Eltrombopag Teva 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 reduce or prevent bleeding.

• Eltrombopag Teva is used to treat a bleeding disorder called immune (primary) thrombocytopenia (ITP) in patients aged 1 year and older who have already taken other medicines (corticosteroids or immunoglobulins) that have not worked.

TIP is caused by a low number of platelets in the blood (thrombocytopenia).
People with TIP have an increased risk of bleeding. Symptoms that patients with TIP may notice include petechiae (round, smooth, red spots the size of a pinhead under the skin), bruising, nosebleeds, bleeding gums, and the inability to control
bleeding if they cut or injure themselves.

• Eltrombopag Teva can also be used to treat low platelet counts (thrombocytopenia) in adults with chronic hepatitis C virus (HCV) infection, if they have had problems with side effects during treatment with interferon. Many people
People with hepatitis C have low platelet counts, not only as a result of the disease but also because of some of the antiviral medicines used to treat it. Taking Eltrombopag Teva may make it easier for you to take a regular treatment regimen.
complete with antiviral medication (peginterferon and ribavirin).

• Eltrombopag Teva can also be used in adult patients with low blood cell counts caused by severe aplastic anaemia (SAA). SAA is a disease in which the bone marrow is affected, causing a shortage of red blood cells (anaemia), white blood cells (leukopenia) and platelets.
(thrombocytopenia).

Do not take Eltrombopag Teva:
- if you are allergic to eltrombopag or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor before using Eltrombopag Teva.

Pregnancy and breastfeeding:
Do not use Eltrombopag Teva if you are pregnant unless your doctor tells you to. The effect of Eltrombopag Teva during pregnancy is not known.
• Tell your doctor if you are pregnant, think you may be pregnant or are planning to become pregnant.
• Use a reliable method of contraception while taking Eltrombopag Teva to prevent pregnancy.
• If you become pregnant while taking Eltrombopag Teva, tell your doctor.
Do not breast-feed while taking Eltrombopag Teva. It is not known whether Eltrombopag Teva passes into breast milk.
➔ If you are breastfeeding or planning to breastfeed, tell your doctor.

Driving and using machines:
Eltrombopag Teva may cause dizziness and may have other side effects that may affect alertness.
➔ Do not drive or use machines unless you are sure you are not affected.

Always take this medicine exactly as your doctor has told you. Talk to your doctor or pharmacist if you are not sure. Do not change the dose or time of day you take Eltrombopag Teva unless your doctor or pharmacist tells you to. During treatment with Eltrombopag Teva you will be supervised by a doctor who is experienced in treating your condition.

How much to take
For TYPE
Adults and children and adolescents (6 to 17 years) – the usual starting dose for people with TIP is one 50 mg tablet of Eltrombopag Teva per day. If you are of East/South-East Asian origin you may need to start treatment with a lower dose of 25 mg.
Children (1 - 5 years) - the usual starting dose in children with TIP is one 25 mg Eltrombopag Teva tablet per day.

For hepatitis C:
Adults - the usual starting dose for adults with hepatitis C is one 25 mg Eltrombopag Teva tablet per day.
If you are of East/Southeast Asian origin, you will start treatment with the same dose of 25 mg.

For AAS:
Adults - the usual starting dose for adults with ASA is one 50 mg tablet of Eltrombopag Teva per day. If you are of East/South-East Asian origin, you may need to start with a lower dose of 25 mg.
It may take 1 to 2 weeks for Eltrombopag Teva to start working. Depending on your response to Eltrombopag Teva, your doctor may recommend changing your daily dose.

How to take the tablets:
Swallow the tablet whole with water.
Eltrombopag Teva 25 mg tablet can be divided into equal doses.
Eltrombopag Teva 50 mg tablet can be divided into equal doses.

When to take Eltrombopag Teva:
Make sure -
• 4 hours before taking Eltrombopag Teva
• and for 2 hours after taking Eltrombopag Teva do not consume any of the following:
• dairy products, such as cheese, butter, yogurt, or ice cream
• milk or milkshakes, drinks containing milk, yogurt or cream
• antacids, which are a type of medicine for indigestion and heartburn
• some mineral and vitamin supplements, which include iron, calcium, magnesium, aluminum, selenium, and zinc

For more advice on appropriate foods and drinks, talk to your doctor.

If you take them, the medicine will not be absorbed properly into your body.

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

- The active substance in Eltrombopag Teva is eltrombopag.
25 mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag.
50 mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag.
75 mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg eltrombopag.
- The other ingredients are: microcrystalline cellulose (PH 101) (E460(i)), hypromellose, mannitol (E421), povidone, microcrystalline cellulose (PH 102) (E460(i)), sodium starch glycolate (type B), colloidal anhydrous silica, talc (E553b), magnesium stearate.
Eltrombopag Teva 25 mg film-coated tablets also contain hypromellose (E464), titanium dioxide (E171), macrogol (E1521).
Eltrombopag Teva 50 mg film-coated tablets also contain hypromellose (E464), titanium dioxide (E171), macrogol (E1521), yellow iron oxide (E172) and red iron oxide (E172).
Eltrombopag Teva 75 mg film-coated tablets also contain hypromellose (E464), titanium dioxide (E171), macrogol (E1521), red iron oxide (E172) and black iron oxide (E172).

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

28 film-coated tablets