Revolade 25 mg film-coated tablets

Revolade 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 ( idiopathic) thrombocytopenic purpura (ITP) in adult patients (aged 18 years and over) who have had their spleen removed and have received prior treatment with corticosteroids or immunoglobulins, and these medicines did not work. ITP is caused by a low blood platelet count ( thrombocytopenia). People with ITP have an increased risk of bleeding, and may notice symptoms such as petechiae (pinpoint sized 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 may also be used in previously treated adult patients (aged 18 years and over) with chronic ITP where surgery to remove the spleen is not an option.

Don?t take Revolade

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

Take special care with Revolade

Your doctor needs to know before you take Revolade:

• if you have liver problems. You should not be given Revolade unless your doctor considers that the expected benefits outweigh the risk of blood clots
• if you are at risk of blood clots in your veins or arteries, or you know that blood clots are common in your family. The risk of blood clots may be increased in the following

circumstances: if you are elderly, if you have been bedridden for a long time, if you have cancer ( malignancy), if you are taking the contraceptive birth control pill or hormone replacement therapy, if you have undergone recent surgery or received a physical injury ( trauma), if you are overweight ( obese), if you are a smoker.

• If any of these circumstances apply to you please tell your doctor before starting treatment.
• if you have cataracts (the lens of the eye getting cloudy) Tell your doctor if any of these apply to you.

Checking for cataracts
Your doctor may recommend that you are checked for cataracts as part of routine eye tests.

You will need regular blood 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.

Revolade can increase some blood markers indicating liver damage. 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 physical signs of liver damage.

Tell your doctor i mmediately if you have any of these signs and symptoms of liver problems:

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

If you stop taking Revolade a low blood platelet count ( thrombocytopenia) is likely to reoccur within several days. If you stop taking Revolade your platelet count will have to be monitored, and your doctor will discuss appropriate precautions with you.

If you have very high blood platelet counts, this may increase the risk of blood clotting, however blood clots can occur 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.

Tell your doctor i mmediately if you have any of these signs and symptoms of a blood clot:

swelling, pain or tenderness in one leg ( Deep vein thrombosis)

sudden shortness of breath especially when accompanied with sharp pain in the chest and/or rapid breathing ( Pulmonary embolism)

abdominal pain, enlargered abdomen, blood in stool ( Portal vein thrombosis)

Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, have taken any recently, or if you start new ones. This includes herbal medicines and other medicines you can obtain without a prescription.

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
• medicines called statins, used to lower cholesterol
• minerals such as iron, calcium, magnesium, aluminium, selenium and zinc which may be found in vitamin and mineral supplements
• medicines such as methotrexate and topotecan, used to treat cancer

See Section 3, ?How to take Revolade?, for more information about taking antacids, vitamins and mineral supplements

Talk to your doctor if you take any of these. Some of them are not to be taken with Revolade,, or your 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 which are given to prevent blood clots ( anticoagulants or antiplatelet therapy) there is a greater risk of bleeding. Your doctor will discuss this with you.

If you are taking corticosteroids, danazol, and/or azathioprine these may be reduced or

stopped when given together with Revolade.

Revolade with food and drink

Revolade is not to be taken with dairy foods or drinks as the absorption of the medicine is affected by the calcium in dairy products. For details, see Section 3, How to take Revolade.

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 or planning to become pregnant.
• 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

No studies on the effects of Revolade on the ability to drive or use machines have been performed.

Always take Revolade exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

The usual starting dose is one 50 mg tablet of Revolade a day. People of East Asian origin (Chinese, Japanese, Taiwanese or Korean) may need to start at a lower dose of 25 mg.

Swallow the tablet whole, with some water.

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.

Revolade is not recommended for people aged under 18, as the safety and effectiveness have not yet been shown.

When to take it

Don?t take Revolade in the 4 hours before or after:

• dairy foods such as cheese, butter, yoghurt or ice cream
• milk or milk shakes, drinks made with milk, yoghurt or cream
• antacids, which are medicines for indigestion
• 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, 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. It is recommended that you are monitored for any signs or symptoms of side effects and that you are given appropriate treatment immediately.

If you forget to take Revolade

Take the next dose at the usual time. Don?t take a double dose to make up for a forgotten dose.

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.

Like all medicines, Revolade can cause side effects, although not everybody gets them.

Bleeding after you stop treatment

Within two weeks of stopping Revolade, your blood platelet count will usually drop back down to what it was before you started taking Revolade. The lower platelet count may increase your risk of bleeding. Your doctor will check your platelet counts for at least 4 weeks after you stop taking Revolade.

Tell your doctor if you have any bruising or bleeding after you stop taking Revolade.

Problems with your bone marrow

People with ITP may have problems with their bone marrow. Medicines like Revolade could make this problem 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.

High platelet counts

Your doctor will check your blood platelet count during treatment. If your platelet count gets too high, your dose of Revolade may need to be changed, or you may need to stop taking it.

Higher risk of blood clots

People with ITP may have a higher risk of blood clots, and medicines like Revolade could make this problem worse.

If you develop signs and symptoms of a blood clot, such as:

swelling, pain or tenderness in one leg ( Deep vein thrombosis)

sudden shortness of breath, especially when accompanied with sharp pain in the chest and/or rapid breathing ( Pulmonary embolism)

abdominal pain, enlargered abdomen, blood in stool ( Portal vein thrombosis)

Contact a doctor immediately..

Very common side effects

These may affect more than 1 in 10 people

• headache

Common side effects

These may affect up to 1 in 10 people

• difficulty in sleeping ( insomnia)
• constipation, pain in stomach
• feeling sick ( nausea)
• diarrhoea
• cloudy lens in the eye ( cataract)
• dry eye
• increase in bilirubin (a substance produced by the liver) ( hyperbilirubinaemia)
• liver not working well ( hepatic function abnormal)
• unusual hair loss or thinning ( alopecia)
• skin rash
• itching ( pruritus)
• joint pain ( arthralgia)
• muscle pain ( myalgia), muscle spasm
• bone pain
• lack of energy (fatigue)
• tingling or numbness of the hands or feet ( paraesthesia)
• swelling of the hands, ankles or feet ( oedema peripheral)

Common side effects that may show up in blood tests:

• increase of liver enzymes ( aspartate and alanine transaminases)
• increase in bilirubin (a substance produced by the liver)
• increase in the amounts of proteins

Uncommon side effects

These may affect up to 1 in 100 people

• interruption of blood supply to part of the heart ( acute myocardial infarction)
• sudden blocking of a blood vessel by blood clot ( embolism)
• sudden shortness of breathe, especially when accompanied with sharp pain in the chest and /or rapid breathing ( pulmonary embolism)
• the loss of function of part of the lung caused by a blockage in the lung artery ( pulmonary infarction)
• heart beating faster ( tachycardia), palpitations, fast or irregular heart beat, bluish discolouration of the skin ( cyanosis) high blood pressure ( hypertension)
• inflammation of a vein ( thrombophlebitis superficial)
• localised swelling filled with blood from a break in a blood vessel ( haematoma)
• sore throat and discomfort when swallowing, inflammation of the lungs, sinuses, tonsils, nose and throat
• loss of appetite ( anorexia)
• painful swollen joints caused by uric acid (food break down product) ( Gout)
• problems sleeping, anxiety, depression, lack of interest, mood changes
• dizziness, feeling drowsy, problems with balance, taste, speech and nerve function, migraine, shaking ( tremor)
• problems with the liver including: level of substances (enzymes) produced by the liver increased, bile produced by liver to aid digestion of food cannot flow properly ( cholestasis)
• problems with the eyes, including blurred and less clear vision
• ear pain, spinning sensation ( vertigo)
• cough, problems with nose, throat and sinuses, breathing problems when sleeping
• problems with digestive system including: being sick ( vomiting), painful swollen stomach, wind, bowel movements frequent and discoloured, haemorrhoids, dry or sore mouth, indigestion, sensitive tongue, bleeding gums, nose bleed
• changes to skin including, excessive sweating, itching bumpy rash, red spots, changes in appearance
• muscular weakness, pain in arms and legs, sensation of heaviness
• kidney problems including: inflammation of the kidney, excessive urination at night
• generally feeling unwell, high temperature, feeling hot, chest pain, bruising

Uncommon side effects that may show up in blood tests:

• decrease in number of red blood cells ( anaemia), white blood cells and platelets
• changes in the make-up of the blood
• changes in levels of uric acid, calcium and potassium

If you get side effects
Tell your doctor or pharmacist if any of the side effects becomes severe or troublesome, or if you notice any side effects not listed in this leaflet.

Keep out of the sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Revolade contains

25 mg film-coated tablets

The active substance in Revolade is eltrombopag olamine. Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag.

The other ingredients are: hypromellose, macrogol 400, magnesium stearate, mannitol (E421), microcrystalline cellulose, polysorbate 80, povidone (K30), sodium starch glycolate Type A titanium dioxide (E171).

50 mg film-coated tablets

The active substance in Revolade is eltrombopag olamine. Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag.

The other ingredients are: hypromellose, iron oxide red (E172), iron oxide yellow (E172), macrogol 400, magnesium stearate, mannitol (E421), microcrystalline cellulose, povidone (K30), sodium starch glycolate Type A, titanium dioxide (E171).

What Revolade looks like and contents of the pack

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.

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
GlaxoSmithKline Trading Services Ltd
6900 Cork Airport Business Park
Kinsale Road
Cork
Ireland

Manufacturer
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)
Priory Street, Ware
Hertfordshire, SG12 0DJ
United Kingdom

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

BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 02 656 21 11 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. BelgiqueBelgien TélTel 32 02 656 21 11

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Lietuva

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Tel: + 370 5 264 90 00
info.lt@gsk.com

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