Revolade 25 mg powder for oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Revolade 25 mg oral suspension powder

eltrombopag

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• The information in this leaflet is intended for you or your child, even though the leaflet refers to "you".

Leaflet contents

1. What Revolade is and what it is used for
2. What you need to know before taking 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, used to help increase the number of platelets in the blood. Platelets are blood cells that help reduce or prevent bleeding.

• Revolade is used to treat a blood disorder called immune (primary) thrombocytopenia (ITP) in patients over 1 year of age who have already taken other medications (corticosteroids or immunoglobulins) that were not effective.

ITP is caused by a low platelet count (thrombocytopenia). People with ITP have an increased risk of bleeding. Symptoms that patients with ITP may experience include petechiae (small, round, flat, red spots under the skin), bruising, nosebleeds, bleeding gums, and difficulty controlling bleeding if cut or injured.

• Revolade may also be used to treat low platelet levels (thrombocytopenia) in adults with hepatitis C virus (HCV) infection, in cases where they have experienced problems with adverse effects from interferon-based treatment. Many people with hepatitis have low platelet counts, not only due to the disease itself but also because of the antiviral treatments used to treat it. Taking Revolade may help you complete your course of antiviral therapy (peginterferon and ribavirin).

• Revolade may also be used in patients with low blood cell counts caused by severe aplastic anaemia (SAA). SAA is a condition in which the bone marrow is damaged, leading to a deficiency of red blood cells (anaemia), white blood cells (leucopenia), and platelets (thrombocytopenia).

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

Do not take Revolade

• if you are allergic to eltrombopag or to any of the other ingredients of this medicine (listed in section 6 under the heading "Composition of Revolade").

Consult your doctor if you think this may affect you.

Warnings and precautions

Talk to your doctor before starting to take Revolade:

• if you have liver problems. People who have a low platelet count and also advanced chronic liver disease (long-standing) are at higher risk of adverse effects, liver damage that may be fatal, and blood clots. If your doctor considers that the benefit of Revolade outweighs the risks, you will be closely monitored during treatment.
• if you are at risk of developing a blood clot in veins or arteries, or if you know that blood clots are common in your family.

The risk of developing a blood clot may be higher in the following circumstances:

• if you are elderly
• if you have been bedridden for a long period of time
• if you have cancer
• if you are taking oral contraceptives or hormone replacement therapy
• if you have recently undergone surgery or suffered physical injury
• if you are significantly overweight (obesity)
• if you are a smoker
• if you have advanced chronic liver disease.

If you are in any of these situations, inform your doctor before starting treatment. You should not take Revolade unless your doctor considers that the expected benefit outweighs the risk of developing blood clots.

• if you have cataracts (clouding of the eye's lens).
• if you have another blood disorder, such as myelodysplastic syndrome (MDS). Before starting Revolade, your doctor will perform tests to confirm you do not have this condition. If you have MDS and take Revolade, your MDS may worsen.

Inform your doctor if you are in any of these situations.

Eye examinations

Your doctor will recommend that you have an eye examination to check for cataracts. If you do not routinely have eye exams, your doctor will ask you to have them. Your retina (the light-sensitive layer of cells at the back of the eye) should also be examined to check for bleeding in or around the retina.

You will need regular blood tests

Before you start taking Revolade, your doctor will perform a blood test to check your blood cells, including platelets. These tests will be repeated frequently while you are taking the medicine.

Blood tests to check liver function

Revolade may cause blood test results indicating liver damage—an increase in certain liver enzymes, especially bilirubin and alanine/aspartate transaminase. If you are taking interferon, the standard treatment used together with Revolade to treat low platelet counts due to hepatitis C, this may worsen existing liver problems.

You will have blood tests before starting Revolade and regularly during treatment to monitor your liver function. It may be necessary to interrupt treatment with Revolade if these markers increase too much or if you develop any other signs of liver damage.

Read the information “Liver problems” in section 4 of this leaflet

Blood tests to monitor platelet count (levels)

If you stop treatment with Revolade, your platelet levels are likely to become low again (thrombocytopenia) within a few days. Your platelet levels will be monitored, and your doctor will advise you on the necessary precautions.

Very high platelet levels may increase the risk of blood clots. However, blood clots can also form when platelet levels are normal or even low. Your doctor will adjust the dose of Revolade to ensure that the platelet count does not become too high.

Seek immediate medical help if you experience any of the following signs of a blood clot:

• swelling, pain, or tenderness in one leg
• sudden shortness of breath, rarely accompanied by sharp chest pain or rapid breathing
• abdominal pain (stomach), enlarged abdomen, blood in stools.

Bone marrow examinations

In people with bone marrow disorders, medicines like Revolade may worsen these conditions. Signs of bone marrow changes may appear as abnormal results in blood tests. Your doctor may also perform tests to directly assess your bone marrow during treatment with Revolade.

Monitoring for gastrointestinal bleeding

If you are taking interferon, the standard treatment used together with Revolade, you will be monitored for any signs of bleeding in your stomach or intestines after stopping Revolade.

Heart monitoring

Your doctor may, if necessary, monitor your heart during treatment with Revolade using an electrocardiogram (ECG).

Elderly people (65 years and older)

There is limited data on the use of Revolade in patients aged 65 years or older. If you are 65 or older, caution should be exercised when using Revolade.

Children and adolescents

Revolade is not recommended for children under 1 year of age with ITP. It is also not recommended for children under 18 years of age with low platelet counts due to hepatitis C or severe aplastic anemia.

Other medicines and Revolade

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

Some commonly used medicines may interact with Revolade (including prescription and non-prescription medicines and minerals). These include:

• antacids used to treat indigestion, heartburn, or stomach ulcers (see also section 3 "When to take it").
• statins, used to lower cholesterol
• some medicines used to treat HIV infection, such as lopinavir and/or ritonavir
• cyclosporine, used in organ transplantation or in immunological disorders
• minerals such as iron, calcium, magnesium, aluminium, selenium, and zinc, which may be present in vitamin and mineral supplements (see also section 3 "When to take it").
• medicines such as methotrexate and topotecan, used to treat cancer

Consult your doctor if you are taking any of these medicines. Some should not be taken with Revolade, dose adjustments may be needed, or you may need to change the timing of administration. Your doctor will review your current medications and recommend alternatives if necessary.

If you are also taking medicines to prevent blood clots, there is an increased risk of bleeding. Your doctor will discuss this with you.

If you are taking corticosteroids, danazol, and/or azathioprine together with Revolade, it may be necessary to reduce the dose or discontinue treatment with these medicines.

Taking Revolade with food and drinks

Do not take Revolade with food or dairy drinks, as the calcium in dairy products affects the absorption of the medicine. For more information, see section 3, "When to take it".

Pregnancy and breastfeeding

Do not take Revolade if you are pregnant unless specifically advised by your doctor. The effect of Revolade during pregnancy is unknown.

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

Do not breastfeed while taking Revolade. It is unknown whether Revolade passes into breast milk.

If you are breastfeeding or plan to breastfeed, inform your doctor.

Driving and using machines

Revolade may cause dizziness and other adverse effects that may reduce your alertness.

Do not drive or operate machinery unless you are certain that Revolade does not affect you.

3. How to take Revolade

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again. Do not change the dose or treatment schedule of Revolade unless your doctor or pharmacist advises you to do so. While you are taking Revolade, you will be under the supervision of a specialist doctor experienced in treating your condition.

How much to take

For ITP

Adults and children (6 to 17 years of age) – the usual starting dose for ITP is two 25 mg sachets of Revolade per day. If you are of East or Southeast Asian ancestry, you may need to start treatment with a lower dose of 25 mg.

Children (1 to 5 years of age) – the usual starting dose for ITP is one 25 mg sachet of Revolade per day.

For Hepatitis C

Adults – the usual starting dose for hepatitis C is one 25 mg sachet of Revolade per day. If you are of East or Southeast Asian ancestry, start treatment with the same 25 mg dose.

For SAA

Adults – the usual starting dose for SAA is two 25 mg sachets of Revolade per day. If you are of East or Southeast Asian ancestry, you may need to start treatment with a lower dose of 25 mg.

Revolade may take 1 to 2 weeks to start working. Depending on your response to Revolade, your doctor may recommend adjusting your daily dose.

How to take a dose of the medicine

The oral suspension powder comes in sachets, and you must mix the contents before taking the medicine. Instructions on how to mix and administer the medicine are provided in Instructions for Use located after section 6 of this leaflet. If you have any doubts or do not understand the Instructions for Use, consult your doctor, nurse, or pharmacist.

IMPORTANT – Use the medicine immediately after mixing it with water. If you do not use it within 30 minutes of mixing, you will need to prepare a new dose. Do not reuse the oral dosing syringe. Always use a new oral dosing syringe each time you prepare a new dose of Revolade oral suspension.

When to take it

Make sure that –

• during the 4 hours before taking Revolade
• and during the 2 hours after taking Revolade

you do not consume any of the following:

• dairy products such as cheese, butter, yoghurt, or ice cream
• milk or milkshakes , drinks made with milk, 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, your body will not properly absorb the medicine.

For further information on suitable foods and drinks, consult your doctor.

If you take more Revolade than you should

Contact your doctor or pharmacist immediately. If possible, show them the packaging or this leaflet. You will be monitored for signs or symptoms of adverse effects and will be given appropriate treatment immediately.

If you forget to take Revolade

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

If you stop taking Revolade

Do not stop taking Revolade without first consulting your doctor. If your doctor advises you to stop treatment, your platelet levels will be monitored weekly for four weeks. See also “Bleeding or bruising after stopping treatment” in section 4.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Symptoms to which you need to pay attention: consult your doctor

Patients taking Revolade for either ITP or low platelet counts associated with hepatitis C may develop signs related to potentially serious adverse effects. It is important that you inform your doctor if you develop any of these symptoms.

Increased risk of thrombosis

Some people may have an increased risk of developing blood clots, and medicines such as Revolade may worsen this condition. Sudden blockage of a blood vessel by a clot is an uncommon adverse effect, affecting up to 1 in 100 people.

Seek immediate medical help if you experience any signs or symptoms of thrombosis, such as:

• swelling, pain, warmth, redness, or tenderness in one leg
• sudden shortness of breath, occasionally accompanied by sharp chest pain or rapid breathing.
• abdominal pain (stomach), enlarged abdomen, blood in your stools.

Liver problems

Revolade may cause changes detectable in blood tests, which could indicate liver damage. Liver problems (elevated liver enzymes 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 signs of liver problems:

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

contact your doctor immediately

Bleeding or bruising after stopping treatment

Within two weeks after stopping treatment with Revolade, your platelet levels will typically fall to levels similar to those before starting Revolade. A decrease in platelet levels may increase the risk of bleeding or bruising. Your doctor will monitor your platelet levels for at least four weeks after stopping Revolade.

Contact your doctor if you experience bleeding or bruising after stopping Revolade.

Some people experience gastrointestinal bleeding after discontinuing peginterferon, ribavirin, and Revolade. Symptoms include:

• black, tarry stools (discoloration of stools is an uncommon adverse effect affecting up to 1 in 100 people)
• blood in the stools
• vomiting blood or material resembling coffee grounds

Contact your doctor immediately if you experience any of these symptoms.

The following adverse effects have been reported with Revolade treatment in adult patients with ITP

Very common adverse effects

May affect more than 1 in 10 people

• cold
• dizziness (nausea)
• diarrhea
• cough
• infection of the nose, sinuses, throat, and respiratory tract (upper respiratory tract infection)
• back pain

Very common adverse effects detectable in blood tests

• increased liver enzymes (alanine aminotransferase (ALT))

Common adverse effects

May affect up to 1 in 10 people

• muscle pain, muscle spasms, muscle weakness
• bone pain
• heavy menstrual periods
• sore throat and discomfort when swallowing
• eye problems including abnormal eye test results, dry eyes, eye pain, blurred vision
• vomiting
• influenza
• cold sores
• pneumonia
• sinus irritation and inflammation (swelling)
• inflammation (swelling) and infection of the tonsils
• lung, sinus, nose, and throat infections
• gum inflammation
• loss of appetite
• tingling, itching, or numbness
• decreased skin sensitivity
• drowsiness
• ear pain
• pain, swelling, and tenderness in one leg (usually the calf), with warm skin in the affected area (signs of a deep vein thrombosis)
• localized swelling filled with blood due to rupture of a blood vessel (hematoma)
• hot flushes
• mouth disorders including dryness or irritation of the mouth, tongue sensitivity, bleeding gums, mouth ulcers
• runny nose
• toothache
• abdominal pain
• abnormal liver function
• skin changes including excessive sweating, itchy rash, red spots, changes in skin appearance
• hair loss
• foamy or bubbly urine (signs of protein in urine)
• elevated temperature, feeling of warmth
• chest pain
• feeling of weakness
• difficulty sleeping, depression
• migraine
• decreased vision
• sensation of spinning (vertigo)
• flatulence

Common adverse effects detectable in blood tests:

• decreased number of red blood cells (anemia)
• decreased number of platelets (thrombocytopenia)
• decreased number of white blood cells
• decreased hemoglobin levels
• increased number of eosinophils
• increased number of white blood cells (leukocytosis)
• increased uric acid levels
• decreased potassium levels
• increased creatinine levels
• increased alkaline phosphatase levels
• increased liver enzymes (aspartate aminotransferase (AST))
• increased blood bilirubin levels (a substance produced by the liver)
• increased levels of certain proteins

Uncommon adverse effects

May affect up to 1 in 100 people:

• allergic reaction

• interruption of blood supply to parts of the heart

• sudden shortness of breath, especially when accompanied by sharp chest pain and/or rapid breathing, which could be signs of a pulmonary embolism (see “Increased risk of thrombosis” above in section 4)

• partial loss of lung function caused by blockage of the pulmonary artery

• possible pain, swelling, and/or redness around a vein, which could be signs of venous thrombosis

• yellowish skin and/or abdominal pain, which could indicate bile duct obstruction, liver injury, or drug-induced liver damage (see “Liver problems” above in section 4)

• drug-induced liver injury

• faster heartbeat, irregular heartbeat, bluish discoloration of the skin, heart rhythm disturbances (prolongation of the QT interval), which could indicate a cardiovascular disorder

• blood clots

• hot flushes

• joint pain and swelling due to uric acid (gout)

• lack of interest, mood changes, uncontrollable or unexpected crying

• balance problems, speech and nervous system disturbances, tremors

• pain or abnormal sensations in the skin

• paralysis on one side of the body

• migraine with aura

• nerve pain

• dilation or swelling of blood vessels causing headache

• eye problems including excessive tearing, clouding of the eye lens (cataracts), retinal hemorrhage, dry eyes

• nose, throat, and sinus problems, breathing difficulties during sleep

• mouth and throat blisters/pain

• loss of appetite

• digestive system problems including frequent bowel movements, food poisoning, blood in stools, vomiting blood

• rectal bleeding, changes in stool color, abdominal swelling, constipation

• mouth disorders including dryness or irritation of the mouth, tongue pain, bleeding gums, mouth discomfort

• sunburn

• feeling hot, anxiety

• redness or inflammation around wounds

• bleeding around a catheter (if present) in the skin

• sensation of a foreign body

• kidney problems including: kidney inflammation, excessive urination (increased need to urinate) at night, kidney failure, white blood cells in urine

• cold sweat

• general malaise

• skin infection

• skin changes including skin discoloration, peeling, redness, itching, and sweating

• muscle weakness

• rectal and colon cancer

Uncommon adverse effects detectable in blood tests:

• changes in the shape of white blood cells
• presence of immature white blood cells, which may indicate certain diseases
• increased number of platelets
• decreased calcium levels
• decreased number of red blood cells (anemia) caused by excessive destruction of red blood cells (hemolytic anemia)
• increased number of myelocytes
• increased neutrophils
• increased blood urea levels
• increased protein in urine
• increased blood albumin levels
• increased total protein levels
• decreased blood albumin levels
• increased urine pH
• increased hemoglobin levels

The following adverse effects have been reported with Revolade treatment in children (1 to 17 years) with ITP

If these adverse effects worsen, please inform your doctor, pharmacist, or nurse.

Very common adverse effects

May affect more than 1 in 10 children

• infection of the nose, sinuses, throat, and upper respiratory tract, cold (upper respiratory tract infection)
• diarrhea
• abdominal pain
• cough
• elevated temperature
• dizziness (nausea)

Common adverse effects

May affect up to 1 in 10 children

• difficulty sleeping (insomnia)
• toothache
• sore throat and nasal pain
• itching, runny or blocked nose
• sore throat, runny nose, nasal congestion, and sneezing
• mouth disorders including dryness, irritation in the mouth, tongue sensitivity, bleeding gums, mouth ulcers

The following adverse effects have been reported with Revolade treatment in combination with peginterferon and ribavirin in patients with HCV

Very common adverse effects

May affect more than 1 in 10 people:

• headache
• loss of appetite
• cough
• dizziness (nausea), diarrhea
• muscle pain, muscle weakness
• itching
• feeling tired
• fever
• hair loss
• feeling of weakness
• flu-like malaise
• swelling of hands or feet
• chills

Very common adverse effects detectable in blood tests:

• decreased number of red blood cells (anemia)

Common adverse effects

May affect up to 1 in 10 people:

• urinary tract infection

• inflammation of nasal passages, throat, and mouth, flu-like symptoms, dryness, irritation or inflammation of the mouth, toothache

• weight loss

• sleep disorders, abnormal drowsiness, depression, anxiety

• dizziness, attention and memory problems, mood changes

• decreased brain function due to liver damage

• tingling or numbness in hands and feet

• fever, headache

• eye problems including clouding of the eye lens (cataracts), dry eyes, small yellow deposits in the retina, yellow discoloration of the whites of the eyes

• retinal bleeding

• sensation of spinning

• rapid and irregular heartbeats (palpitations), difficulty breathing

• productive cough, runny nose, influenza, cold sores, sore throat and discomfort when swallowing

• digestive system disorders including vomiting, stomach pain, indigestion, constipation, bloated stomach, taste disturbances, hemorrhoids, abdominal pain/discomfort, swelling and bleeding of blood vessels in the throat (esophagus)

• toothache

• liver problems, including liver tumor, yellowing of the whites of the eyes or skin (jaundice), drug-induced liver damage (see “Liver problems” above in section 4)

• skin changes including rash, dry skin, eczema, skin redness, itching, excessive sweating, unusual skin growth, hair loss

• joint pain, back pain, bone pain, limb pain (arms, legs, hands, feet), muscle spasms

• irritability, general malaise, skin reactions such as redness, swelling, and pain at the injection site, chest pain and discomfort, fluid retention in the body or limbs causing swelling

• infection of the nose, sinuses, throat, and respiratory tract, cold (upper respiratory tract infection), inflammation of the mucosa lining the bronchi

• depression, anxiety, sleep problems, nervousness

Common adverse effects detectable in blood tests:

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

Uncommon adverse effects

May affect up to 1 in 100 people:

• pain when urinating

• heart rhythm disturbances (prolongation of the QT interval)

• stomach flu (gastroenteritis), sore throat

• mouth blisters/pain, stomach inflammation

• skin changes including color changes, peeling, skin redness, itching, skin lesions, and night sweats

• blood clots in liver veins (possible liver and/or digestive system damage)

• poor clotting in small blood vessels with kidney failure

• itching and bruising at injection site, chest discomfort

• decreased number of red blood cells (anemia) caused by massive destruction of red blood cells (hemolytic anemia)

• confusion, agitation

• liver failure

The following adverse effects have been observed with Revolade treatment in patients with severe aplastic anemia (SAA)

If these adverse effects worsen, please inform your doctor, pharmacist, or nurse.

Very common adverse effects

May affect more than 1 in 10 people:

• cough
• headache
• mouth and throat pain
• diarrhea
• dizziness, nausea
• joint pain (arthralgia)
• limb pain (arms, legs, hands, feet)
• vertigo
• feeling very tired
• fever
• chills
• eye itching
• mouth blisters
• bleeding gums
• abdominal pain
• muscle spasms

Very common adverse effects detectable in blood tests

• abnormal changes in bone marrow cells
• increased liver enzymes (aspartate aminotransferase (AST))

Common adverse effects

May affect up to 1 in 10 people:

• anxiety
• depression
• feeling cold
• general malaise
• eye problems including vision problems, clouding of the eye lens (cataracts), spots or deposits in the eye (vitreous floaters), dry eyes, eye itching, yellowing of the whites of the eyes or skin
• nosebleeds
• digestive problems including difficulty swallowing, mouth pain, swollen tongue, vomiting, loss of appetite, stomach pain/discomfort, bloated stomach, flatulence/digestive gas, constipation, intestinal motility disorders that may cause constipation, bloating, diarrhea and/or the aforementioned symptoms, changes in stool color
• fainting
• skin problems including red or purple spots due to bleeding under the skin (petechiae), rash, itching, hives, skin lesions
• back pain
• muscle pain
• bone pain
• weakness (asthenia)
• swelling of the lower limbs due to fluid accumulation
• abnormal urine color
• interruption of blood flow to the spleen (splenic infarction)
• runny nose

Common adverse effects detectable in blood tests

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

Adverse effects with unknown frequency

Frequency cannot be estimated from the available data

• skin discoloration
• darkening of the skin
• drug-induced liver injury

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Revolade

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

Do not use this medicine after the expiry date stated on the packaging and sachet.

This medicine does not require any special storage conditions.

Do not open the sachet until ready to use. Once mixed, Revolade should be administered immediately, but may be stored for no more than 30 minutes at room temperature.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging when they are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Revolade

25 mg oral suspension powder

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

The other components are: mannitol (E421), sucralose and xanthan gum.

Nature of the product and contents of the container

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

Marketing Authorization Holder

Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer responsible

Lek d.d
Verovskova Ulica 57
Ljubljana 1526
Slovenia

Novartis Pharmaceutical Manufacturing LLC
Verovskova Ulica 57
Ljubljana 1000
Slovenia

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium Novartis Pharma N.V. Tel/Tel: +32 2 246 16 11	Lithuania SIA Novartis Baltics Lithuania Branch Tel: +370 5 269 16 50
	Luxembourg/Luxembourg Novartis Pharma N.V. Tel/Tel: +32 2 246 16 11
Czech Republic Novartis s.r.o. Tel: +420 225 775 111	Hungary Novartis Hungária Kft. Tel.: +36 1 457 65 00
Denmark Novartis Healthcare A/S Tlf: +45 39 16 84 00	Malta Novartis Pharma Services Inc. Tel: +356 2122 2872
Germany Novartis Pharma GmbH Tel: +49 911 273 0	Netherlands Novartis Pharma B.V. Tel: +31 88 04 52 555
Estonia SIA Novartis Baltics Estonia Branch Tel: +372 66 30 810	Norway Novartis Norge AS Tlf: +47 23 05 20 00
Greece Novartis (Hellas) S.A. Tel: +30 210 281 17 12	Austria Novartis Pharma GmbH Tel: +43 1 86 6570
Spain Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00	Poland Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
France Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00	Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Croatia Novartis Hrvatska d.o.o. Tel. +385 1 6274 220	Romania Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Ireland Novartis Ireland Limited Tel: +353 1 260 12 55	Slovenia Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Iceland Vistor hf. Tel: +354 535 7000	Slovakia Novartis Slovakia s.r.o. Tel: +421 2 5542 5439
Italy Novartis Farma S.p.A. Tel: +39 02 96 54 1	Finland/Sweden Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200
Cyprus Novartis Pharma Services Inc. Tel: +357 22 690 690	Sweden Novartis Sverige AB Tel: +46 8 732 32 00
Latvia SIA Novartis Baltics Tel: +371 67 887 070

Date of last review of the summary of product characteristics:

Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.

INSTRUCTIONS FOR USE

Revolade® 25 mg oral suspension powder

(eltrombopag)

Read and follow the instructions below to prepare a dose of Revolade and administer it to the patient. If you have any questions, or if any component of the kit is damaged or missing, consult your doctor, nurse, or pharmacist.

Before you begin

Read these messages first

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

Administer the medicine to the patient immediately after mixing the powder with water. If you do not use the medicine within 30 minutes, you will need to prepare a new dose.

Dispose of any unused mixture in the trash. Do not pour it down the drain.

• Avoid contact of the medicine with your skin. If contact occurs, wash the area immediately with water and soap. If you develop an allergic reaction or have any concerns, contact your doctor.
• If you spill the powder or liquid, clean it up with a damp cloth (see step 14 of these instructions).
• Be careful — children must not play with the bottle, cap, lid, or syringes, as there is a risk of suffocation if children put them in their mouth.

What you need

Each Revolade oral suspension powder kit contains:

30 powder sachets
1 reusable mixing bottle with stopper and cap (note — the mixing bottle may become stained)
30 single-use oral dosing syringes

To prepare and administer the dose of Revolade, you will need:

• The correct number of sachets prescribed by your doctor (included in the kit)
• 1 reusable bottle with cap and lid (included in the kit)
• 1 single-use oral dosing syringe (included in the kit)
• 1 clean glass or cup with drinking water (not included)
• Scissors to cut the sachet (not included)

Check that the bottle, cap, and lid are dry before use. Prepare the dose
Check that the cap is not attached to the mixing bottle.
Fill the syringe with 20 ml of water from the glass or cup. Use a new oral dosing syringe each time you prepare a new dose of Revolade oral suspension. Push the plunger fully to the end of the syringe. Place the tip of the syringe at the bottom of the water. Pull the plunger until the syringe fills to the 20 ml mark.
Pour the water into the open mixing bottle. Slowly push the plunger fully to the end of the syringe.
Take from the kit only the number of sachets prescribed for one dose. Dose of 25 mg — 1 sachet Dose of 50 mg — 2 sachets Dose of 75 mg — 3 sachets
Add the powder from the number of prescribed sachets into the bottle. Tap the top of each sachet to ensure the contents are at the bottom. Cut the top off each sachet with scissors. Pour the contents of each sachet into the mixing bottle. Be careful not to spill the powder outside the bottle.
Screw the cap onto the bottle. Make sure the lid is securely tightened with the cap so that it is properly closed.
Carefully and slowly shake the bottle forward and backward for at least 20 seconds to mix the powder with water. Do not shake vigorously — this may cause foaming.
Administer the dose to the patient
Ensure the plunger is at the end of the syringe. Remove the lid from the cap of the mixing bottle. Insert the tip of the syringe into the opening in the bottle cap.
Fill the syringe with the medication. Turn the bottle upside down with the syringe attached. Pull the plunger until all the medication is drawn into the syringe. The medication is a dark brown liquid. Remove the syringe from the bottle.
Administer the medication to the patient immediately after preparing the dose. Place the tip of the syringe inside the patient's cheek. Slowly push the plunger fully to the end to deliver the medication into the patient's mouth. Ensure the patient has time to swallow.
IMPORTANT: You have administered nearly the full dose to the patient. A small amount remains in the bottle, even if not visible. Now you need to complete steps 11 to 13 to ensure the patient receives the complete dose.
Once again, fill the syringe, this time with 10 ml of water. Push the plunger fully to the end of the syringe. Place the tip of the syringe at the bottom of the water. Pull the plunger until the syringe fills to the 10 ml mark.
Pour the water into the mixing bottle. Insert the tip of the syringe into the opening in the bottle cap. Slowly push the plunger fully to the end of the oral syringe. Replace the lid on the cap of the mixing bottle.
13. Repeat steps 7 to 10 – gently shake the bottle to mix the remaining medication, then administer all remaining liquid to the patient.
For cleaning
If you spill the powder or mixture, clean it up with a disposable cloth. You may wear disposable gloves to avoid skin staining. Dispose of the cleaning cloth and gloves in the trash.
Clean the mixing equipment. Discard the used oral syringe. Always use a new oral dosing syringe each time you prepare a new dose of Revolade oral suspension. Rinse the mixing bottle and lid with tap water. (The mixing bottle may become stained due to the medication. This is normal.) Allow all equipment to air dry. Wash your hands with soap and water.
After using all 30 sachets in the kit, discard the bottle. Always use a new complete kit every 30 sachets.

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