Eltrombopag Teva

Patient Information Leaflet

Eltrombopag Teva 25 mg film-coated tablets, 50 mg film-coated tablets, 75 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

What is in this leaflet

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

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

Eltrombopag Teva contains eltrombopag, which belongs to a group of medicines known as thrombopoietin receptor agonists. It is used to increase the number of platelets in the blood. Platelets are blood cells that help reduce or prevent bleeding.

• Eltrombopag Teva is used to treat a blood clotting disorder called immune (primary) thrombocytopenia (ITP) in patients aged 1 year and older who have already taken 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 that patients with ITP may notice include: petechiae (small, flat, round red spots under the skin), bruising, epistaxis (nosebleeds), bleeding gums, and difficulty controlling bleeding from cuts or wounds.

• Eltrombopag Teva may also be used to treat low platelet counts (thrombocytopenia) in adults with hepatitis C virus (HCV) infection who have experienced problems with side effects during interferon treatment. Many people with hepatitis C have low platelet counts, not only due to the disease itself but also because of certain antiviral medicines used to treat it. Taking Eltrombopag Teva may help enable completion of a full course of antiviral medicines (peginterferon and ribavirin).

2. What you need to know before taking Eltrombopag Teva

Do not take Eltrombopag Teva:

• if you are allergic to eltrombopag or to any of the other ingredients of this medicine (listed in section 6).
• Check with your doctor if you think this applies to you.

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

• 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 believes that the benefits of taking Eltrombopag Teva 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 clots are common in your family. You may be at increased risk of developing blood clots:
  • if you are elderly
  • if you have to remain bedridden for a prolonged period
  • if you have cancer
  • if you are taking oral contraceptives or hormone replacement therapy
  • if you have recently undergone surgery or suffered a physical injury
  • 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 Teva unless your doctor considers that the expected benefits outweigh the risk 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). Before you start taking Eltrombopag Teva, your doctor will perform tests to check that you do not have this blood disorder. If you have MDS and take Eltrombopag Teva, your condition may worsen. → Inform your doctor if any of these apply to you.

Eye examinations
Your doctor will recommend that you undergo regular check-ups for cataracts. If you do not have routine eye examinations, your doctor will schedule regular tests. You may also be monitored for signs of bleeding inside or around the retina (the layer of light-sensitive cells at the back of the eye).
You will need regular monitoring
Before starting Eltrombopag Teva, your doctor will perform blood tests to monitor your blood cells, including platelets. These tests will be repeated at intervals during treatment.
Blood tests for liver function
Eltrombopag may cause abnormal blood test results that could indicate liver damage

• an increase in certain liver enzymes, particularly bilirubin and alanine/aspartate aminotransferase. If you are receiving interferon-based treatments in combination with Eltrombopag Teva 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 Teva and at regular intervals during treatment. It may be necessary to stop taking Eltrombopag Teva if levels of these substances rise excessively 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 treatment with Eltrombopag Teva, your platelet count is likely to decrease 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 form when platelet count is normal or even low. Your doctor will adjust the dose of Eltrombopag Teva to ensure that your platelet count does not become too high.

Contact a doctor immediately 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 if accompanied by sharp chest pain or rapid breathing
• abdominal (stomach) pain, abdominal swelling, blood in the stools.

Tests to monitor bone marrow
In people with bone marrow problems, medicines such as eltrombopag could worsen the condition. Signs of bone marrow changes may appear as abnormalities in blood test results. Your doctor may also perform tests to monitor
Monitoring for gastrointestinal bleeding
If you are receiving interferon-based treatments in combination with Eltrombopag Teva, you will be monitored for signs of bleeding in the stomach or intestines after stopping Eltrombopag Teva.
Heart monitoring
Your doctor may consider it necessary to monitor your heart during treatment with Eltrombopag Teva and may perform an electrocardiogram (ECG).
Elderly patients (aged 65 years or older)
There is limited data on the use of eltrombopag in patients aged 65 years or older. Caution should be exercised when administering Eltrombopag Teva to patients aged 65 years or older.
Children and adolescents
Eltrombopag Teva is not recommended for children under 1 year of age with ITP. Also, it is not recommended for people under 18 years of age with low platelet count due to hepatitis C.
Other medicines and Eltrombopag Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription and vitamins.
Some commonly used medicines interact with Eltrombopag Teva, including prescription and over-the-counter medicines and minerals. These include:

• antacid medicines 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 used to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine used in the context of organ transplants or immune disorders
• minerals such as iron, calcium, magnesium, aluminium, selenium and zinc, which may be present 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 should not be taken with Eltrombopag Teva, or you may need to adjust the dose or change the timing of administration. Your doctor will review the medicines you are taking and, if necessary, suggest a suitable alternative.

If you are also taking medicines to prevent blood clots, your risk of bleeding will be higher. 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 Teva.
Eltrombopag Teva with food and drinks
Do not take Eltrombopag Teva with food or drinks containing milk, 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 Teva during pregnancy, unless specifically recommended by your doctor. The effect of eltrombopag during pregnancy is not known.

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

Do not breastfeed while taking Eltrombopag Teva. It is not known whether eltrombopag passes into breast milk.
➔ If you are breastfeeding or planning to breastfeed, inform your doctor.
Driving and using machines
Eltrombopag Teva may cause dizziness and other side effects that may reduce alertness.
➔ Do not drive or operate machinery unless you are certain that you are not affected by these symptoms.
Eltrombopag Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Eltrombopag Teva

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag Teva unless your doctor or pharmacist advises you to do so. While taking Eltrombopag Teva, you will be monitored by a doctor experienced in the treatment of your condition.

How much to take

For ITP

Adults and children (6 to 17 years): the recommended starting dose for ITP is one 50 mg tablet of Eltrombopag Teva once 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): the recommended starting dose for ITP is one 25 mg tablet of Eltrombopag Teva once daily.

For hepatitis C

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

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

How to take the tablets

Swallow the tablet with some water.

The 25 mg tablet of Eltrombopag Teva may be divided into two equal doses.

The 50 mg tablet of Eltrombopag Teva may be divided into two equal doses.

When to take it

Make sure that –

• in the 4 hours before taking Eltrombopag Teva
• and in the 2 hours after taking Eltrombopag Teva

you do not consume the following:

• Dairy products such as cheese, butter, yoghurt, or ice cream
• Milk or milk-based smoothies, milk-containing drinks, yoghurt, or cream
• Antacids, a type of medicine for indigestion and heartburn
• certain mineral and vitamin supplements including iron, calcium, magnesium, aluminium, selenium, and zinc

Otherwise, the medicine will not be properly absorbed into your body.

Taking Eltrombopag Teva

4 hours before
… and 2 hours
after taking
Eltrombopag
Teva
NO dairy products, antacids, or mineral
supplements
For further advice on suitable foods and drinks, please consult your doctor.

If you take more Eltrombopag Teva 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 will be given appropriate treatment immediately.

If you forget to take Eltrombopag Teva

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

If you stop taking Eltrombopag Teva

Do not stop taking Eltrombopag Teva without talking 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 everyone gets them.
Symptoms requiring attention: consult a doctor
People taking Eltrombopag Teva for ITP or low platelet count due to hepatitis C may develop signs of potentially serious side effects. If you
develop these symptoms, it is important to inform your doctor.
Increased risk of blood clots
Some people may have a higher risk of blood clots, and medicines such as eltrombopag could worsen this problem. Sudden blockage of a blood vessel due to a blood clot is an uncommon side effect and may affect up to 1 in 100 people.

Seek immediate medical help if you develop signs and symptoms of a blood clot,
for example:

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

Liver problems
Eltrombopag may cause changes detectable in blood tests, which could 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 experience any of the following signs of liver problems:

• yellowing of the skin or whites of the eyes (jaundice)
• urine of an unusually dark colour
• inform your doctor immediately.

Bleeding or bruising after stopping treatment
Within two weeks of stopping treatment with Eltrombopag Teva, platelet count usually returns to the level seen before starting treatment. 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 stopping treatment with Eltrombopag Teva.
→ Inform your doctor if you experience bleeding or bruising after stopping Eltrombopag Teva.
Some people may experience bleeding in the gastrointestinal tract after stopping the medication:

• black, tarry stools (change in stool colour is an uncommon side effect that may affect up to 1 in 100 people)
• blood in the stool
• vomiting blood or material that looks like coffee grounds → Inform your doctor immediately if you experience any of these symptoms.

The following side effects have been reported with eltrombopag treatment in
adults with ITP:
Very common side effects
May affect more than 1 in 10 people:

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

Very common side effects detectable in blood tests:

• increased liver enzymes (alanine aminotransferase (ALT)).

Common side effects
May affect up to 1 in 10 people:

• muscle pain, muscle cramps, muscle weakness
• bone pain
• heavy menstrual periods
• sore throat and difficulty swallowing
• eye problems including abnormal eye tests, dry eyes, eye pain and blurred vision
• vomiting
• influenza
• cold sores
• pneumonia
• irritation and inflammation (swelling) of the sinuses
• inflammation (swelling) and infection of the tonsils
• infection of the lungs, sinuses, nose and throat
• inflammation of the gum tissue
• loss of appetite
• tingling, prickling or numbness sensation, commonly known as “pins and needles”
• decreased skin sensitivity
• drowsiness
• ear pain
• pain, swelling and tenderness in one leg (usually calf) with warm skin in the affected area (signs of a blood clot in a deep vein)
• localized swelling filled with blood due to rupture of a blood vessel (haematoma)
• hot flushes
• mouth problems including dry mouth, mouth pain, sore tongue, bleeding gums, mouth ulcers
• runny nose
• toothache
• abdominal pain
• liver function abnormalities
• skin problems including excessive sweating, irregular and itchy rash, red spots, changes in skin appearance
• hair loss
• foamy, bubbly or frothy urine (signs of protein in the urine)
• high temperature, feeling of warmth
• chest pain
• feeling of weakness
• sleep disorders, depression
• migraine
• decreased vision
• dizziness (vertigo)
• gas/intestinal wind.

Common side effects detectable in 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 in the blood (a substance produced by the liver)
• increased levels of certain proteins.

Uncommon side effects
May affect up to 1 in 100 people:

• allergic reaction
• interruption of blood flow to part of the heart
• sudden breathing failure, especially if accompanied by sharp chest pain and/or rapid breathing, which may be a sign of a blood clot in the lungs (see 'Increased risk of blood clots' at the beginning of section 4)
• loss of function in part of the lung caused by 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)
• liver damage due to medication use
• rapid heartbeat, irregular heartbeat, bluish skin colouration, heart rhythm disorders (QT prolongation), which could be signs of a heart and blood vessel disorder
• blood clot
• redness
• painful swelling of joints caused by uric acid (gout)
• lack of interest, mood changes, uncontrollable crying or crying at unexpected times
• balance problems, speech and nervous system problems, 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's 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 the stool, vomiting with blood
• rectal bleeding, change in stool colour, abdominal swelling, constipation
• mouth problems including dry mouth, painful mouth, painful tongue, bleeding gums, mouth discomfort
• sunburn
• feeling of warmth, feeling of anxiety
• redness or swelling around a wound
• bleeding around a skin catheter (if present)
• foreign body sensation
• kidney problems including kidney inflammation, excessive urination at night, kidney failure, white blood cells in urine
• cold sweating
• general feeling of malaise
• skin infection
• skin changes including discolouration, peeling, redness, itching and sweating
• muscle weakness
• rectal and colon cancer.

Uncommon side 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 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 level.

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

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

Common side effects
May affect up to 1 in 10 children:

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

The following side effects have been reported with eltrombopag treatment in
combination with peginterferon and ribavirin in patients with HCV:
Very common side effects
May affect more than 1 in 10 people:

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

Very common side effects detectable in blood tests:

• decreased number of red blood cells (anaemia)

Common side effects
May affect up to 1 in 10 people:

• urinary tract infection
• inflammation of nasal passages, throat and mouth, flu-like symptoms, dry mouth, painful or inflamed mouth, toothache
• weight loss
• sleep disorders, abnormal drowsiness, depression, anxiety
• dizziness, attention and memory problems, mood changes
• decreased brain function following liver damage
• tingling or numbness in hands or feet
• fever, headache
• eye problems including clouding of the lens (cataract), dry eyes, small yellow deposits in the retina, yellowing of the whites of the eyes
• retinal bleeding
• dizziness (vertigo)
• fast or irregular heartbeat (palpitations), shortness of breath
• productive cough, runny nose, influenza, cold sores, sore throat and difficulty swallowing
• digestive problems including vomiting, stomach ache, indigestion, constipation, bloated stomach, 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), liver damage due to medicines (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 reactions 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 disorders, nervousness.

Common side effects detectable in blood tests:

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

Uncommon side effects
May affect up to 1 in 100 people:

• painful urination
• heart rhythm disorders (QT interval prolongation)
• stomach flu (gastroenteritis), sore throat
• mouth blisters/ulcers, stomach inflammation
• skin changes including colour change, 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 with eltrombopag treatment in
patients with severe aplastic anaemia (SAA):
If these side effects worsen, inform your doctor, pharmacist or nurse.
Very common side effects
May affect more than 1 in 10 people.

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

Very common side effects detectable in blood tests

• abnormal changes in bone marrow cells
• increased liver enzyme levels (aspartate aminotransferase (AST)).

Common side effects
May affect up to 1 in 10 people.

• anxiety
• depression
• feeling cold
• general feeling of malaise
• eye problems including vision problems, blurred vision, clouding of the eye's lens (cataract), spots or deposits in the eye (floaters in the vitreous), dry eyes, eye itching, yellowing of the whites of the eyes or skin
• nosebleeds
• digestive problems including difficulty swallowing, mouth pain, swollen tongue, vomiting, loss of appetite, stomach pain/discomfort, bloated stomach, gas/intestinal wind, constipation, intestinal motility disorders 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 caused by 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
• abnormally coloured urine
• interruption of blood flow to the spleen (splenic infarction)
• runny nose.

Common side effects detectable in blood tests

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

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

• change in skin colour
• darkening of the skin
• liver damage due to medication use.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eltrombopag Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of medicines 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 Teva contains
25 mg film-coated tablets
50 mg film-coated tablets
75 mg film-coated tablets
The other ingredients are: microcrystalline cellulose (PH 101) (E460(i)), mannitol (E421), povidone,
microcrystalline cellulose (PH 102) (E460(i)), sodium carboxymethylstarch (type B), colloidal anhydrous
silica, talc (E553b), magnesium stearate.
Eltrombopag Teva 25 mg film-coated tablets also contain hypromellose (E464), titanium dioxide (E171),
macrogol (E1521).
Eltrombopag Teva 50 mg film-coated tablets also contain hypromellose (E464), titanium dioxide (E171),
macrogol (E1521), yellow iron oxide (E172) and red iron oxide (E172).
Eltrombopag Teva 75 mg film-coated tablets also contain hypromellose (E464), titanium dioxide (E171),
macrogol (E1521), red iron oxide (E172) and black iron oxide (E172).

Description of the appearance of Eltrombopag Teva and contents of the pack
Eltrombopag Teva 25 mg film-coated tablets are round, white, with “25” engraved on one side and a
breakline on the other side.
Eltrombopag Teva 50 mg film-coated tablets are round, light brown, with “50” engraved on one side and
a breakline on the other side.
Eltrombopag Teva 75 mg film-coated tablets are round, pink, with “75” engraved on one side.
Available in aluminium blisters in packs containing 14, 28, 30, or 84 film-coated tablets, or in unit-dose
aluminium blisters in packs containing 14x1, 28x1, 30x1, or 84x1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan
Italy
Manufacturer
Actavis Ltd.
BLB015, BLB016, Bulebel Industrial Estate,
ZTN3000 - Zejtun
Malta