Revolade 50 mg 28 Tablet

What Eltrombopag olamine is and what it is used for:

• Eltrombopag olamine 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 thathelp to reduce or prevent bleeding.
• Eltrombopag olamine 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 (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.
• Eltrombopag olamine 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 Eltrombopag olamine may make it easier for you to complete a full course of antiviral medicine (peginterferon and ribavirin).
• Eltrombopag olamine 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).

What you need to know before you use Eltrombopag olamine :

Do not use Eltrombopag olamine:

• If you are allergic to eltrombopag or any of the other ingredients of this medicine

Warnings and precautions:

Talk to your doctor or pharmacist before taking Eltrombopag olamine if:

• 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 Eltrombopag olamine 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 you have cataracts (the lens of the eye getting cloudy)
• If you have another blood condition, such as myelodysplastic syndrome (MDS).
• Your doctor will carry out tests to check that you do not have this blood condition before you start Eltrombopag olamine .
• If you have MDS and take Eltrombopag olamine , your MDS may get worse.

Children and adolescents:

• Eltrombopag olamine 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 Eltrombopag olamine :

• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
• This includes medicines obtained without prescription and vitamins.
• Some everyday medicines interact with Eltrombopag olamine – including prescription and non-prescription medicines and minerals.
• These include:
• 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
• Medicines such as methotrexate and topotecan, to treat cancer
• Antacid medicines to treat indigestion, heartburn or stomach ulcers
• If you are also taking medicines to prevent blood clots there is a greater risk of bleeding.
• Your doctor will discuss this with you.
• If you are taking corticosteroids, danazol, and/or azathioprine you may need to take a lower dose or to stop taking them while you are taking Eltrombopag olamine .
• Eltrombopag olamine with food and drink
• Do not take Eltrombopag olamine with dairy foods or drinks as the calcium in dairy products affects the absorption of the medicine.

How to use Eltrombopag olamine :

• 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 Eltrombopag olamine unless your doctor or pharmacist advises you to.
• While you are taking Eltrombopag olamine , 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 Eltrombopag olamine a day.
• If you are of 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 Eltrombopag olamine a day.

For hepatitis C:

• Adults - the usual starting dose for hepatitis C is one 25 mg tablet of Eltrombopag olamine a day.
• If you are of 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 Eltrombopag olamine a day.
• If you are of Asian origin (Chinese, Japanese, Taiwanese, Thai or Korean) you may need to start at a lower dose of 25 mg.
• Eltrombopag olamine may take 1 to 2 weeks to work.
• Based on your response to Eltrombopag olamine 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 Eltrombopag olamine and the 2 hours after you take Eltrombopag olamine 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.
• If you take more Eltrombopag olamine 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 Eltrombopag olamine
• Take the next dose at the usual time.
• Do not take more than one dose of Eltrombopag olamine in one day.

Possible side effects:

• Stop using the product and seek immediate medical attention if
  you develop urticaria, rash, tightness of the chest, wheezing, hypotension
• Tell your doctor immediately if you experience any of the following symptoms after taking this medicine.

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
• Bleeding or bruising
• 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

How to store Eltrombopag olamine :

• 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.