if the patient is allergic to eltrombopag or any of the other ingredients of this medicine (listed in section 6 under "What Eltrombopag Sandoz contains"). The patient should consult a doctor if they think this applies to them.

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

• if the patient has liver disease. Patients with low platelet counts and/or 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 this medicine outweigh the risks, the patient will be closely monitored during treatment;
• if the patient is at risk of developing blood clots in veins or arteries, or if blood clots are common in the patient's family. 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 cancer
  • if the patient is taking oral contraceptives or hormone replacement therapy
  • if the patient has recently undergone surgery or suffered trauma
  • if the patient is overweight
  • if the patient smokes
  • if the patient has advanced chronic liver disease
    The patient should inform the doctor before starting treatment if any of the above conditions apply. Do not take Eltrombopag Sandoz unless the doctor considers that the expected benefits outweigh the risk of blood clots.
• if the patient has cataracts (clouding of the eye's lens)
• if the patient has other blood disorders, such as myelodysplastic syndrome (MDS). Before starting treatment with Eltrombopag Sandoz, the doctor will perform tests to rule out this condition. If the patient has MDS and takes this medicine, MDS may worsen. The patient should inform the doctor if any of the above situations apply.

Ophthalmological examination
The treating doctor will recommend regular eye examinations to detect cataracts. If the patient does not routinely undergo ophthalmological examinations, the doctor should arrange for regular check-ups. Examinations 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 Eltrombopag Sandoz, the doctor will perform blood tests to assess blood cells, including platelets. These tests will be repeated periodically during treatment.

Blood tests to monitor liver function
Eltrombopag use may lead to blood test results indicating possible liver damage—elevated levels of certain liver enzymes, particularly alanine aminotransferase and aspartate aminotransferase, and increased bilirubin concentration. If the patient is receiving interferon-based therapy concurrently with Eltrombopag Sandoz for thrombocytopenia associated with hepatitis C, certain liver conditions may worsen.
Before starting Eltrombopag Sandoz and periodically during treatment, blood tests to assess liver function will be performed. It may be necessary to discontinue Eltrombopag Sandoz if these substances increase to excessively high levels or if other signs of liver damage occur.
Please refer to the information in section 4 of this leaflet, "Liver disease".

Monitoring of platelet count
If the patient stops taking Eltrombopag Sandoz, platelet counts may decrease again within a few days. Platelet counts will be monitored, and the treating doctor will discuss appropriate precautions with the patient.
A very high platelet count may increase the risk of blood clots. However, blood clots may also occur when platelet counts are normal or low. The treating doctor will adjust the dose of Eltrombopag Sandoz to prevent excessive increases in platelet count.
Seek immediate medical attention if the patient experiences any of the following symptoms of blood clots:

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

Bone marrow examinations
In patients with bone marrow disorders, medicines such as Eltrombopag Sandoz may worsen these conditions. Changes in the bone marrow may be indicated by abnormal blood test results. The treating doctor may recommend direct bone marrow examinations during treatment with Eltrombopag Sandoz.

Tests to detect gastrointestinal bleeding
If the patient is receiving interferon-based therapy concurrently with Eltrombopag Sandoz, they will be monitored for signs of bleeding from the stomach or intestines after stopping Eltrombopag Sandoz treatment.

Heart examinations
The doctor may consider it necessary to monitor the patient's heart during treatment with Eltrombopag Sandoz and may perform an electrocardiogram (ECG).

Elderly patients (65 years and older)
Limited data are available on the use of eltrombopag in patients aged 65 years and older. Caution should be exercised when using Eltrombopag Sandoz in patients aged 65 years and older.

Children and adolescents
Eltrombopag is not recommended for children under 1 year of age with immune thrombocytopenia.
The medicine is also not recommended for patients under 18 years of age with thrombocytopenia due to hepatitis C virus infection.

Eltrombopag Sandoz and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription and vitamins.
Some commonly used medicines interact with Eltrombopag Sandoz—including both prescription and over-the-counter medicines, as well as mineral supplements. These include:

• antacids used to treat indigestion, heartburn, or stomach ulcers (see also "When to take the medicine" in section 3)
• statins, which lower cholesterol levels
• certain medicines used to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine, used in transplant patients or in autoimmune diseases
• minerals 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 the doctor if the patient is taking any of the medicines listed above. Some of these should not be taken while using Eltrombopag Sandoz; others may require dose adjustments or appropriate timing of administration. The doctor will review all medicines the patient is taking and recommend changes if necessary.
If the patient is taking anticoagulant medicines to prevent blood clots, 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 treatment with Eltrombopag Sandoz.

Taking Eltrombopag Sandoz with food and drink
Eltrombopag Sandoz must not be taken with dairy products or dairy-based drinks, as the calcium in these 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 Sandoz during pregnancy unless the doctor specifically advises it. The effect of Eltrombopag Sandoz during pregnancy is unknown.

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

Breastfeeding is not recommended during treatment with Eltrombopag Sandoz. It is not known whether Eltrombopag Sandoz passes into breast milk.
Inform the doctor if the patient is breastfeeding or planning to breastfeed.

Driving and operating machinery
Eltrombopag Sandoz may cause dizziness and other adverse effects that may impair concentration.
Do not drive or operate machinery unless the patient is certain that these symptoms do not occur.

Eltrombopag Sandoz contains isomalt and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
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 Sandoz

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag Sandoz
unless instructed by your doctor or pharmacist. While taking Eltrombopag Sandoz, the patient
will remain under the care of a doctor experienced in managing the disease affecting the patient.

How much medicine to take

In 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 Sandoz once daily.
Patients of East Asian/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 Sandoz once daily.

In chronic hepatitis C
Adults: the usual starting dose in chronic hepatitis C is one 25 mg tablet of Eltrombopag Sandoz
once daily. Patients of East Asian/Southeast Asian origin should start treatment with the same
25 mg dose.

The effect of Eltrombopag Sandoz may begin within 1 to 2 weeks. Depending on the patient's
response to treatment with Eltrombopag Sandoz, the doctor may adjust the daily dose.

How to take the tablets
The tablets should be swallowed whole with water.

When to take the medicine
Make sure that –

• within 4 hours before taking Eltrombopag Sandoz
• and within 2 hours after taking Eltrombopag Sandoz
• the patient does not consume:
• dairy products such as cheese, butter, yoghurt, ice cream
• milk or milk-containing drinks, yoghurts 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 improper absorption of Eltrombopag Sandoz.

Consult your doctor for more information regarding suitable foods and drinks.

Taking more Eltrombopag Sandoz than prescribed
Contact your doctor or pharmacist immediately. If possible, show them the medicine packaging or
this leaflet. The patient's condition will be monitored for any adverse effects, and appropriate
treatment will be given promptly.

If you miss a dose of Eltrombopag Sandoz
Take the next dose at the usual time. Do not take more than one dose of Eltrombopag Sandoz per day.

Stopping Eltrombopag Sandoz
Do not stop taking Eltrombopag Sandoz 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Symptoms to watch for: consult a doctor immediately
In patients treated with Eltrombopag Sandoz for primary immune thrombocytopenia or
thrombocytopenia associated with hepatitis C, symptoms of serious adverse reactions may occur.
It is important to inform your doctor if any of these symptoms appear.

Increased risk of blood clots
Some patients may have an increased risk of blood clots, and medicines such as Eltrombopag
Sandoz may increase this risk. 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 blood clots:

• 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 Sandoz may cause changes detectable in blood tests, which may indicate liver
damage. Liver function abnormalities (increased liver enzyme levels 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 urine
  seek immediate medical advice.

Bleeding or bruising after stopping treatment
Usually within two weeks of stopping Eltrombopag Sandoz, the patient's platelet count decreases
to the level observed before starting treatment with Eltrombopag Sandoz. Low platelet count may
increase the risk of bleeding or bruising. Your doctor will monitor the patient's platelet count for
at least 4 weeks after stopping Eltrombopag Sandoz.
Inform your doctor if bruising or bleeding occurs after stopping Eltrombopag Sandoz.
Some patients may experience gastrointestinal bleeding after discontinuing peginterferon,
ribavirin, and eltrombopag. 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 material resembling coffee grounds
  Inform your doctor immediately if any of these symptoms occur.

The following adverse reactions have been reported as associated with eltrombopag treatment in adult patients with primary immune thrombocytopenia:

Very common adverse reactions (may occur in more than 1 in 10 patients):

• nose, sinus, throat, and upper respiratory tract infections (upper respiratory tract infection)
• cough, common cold
• nausea, diarrhoea
• 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):

• influenza, cold sores, pneumonia, irritation and inflammation (swelling) of sinuses, inflammation (swelling) and infection of tonsils, infection of lungs, sinuses, nose and throat, gingivitis, sore throat and discomfort when swallowing
• loss of appetite
• sleep disturbances, depression
• reduced skin sensation, tingling, pricking, or numbness, drowsiness, migraine
• eye disorders, including abnormal eye test results, dry eyes, eye pain, blurred vision
• ear pain, sensation of spinning (dizziness)
• 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
• nasal discharge
• oral disorders, including dry mouth, mouth pain, tongue sensitivity, bleeding gums, mouth ulcers, toothache, vomiting, abdominal pain, flatulence
• abnormal liver function
• skin changes including excessive sweating, raised itchy rash, red spots, skin appearance changes, hair loss
• muscle pain, muscle cramps, muscle weakness, bone pain
• passing foamy urine with presence of air bubbles (symptoms of protein in urine)
• heavy menstrual bleeding
• high body temperature, feeling of warmth, chest pain, feeling of weakness

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 number of white blood cells (leucocytosis)
• increased uric acid concentration, decreased potassium concentration
• increased liver enzyme activity (aspartate aminotransferase (AspAT)), increased blood bilirubin concentration (a substance produced by the liver)
• increased concentration of certain proteins, increased creatinine concentration
• increased alkaline phosphatase activity

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• skin infection
• colorectal cancer
• allergic reaction
• loss of appetite, painful joint swelling caused by uric acid (gout)
• lack of interest, mood changes, uncontrollable or unexpected crying
• balance, speech and nerve function disorders, tremors, paralysis on one side of the body, migraine with aura, nerve damage, blood vessel dilation or swelling causing headache
• eye disorders, including excessive tearing, clouding of the eye lens (cataract), retinal haemorrhage, dry eyes
• rapid heartbeat, irregular heartbeat, bluish skin discoloration, heart rhythm disorders (QT interval prolongation), which may indicate heart and blood vessel problems, interruption of blood flow to part of the heart
• possible pain, swelling and (or) redness around a vein, which may indicate venous thrombosis, blood clot, redness
• 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 of part of the lung due to blockage of the pulmonary artery, nose, throat and sinus disorders, breathing disorders during sleep
• oral disorders, including dry or painful mouth, tongue pain, bleeding gums, oral discomfort, blisters or ulcers in mouth and throat, gastrointestinal disorders including frequent bowel movements, food poisoning, blood in stool, bloody vomiting, rectal bleeding, change in stool colour, abdominal bloating, constipation
• yellowing of skin and (or) abdominal pain, which may indicate bile duct obstruction, liver disease, liver damage due to inflammation (see "Liver problems" above in section 4), drug-induced liver damage
• painful or abnormal skin sensations, skin changes, including skin discolouration, peeling, redness, itching and sweating
• muscle weakness
• kidney disorders including: kidney inflammation, excessive urination at night, kidney failure, presence of white blood cells in urine
• feeling of warmth, restlessness, bleeding around catheter (if present) into skin, redness or swelling at wound site, general malaise, sensation of foreign body
• sunburn

Uncommon adverse reactions detectable in laboratory tests:

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

The following additional adverse reactions have been reported as associated with eltrombopag treatment in children (aged 1 to 17 years) with ITP:
If these adverse reactions worsen, inform your doctor, pharmacist, or nurse.

Very common adverse reactions (may occur in more than 1 in 10 children):

• nose, sinus, throat, and upper respiratory tract infections, common cold (upper respiratory tract infection)
• cough
• nausea, diarrhoea, abdominal pain
• high body temperature

Common adverse reactions (may occur in up to 1 in 10 children):

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

The following adverse reactions have been reported as associated with eltrombopag treatment in combination with peginterferon and ribavirin in patients with hepatitis C:

Very common adverse reactions (may occur in more than 1 in 10 patients):

• loss of appetite
• headache
• cough
• nausea, diarrhoea
• itching, swelling of hands or feet, unusual hair loss
• muscle pain, muscle weakness
• fever, feeling of fatigue, flu-like illness, weakness, 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, nose, sinus, throat and upper respiratory tract infections, common cold (upper respiratory tract infection), bronchial mucosal inflammation, nasal passage inflammation, throat and oral cavity inflammation, flu-like symptoms, dry mouth, pain or inflammation of oral cavity, toothache, common cold
• 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
• vision disorders, including: clouding of the eye lens (cataract), dry eyes, 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, cough with sputum, runny nose, sore throat and discomfort when swallowing
• gastrointestinal disorders including: vomiting, abdominal pain, indigestion, constipation, abdominal bloating, taste disturbances, haemorrhoids, stomach pain or discomfort, blood vessel swelling and bleeding in the oesophagus, toothache
• liver 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, skin redness, itching, excessive sweating, unusual 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 injection site, chest pain and discomfort, fluid accumulation in the body or limbs causing swelling
• depression, anxiety, sleep disorders, restlessness
• fever, headache

Common adverse reactions detectable in blood tests:

• increased blood sugar (glucose) concentration, decreased number of white blood cells, decreased number of neutrophils, decreased blood albumin concentration, decreased haemoglobin concentration, increased blood bilirubin concentration (a substance produced in the liver), changes in activity of enzymes involved in blood coagulation

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor,
pharmacist, or nurse.
Adverse reactions 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 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 Sandoz

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 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 sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the pack and other information

What Eltrombopag Sandoz contains

• The active substance in Eltrombopag Sandoz is eltrombopag olamine.

Eltrombopag Sandoz 12.5 mg: each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg of eltrombopag.
Eltrombopag Sandoz 25 mg: each film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.
Eltrombopag Sandoz 50 mg: each film-coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag.
Eltrombopag Sandoz 75 mg: each film-coated tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag.
The other ingredients are: microcrystalline cellulose, mannitol, povidone (K29/32), isomalt, calcium silicate, sodium carboxymethyl starch (type A), magnesium stearate (tablet core); hypromellose 2910 (5 mPas), titanium dioxide (E 171), iron oxide red (E 172), triacetin (tablet coating).
Eltrombopag Sandoz 12.5 mg, 25 mg and 50 mg film-coated tablets also contain iron oxide yellow (E 172).

What Eltrombopag Sandoz looks like and contents of the pack
Eltrombopag Sandoz 12.5 mg are round, biconvex film-coated tablets (tablets), orange to brown in colour, imprinted with "I" on one side, approximately 5.5 mm in diameter.
Eltrombopag Sandoz 25 mg are round, biconvex film-coated tablets (tablets), dark pink in colour, imprinted with "II" on one side, approximately 8 mm in diameter.
Eltrombopag Sandoz 50 mg are round, biconvex film-coated tablets (tablets), pink in colour, imprinted with "III" on one side, approximately 10 mm in diameter.
Eltrombopag Sandoz 75 mg are round, biconvex film-coated tablets (tablets), red to brown in colour, imprinted with "IV" on one side, approximately 12 mm in diameter.
Eltrombopag Sandoz 12.5 mg, 25 mg, 50 mg, 75 mg is packed in cardboard boxes containing 10, 14, 28, 30 or 84 film-coated tablets in blister packs or in cardboard boxes containing 10 x 1, 14 x 1, 28 x 1, 30 x 1 or 84 x 1 film-coated tablet in single-dose blisters, or in multipacks containing 84 film-coated tablets (3 packs of 28 film-coated tablets).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
Tel. 22 209 70 00

Manufacturer
Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon Hispania S.L.
c/ Castelló, 1
Sant Boi de Llobregat
08830 Barcelona
Spain

This medicinal product is authorised in the European Economic Area under the following names:

Eltrombopag Sandoz, 12.5 mg
Austria Eltrombopag Sandoz 12.5 mg – Filmtabletten
Croatia Eltrombopag Sandoz 12.5 mg filmom obložene tablete
Cyprus Eltrombopag Sandoz
Estonia Eltrombopag Sandoz
Germany Eltrombopag - 1 A Pharma 12.5 mg Filmtabletten
Greece Eltrombopag/Sandoz
Hungary Eltrombopag Sandoz 12.5 mg filmtabletta
Ireland Eltrombopag Rowex 12.5 mg film-coated tablets
Latvia Eltrombopag Sandoz 12.5 mg apvalkotās tabletes
Lithuania Eltrombopag Sandoz 12.5 mg plėvele dengtos tabletės
Poland Eltrombopag Sandoz
Romania Eltrombopag Sandoz 12.5 mg comprimate filmate
Slovenia Eltrombopag Sandoz 12.5 mg filmsko obložene tablete

Eltrombopag Sandoz, 25 mg
Austria Eltrombopag Sandoz 25 mg – Filmtabletten
Bulgaria Eltrombopag Sandoz/Елтромбопаг Сандоз
Croatia Eltrombopag Sandoz 25 mg filmom obložene tablete
Cyprus Eltrombopag Sandoz
Czech Republic Eltrombopag Sandoz
Estonia Eltrombopag Sandoz
Finland Eltrombopag Sandoz 25 mg tabletti, kalvopäällysteinen
France ELTROMBOPAG SANDOZ 25 mg, comprimé pelliculé
Germany Eltrombopag - 1 A Pharma 25 mg Filmtabletten
Greece Eltrombopag/Sandoz
Hungary Eltrombopag Sandoz 25 mg filmtabletta
Ireland Eltrombopag Rowex 25 mg film-coated tablets
Italy Eltrombopag Sandoz
Latvia Eltrombopag Sandoz 25 mg apvalkotās tabletes
Lithuania Eltrombopag Sandoz 25 mg plėvele dengtos tabletės
Norway Eltrombopag Sandoz
Poland Eltrombopag Sandoz
Romania Eltrombopag Sandoz 25 mg comprimate filmate
Slovakia Eltrombopag Sandoz
Slovenia Eltrombopag Sandoz 25 mg filmsko obložene tablete
Spain Eltrombopag Sandoz 25 mg comprimidos recubiertos con película EFG
Sweden Eltrombopag Sandoz

Eltrombopag Sandoz, 50 mg
Austria Eltrombopag Sandoz 50 mg – Filmtabletten
Bulgaria Eltrombopag Sandoz/Елтромбопаг Сандоз
Croatia Eltrombopag Sandoz 50 mg filmom obložene tablete
Cyprus Eltrombopag Sandoz
Czech Republic Eltrombopag Sandoz
Denmark Eltrombopag Sandoz
Estonia Eltrombopag Sandoz
Finland Eltrombopag Sandoz 50 mg tabletti, kalvopäällysteinen
France ELTROMBOPAG SANDOZ 50 mg, comprimé pelliculé
Germany Eltrombopag - 1 A Pharma 50 mg Filmtabletten
Greece Eltrombopag/Sandoz
Hungary Eltrombopag Sandoz 50 mg filmtabletta
Ireland Eltrombopag Rowex 50 mg film-coated tablets
Italy Eltrombopag Sandoz
Latvia Eltrombopag Sandoz 50 mg apvalkotās tabletes
Lithuania Eltrombopag Sandoz 50 mg plėvele dengtos tabletės
Norway Eltrombopag Sandoz
Poland Eltrombopag Sandoz
Romania Eltrombopag Sandoz 50 mg comprimate filmate
Slovakia Eltrombopag Sandoz
Slovenia Eltrombopag Sandoz 50 mg filmsko obložene tablete
Spain Eltrombopag Sandoz 50 mg comprimidos recubiertos con película EFG
Sweden Eltrombopag Sandoz

Eltrombopag Sandoz, 75 mg
Austria Eltrombopag Sandoz 75 mg – Filmtabletten
Croatia Eltrombopag Sandoz 75 mg filmom obložene tablete
Cyprus Eltrombopag Sandoz
Denmark Eltrombopag Sandoz
Estonia Eltrombopag Sandoz
Finland Eltrombopag Sandoz 75 mg tabletti, kalvopäällysteinen
France ELTROMBOPAG SANDOZ 75 mg, comprimé pelliculé
Germany Eltrombopag - 1 A Pharma 75 mg Filmtabletten
Greece Eltrombopag/Sandoz
Hungary Eltrombopag Sandoz 75 mg filmtabletta
Ireland Eltrombopag Rowex 75 mg film-coated tablets
Italy Eltrombopag Sandoz
Latvia Eltrombopag Sandoz 75 mg apvalkotās tabletes
Lithuania Eltrombopag Sandoz 75 mg plėvele dengtos tabletės
Norway Eltrombopag Sandoz
Poland Eltrombopag Sandoz
Romania Eltrombopag Sandoz 75 mg comprimate filmate
Slovakia Eltrombopag Sandoz
Slovenia Eltrombopag Sandoz 75 mg filmsko obložene tablete
Sweden Eltrombopag Sandoz

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