Prevymis 480 mg comprimidos recubiertos con pelicula

Patient Information Leaflet

PREVYMIS 240mg Film-Coated Tablets

PREVYMIS 480mg Film-Coated Tablets

letermovir

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

1.What PREVYMIS is and what it is used for

2.What you need to know before you start taking PREVYMIS

3.How to take PREVYMIS

4.Possible side effects

5.Storage of PREVYMIS

6.Contents of the pack and additional information

PREVYMIS is a prescription antiviral medication containing the active ingredient letermovir.

PREVYMIS is a medication for adults who have recently undergone a stem cell transplant (bone marrow) or kidney transplant. The medication helps prevent you from contracting the disease caused by CMV (cytomegalovirus).

CMV is a virus. For most people, CMV does not cause any harm. However, if your immune system is weakened after receiving a stem cell transplant or kidney transplant, you may be at high risk of contracting CMV.

Do not take PREVYMIS:

• if you are allergic to letermovir or any of the other components of this medication (listed in section6).
• if you are taking any of the following medications:
• • pimozide – used for Tourette's syndrome
  • ergot alkaloids (such as ergotamine and dihydroergotamine)– used for migraines.
• if you are taking the following herbal medication:
• • St. John's Wort (Hypericum perforatum)

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

If you are taking PREVYMIS with ciclosporin, do not take the following medications:

Warnings and precautions

If you are also taking a medication to treat high cholesterol (see the list of medications in the section “Other medications and PREVYMIS”), inform your doctor immediately if you experienceunexplained muscle pain or discomfort, especially if you are feeling unwell or have a fever. It may be necessary to change your medication or dosage. For more information, see the package insert for your other medication.

You may need additional blood tests to monitor the following medications:

• Ciclosporin, tacrolimus, sirolimus
• Voriconazole

Children and adolescents

PREVYMIS should not be used in children and adolescents under 18years of age. This is because PREVYMIS has not been studied in this age group.

Other medications and PREVYMIS

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because PREVYMIS may affect the functioning of other medications and other medications may affect the functioning of PREVYMIS. Your doctor or pharmacist will inform you if it is safe to take PREVYMIS with other medications.

There are some medications thatshould not be takenwith PREVYMIS (see the list in "Do not take PREVYMIS:”).

There are some additional medications thatshould not be takenwith PREVYMIS and ciclosporin (see the list in “If you are taking PREVYMIS with ciclosporin, do not take the following medications:”).

Additionally, inform your doctor if you are taking any of the following medications. This is because your doctor may need to change your medications or change the dosage of your medications:

• alfentanil – for intense pain
• fentanil – for intense pain
• quinidine – for heart rhythm disorders

• ciclosporin, tacrolimus, or sirolimus – used to prevent transplant rejection
• voriconazole – for fungal infections
• statins, such as atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin – to treat high cholesterol
• gliburide, repaglinide – for high blood sugar
• carbamazepine, phenobarbital, phenytoin – for seizures or epilepsy
• dabigatran, warfarin – used to thin the blood or prevent blood clots
• midazolam – used as a sedative
• amiodarone – used to correct irregular heartbeats
• oral contraceptive steroids– for birth control
• omeprazole, pantoprazole – for stomach ulcers and other stomach problems
• nafcillin – for bacterial infections
• rifabutin, rifampicin – for fungal infections
• thioridazine – for psychiatric disorders
• bosentan – for high blood pressure in the pulmonary blood vessels
• efavirenz, etravirine, nevirapine, lopinavir, ritonavir – for HIV
• modafinil – to stay awake

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

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. PREVYMIS is not recommended during pregnancy. This is because PREVYMIS has not been studied during pregnancy and it is unknown if PREVYMIS may harm the fetus during pregnancy.

Breastfeeding

If you are breastfeeding or plan to breastfeed, consult your doctor before using this medication. PREVYMIS is not recommended while breastfeeding. This is because it is unknown if PREVYMIS passes into breast milk and may pass to your baby.

Driving and operating machines

PREVYMIS may have a small effect on your ability to drive and operate machines (see section4 “Possible side effects” later). Some patients have reported fatigue (feeling extremely tired) or dizziness (feeling like you are spinning) during treatment with PREVYMIS. If you experience either of these effects, do not drive or operate machines until the effect has passed.

PREVYMIS contains lactose

PREVYMIS contains lactose monohydrate. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

PREVYMIS contains sodium

This medication contains less than1mmolof sodium (23mg) per tablet; this is, essentially “sodium-free”.

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

How much to take

The recommended dose of PREVYMIS is one 480 mg tablet once a day. If you are also taking ciclosporin, your doctor will reduce the dose of PREVYMIS to one 240 mg tablet once a day.

• Take PREVYMIS at the same time every day.
• Take it with or without food.

How to take

• Swallow the tablet whole with a little water. Do not break, crush, or chew the tablet.

If you take more PREVYMIS than you should

If you take more PREVYMIS than you should, contact your doctor immediately.

If you forget to take PREVYMIS

It is very important not to forget or miss any dose of PREVYMIS.

• If you forget to take a dose, take it as soon as you remember. But if it is almost time for your next dose, skip the missed dose. Take the next dose at the usual time.
• Do not take a double dose of PREVYMIS at the same time to make up for the missed doses.
• If you are unsure of what to do, contact your doctor or pharmacist.

Do not interrupt treatment with PREVYMIS

Do not interrupt treatment with PREVYMIS without consulting your doctor first. Do not run out of PREVYMIS. This way, the medication will be more effective in preventing CMV infection after receiving a stem cell transplant or a kidney transplant.

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.

Frequent:may affect up to 1 in 10people

• diarrhea
• nausea
• vomiting

Rare:may affect up to 1 in 100people

• allergic reaction (hypersensitivity)‑symptoms may include buzzing, difficulty breathing, skin rash or hives, itching, inflammation
• loss of appetite
• alteration of taste
• headache
• sensation of spinning (dizziness)
• stomach pain
• abnormalities in laboratory tests to check liver function (e.g., elevated liver enzymes)
• muscle spasms
• elevated creatinine levels in blood tests
• sensation of fatigue (fatigue)
• swelling of hands or feet

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 thenational notification system included in theAppendix V. 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 blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Store in the original packaging to protect it from moisture.

Medicines should not be thrown down the drainsor 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 PREVYMIS

The active ingredient is letermovir. Each film-coated tablet contains 240mg of letermovir or 480mg of letermovir.

The other components are:

Tablet core

Microcrystalline cellulose(E460), sodium croscarmellose(E468), povidone(E1201), anhydrous colloidal silica(E551), magnesium stearate(E470b).

Film coating

Lactose monohydrate, hypromellose(E464), titanium dioxide(E171), triacetin(E1518), yellow iron oxide(E172), red iron oxide (only in the 480mg tablets)(E172), carnauba wax(E903). See section2 “PREVYMIS contains lactose” and “PREVYMIS contains sodium”.

Appearance of the product and contents of the pack

PREVYMIS 240mg film-coated tablet (“tablet”) is presented as an oval-shaped tablet of yellow color, with the inscription "591" on one face and the corporate logo on the other face. The tablet measures 16.5mm in length and 8.5mm in width.

PREVYMIS 480mg film-coated tablet (“tablet”) is presented as an oval-shaped biconvex tablet of pink color, with the inscription "595" on one face and the corporate logo on the other face. The tablet measures 21.2mm in length and 10.3mm in width.

The 28x1tablets are packaged in a box containing blister packs with a pre-cut single-dose polyamide/aluminium/PVC‑aluminium (a total of 28tablets).

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

Last review date of this leaflet:{MM/AAAA}.

More detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.