Livtencity 200 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

LIVTENCITY 200 mg film-coated tablets

maribavir

This medicinal product is subject to additional monitoring, which will enable rapid detection of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

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

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

Contents of the leaflet

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

1. What LIVTENCITY is and what it is 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 CMV (cytomegalovirus) infection that has not cleared up or has come back after taking another antiviral medicine.

CMV is a virus that many people carry without symptoms and normally remains in the body without causing harm. However, if the immune system becomes weakened following an organ or bone marrow transplant, there is a higher risk of becoming ill due to CMV.

2. What you need to know before taking LIVTENCITY

Do not take LIVTENCITY

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

• if you are taking any of the following medicines:

• ganciclovir (used to manage CMV infection)

• valganciclovir (used to manage CMV infection)

LIVTENCITY must not be given if any of the above apply to you. If in doubt, consult your doctor, pharmacist, or nurse before receiving LIVTENCITY.

Warnings and precautions

Talk to your doctor or pharmacist before taking LIVTENCITY if you are already being treated with cyclosporine, tacrolimus, sirolimus, or everolimus (medicines used to prevent transplant rejection). Additional blood tests may be needed to monitor the blood levels of these medicines. High levels of these medicines may cause serious side effects.

Children and adolescents

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

Other medicines and LIVTENCITY

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 whether it is safe to take LIVTENCITY with other medicines.

There are some medicines that you must not take with LIVTENCITY. See the list under "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 their doses:

• rifabutin, rifampicin – for tuberculosis (TB) or related infections
• St. John’s wort (Hypericum perforatum) – a herbal remedy for depression and sleep problems
• statins, such as atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin – for high cholesterol
• carbamazepine, phenobarbital, phenytoin – generally used for seizures or convulsions (epilepsy)
• efavirenz, etravirine, nevirapine – for treating HIV infection
• antacid (oral suspension of aluminium and magnesium hydroxide) – for heartburn or indigestion due to excess stomach acid
• famotidine – for heartburn or indigestion 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 – an anticoagulant
• oral contraceptive steroids – to prevent pregnancy
• midazolam – used as a sedative

You may 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 become pregnant, consult your doctor before using this medicine. LIVTENCITY is not recommended during pregnancy, as it has not been studied in pregnancy and it is unknown whether LIVTENCITY could harm your unborn baby.

Breast-feeding

If you are breast-feeding or planning to breast-feed, consult your doctor before taking this medicine. Breast-feeding is not recommended during treatment with LIVTENCITY, as it is unknown whether LIVTENCITY passes into breast milk or could affect the baby.

Driving and using machines

LIVTENCITY has no influence on the ability to drive or 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

Follow exactly the instructions for using this medicine given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

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

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 miss a dose and there are 3 hours or less until your next scheduled dose, skip the missed dose and return to your regular dosing 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 first consulting your doctor. Taking LIVTENCITY as recommended should give you the best chance of clearing the CMV infection and/or disease.

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

4. Possible adverse effects

Like all medicines, this medicine 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 common (may affect more than 1 in 10 people):

• changes in the taste of things
• nausea
• diarrhea
• vomiting
• tiredness (fatigue)

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

• increased blood concentrations of medications used to prevent transplant rejection
• stomach (abdominal) pain
• loss of appetite
• headache
• weight loss

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

By reporting adverse 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 stated on the carton and on the label of the vial after EXP. The expiry date refers to the last day of the month indicated.

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 and packaging you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of LIVTENCITY

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

• The other components (excipients) are:

• Tablet core:
  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), aluminium lake of brilliant blue FCF (EU) (E133)

Appearance of the product and contents of the container

LIVTENCITY 200 mg film-coated tablets are blue, oval-shaped and biconvex, with the imprint «SHP» on one side and «620» on the other.

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

Only certain pack sizes may be marketed.

Marketing Authorization 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, contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: 02/2023

Other sources of information

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