Package Insert: Information for the Patient

Mulpleo 3 mg Film-Coated Tablets

lusutrombopag

Read the entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Mulpleo contains the active ingredient lusutrombopag, which belongs to a group of medications called thrombopoietin receptor agonists. The medication helps to increase the number ofplateletsin the blood. Platelets are blood components that help to coagulate the blood and thus prevent bleeding.

Mulpleo is used toreduce the risk of bleeding during surgical and other procedures(including dental extractions and endoscopy). It is administered to adults with low platelet counts due to chronic liver disease.

Do not take Mulpleo:

• if you are allergicto lusutrombopag or to any of the other ingredients in this medicine(listed in thesection 6 in«Composition of Mulpleo»).

?Consult your doctorbefore starting to take Mulpleo, if this is your case.

Warnings and precautions

Consult your doctor:

• if you are at risk of developingblood clots in the veins or arteries, or if you have had blood clots in the past;
• if you have severe liver disease;
• if you have had your spleen removed;
• if you are receiving interferon treatment.

?Consult your doctorbefore taking Mulpleo, if this is your case.

Blood clot signs:be aware of the following signs:

• swelling, pain, heat, rednessor tenderness in the leg;
• sudden difficulty breathing, especially with a sharp chest pain or rapid breathing;
• abdominal pain(stomach), swollen abdomen and blood in the stool.

?Seek medical attention immediatelyif you notice any of these signs.

Children and adolescents

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

Other medicines and Mulpleo

Inform your doctor if you are taking, have taken recently or may need to take any other medicine.

Pregnancy and breastfeeding

Do not take Mulpleounless your doctor recommends it specifically. The effect of Mulpleo during pregnancy is unknown.

• If you are pregnant, think you may be pregnant or intend to become pregnant,consult your doctor.
• Use reliable contraceptive methodswhile taking Mulpleo.
• If you become pregnantduring treatment with Mulpleo, inform your doctorimmediately.

Do not breastfeed during treatmentwith Mulpleo, as it is unknown if the medicine passes into breast milk.

→If you are already breastfeeding, speak with your doctor immediately.

Driving and operating machines

Mulpleo has no known effect on the ability to drive or operate machines.

Mulpleo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:Take one tablet once a day, at the same time every day, for only seven days. Take the tablet with a liquid and swallow it whole. Do not chew, break, or crush the tablet. You can take it with food or between meals.

Your treatment will begin at least 8 days before your surgical operation or procedure. Do not change the dose or dosing schedule of Mulpleo unless instructed by your doctor or pharmacist.

If you have severe liver disease,inform your doctor before taking Mulpleo.

If you take more Mulpleo than you should

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

If you forgot to take a tablet

If you forgot to take a Mulpleo tablet, take it as soon as possible on the same day.

Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Mulpleo

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Increased risk of blood clots

Certain people may be at a higher risk of developing blood clots — including people with liver disease — and medications like Mulpleo may exacerbate this problem.

Symptoms of a blood clot: Be aware of the following symptoms:

• Swelling, pain, heat, redness, or tenderness in the leg;
• Sudden difficulty breathing, especially with a stabbing chest pain or rapid breathing;
• Abdominal pain (stomach), swollen abdomen, and blood in the stool.

? Seek medical attention immediately if you notice any of these symptoms.

Adverse effects that occur frequently

(may affect up to 1 in 10 people)

• Headache;
• Nausea;
• Blood clots in the liver (portal vein thrombosis);
• Skin rash.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in the Appendix V .

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blisters after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medication does not require any special storage temperature.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Mulpleo

• The active ingredient is lusutrombopag. Each film-coated tablet contains 3 mg of lusutrombopag.
• The other components are:
• Core of the tablet:mannitol, microcrystalline cellulose, magnesium oxide, sodium lauryl sulfate, hydroxypropyl cellulose, calcium carmelose, and magnesium stearate (see section 2 “Mulpleo contains sodium”).
• Film coating of the tablet:hypromellose, titanium dioxide, triethyl citrate, talc, and iron oxide red (E172).

Appearance of the product and contents of the package

Mulpleo 3 mg film-coated tablets are film-coated tablets of 7.0 mm in diameter, round, and light red in color, engraved with the commercial brand name of Shionogi above the identifier code “551” on one side and the concentration “3” on the other.

Mulpleo is presented in aluminum blisters in a box containing 7 film-coated tablets.

Marketing Authorization Holder

Shionogi B.V.

Herengracht 464

1017CA Amsterdam

Netherlands

Responsible for manufacturing

Shionogi B.V.

Herengracht 464

1017CA Amsterdam

Netherlands

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet: January 2024

Other sources of information

Further information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.