Tocieta 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.

Tocieta is used to treat a bleeding disorder called immune (primary) thrombocytopenia (ITP) in patients 1 year of age 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 experience include petechiae (round, smooth, pin-point-sized red spots under the skin), bruising, nosebleeds, bleeding gums, and the inability to control bleeding if they cut or injure themselves.

Tocieta 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 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 Tocieta can make it easier for you to take a full course of antiviral medicine (peginterferon and
ribavirin).

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

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

Before using Tocieta, consult your doctor.

Pregnancy and breastfeeding:
Do not use Tocieta if you are pregnant unless your doctor tells you to. The effect of eltrombopag 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 Tocieta to prevent pregnancy.
If you become pregnant while taking Tocieta, tell your doctor.
Do not breast-feed while taking Tocieta. It is not known whether eltrombopag passes into breast milk.
If you are breast-feeding or planning to breast-feed, tell your doctor.

Driving and using machines:
Tocieta can cause dizziness and may have other side effects that can affect attention.
Do not drive or use machines unless you are sure you are not affected.

Tocieta contains isomalt and sodium:
If you have been told by your doctor that you have an intolerance to some types of sugars, talk to your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.

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 taking Tocieta unless your doctor or pharmacist has told you to. During treatment with Tocieta you will be supervised by an experienced doctor who is specialised in the treatment of your condition.

How much to take:
For TYPE
Adults and children and adolescents (6 - 17 years) - the usual starting dose for people with TIP is one 50 mg tablet of Tocieta 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 tablet of Tocieta per day.

For hepatitis C:
Adults - the usual starting dose in adults with hepatitis C is one 25 mg tablet of Tocieta 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 Tocieta per day. If you are of East/Southeast Asian origin, you may need to start with a lower dose of 25 mg.

It may take 1 to 2 weeks for Tocieta to start working. Depending on your response to Tocieta, your doctor may recommend changing your daily dose.

How to take the tablets:
Swallow the tablet whole with a sufficient amount of water.

When to take Tocieta:
Make sure
- 4 hours before taking Tocieta
- and for 2 hours after you take Tocieta

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.

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

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

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

- The active substance is eltrombopag olamine
Tocieta 25 mg: each film-coated tablet contains eltrombopag olamine, equivalent to eltrombopag 25 mg
Tocieta 50 mg: each film-coated tablet contains eltrombopag olamine, equivalent to eltrombopag 50 mg
- The other ingredients are: microcrystalline cellulose, mannitol, povidone, isomalt (E 953), calcium silicate, sodium starch glycolate, magnesium stearate (tablet core); hypromellose, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), triacetin (tablet film).

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

28 film-coated tablets