Promacta
(Eltrombopag Olamine)

What Promacta 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 (idiopathic) thrombocytopenic purpura (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).

How to take Promacta

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 Asian origin (Chinese, Japanese, Taiwanese, Thai or Korean) 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 Asian origin (Chinese, Japanese, Taiwanese, Thai or Korean) 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 Asian origin (Chinese, Japanese, Taiwanese, Thai or Korean) 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. 5 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. Youwill 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.

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. NO dairy products, antiacids or mineral supplements Take Revolade For 4 hours before you take Revolade... ... and for 2 hours after 6 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 (bile not flowing properly) 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. Other possible side effects in adults with ITP

Common side effects These may affect up to 1 in 10 people:
• feeling sick (nausea)
• diarrhoea
• cloudy lens in the eye (cataract)
• dry eyes
• unusual hair loss or thinning
• skin rash
• itching
• muscle pain, muscle spasm
• back pain
• bone pain
• tingling or numbness of the hands or feet
• heavy menstrual period
• mouth ulcers 7

Common side effects that may show up in blood tests:
• increase of liver enzymes
• increase in bilirubin (a substance produced by the liver)
• increased levels of some proteins

Uncommon side effects These may affect up to 1 in 100 people:
• 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
• liver problems, including yellowing of the eyes and skin (see ‘Liver problems’ earlier in section 4)
• heart beating faster, irregular heartbeat, bluish discolouration of the skin
• disturbances of heart rhythm (QT prolongation)
• inflammation of a vein
• 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
• flu (influenza)
• pneumonia
• loss of appetite
• painful swollen joints caused by uric acid (gout)
• problems sleeping, depression, lack of interest, mood changes
• feeling drowsy, problems with balance speech and nerve function, migraine, shaking
• eye problems, including blurred and less clear vision
• ear pain, spinning sensation (vertigo)
• problems with the nose, throat and sinuses, breathing problems when sleeping
• digestive system problems including: being sick (vomiting), wind, frequent bowel movements, stomach pain and tenderness, food poisoning
• cancer of the rectum
• mouth problems, including dry or sore mouth sensitive tongue, bleeding gums
• skin changes including, excessive sweating, itching bumpy rash, red spots, changes in appearance
• sunburn
• redness or swelling around a wound
• bleeding around a catheter (if present) into the skin
• sensation of a foreign body
• muscular weakness
• kidney problems including: inflammation of the kidney, excessive urination at night, kidney failure, urinary tract infection, white cells in urine
• generally feeling unwell, high temperature, feeling hot, chest pain
• cold sweat
• inflammation of the gum tissue
• infection of skin

Uncommon side effects that may show up in blood tests:
• decreased number of red blood cells (anaemia), white blood cells and platelets
• increased number of red blood cells
• changes in the make-up of the blood
• changes in levels of uric acid, calcium and potassium 8 Other possible side effects in children with ITP

Very common side effects These may affect more than 1 in 10 children:
• sore throat, runny nose, nasal congestion and sneezing
• infection in the nose, sinuses, throat and upper airways, common cold (upper respiratory tract infection)
• diarrhoea

Common side effects These may affect up to 1 in 10 children:
• difficulty in sleeping (insomnia)
• abdominal pain
• toothache
• cough
• pain in the nose and throat
• itchy, runny or blocked nose
• high temperature Other possible side effects in people with hepatitis C

Very common side effects These may affect more than 1 in 10 people:
• headache
• decreased appetite
• difficulty in sleeping (insomnia)
• cough
• feeling sick (nausea), diarrhoea
• muscle pain, itching, lack of energy, high temperature, 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, confusion, depression, anxiety, agitation
• dizziness, problems with attention and memory,
• tingling or numbness of the hands or feet
• inflammation in the brain
• 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 in or around the retina (in the back of the eye)
• spinning sensation, fast or irregular heartbeat (palpitations), shortness of breath
• cough bringing up phlegm
• digestive system problems, including: being sick (vomiting), stomach pain, indigestion, constipation, swollen stomach, taste disturbances, inflammation of the stomach, piles (haemorrhoids), swollen blood vessels and bleeding in the gullet (oesophagus), irritation of the gut 9
• liver problems, including blood clot, yellowing of the whites of the eye or skin (jaundice), tumour in the liver (see ‘Liver problems’ earlier in section 4)
• skin changes, including: rash, dry skin, eczema, redness of the skin, itching, excessive sweating, unusual skin growths
• joint pain, back pain, bone pain, pain in the hands or feet, muscle spasms
• irritability, generally feeling unwell, chest pain and discomfort
• injection site reaction
• disturbances of heart rhythm (QT prolongation)

Common side effects that may show up in blood tests:
• increased blood sugar (glucose)
• reduced number of white blood cells
• reduced blood proteins
• breakdown of red blood cells (haemolytic anaemia)
• increased 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:
• pain when passing urine Side effects with frequency not known Frequency cannot be estimated from the available data
• skin discolouration

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

Very common side effects These may affect more than 1 in 10 people.
• cough
• headache
• shortness of breath (dyspnoea)
• pain in the nose and throat
• runny nose (rhinorrhoea)
• abdominal pain
• diarrhoea
• nausea
• bruising (ecchymosis)
• joint pain (arthralgia)
• muscle spasms
• pain in extremities (arms, legs, hands and feet)
• dizziness
• feeling very tired (fatigue)
• fever
• inability to sleep (insomnia)

Very common side effects that may show up in the blood tests
• increase in some liver enzymes (transaminases) Laboratory tests may show abnormal changes to the cells in your bone marrow. 10

Common side effects These may affect up to 1 in 10 people.
• anxiety
• depression
• feeling cold
• feeling unwell
• eye problems including: blurred and less clear vision, cloudy lens in the eye (cataract), spots or deposits in eye (vitreous floaters), dry eye, itchy eye, yellowing of the whites of the eye or skin
• nose bleed (epistaxis)
• bleeding of the gums
• blisters in the mouth
• digestive system problems including: being sick (vomiting), change in appetite (increased or decreased) stomach pain/discomfort, swollen stomach, passing wind, change in stool colour
• fainting
• skin problems including: Small red or purple spot caused by bleeding into the skin (petechiae) rash, itching, skin lesion
• back pain
• muscle pain
• bone pain
• weakness (asthenia)
• swelling of tissues, usually in the lower limbs, due to the accumulation of fluids
• abnormal colored urine
• interruption in blood supply to spleen (splenic infarction)

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)
• decreased number of white blood cells (neutropenia)
• decrease in sugar level (hypoglycemia)
• increased bilirubin (a substance produced by the liver) Side effects with frequency not known Frequency cannot be estimated from the available data
• skin discolouration

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

How to Store Promacta

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. 11 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.