Eltrombopag 50 mg film-coated tablets

• 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

Talk to your doctor before taking Eltrombopag:

• if you have liver problems. People who have low platelet counts as well as advanced chronic (long-term) liver disease are more at risk of side effects, including life-threatening liver damage and 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 blood clots in your veins or arteries, or you know that blood clots are common in your family.
  You may be at higher risk of blood clots:
  • as you get older
  • if you have had to stay in bed for a long time
  • if you have cancer
  • if you are taking the contraceptive birth control pill or hormone replacement therapy
  • if you have recently had surgery or received 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, tell your doctor before starting treatment. You should not take Eltrombopag unless your doctor considers that the expected benefits outweigh the risk of blood clots.
• if you have cataracts (the lens of the eye getting cloudy)
• if you have another blood condition, such as myelodysplastic syndrome (MDS). Your doctor will carry out tests to check that you do not have this blood condition before you start Eltrombopag . If you have MDS and take this medicine, your MDS may get worse.

Tell your doctor if any of these apply to you.

Your doctor will recommend that you are checked for cataracts. If you do not have routine eye-tests your doctor should arrange regular testing. You may also be checked for the occurrence of any bleeding in or around your retina (the light-sensitive layer of cells at the back of the eye).

Before you start taking Eltrombopag , your doctor will carry out blood tests to check your blood cells, including platelets. These tests will be repeated at intervals while you are taking it.

Eltrombopag can cause blood test results that may be signs of liver damage - an increase of some liver enzymes, especially bilirubin and alanine / aspartate transaminases. If you are taking interferon-based treatments together with Eltrombopag to treat low platelet count due to hepatitis C, some liver problems can get worse.

You will have blood tests to check your liver function before you start taking Eltrombopag and at intervals while you are taking it. You may need to stop taking Eltrombopag if the amount of these substances increases too much, or if you get other signs of liver damage.

Read the information ‘Liver problems’ in section 4 of this leaflet.

If you stop taking Eltrombopag, your blood platelet count is likely to become low again within several days. The platelet count will be monitored, and your doctor will discuss appropriate precautions with you.

A very high blood platelet count may increase the risk of blood clotting. However blood clots can also form with normal or even low platelet counts. Your doctor will adjust your dose of Eltrombopag to ensure that your platelet count does not become too high.

Get medical help immediately if you have any of these signs of a blood clot:

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

In people who have problems with their bone marrow, medicines like Eltrombopag could make the problems worse. Signs of bone marrow changes may show up as abnormal results in your blood tests. Your doctor may also carry out tests to directly check your bone marrow during treatment with Eltrombopag.

If you are taking interferon-based treatments together with Eltrombopag you will be monitored for any signs of bleeding in your stomach or intestine after you stop taking this medicine.

Your doctor may consider it necessary to monitor your heart during treatment with Eltrombopag and carry out an electrocardiogram (ECG) test.

There are limited data on the use of eltrombopag in patients aged 65 years and older. Care should be taken when using Eltrombopag if you are aged 65 years or above.

Eltrombopag is not recommended for children aged under 1 year who have ITP. It is also not recommended for people under 18 years with low platelet counts due to hepatitis C. Eltrombopag is also available as a powder for oral suspension, for children and patients who are unable to swallow hard tablets.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without prescription and vitamins.

Some everyday medicines interact with eltrombopag – including prescription and non-prescription medicines and minerals. These include:

• antacid medicines to treat indigestion, heartburn or stomach ulcers (see also ‘When to take it’ in section 3)
• medicines called statins, to lower cholesterol
• some medicines to treat HIV infection, such as lopinavir and/or ritonavir
• ciclosporin used in the context of transplantations or immune diseases
• 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, to treat cancer.

Talk to your doctor if you take any of these. Some of them are not to be taken with Eltrombopag, or the dose may need adjusting, or you may need to alter the timing of when you take them. Your doctor will review the medicines you are taking, and suggest suitable replacements if necessary.

If you are also taking medicines to prevent blood clots there is a greater risk of bleeding. 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 to stop taking them while you are taking Eltrombopag.

Do not take Eltrombopag with dairy foods or drinks as the calcium in dairy products affects the absorption of the medicine. For more information, see ‘When to take it’ in section 3.

Don’t use Eltrombopag if you are pregnant unless your doctor specifically recommends it. The effect of eltrombopag during pregnancy is not known.

• Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
• Use a reliable method of contraception while you’re taking Eltrombopag, to prevent pregnancy.
• If you do become pregnant during treatment with Eltrombopag, tell your doctor.

Don’t breast-feed while you are taking Eltrombopag. It is not known whether eltrombopag passes into breast-milk.

If you are breast-feeding or planning to breast-feed, tell your doctor.

Eltrombopag can make you dizzy and have other side effects that make you less alert.

Don’t drive or use machines unless you are sure you’re not affected.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

For ITP

Adults and children (6 to 17 years) – the usual starting dose for ITP is one 50 mg tablet of Eltrombopag a day.

If you are of East-/Southeast-Asian origin you may need to start at a lower dose of 25 mg.

Children (1 to 5 years) — the usual starting dose for ITP is one 25 mg tablet of Eltrombopag a day. Eltrombopag is also available as a powder for oral suspension, for children and patients who are unable to swallow hard tablets.

For hepatitis C

Adults - the usual starting dose for hepatitis C is one 25 mg tablet of Eltrombopag a day.

If you are of East-/Southeast-Asian origin you will start on the same 25 mg dose.

Eltrombopag may take 1 to 2 weeks to work. Based on your response to Eltrombopag your doctor may recommend that your daily dose is changed.

Swallow the tablet whole, with some water.

Make sure that

• in the 4 hours before you take Eltrombopag
• and the 2 hours after you take Eltrombopag

you don’t consume any of the following:

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

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

For more advice about suitable foods and drinks, talk to your doctor.

Contact a doctor or pharmacist immediately. If possible show them the pack, or this leaflet. You will be monitored for any signs or symptoms of side effects and given appropriate treatment immediately.

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

Don’t stop taking Eltrombopag without talking to your doctor. If your doctor advises you to stop treatment, your platelet count will then be checked each week for four weeks. See also ‘Bleeding or bruising after you stop treatment’ in section 4.

People taking eltrombopag for either ITP or low blood platelet counts due to hepatitis C could develop signs of potentially serious side effects. It is important to tell a doctor if you develop these symptoms.

Higher risk of blood clots

Certain people may have a higher risk of blood clots, and medicines like Eltrombopag could make this problem worse. The sudden blocking of a blood vessel by a blood clot is an uncommon side effect and may affect up to 1 in 100 people.

Get medical help immediately if you develop signs and symptoms of a blood clot, such as:

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

Liver problems

Eltrombopag can cause changes that show up in blood tests, and may be signs of liver damage. Liver problems (increased enzymes showing up 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 have either of these signs of liver problems:

• yellowing of the skin or the whites of the eyes (jaundice)
• unusually dark-coloured urine

tell your doctor immediately.

Bleeding or bruising after you stop treatment

Within two weeks of stopping Eltrombopag, your blood platelet count will usually drop back down to what it was before starting Eltrombopag. The lower platelet count may increase the risk of bleeding or bruising. Your doctor will check your platelet count for at least 4 weeks after you stop taking this medicine.

Tell your doctor if you have any bleeding or bruising after stopping Eltrombopag.

Some people have bleeding in the digestive system after they stop taking peginterferon, ribavirin, and eltrombopag. Symptoms include:

• black tarry stools (discoloured bowel movements are a uncommon side effect that may affect up to 1 in 100 people)
• blood in your stools
• vomiting blood or something that looks like coffee grounds

Tell your doctor immediately if you have any of these symptoms.

Very common side effects

These may affect more than 1 in 10 people:

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

Very common side effects that may show up in blood tests:

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

Common side effects

These may affect up to 1 in 10 people:

• muscle pain, muscle spasm, muscle weakness
• bone pain
• heavy menstrual period
• sore throat and discomfort when swallowing
• eye problems including abnormal eye test, dry eye, eye pain and blurred vision
• vomiting
• flu (influenza)
• cold sore
• 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
• feeling of tingling, prickling or numbness, commonly called “pins and needles”
• decreased skin sensations
• feeling drowsy
• ear pain
• pain, swelling and tenderness in one of your legs (usually the calf) with warm skin in the affected area (signs of a blood clot in a deep vein)
• localised swelling filled with blood from a break in a blood vessel (haematoma)
• hot flushes
• mouth problems including dry mouth, sore mouth, sensitive tongue, bleeding gums, mouth ulcers
• runny nose
• toothache
• abdominal pain
• abnormal liver function
• skin changes including excessive sweating, itching bumpy rash, red spots, changes in appearance of the skin
• hair loss
• foamy, frothy or bubbly-looking urine (signs of protein in urine)
• high temperature, feeling hot
• chest pain
• feeling weak
• problems sleeping, depression
• migraine
• decreased vision
• spinning sensation (vertigo)
• digestive wind/gas

Common side effects that may show up in blood test:

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

Uncommon side effects

These may affect up to 1 in 100 people:

• allergic reaction
• interruption of blood supply to part of the heart
• sudden shortness of breath, especially when accompanied with sharp pain in the chest and /or 8 rapid breathing, which could be signs of a blood clot in the lungs (see ‘Higher risk of blood clots’ earlier in section 4)
• the loss of function of part of the lung caused by a blockage in the lung artery
• possible pain, swelling, and/or redness around a vein which could be signs of blood clot in a vein
• yellowing of the skin and/or abdominal pain which could be signs of a blockage in the bile tract, lesion on liver, liver damage due to inflammation (see ‘Liver problems’ earlier in section 4)
• liver injury due to medication
• heart beating faster, irregular heartbeat, bluish discolouration of the skin, disturbances of heart rhythm (QT prolongation) which could be signs of a disorder related to the heart and the blood vessels
• blood clot
• flushing
• painful swollen joints caused by uric acid (gout)
• lack of interest, mood changes, crying that is difficult to stop, or occurs at unexpected times
• problems with balance, speech and nerve function, shaking
• painful or abnormal skin sensations
• paralysis on one side of the body
• migraine with aura
• nerve damage
• dilation or swelling of blood vessels that cause headache
• eye problems including increased production of tears, cloudy lens in the eye (cataract), bleeding of the retina, dry eyes
• problems with the nose, throat and sinuses, breathing problems when sleeping
• mouth and throat blisters/sores
• loss of appetite
• digestive system problems including frequent bowel movements, food poisoning, blood in stool, vomiting of blood
• rectal bleeding, change in stool colour, abdominal bloating, constipation
• mouth problems, including dry or sore mouth, tongue pain, bleeding gums, discomfort in mouth
• sunburn
• feeling hot, feeling anxious
• redness or swelling around a wound
• bleeding around a catheter (if present) into the skin
• sensation of a foreign body
• kidney problems including inflammation of the kidney, excessive urination at night, kidney failure, white cells in urine
• cold sweat
• generally feeling unwell
• infection of the skin
• skin changes including skin discolouration, peeling, redness, itching and sweating
• muscular weakness
• cancer of rectum and colon

Uncommon side effects that may show up in laboratory tests:

• changes in the shape of red blood cells
• presence of developing white blood cells which may be indicative of certain diseases
• increased number of platelets
• decreased levels of calcium
• 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
• increased levels of protein in urine
• increased levels of blood albumin
• increased levels of total protein
• decreased levels of blood albumin
• increased pH of urine
• increased level of haemoglobin

If these side effects become severe, please tell your doctor, pharmacist or nurse.

Very common side effects

These may affect more than 1 in 10 children:

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

Common side effects

These may affect up to 1 in 10 children:

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

Very common side effects

These may affect more than 1 in 10 people:

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

Very common side effects that may show up in blood tests:

• decreased number of red blood cells (anaemia)

Common side effects

These may affect up to 1 in 10 people

• infection of the urinary system
• inflammation of the nasal passages, throat and mouth, flu-like symptoms, dry mouth, sore or inflamed mouth, toothache
• weight loss
• sleep disorders, abnormal drowsiness, depression, anxiety
• dizziness, problems with attention and memory, change in mood
• decreased brain function further to liver injury
• tingling or numbness of the hands or feet
• fever, headache
• eye problems, including cloudy lens in the eye (cataract), dry eye, small yellow deposits in the retina, yellowing of the whites of the eye
• bleeding of the retina • spinning sensation (vertigo)
• fast or irregular heartbeat (palpitations), shortness of breath
• cough bringing up phlegm, runny nose, flu (influenza), cold sore, sore throat and discomfort when swallowing
• digestive system problems, including vomiting, stomach pain, indigestion, constipation, swollen stomach, taste disturbances, piles (haemorrhoids), stomach pain/discomfort, swollen blood vessels and bleeding in the gullet (oesophagus)
• toothache
• liver problems, including tumour in the liver, yellowing of the whites of the eyes or skin (jaundice), liver injury due to medication (see ‘Liver problems’ earlier in section 4)
• skin changes, including rash, dry skin, eczema, redness of the skin, itching, excessive sweating, unusual skin growths, hair loss
• joint pain, back pain, bone pain, pain in extremities (arms, legs, hands or feet), muscle spasms
• irritability, generally feeling unwell, skin reaction such as redness or swelling and pain at the site of injection, chest pain and discomfort, build-up of fluid in the body or extremities causing swelling
• infection in the nose, sinuses, throat and upper airways, common cold (upper respiratory tract infection), inflammation of mucous membrane lining the bronchi
• depression, anxiety, sleep problems, nervousness

Common side effects that may show up in blood tests:

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

Uncommon side effects

(may affect up to 1 in 100 people)

• painful urination
• disturbances of heart rhythm (QT prolongation)
• stomach flu (gastroenteritis), sore throat
• mouth blisters/sores, inflammation of the stomach
• skin changes including change in colour, peeling, redness, itching, lesion and night sweats
• blood clots in a vein to the liver (possible liver and/or digestive system damage)
• abnormal blood clotting in small blood vessels with kidney failure
• rash, bruising at the injection site, chest discomfort
• decreased number of red blood cells (anaemia) caused by excessive destruction of red blood cells (haemolytic anaemia)
• confusion, agitation
• liver failure

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.co.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is eltrombopag olamine.
  Eltrombopag 12.5 mg: Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg eltrombopag.
  Eltrombopag 25 mg: Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag.
  Eltrombopag 50 mg: Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag.
  Eltrombopag 75 mg: Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg eltrombopag.
• The other ingredients are: cellulose microcrystalline, mannitol, povidone, isomalt (E 953), calcium silicate, sodium starch glycolate, magnesium stearate (tablet core); hypromellose, titanium dioxide (E171), iron oxide red (E 172), iron oxide yellow (E 172), triacetin (tablet coating).

Eltrombopag 12.5 mg are orange to brown, round, biconvex film-coated tablets with with “I” debossed on one side and with a diameter of approximately 5.5 mm.

Eltrombopag 25 mg are dark pink, round, biconvex film-coated tablet with with “II” debossed on one side and with a diameter of approximately 8 mm.

Eltrombopag 50 mg are pink, round, biconvex film-coated tablet with with “III” debossed on one side and with a diameter of approximately 10 mm.

Eltrombopag 75 mg are red to brown, round, biconvex film-coated tablet with with “IV” debossed on one side and with a diameter of approximately 12 mm.

Eltrombopag 12.5 mg is available in boxes containing 10, 14, 28, 30 or 84 film-coated tablets packed in blisters, or boxes containing 10x1, 14x1, 28x1, 30x1 or 84x1 film-coated tablets packed in unit-dose blisters.

Eltrombopag 25 mg is available in boxes containing 10, 14, 28, 30 or 84 film-coated tablets packed in blisters, or boxes containing 10x1, 14x1, 28x1, 30x1 or 84x1 film-coated tablets packed in unit-dose blisters.

Eltrombopag 50 mg is available in boxes containing 10, 14, 28, 30 or 84 tablets packed in film-coated blisters, or boxes containing 10x1, 14x1, 28x1, 30x1 or 84x1 film-coated tablets packed in unit-dose blisters.

Eltrombopag 75 mg is available in boxes containing 10, 14, 28, 30 or 84 tablets packed in film-coated blisters, or boxes containing 10x1, 14x1, 28x1, 30x1 or 84x1 film-coated tablets packed in unit-dose blisters.

Not all pack sizes may be marketed.