Revolade - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package Leaflet: Information for the patient

Revolade 12.5 mg film-coated tablets Revolade 25 mg film-coated tablets Revolade 50 mg film-coated tablets Revolade 75 mg film-coated tablets eltrombopag

Read all of this leaflet carefully before you start 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 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 of the side effects talk to your doctor or pharmacist. This includes any possible

side effects not listed in this leaflet. See section 4

What is in this leaflet :

• 1. What Revolade is and what it is used for

• 2. What you need to know before you take Revolade

• 3. How to take Revolade

• 4. Possible side effects

• 5. How to store Revolade

• 6. Contents of the pack and other information

1. What Revolade is and what it is used for

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

• Revolade is used to treat a bleeding disorder called immune (primary) thrombocytope­nia (ITP)

in patients aged 1 year and above who have already taken other medicines (corticosteroids or immunoglobulins), which have not worked.

ITP is caused by a low blood platelet count (thrombocytopenia). People with ITP have an increased risk of bleeding. Symptoms patients with ITP may notice include petechiae (pinpointsized flat round red spots under the skin), bruising, nosebleeds, bleeding gums and not being able to control bleeding if they are cut or injured.

• Revolade can also be used to treat low platelet count (thrombocytopenia) in adults with

hepatitis C virus (HCV) infections, if they have had problems with side effects while on interferon treatment. Many people with hepatitis C have low platelet counts, not only as a result of the disease, but also due to some of the antiviral medicines that are used to treat it. Taking Revolade may make it easier for you to complete a full course of antiviral medicine (peginterferon and ribavirin).

• Revolade may also be used to treat adult patients with low blood counts caused by severe

aplastic anaemia (SAA). SAA is a disease in which the bone marrow is damaged, causing a deficiency of the red blood cells (anaemia), white blood cells (leukopenia) and platelets (thrombocytopenia).

2. What you need to know before you take Revolade

Do not take Revolade

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

• section 6 under ‘What Revolade contains ’).

• ■^ Check with your doctor if you think this applies to you.

Warnings and precautions

Talk to your doctor before taking Revolade:

• 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 Revolade 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 Revolade 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 Revolade. If you have MDS and take Revolade, your MDS may get worse.

■^ Tell your doctor if any of these apply to you.

Eye examinations

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).

You will need regular tests

Before you start taking Revolade, 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.

Blood tests for liver function

Revolade 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 Revolade 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 Revolade and at intervals while you are taking it. You may need to stop taking Revolade 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.

Blood tests for platelet count

If you stop taking Revolade, 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 Revolade 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

Tests to check your bone marrow

In people who have problems with their bone marrow, medicines like Revolade 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 Revolade.

Checks for digestive bleeding

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

Heart monitoring

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

Older people (65 years and above)

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

Children and adolescents

Revolade 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 or severe aplastic anaemia.

Other medicines and Revolade

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 Revolade – 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 Revolade, 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 Revolade.

Revolade with food and drink

Do not take Revolade 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.

Pregnancy and breast-feeding

Don’t use Revolade if you are pregnant unless your doctor specifically recommends it. The effect of

Revolade 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 Revolade, to prevent pregnancy
• If you do become pregnant during treatment with Revolade, tell your doctor.

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

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

Driving and using machines

Revolade 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.

Revolade contains sodium

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

3. How to take Revolade

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Do not change the dose or schedule for taking Revolade unless your doctor or pharmacist advises you to. While you are taking Revolade, you will be under the care of a doctor with specialist experience in treating your condition.

How much to take

For ITP

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

For hepatitis C

Adults - the usual starting dose for hepatitis C is one 25 mg tablet of Revolade a day. If you are of East-/Southeast-Asian origin you will start on the same 25 mg dose.

For SAA

Adults - the usual starting dose for SAA is one 50 mg tablet of Revolade a day. If you are of East-/Southeast-Asian origin you may need to start at a lower dose of 25 mg.

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

How to take the tablets

Swallow the tablet whole, with some water.

When to take it

Make sure that –

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

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.

If you take more Revolade than you should

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.

If you forget to take Revolade

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

If you stop taking Revolade

Don’t stop taking Revolade 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.

If you have any further questions on the use of 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 needing attention: see a doctor

People taking Revolade 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 Revolade 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

Revolade 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 Revolade, your blood platelet count will usually drop back down to what it was before starting Revolade. 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 Revolade.

• ■ ^ Tell your doctor if you have any bleeding or bruising after stopping Revolade.

Some people have bleeding in the digestive system after they stop taking peginterferon, ribavirin, and Revolade. 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.

The following side effects have been reported to be associated with treatment with Revolade in adult patients with ITP:

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

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

The following additional side effects have been reported to be associated with treatment with

Revolade in children (aged 1 to 17 years) with ITP:

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

The following side effects have been reported to be associated with treatment with Revolade in combination with peginterferon and ribavirin in patients with HCV:

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

These 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

The following side effects have been reported to be associated with treatment with Revolade in patients with severe aplastic anaemia (SAA):

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 people.

• cough
• headache
• mouth and throat pain
• diarrhoea
• feeling sick (nausea)
• joint pain (arthralgia)
• pain in extremities (arms, legs, hands and feet)
• dizziness
• feeling very tired
• fever
• chills
• itchy eyes
• blisters in the mouth
• bleeding of the gums
• abdominal pain
• muscle spasms

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

• abnormal changes to the cells in your bone marrow
• increased levels of liver enzymes (aspartate aminotransfera­se (AST))

Common side effects

These may affect up to 1 in 10 people.

• anxiety
• depression
• feeling cold
• generally feeling unwell
• eye problems including vision problems, blurred vision, cloudy lens in the eye (cataract), spots

or deposits in eye (vitreous floaters), dry eye, itchy eye, yellowing of the whites of the eyes or skin

• nose bleed
• digestive system problems including difficulty swallowing, mouth pain, swollen tongue,

vomiting, loss of appetite, stomach pain/discomfort, swollen stomach, digestive wind/gas, constipation, intestinal motility disorder which can cause contipation, bloating, diarrhea and/or above mentioned symptoms, change in stool colour

• fainting
• skin problems including small red or purple spots caused by bleeding into the skin (petechiae)

rash, itching, hives, skin lesion

• back pain
• muscle pain
• bone pain
• weakness (asthenia)
• swelling of the lower limbs due to the accumulation of fluids
• abnormal colored urine
• interruption in blood supply to spleen (splenic infarction)
• runny nose

Common side effects that may show up in the blood tests

• increase in enzymes due to muscle breakdown (creatine phosphokinase)
• accumulation of iron in the body (iron overload)
• decrease in blood sugar levels (hypoglycaemia)
• increased levels of blood bilirubin (a substance produced by the liver)
• decreased levels of white blood cells

Side effects with frequency not known

Frequency cannot be estimated from the available data

• skin discolouration
• darkening of the skin
• liver injury due to medication

Reporting of side effects

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 national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Revolade

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Revolade contains

The active substance in Revolade is eltrombopag.

12.5 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg eltrombopag.

25 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag.

50 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag.

75 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg eltrombopag.

The other ingredients are: hypromellose, macrogol 400, magnesium stearate, mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate, titanium dioxide (E171).

Revolade 12.5 mg and 25 mg film-coated tablets also contain polysorbate 80 (E433).

Revolade 50 mg film-coated tablets also contain iron oxide red (E172) and iron oxide yellow (E172).

Revolade 75 mg film-coated tablets also contain iron oxide red (E172) and iron oxide black (E172).

What Revolade looks like and contents of the pack

Revolade 12.5 mg film-coated tablets are round, biconvex, white, debossed with ‘GS MZ1’ and ‘12.5’ on one side.

Revolade 25 mg film-coated tablets are round, biconvex, white, debossed with ‘GS NX3’ and ‘25’ on one side.

Revolade 50 mg film-coated tablets are round, biconvex, brown, debossed with ‘GS UFU’ and ‘50’ on one side.

Revolade 75 mg film-coated tablets are round, biconvex, pink, debossed with ‘GS FFS’ and ‘75’ on one side.

They are supplied in aluminum blisters in a carton containing 14 or 28 film-coated tablets and multipacks containg 84 (3 packs of 28) film-coated tablets).

Not all pack sizes may be available in your country.

Marketing authorisation holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Lek d.d

Verovskova Ulica 57

Ljubljana 1526

Slovenia

Novartis Farmacéutica SA

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Glaxo Wellcome S.A.

Avenida de Extremadura 3

09400 Aranda de Duero

Burgos

Spain

For any information about this medicine, please

Authorisation Holder:

België/Belgiqu­e/Belgien

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Efcnrapua

Novartis Bulgaria EOOD

Ten: +359 2 489 98 28

Česká republika

Novartis s.r.o.

Tel: +420 225 775 111

Danmark

Novartis Healthcare A/S

Tlf: +45 39 16 84 00

Deutschland

Novartis Pharma GmbH

Tel: +49 911 273 0

Eesti

SIA Novartis Baltics Eesti filiaal

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EMàôa Novartis (Hellas) A.E.B.E. Tql: +30 210 281 17 12	Österreich Novartis Pharma GmbH Tel: +43 1 86 6570
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This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:.

Package Leaflet: Information for the patient

Revolade 25 mg powder for oral suspension eltrombopag

Read all of this leaflet carefully before you start 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 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 of the side effects talk to your doctor or pharmacist. This includes any possible

side effects not listed in this leaflet. See section 4

What is in this leaflet :

• 1. What Revolade is and what it is used for

• 2. What you need to know before you take Revolade

• 3. How to take Revolade

• 4. Possible side effects

• 5. How to store Revolade

• 6. Contents of the pack and other information

Instructions for use

1. What Revolade is and what it is used for

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

• Revolade is used to treat a bleeding disorder called immune (primary) thrombocytope­nia (ITP)

in patients aged 1 year and above who have already taken other medicines (corticosteroids or immunoglobulins), which have not worked.

ITP is caused by a low blood platelet count (thrombocytopenia). People with ITP have an increased risk of bleeding. Symptoms patients with ITP may notice include petechiae (pinpointsized flat round red spots under the skin), bruising, nosebleeds, bleeding gums and not being able to control bleeding if they are cut or injured.

• Revolade can also be used to treat low platelet count (thrombocytopenia) in adults with

hepatitis C virus (HCV) infections, if they have had problems with side effects while on interferon treatment. Many people with hepatitis C have low platelet counts, not only as a result of the disease, but also due to some of the antiviral medicines that are used to treat it. Taking Revolade may make it easier for you to complete a full course of antiviral medicine (peginterferon and ribavirin).

• Revolade may also be used to treat adult patients with low blood counts caused by severe

aplastic anaemia (SAA). SAA is a disease in which the bone marrow is damaged, causing a deficiency of the red blood cells (anaemia), white blood cells (leukopenia) and platelets (thrombocytopenia).

2. What you need to know before you take Revolade

Do not take Revolade

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

• section 6 under ‘What Revolade contains ’).

• ■^ Check with your doctor if you think this applies to you.

Warnings and precautions

Talk to your doctor before taking Revolade:

• 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 Revolade 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 Revolade 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 Revolade. If you have MDS and take Revolade, your MDS may get worse.

■^ Tell your doctor if any of these apply to you.

Eye examinations

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).

You will need regular tests

Before you start taking Revolade, 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.

Blood tests for liver function

Revolade 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 Revolade 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 Revolade and at intervals while you are taking it. You may need to stop taking Revolade 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.

Blood tests for platelet count

If you stop taking Revolade, 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 Revolade 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

Tests to check your bone marrow

In people who have problems with their bone marrow, medicines like Revolade 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 Revolade.

Checks for digestive bleeding

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

Heart monitoring

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

Older people (65 years and above)

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

Children and adolescents

Revolade 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 or severe aplastic anaemia.

Other medicines and Revolade

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 Revolade – 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 Revolade, 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 Revolade.

Revolade with food and drink

Do not take Revolade 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.

Pregnancy and breast-feeding

Don’t use Revolade if you are pregnant unless your doctor specifically recommends it. The effect of Revolade 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 Revolade, to prevent pregnancy
• If you do become pregnant during treatment with Revolade, tell your doctor.

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

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

Driving and using machines

Revolade 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.

3. How to take Revolade

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Do not change the dose or schedule for taking Revolade unless your doctor or pharmacist advises you to. While you are taking Revolade, you will be under the care of a doctor with specialist experience in treating your condition.

How much to take

For ITP

Adults and children (6 to 17 years) - the usual starting dose for ITP is two 25 mg sachets of Revolade 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 sachet of Revolade a day.

For hepatitis C

Adults - the usual starting dose for hepatitis C is one 25 mg sachet of Revolade a day. If you are of East-/Southeast-Asian origin you will start on the same 25 mg dose.

For SAA

Adults - the usual starting dose for SAA is two 25 mg sachets of Revolade a day. If you are of East-/Southeast-Asian origin you may need to start at a lower dose of 25 mg.

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

How to give a dose of medicine

The powder for oral suspension is in sachets, the contents of which will need to mixed before you can take the medicine. After section 6 of this leaflet there are

Instructions For Use

on how to mix and administer the medicine. If you have questions or do not understand the Instructions For Use, talk to your doctor, nurse or pharmacist.

IMPORTANT — Use the medicine immediately after you have mixed the powder with water. If you do not use it within 30 minutes of mixing it, you will need to mix a new dose. Do not re-use the oral dosing syringe. A new single-use oral dosing syringe should be used to prepare each dose of Revolade for oral suspension.

When to take it

Make sure -

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

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.

If you take more Revolade than you should

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.

If you forget to take Revolade

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

If you stop taking Revolade

Don’t stop taking Revolade 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.

If you have any further questions on the use of 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 needing attention: see a doctor

People taking Revolade 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 Revolade 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

Revolade 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 Revolade, your blood platelet count will usually drop back down to what it was before starting Revolade. 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 Revolade.

• ■ ^ Tell your doctor if you have any bleeding or bruising after stopping Revolade.

Some people have bleeding in the digestive system after they stop taking peginterferon, ribavirin, and Revolade. 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.

The following side effects have been reported to be associated with treatment with Revolade in adult patients with ITP:

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

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

The following additional side effects have been reported to be associated with treatment with

Revolade in children (aged 1 to 17 years) with ITP:

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

The following side effects have been reported to be associated with treatment with Revolade in combination with peginterferon and ribavirin in patients with HCV:

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

These 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

The following side effects have been reported to be associated with treatment with Revolade in patients with severe aplastic anaemia (SAA):

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 people.

• cough
• headache
• mouth and throat pain
• diarrhoea
• feeling sick (nausea)
• joint pain (arthralgia)
• pain in extremities (arms, legs, hands and feet)
• dizziness
• feeling very tired
• fever
• chills
• itchy eyes
• blisters in the mouth
• bleeding of the gums
• abdominal pain
• muscle spasms

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

• abnormal changes to the cells in your bone marrow
• increased levels of liver enzymes (aspartate aminotransfera­se (AST))

Common side effects

These may affect up to 1 in 10 people.

• anxiety
• depression
• feeling cold
• generally feeling unwell
• eye problems including vision problems, blurred vision, cloudy lens in the eye (cataract), spots

or deposits in eye (vitreous floaters), dry eye, itchy eye, yellowing of the whites of the eyes or skin

• nose bleed
• digestive system problems including difficulty swallowing, mouth pain, swollen tongue,

vomiting, loss of appetite, stomach pain/discomfort, swollen stomach, digestive wind/gas, constipation, intestinal motility disorder which can cause contipation, bloating, diarrhea and/or above mentioned symptoms, change in stool colour

• fainting
• skin problems including small red or purple spots caused by bleeding into the skin (petechiae)

rash, itching, hives, skin lesion

• back pain
• muscle pain
• bone pain
• weakness (asthenia)
• swelling of the lower limbs due to the accumulation of fluids
• abnormal colored urine
• interruption in blood supply to spleen (splenic infarction)
• runny nose

Common side effects that may show up in the blood tests

• increase in enzymes due to muscle breakdown (creatine phosphokinase)
• accumulation of iron in the body (iron overload)
• decrease in blood sugar levels (hypoglycaemia)
• increased levels of blood bilirubin (a substance produced by the liver)
• decreased levels of white blood cells

Side effects with frequency not known

Frequency cannot be estimated from the available data

• skin discolouration
• darkening of the skin
• liver injury due to medication

Reporting of side effects

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 national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Revolade

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the sachet.

This medicine does not require any special storage conditions.

Do not open the foil sachets until ready for use. After mixing, Revolade oral suspension should be administered immediately, but may be stored for no more than 30 minutes at room temperature.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Revolade contains

25 mg powder for oral suspension

The active substance in Revolade is eltrombopag. Each sachet contains a powder for reconstitution that delivers 32 mg eltrombopag olamine, equivalent to 25 mg of eltrombopag free acid.

The other ingredients are: mannitol, sucralose and xanthan gum.

What Revolade looks like and contents of the pack

Revolade 25 mg powder for oral suspension is available in kits containing 30 sachets; each sachet contains a reddish-brown to yellow powder. Each pack contains 30 sachets, one 40 ml reusable mixing bottle with lid and cap, and 30 single-use oral dosing syringes.

Marketing authorisation holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Lek d.d

Verovskova Ulica 57

Ljubljana 1526

Slovenia

Novartis Pharma GmbH

RoonstraBe 25

D-90429 Nuremberg

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11	Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50
Efcnrapua	Luxembourg/Lu­xemburg
Novartis Bulgaria EOOD	Novartis Pharma N.V.
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This leaflet was last revised in.

Detailed information on this medicine is available on the European Medicines Agency web site:.

INSTRUCTIONS FOR USE

Revolade 25 mg powder for oral suspension

(eltrombopag)

Read and follow these instructions to prepare a dose of Revolade and give it to the patient. If you have any questions, or if you damage or lose any of the supplies in your kit, ask your doctor, nurse or pharmacist for advice

Before you start

Read these messages first

• Revolade powder must be mixed only with water at room temperature.

Give the medicine to the patient immediately after you have mixed the powder with water. If you don’t use the medicine within 30 minutes of mixing it, you will need to mix a new dose. Dispose of the unused mixture in your household waste; don’t pour it down the drain.

• Try not to let the medicine touch your skin. If this happens, wash the area immediately with

soap and water. If you get a skin reaction, or if you have any questions, contact the doctor.

• If you spill any powder or liquid, clean it up with a damp cloth (see step 14 of the instructions).

• Take care that children do not play with the bottle, cap, lid or syringes — there is a risk of

choking if children put them in their mouth.

What you need

Each Revolade powder for oral suspension kit contains:

• The correct number of sachets your doctor has prescribed (supplied in the kit)

• 1 reusable mixing bottle with lid and cap (supplied in the kit)

• 1 single-use oral dosing syringe (supplied in the kit)

• 1 clean glass or cup filled with drinking water (not supplied)

• scissors to cut sachet (not supplied)

  Make sure that the bottle, cap and lid are dry before you use them. To prepare the dose

  1. Make sure the lid is not on the mixing bottle.

  2. Fill the syringe with 20 ml drinking water from the glass or cup. A new single-use oral dosing syringe should be used to prepare each dose of Revolade for oral suspension. Start with the plunger pushed all the way into the syringe. Put the tip of the syringe all the way into the water Pull back on the plunger to the 20 ml mark on the syringe.

• 25 mg dose — 1 sachet

• 50 mg dose — 2 sachets

• 75 mg dose — 3 sachets

5. Add the powder from the prescribed number of sachets to the bottle.

• Tap the top of each sachet to make sure the contents fall to

the bottom

• Cut off the top of each sachet with scissors

• Empty all contents of each sachet into the mixing bottle

• Make sure not to spill the powder outside the mixing bottle.

–2⁷^'

6. Screw the lid onto the mixing bottle. Make sure the cap is firmly pushed onto the lid, so it is closed.

7. Gently and slowly shake the mixing bottle backwards and forwards for at least 20 seconds to mix the water with the powder.

Don’t shake the bottle hard — that could make the medicine

foam.

To give a dose to a patient

8. Make sure the plunger is pushed all the way into the syringe.

• Pull cap off the lid of the mixing bottle

• Insert the syringe tip into the hole in the bottle lid.

9. Fill the syringe with the medicine.

• Turn the mixing bottle upside-down together with the

syringe.

• Pull back the plunger until all the medicine is in the syringe.

• The medicine is a dark brown liquid.

• Remove the syringe from the bottle.

10. Give the medicine to the patient. Do this straight away when you have mixed the dose. Place the tip of the syringe into the inside of the patient’s cheek. Slowly push the plunger all the way down so the medicine goes into the patient’s mouth. Make sure the patient has time to swallow.
IMPORTANT: You have now given the patient nearly all of their dose of medicine. But there will still be some left in the bottle, even though you may not be able to see it. Now you need to complete steps 11 to 13 to make sure the patient receives all of the medicine.
11. Again fill the syringe, this time with 10 ml of drinking water. Start with the plunger pushed all the way down into the syringe. Put the tip of the syringe all the way into the water Pull back on the plunger to the 10 ml mark on the syringe.	iQmL^
12. Empty the water into the mixing bottle. Insert the tip of the syringe into the hole in the lid of the mixing bottle. Slowly push the plunger all the way into the syringe. Push the cap firmly back on to the lid of the mixing bottle.
13. Repeat steps 7 to 10 – gently shake the bottle to mix the rest of t rest of the liquid to the patient.	he medicine, then give all the
To clean up
14. If you have spilt any powder or mixed medicine, clean it up with a damp disposable cloth. You may choose to wear disposable gloves so your skin doesn’t get stained. Dispose of the cloth and gloves used to clean up the spillage in your household waste.
15. Clean the mixing equipment. Throw away the used oral dosing syringe. A new oral dosing syringe should be used to prepare each dose of Revolade for oral suspension. Rinse the mixing bottle and lid under running water. (The mixing bottle may become stained from the medicine. This is normal.) Let all the equipment dry in the air. Wash your hands with soap and water.
After you have used all 30 sachets in the kit, dispose of the bottle. Always start with a complete new kit for each 30 sachets.

Keep Revolade powder for oral suspension, including the dosing kit, and all medicines out of the reach of children.

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