LIVTENCITY 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

LIVTENCITY 200 mg Film-Coated Tablets

maribavir

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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.

Contents of the Package Leaflet

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

1. What is LIVTENCITY and what is it used for

LIVTENCITY is an antiviral medicine that contains the active substance maribavir.

It is a medicine used to treat adults who have received an organ or bone marrow transplant and have developed a cytomegalovirus (CMV) infection that has not gone away or has come back after taking another antiviral medicine.

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, you may be at a higher risk of becoming ill due to CMV.

2. What you need to know before you take LIVTENCITY

Do not take LIVTENCITY

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• if you are taking any of these medicines:

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

Do not take LIVTENCITY if any of the above applies to you. If you are unsure, consult your doctor, pharmacist, or nurse before taking LIVTENCITY.

Warnings and precautions

Consult your doctor or pharmacist before taking LIVTENCITY if you are already being treated with ciclosporin, tacrolimus, sirolimus, or everolimus (medicines to prevent transplant rejection). You may need to have extra blood tests to check the levels of these medicines in your blood. High levels of these medicines can cause serious side effects.

Children and adolescents

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

Other medicines and LIVTENCITY

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

There are some medicines that you should not take with LIVTENCITY. See the list "Do not take LIVTENCITY".

Tell your doctor if you are taking any of the following medicines, as your doctor may need to change your medicines or adjust the dose of them:

• rifabutin, rifampicin – for tuberculosis (TB) or related infections
• St. John's Wort (Hypericum perforatum) – a herbal medicine for depression and sleep problems
• statins, such as atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin – for high cholesterol
• carbamazepine, phenobarbital, phenytoin – usually for seizures or convulsions (epilepsy)
• efavirenz, etravirine, nevirapine – for treating HIV infection
• antacids (oral suspension of aluminium hydroxide and magnesium hydroxide) – for heartburn or dyspepsia due to excess stomach acid
• famotidine – for heartburn or dyspepsia due to excess stomach acid
• digoxin – a heart medicine
• clarithromycin – an antibiotic
• ketoconazole and voriconazole – for fungal infections
• diltiazem – a heart medicine
• dextromethorphan – a cough medicine
• warfarin – a blood thinner
• oral contraceptive steroids – to prevent pregnancy
• midazolam – used as a sedative

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

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. It is not recommended to use LIVTENCITY during pregnancy, as it has not been studied in pregnancy and it is not known whether LIVTENCITY can harm your baby while you are pregnant.

Breast-feeding

If you are breast-feeding or plan to breast-feed, ask your doctor for advice before taking this medicine. It is not recommended to breast-feed during treatment with LIVTENCITY, as it is not known whether LIVTENCITY passes into breast milk or whether it could affect your baby.

Driving and using machines

LIVTENCITY has no influence on the ability to drive and use machines.

LIVTENCITY contains sodium

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

3. How to take LIVTENCITY

Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. If you are unsure, ask your doctor, pharmacist, or nurse.

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

If you take more LIVTENCITY than you should

If you take too much LIVTENCITY, tell your doctor immediately.

If you forget to take LIVTENCITY

If you miss a dose and it is 3 hours or less before your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for missed doses.

If you stop taking LIVTENCITY

Even if you feel better, do not stop taking LIVTENCITY without talking to your doctor first. Taking LIVTENCITY as recommended should give you the best chance of getting rid of the CMV infection and/or disease.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor, pharmacist, or nurse if you notice any of the following side effects:

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

• changes in taste
• nausea
• diarrhea
• vomiting
• fatigue

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

• increased levels in the blood of medicines used to prevent transplant rejection
• stomach pain (abdominal pain)
• loss of appetite
• headache
• weight loss

Reporting of side effects

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 European Medicines Agency website: http://www.ema.europa.eu. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of LIVTENCITY

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

Do not use this medicine after the expiry date which is stated on the carton and on the label of the bottle after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of LIVTENCITY

• The active substance is maribavir. Each film-coated tablet contains 200 mg of maribavir
• The other ingredients are

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

• Coating of the tablet:
• Polyvinyl alcohol (E1203), Macrogol (i.e., polyethylene glycol) (E1521), titanium dioxide (E171), talc (E553b), brilliant blue FCF aluminum lake (EU) (E133)

Appearance of the product and pack size

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

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

Not all 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

You can get more information about this medicine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet: 02/2023

Other sources of information

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