Mulpleo 3 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Mulpleo is and what it is used for
2. What you need to know before you take Mulpleo
3. How to take Mulpleo
4. Possible side effects
5. How to store Mulpleo
6. Contents of the pack and other information

• if you are allergic to lusutrombopag or any of the other ingredients of this medicine (listed in section 6 under ‘What Mulpleo contains’).

• Check with your doctor if this applies to you before you take Mulpleo

Talk to your doctor:

• if you are at risk of blood clots in your veins or arteries, or if you previously have had blood clots
• if you have severe liver disease
• if your spleen has been removed
• if you are having interferon treatment.

• Talk to your doctor before taking Mulpleo, if any of these applies.

Signs of a blood clot: look out for any of the signs below:

• swelling, pain, heat, redness, or tenderness in your leg
• sudden shortness of breath, especially with sharp pain in the chest or rapid breathing
• pain in the abdomen (tummy), swollen abdomen, blood in your stools.

• Get medical help immediately if you notice any of these.

Do not give this medicine to children or adolescents under the age of 18 years, because the medicine has not been studied in children and adolescents.

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Do not take Mulpleo if you are pregnant unless your doctor specifically recommends it. The effect of Mulpleo during pregnancy is not known.

• Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
• Use reliable methods of contraception while you are taking Mulpleo.
• If you do become pregnant during treatment with Mulpleo, tell your doctor immediately.

Do not breast-feed during treatment with Mulpleo, as it is not known if the medicine passes into milk.

• If you are already breast-feeding, talk to your doctor immediately.

Mulpleo has no known effects on your ability to drive or to use machines.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

If you have taken more Mulpleo than you should, talk to your doctor or go to the hospital. If possible, show them the pack, or this leaflet. You may be monitored for side effects associated with excessive platelets such as blood clots (see section 2, ‘Warnings and precautions’, and section 4, ‘Possible side effects’).

If you miss a tablet of Mulpleo, take it as soon as you remember on the same day.

Do not take a double dose to make up for a forgotten tablet.

Do not stop taking Mulpleo without talking to your doctor and do not take Mulpleo for more than 7 days.

Certain people may have a higher risk of blood clots, including people with liver disease, and medicines like Mulpleo could make this problem worse.

Signs of a blood clot: look out for any of the signs below:

• swelling, pain, heat, redness, or tenderness in your leg
• sudden shortness of breath, especially with sharp pain in the chest or rapid breathing
• pain in the abdomen (tummy), swollen abdomen, blood in your stools.

• Get medical help immediately if you notice any of these.

Common side effects

(may affect up to 1 in 10 people)

• Headache
• Nausea
• Blood clot in the liver (portal vein thrombosis)
• Rash.

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 via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is lusutrombopag. Each film-coated tablet contains 3 mg lusutrombopag.
• The other ingredients are:
  • Tablet core: mannitol, microcrystalline cellulose, magnesium oxide, sodium lauryl sulfate, hydroxypropylcellulose, carmellose calcium and magnesium stearate
  • Film coating: hypromellose, titanium dioxide, triethyl citrate, talc and red-ferric oxide (E172)

Mulpleo 3 mg film-coated tablets are light red, 7 mm, round, film-coated tablets debossed with the Shionogi trademark above the identifier code “551” on one side and debossed with the strength “3” on the other side.

Mulpleo is supplied in aluminium blisters in a carton containing 7 film-coated tablets.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: