Livtencity

Patient Information Leaflet

LIVTENCITY 200 mg film-coated tablets

maribavir
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this 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 side effects
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.
This medicine is used to treat adults who have undergone an organ or bone marrow transplant and have developed a cytomegalovirus (CMV) infection that has not resolved or has recurred after treatment with another antiviral medicine.
Cytomegalovirus is a virus that is asymptomatic in many people and normally remains in the body without causing any harm. However, if the immune system is weakened following an organ or bone marrow transplant procedure, there is a higher risk of developing this infection.

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 cytomegalovirus infection) or valganciclovir (used to manage cytomegalovirus infection)

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

Warnings and precautions

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

Children and adolescents

LIVTENCITY must not be used in children and 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 take any other medicines, because LIVTENCITY may affect how other medicines work, and other medicines may affect how LIVTENCITY works. Your doctor or pharmacist will advise you whether it is safe to take LIVTENCITY with other medicines.

There are medicines that must not be taken with LIVTENCITY. See the list under the heading “Do not take LIVTENCITY”.

Additionally, inform your doctor if you are taking any of the following medicines, as your doctor may need to adjust your treatment or modify the dose of these medicines:

• rifabutin, rifampicin – for tuberculosis (TB) or related infections
• St. John’s wort (Hypericum perforatum) – a herbal medicine for depression and sleep disorders
• statins, such as atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin – for high cholesterol
• carbamazepine, phenobarbital, phenytoin – typically for seizures or convulsive seizures (epilepsy)
• efavirenz, etravirine, nevirapine – used to treat 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 – for birth control
• 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, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine. LIVTENCITY is not recommended during pregnancy, as it has not been studied in pregnant women and it is unknown whether LIVTENCITY could harm the unborn baby.

Breast-feeding

If you are breast-feeding or planning to breast-feed, inform your doctor before taking this medicine. Breast-feeding is not recommended while taking LIVTENCITY, as it is unknown whether LIVTENCITY passes into breast milk or could affect the breast-fed infant.

Driving and using machines

LIVTENCITY does not affect the ability to drive or use machinery.

LIVTENCITY contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to take LIVTENCITY

Take this medicine exactly as your doctor, pharmacist, or nurse has told you. If you are not sure, ask 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 or crushed tablets.
If you take more LIVTENCITY than you should
If you take too much LIVTENCITY, inform your doctor immediately.
If you forget to take LIVTENCITY
If you forget to take a dose and there are less than 3 hours until the next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the forgotten dose.
If you stop taking LIVTENCITY
Even if you feel better, do not stop taking LIVTENCITY without first talking to your doctor. Taking LIVTENCITY as recommended should give you the best chance of clearing the cytomegalovirus infection and/or disease.
If you have any further 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.
Inform 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 the taste of food
• nausea
• diarrhoea
• vomiting
• tiredness

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 label of the vial after Exp. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LIVTENCITY contains

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

Description of the appearance of LIVTENCITY and the contents of the pack
LIVTENCITY 200 mg film-coated tablets are blue, oval-shaped, biconvex tablets, with "SHP" engraved on one side and "620" on the other side.
The tablets are packed in high-density polyethylene (HDPE) bottles with child-resistant caps, containing 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Takeda Belgium NV Takeda, UAB
Tél/Tel: +32 2 464 06 11 Tel: +370 521 09 070
[email protected] [email protected]

България Luxembourg/Luxemburg
Такеда България ЕООД Takeda Belgium NV
Тел.: +359 2 958 27 36 Tél/Tel: +32 2 464 06 11
[email protected] [email protected]

Česká republika Magyarország
Takeda Pharmaceuticals Czech Republic s.r.o. Takeda Pharma Kft.
Tel: + 420 234 722 722 Tel.: +36 1 270 7030
[email protected] [email protected]

Danmark Malta
Takeda Pharma A/S Τakeda HELLAS S.A.
Tlf: +45 46 77 10 10 Tel: +30 210 6387800
[email protected] [email protected]

Deutschland Nederland
Takeda GmbH Takeda Nederland B.V.
Tel: +49 (0)800 825 3325 Tel: +31 20 203 5492
[email protected] [email protected]

Eesti Norge
Takeda Pharma AS Takeda AS
Tel: +372 6177 669 Tlf: +47 800 800 30
[email protected] [email protected]

Ελλάδα Österreich
Τakeda ΕΛΛΑΣ Α.Ε. Takeda Pharma Ges.m.b.H.
Tηλ: +30 210 6387800 Tel: +43 (0) 800-20 80 50
[email protected] [email protected]

España Polska
Takeda Farmacéutica España S.A. Takeda Pharma Sp. z o.o.
Tel: +34 917 90 42 22 Tel.: +48223062447
[email protected] [email protected]

France Portugal
Takeda France SAS Takeda Farmacêuticos Portugal, Lda.
Tél: + 33 1 40 67 33 00 Tel: + 351 21 120 1457
[email protected] [email protected]

Hrvatska România
Takeda Pharmaceuticals Croatia d.o.o. Takeda Pharmaceuticals SRL
Tel: +385 1 377 88 96 Tel: +40 21 335 03 91
[email protected] [email protected]

Ireland Slovenija
Takeda Products Ireland Ltd Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: 1800 937 970 Tel: + 386 (0) 59 082 480
[email protected] [email protected]

Ísland Slovenská republika
Vistor hf. Takeda Pharmaceuticals Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 (2) 20 602 600
[email protected] [email protected]

Italia Suomi/Finland
Takeda Italia S.p.A. Takeda Oy
Tel: +39 06 502601 Puh/Tel: 0800 774 051
[email protected] [email protected]

Κύπρος Sverige
Τakeda ΕΛΛΑΣ Α.Ε. Takeda Pharma AB
Τηλ.: +30 210 6387800 Tel: 020 795 079
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Takeda Latvia SIA Takeda UK Ltd
Tel: +371 67840082 Tel: +44 (0) 2830 640 902
[email protected] [email protected]

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