Revolade 50 mg eltrombopag Tablets × 28

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.

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.

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.

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.