MULPLEO 3 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Mulpleo 3 mg Film-Coated Tablets

lusutrombopag

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

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

Contents of the Package Leaflet

1. What is Mulpleo and what is it used for
2. What you need to know before taking Mulpleo
3. How to take Mulpleo
4. Possible side effects
5. Storage of Mulpleo
6. Package Contents and Additional Information

1. What is Mulpleo and what is it used for

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

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

2. What you need to know before taking Mulpleo

Do not take Mulpleo:

• if you are allergicto lusutrombopag or any of the other components of this medication (listed in section 6, "Composition of Mulpleo").

Consult your doctorbefore taking Mulpleo if this applies to you.

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 before;
• 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 applies to you.

Signs of a Blood Clot:be aware of the following signs:

• swelling, pain, heat, rednessor pain when touched 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 medication to children or adolescents under 18 years of age, as the medication has not been studied in children and adolescents.

Other Medications and Mulpleo

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

Pregnancy and Breastfeeding

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

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

Do not breastfeedduring treatment with Mulpleo, as it is unknown whether the medication passes into breast milk.

→ If you are already breastfeeding, talk to your doctor immediately.

Driving and Using Machines

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

Mulpleo Contains Sodium

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

3. How to Take Mulpleo

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

Recommended Dose:take one tablet once a day, at the same time each 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 start at least 8 days before your surgical operation or procedure. Do not change the dose or dosing regimen of Mulpleo unless your doctor or pharmacist tells you to.

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 package or this package leaflet. You may be monitored for side effects associated with an excess of platelets, such as blood clots (see section 2, "Warnings and Precautions", and section 4, "Possible Side Effects").

If you forget to take a tablet

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

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

If you stop taking 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 further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Increased Risk of Blood Clots

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

Signs of a Blood Clot:be aware of the following signs:

• swelling, pain, heat, rednessor pain when touched 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.

Frequent Adverse Effects

(may affect up to 1 in 10 people)

• headache;
• nausea;
• blood clots in the liver (portal vein thrombosis);
• skin rash.

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V.

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

5. Storage of Mulpleo

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

Do not use this medication after the expiration date stated on the carton and blister packs after EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect from moisture.

This medication does not require any special storage temperature.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Mulpleo

• The active substance is lusutrombopag. Each film-coated tablet contains 3 mg of lusutrombopag.
• The other ingredients are:
• Tablet Core:mannitol, microcrystalline cellulose, magnesium oxide, sodium lauryl sulfate, hydroxypropylcellulose, calcium carmellose, and magnesium stearate (see section 2, "Mulpleo contains sodium").
• Tablet Film Coating:hypromellose, titanium dioxide, triethyl citrate, talc, and red iron oxide (E172).

Appearance of the Product and Package Contents

Mulpleo 3 mg film-coated tablets are film-coated tablets, 7.0 mm in size, round, and light red in color, engraved with the Shionogi logo above the identifier code "551" on one side and the concentration "3" on the other.

Mulpleo is available in aluminum blisters in a carton containing 7 film-coated tablets.

Marketing Authorization Holder

Shionogi B.V.

Herengracht 464

1017CA Amsterdam

Netherlands

Manufacturer

Shionogi B.V.

Herengracht 464

1017CA Amsterdam

Netherlands

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Package Leaflet: January 2024

Other Sources of Information

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu/.