Eltrombopag Glenmark

Patient Information Leaflet: Information for the User

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

Eltrombopag
Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4. Contents of this leaflet
  1. What Eltrombopag Glenmark is and what it is used for
  2. What you need to know before taking Eltrombopag Glenmark
  3. How to take Eltrombopag Glenmark
  4. Possible side effects
  5. How to store Eltrombopag Glenmark
  6. Contents of the pack and other information

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

Eltrombopag Glenmark contains eltrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists. It is used to help increase the number of platelets in the blood. Platelets are blood cells that help reduce or prevent bleeding.
Eltrombopag Glenmark is used to treat a blood clotting disorder called immune (primary) thrombocytopenia (ITP) in patients (over 1 year of age) 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 in patients with ITP may include petechiae (small flat, round red spots on the skin), bruising, epistaxis (nosebleeds), bleeding gums, and difficulty controlling bleeding in case of cuts or injuries.
Eltrombopag Glenmark may also be used to treat low platelet counts (thrombocytopenia) in patients with hepatitis C virus (HCV) infection, if they have had problems with adverse reactions 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 Glenmark may make it easier for you to complete a full course of antiviral therapy (peginterferon and ribavirin).

2. What you should know before taking Eltrombopag Glenmark

Do not take Eltrombopag Glenmark:

• if you are allergic to eltrombopag or to any of the other ingredients of this medicine

(listed in section 6 “What Eltrombopag Glenmark contains”).
Please check with your doctor if you think this applies to you.
Warnings and precautions
Talk to your doctor before taking Eltrombopag Glenmark:

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

Inform your doctor if any of these situations apply to you.
Eye examination
Your doctor will recommend regular checks for cataracts. If you do not routinely have eye examinations, your doctor will schedule regular eye exams. You may also be monitored for any bleeding in or around the retina (the layer of light-sensitive cells at the back of the eye).
You will need regular blood tests
Before starting Eltrombopag Glenmark, your doctor will perform blood tests to check your blood cells, including platelets. These tests will be repeated at intervals while you are taking the medicine.
Blood tests for liver function
Eltrombopag may alter the results of blood tests that can indicate liver damage – an increase in certain liver enzymes, particularly bilirubin and alanine/aspartate transaminase. If you are receiving interferon-based treatment in combination with Eltrombopag Glenmark 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 Glenmark and during treatment. You may need to stop taking Eltrombopag Glenmark if levels of these enzymes rise too much, or if physical signs of liver damage appear.
Please read the information on ‘Liver problems’ in section 4 of this Leaflet.
Blood tests for platelet count
If you stop taking Eltrombopag Glenmark, your platelet count is likely to decrease again within a few days. Your platelet count will be monitored, and your doctor will advise you on appropriate precautions.
A very high platelet count may increase the risk of blood clots. However, blood clots can also occur with normal or even low platelet counts. Your doctor will adjust the dose of Eltrombopag Glenmark to ensure that your platelet count does not increase too much.
Seek immediate medical help if you experience any of the following signs indicating a blood clot:

• swelling, pain or tenderness in one leg
• sudden onset of shortness of breath, especially together with sharp chest pain or rapid breathing
• abdominal (stomach) pain, bloating of the abdomen, blood in the stools

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

• antacids used to treat indigestion, heartburn or stomach ulcers (see also ‘When to take it’ in section 3)
• medicines called statins, used to lower cholesterol
• certain medicines used to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine, used in transplant patients and in immune disorders
• minerals such as iron, calcium, magnesium, aluminium, selenium and zinc, which may be found in vitamin and mineral supplements (see also “When to take it” in section 3)
• medicines such as methotrexate and topotecan, used to treat cancer

Inform your doctor if you are taking any of these medicines. Some of them cannot be taken with Eltrombopag Glenmark, or you may need a dose adjustment, or the timing of administration may need to be changed. Your doctor will review all the medicines you are taking and, if necessary, suggest appropriate substitutions.
There is an increased risk of bleeding if you are also taking medicines to prevent blood clots. Your doctor will discuss this with you.
If you are taking corticosteroids, danazol and/or azathioprine, you may need to take a lower dose or stop taking them while on Eltrombopag Glenmark.
Eltrombopag Glenmark with food and drink
Do not take Eltrombopag Glenmark with beverages or dairy products such as milk or cheese, 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 Glenmark during pregnancy unless specifically recommended by your doctor. The effect of eltrombopag during pregnancy is not known.

• Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant.
• Use a reliable method of contraception while taking Eltrombopag Glenmark to prevent pregnancy.
• If you become pregnant while being treated with Eltrombopag Glenmark, inform your doctor immediately.

Do not breastfeed while taking Eltrombopag Glenmark. 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 Glenmark may cause dizziness and other side effects that may reduce your ability to concentrate.
Do not drive or operate machinery unless you are certain you are not affected.
Eltrombopag Glenmark contains isomalt and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially ‘sodium-free’.

3. How to take Eltrombopag Glenmark

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

How much to take

For ITP
Adults and children (6 to 17 years of age) – The recommended starting dose for ITP is one 50 mg tablet of Eltrombopag Glenmark daily. If you are of East Asian or South-East Asian origin, you may need to start at a lower dose of 25 mg.
Children (1 to 5 years of age) – The recommended starting dose for ITP is one 25 mg tablet of Eltrombopag Glenmark daily.

For Hepatitis C
Adults – The recommended starting dose for hepatitis C is one 25 mg tablet of Eltrombopag Glenmark daily. If you are of East Asian or South-East Asian origin, you will start with the same dose of 25 mg.

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

How to take the tablets
Swallow the tablet whole with some water.

When to take it
Make sure that

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

you do not consume any of the following:

• foods such as cheese, butter, yoghurt, or ice cream
• milk or milk-based shakes, milk-containing drinks, yoghurt, or cream
• antacids, a type of medicine used for indigestion and heartburn
• certain vitamin and mineral supplements including iron, calcium, magnesium, aluminium, selenium, and zinc.

If you do, the medicine will not be properly absorbed into your body.

For further advice on suitable foods and drinks, speak to your doctor.

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

If you forget to take Eltrombopag Glenmark
Take the next dose at your usual time. Do not take more than one dose of Eltrombopag Glenmark in a day.

If you stop taking Eltrombopag Glenmark
Do not stop taking Eltrombopag Glenmark 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, ask your doctor or pharmacist.

4. Possible side effects

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

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

Liver problems
Eltrombopag Glenmark may cause changes detectable in blood tests that could indicate 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)
• unusually dark-coloured urine
  Inform your doctor immediately.

Bleeding or bruising after stopping treatment
Within two weeks after stopping Eltrombopag Glenmark, platelet counts usually decrease to the level they were before starting Eltrombopag Glenmark. Lower platelet counts may increase the risk of bleeding or bruising. Your doctor will monitor your platelet count for at least 4 weeks after you stop taking this medicine.
Inform your doctor if you experience bleeding or bruising after stopping Eltrombopag Glenmark. Some people have experienced gastrointestinal bleeding after discontinuation.

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

The following side effects have been reported as associated with eltrombopag treatment in adult patients with ITP:
Very common side effects (may affect more than 1 in 10 people)

• nasal, sinus, throat, and upper respiratory tract infections (upper respiratory tract infection)
• cough, cold
• feeling unwell (nausea), diarrhoea
• back pain.

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

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

Common side effects (may affect up to 1 in 10 people)

• influenza, cold sores, pneumonia, irritation and inflammation (swelling) of the sinuses, inflammation (swelling) and infection of the tonsils, lung, sinus, nose, and throat infections, inflammation of the gum tissue, sore throat and pain during swallowing
• loss of appetite
• sleep problems, depression
• decreased skin sensitivity, tingling, prickling or numbness sensation, commonly known as “pins and needles”, drowsiness, headache
• eye problems, including abnormal eye examination, dry eye, blurred vision, decreased vision
• earache, sensation of spinning (vertigo)
• pain, swelling and tenderness in one of the legs (usually calf) with warm skin in the affected area (signs of a blood clot in a deep vein), localized swelling filled with blood from a broken blood vessel (haematoma), hot flushes
• runny nose
• mouth problems including dry mouth, painful mouth, sensitive tongue, bleeding gums, mouth ulcers, toothache, vomiting, abdominal pain, gas/bloating due to digestion
• liver function abnormalities
• skin changes including excessive sweating, itchy rash, red spots, changes in skin appearance, hair loss
• muscle pain, muscle spasm, muscle weakness, bone pain
• foamy, frothy or fizzy-looking urine (signs of protein in the urine)
• heavy menstrual period
• high temperature, feeling of warmth, chest pain, feeling of weakness.

Common side effects that may be evident from blood tests:

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

Uncommon side effects (may affect up to 1 in 100 people)

• skin infection
• rectal and colon cancer
• allergic reaction
• loss of appetite, painful joint swelling due to uric acid (gout)
• lack of interest, mood changes, uncontrollable crying or crying at unexpected times
• balance problems, speech and nervous system dysfunction, tremor, 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
• rapid heartbeat, irregular heartbeat, bluish discolouration of the skin, heart and blood vessel rhythm disorders (QT prolongation) which could be signs of heart problems, interruption of blood flow to part of the heart
• possible pain, swelling and/or redness around a vein which could be signs of blood clot formation in a vein, blood clot, redness
• sudden breathing difficulty, especially if accompanied by acute 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 due to blockage of the pulmonary artery, problems with nose, throat and sinuses, breathing problems during sleep
• mouth problems including dry mouth, painful mouth, painful tongue, bleeding gums, mouth discomfort, mouth and throat blisters/ulcers, digestive system problems including frequent bowel movements, food poisoning, blood in the stool, vomiting blood, rectal bleeding, change in stool colour, abdominal swelling, constipation
• yellowing of the skin and/or abdominal pain which could be signs of bile duct obstruction, liver injury, liver damage due to inflammation (see 'Liver problems' at the beginning of section 4), drug-induced liver damage
• painful or abnormal skin sensations, skin changes including skin discolouration, peeling, redness, itching, and sweating
• muscle weakness
• kidney problems including kidney inflammation, excessive urination at night, kidney failure, white blood cells in urine
• feeling hot, anxiety sensation, bleeding around a catheter (if present) in the skin, redness or swelling around a wound, general malaise, foreign body sensation
• sunburn.

Uncommon side effects that may be evident from laboratory tests:

• changes in red blood cell shape, decrease in red blood cells (anaemia) caused by excessive destruction of red blood cells (haemolytic anaemia), increased myelocytes, increased band neutrophils, presence of immature white blood cells which may indicate certain diseases, increased platelet count, increased haemoglobin level
• decreased calcium levels
• increased blood urea, increased protein levels in urine
• increased albumin levels in blood, increased total protein levels, decreased albumin levels in blood, increased urine pH.

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

• nasal, sinus, throat, and upper airway infections, common cold (upper respiratory tract infection)
• cough
• feeling unwell (nausea), diarrhoea, abdominal pain
• high temperature.

Common side effects (may affect up to 1 in 10 children)

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

The following side effects have been reported as associated 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)

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

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

• decrease in the number of red blood cells (anaemia).

Common side effects (may affect up to 1 in 10 people)

• urinary tract infections, nasal, sinus, throat, and upper airway infections, common cold (upper respiratory tract infection), inflammation of the mucous lining of the bronchi, inflammation of the nasal passages, throat and mouth, flu-like symptoms, dry mouth, painful or inflamed mouth, toothache, fever (influenza), cold sores
• weight loss
• sleep disturbances, abnormal drowsiness, depression, anxiety
• dizziness, problems with concentration and memory, mood changes, decreased brain function due to liver damage, tingling or numbness in hands or feet
• eye problems including clouding of the eye's lens (cataract), dry eye, small yellow deposits in the retina, yellowing of the whites of the eyes, retinal bleeding
• sensation of spinning (vertigo)
• fast or irregular heartbeat (palpitations)
• shortness of breath, cough with phlegm, runny nose, sore throat and discomfort during swallowing
• digestive system problems including vomiting, stomach ache, indigestion, constipation, stomach bloating, taste disturbances, haemorrhoids, stomach pain/discomfort, dilated blood vessels and bleeding in the oesophagus, toothache
• liver problems, including liver tumour, yellowing of the whites of the eyes or skin (jaundice), drug-induced liver damage (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, limb pain (in arms, legs, hands or feet), muscle spasms
• irritability, general feeling of malaise, skin reaction such as redness, swelling and pain at injection site, chest pain and discomfort, fluid accumulation in the body or limbs causing swelling
• depression, anxiety, sleep disturbances, nervousness
• fever, headache.

Common side effects that may be evident from blood tests:

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

Uncommon side effects (may affect up to 1 in 100 people)

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

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Eltrombopag Glenmark

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 that month.
This medicine does not require any special storage conditions.
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 Glenmark contains

• The active substance is eltrombopag olamine.

Eltrombopag Glenmark 12.5 mg: Each film-coated tablet contains eltrombopag olamine
Eltrombopag Glenmark 25 mg: Each film-coated tablet contains eltrombopag olamine
Eltrombopag Glenmark 50 mg: Each film-coated tablet contains eltrombopag olamine
Eltrombopag Glenmark 75 mg: Each film-coated tablet contains eltrombopag olamine

The other components are: microcrystalline cellulose, mannitol, povidone, isomalt (E953),
calcium silicate, sodium starch glycolate, magnesium stearate (tablet core);
hypromellose, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172),
triacetin (tablet coating).

Description of the appearance of Eltrombopag Glenmark and contents of the pack
Eltrombopag Glenmark 12.5 mg film-coated tablets
Orange to brown, round, biconvex, film-coated tablet, imprinted with "I" on one side, approximately 5.5 mm in diameter.
Eltrombopag Glenmark 25 mg film-coated tablets
Dark pink, round, biconvex, film-coated tablet, imprinted with "II" on one side, approximately 8 mm in diameter.
Eltrombopag Glenmark 50 mg film-coated tablets
Pink, round, biconvex, film-coated tablet, imprinted with "III" on one side, approximately 10 mm in diameter.
Eltrombopag Glenmark 75 mg film-coated tablets
Red to brown, round, biconvex, film-coated tablet, imprinted with "IV" on one side, approximately 12 mm in diameter.

Eltrombopag Glenmark 12.5 mg film-coated tablets are available in cartons containing 10, 14, 28, 30 or 84 film-coated tablets in blister packs, or in cartons containing 10x1, 14x1, 28x1, 30x1 or 84x1 film-coated tablets individually blister-packed in unit dose blisters.
Eltrombopag Glenmark 25 mg film-coated tablets are available in cartons containing 10, 14, 28, 30 or 84 film-coated tablets in blister packs, or in cartons containing 10x1, 14x1, 28x1, 30x1 or 84x1 film-coated tablets individually blister-packed in unit dose blisters.
Eltrombopag Glenmark 50 mg film-coated tablets are available in cartons containing 10, 14, 28, 30 or 84 film-coated tablets in blister packs, or in cartons containing 10x1, 14x1, 28x1, 30x1 or 84x1 film-coated tablets individually blister-packed in unit dose blisters.
Eltrombopag Glenmark 75 mg film-coated tablets are available in cartons containing 10, 14, 28, 30 or 84 film-coated tablets in blister packs, or in cartons containing 10x1, 14x1, 28x1, 30x1 or 84x1 film-coated tablets individually blister-packed in unit dose blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Glenmark Arzneimittel GmbH
Industriestr 31
Groebenzell
Bavaria
Germany

Manufacturer(s):
Synthon Hispania S.L.
Calle De Castello 1
Sant Boi De Llobregat
Barcelona
Spain
Synthon B.V.
Microweg 22
Nijmegen, Gelderland, 6545 CM
The Netherlands

This medicinal product is authorized in the European Economic Area Member States
United (Northern Ireland) under the following names:

12.5 mg
NL Eltrombopag Glenmark 12.5 mg tabletten
DK Eltrombopag
ES Eltrombopag Glenmark 12.5 mg comprimidos recubiertos con película EFG
NO Eltrombopag Glenmark
SE Eltrombopag Glenmark
SK Eltrombopag Glenmark 12.5 mg
IT Eltrombopag Glenmark

25 mg
NL Eltrombopag Glenmark 25 mg tabletten
DK Eltrombopag Glenmark
ES Eltrombopag Glenmark 25 mg comprimidos recubiertos con película EFG
NO Eltrombopag Glenmark
PL Eltrombopag Glenmark
SE Eltrombopag Glenmark
SK Eltrombopag Glenmark 25 mg
IT Eltrombopag Glenmark

50 mg
NL Eltrombopag Glenmark 50 mg tabletten
DK Eltrombopag Glenmark
ES Eltrombopag Glenmark 50 mg comprimidos recubiertos con película EFG
NO Eltrombopag Glenmark
PL Eltrombopag Glenmark
SE Eltrombopag Glenmark
SK Eltrombopag Glenmark 50 mg
IT Eltrombopag Glenmark

75 mg
NL Eltrombopag Glenmark 75 mg tabletten
DK Eltrombopag Glenmark
ES Eltrombopag Glenmark 75 mg comprimidos recubiertos con película EFG
NO Eltrombopag Glenmark
SE Eltrombopag Glenmark
SK Eltrombopag Glenmark 75 mg
IT Eltrombopag Glenmark