Prospect: information for the patient

LIVTENCITY 200 mg film-coated tablets

maribavir

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

LIVTENCITY is an antiviral medication that contains the active ingredient maribavir.

It is a medication used to treat adults who have received an organ or bone marrow transplant and have developed a CMV (cytomegalovirus) infection that has not cleared up or has returned after taking another antiviral medication.

CMV is a virus that many people have without symptoms and normally remains in the body without causing any harm. However, if the immune system is weakened after receiving an organ or bone marrow transplant, it may be at a higher risk of becoming ill due to CMV.

Do not take LIVTENCITY

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• if you are taking any of the following medications:

• ganciclovir (used to manage CMV infection)
• valganciclovir (used to manage CMV infection)

LIVTENCITY should not be administered if any of the above circumstances apply. If in doubt, consult your doctor, pharmacist, or nurse before LIVTENCITY is administered.

Warnings and precautions

Consult your doctor or pharmacist before taking LIVTENCITY if you are already being treated with ciclosporin, tacrolimus, sirolimus, or everolimus (medications to prevent transplant rejection). Additional blood tests may be required to verify the concentrations of these medications in the blood. Elevated concentrations of these medications can cause severe side effects.

Children and adolescents

LIVTENCITY should not be used in children or adolescents under 18 years of age, as LIVTENCITY has not been tested in this age group.

Other medications and LIVTENCITY

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, as LIVTENCITY may affect how other medications work, and other medications may affect how LIVTENCITY works. Your doctor or pharmacist will tell you if it is safe to take LIVTENCITY with other medications.

You can ask your doctor, pharmacist, or nurse for a list of medications that may interact with LIVTENCITY.

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. LIVTENCITY is not recommended during pregnancy, as it has not been studied in pregnancy and it is unknown if LIVTENCITY may harm the baby while pregnant.

Breastfeeding

If you are breastfeeding or plan to breastfeed your baby, consult your doctor before taking this medication. LIVTENCITY is not recommended during breastfeeding, as it is unknown if LIVTENCITY may pass into breast milk or affect the baby.

Driving and operating machinery

The influence of LIVTENCITY on the ability to drive and operate machinery is none.

LIVTENCITY contains sodium

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

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

The recommended dose is 400 mg twice a day. This means you should take two LIVTENCITY 200 mg tablets in the morning and two other 200 mg tablets in the evening. You can take this medication with or without food, in the form of a whole tablet or crushed tablet.

If you take more LIVTENCITY than you should

If you take an excessive amount of LIVTENCITY, inform your doctor immediately.

If you forget to take LIVTENCITY

If you forget a dose and there are 3 hours or less until your next dose, skip the missed dose and return to your regular schedule. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with LIVTENCITY

Although you may feel better, do not stop taking LIVTENCITY without first consulting your doctor. Taking LIVTENCITY as recommended should give you the best chance of eliminating the CMV infection and/or disease.

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

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

Inform your doctor, pharmacist, or nurse if you notice any of the following adverse effects:

Very Frequent(may affect more than 1 in 10 people):

• Changes in the taste of things
• Nausea
• Diarrhea
• Vomiting
• Fatigue (tiredness)

Frequent(may affect up to 1 in 10 people):

• Increased blood concentrations of medications used to prevent transplant rejection
• Abdominal pain (stomach pain)
• Loss of appetite
• Headache
• Weight loss

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 theSpanish System for Pharmacovigilance of Medications for Human Use:www.notificaRAM.es

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 label of the bottle after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of LIVTENCITY

• The active ingredient is maribavir. Each film-coated tablet contains 200 mg of maribavir
• The other components (excipients) are

• Core tablet:
• Microcrystalline cellulose (E460(i)), sodium starch glycolate (see section 2), magnesium stearate (E470b)

• Film coating:
• Polyvinyl alcohol (E1203), Macrogol (i.e., polyethylene glycol) (E1521), titanium dioxide (E171), talc (E553b), Brilliant Blue FCF aluminium lake (UE) (E133)

Appearance of the product and contents of the pack

LIVTENCITY 200 mg film-coated tablets are blue, oval-shaped and convex, with the inscription "SHP" on one face and "620" on the other.

The tablets are packed in high-density polyethylene (HDPE) bottles with child-resistant closures and contain 28, 56 or 112 (2 x 56) film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza

50-58 Baggot Street Lower

Dublin 2

D02 HW68

Ireland

Manufacturer

Takeda Ireland Limited

Bray Business Park

Kilruddery

Co. Wicklow

Ireland

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics: 02/2023

Other sources of information

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