PREVYMIS 480 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

PREVYMIS 240mg film-coated tablets

PREVYMIS 480mg film-coated tablets

letermovir

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 pack

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

1. What is PREVYMIS and what is it used for

PREVYMIS is a prescription antiviral medicine that contains the active substance letermovir.

PREVYMIS is a medicine for:

• adults and children weighing at least 15 kg who have recently undergone a stem cell transplant (bone marrow transplant).
• adults and children weighing at least 40 kg who have recently undergone a kidney transplant.

The medicine helps to prevent you from getting 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 or kidney transplant, you may be at high risk of getting sick from CMV.

2. What you need to know before you take PREVYMIS

Do not take PREVYMIS:

• if you are allergic to letermovir or any of the other ingredients of this medicine (listed in section 6).
• if you are taking any of the following medicines:
• • pimozide - used for Tourette's syndrome
  • ergot alkaloids (such as ergotamine and dihydroergotamine) - used for migraine headaches.
• if you are taking the following herbal medicine:
• • St. John's Wort (Hypericum perforatum)

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

If you are taking PREVYMIS with cyclosporine, do not take the following medicines:

• dabigatran - used to prevent blood clots
• atorvastatin, simvastatin, rosuvastatin, pitavastatin - to treat high cholesterol

Warnings and precautions

If you are also taking a medicine to treat high cholesterol (see list of medicines in the section "Other medicines and PREVYMIS"), you must inform your doctor immediately if you have unexplained muscle pain or weakness, especially if you are feeling unwell or have a fever. Then, it may be necessary to change your medicine or dose. For more information, see the leaflet for your other medicine.

Additional blood tests may be needed to monitor the following medicines:

• cyclosporine, tacrolimus, sirolimus
• voriconazole

Children and adolescents

PREVYMIS should not be used in children who weigh less than 5 kg who have received a stem cell transplant (bone marrow transplant) or in children who weigh less than 40 kg who have received a kidney transplant. This is because PREVYMIS has not been studied in these groups.

Other medicines and PREVYMIS

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

There are some medicines that you must not takewith PREVYMIS (see list in "Do not take PREVYMIS:").

There are some additional medicines that you must not takewith PREVYMIS and cyclosporine (see list in "If you are taking PREVYMIS with cyclosporine, do not take the following medicines:").

Also, inform your doctor if you are taking any of the following medicines. This is because your doctor may need to change your medicines or change the dose of your medicines:

• alfentanil - for severe pain
• fentanyl - for severe pain
• quinidine - for heart rhythm disorders

• cyclosporine, 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 steroid contraceptives - 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 lungs
• efavirenz, etravirine, nevirapine, lopinavir, ritonavir - for HIV
• modafinil - to stay awake

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

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. PREVYMIS should not be used during pregnancy. This is because PREVYMIS has not been studied during pregnancy and it is not known whether PREVYMIS could harm the baby during pregnancy.

Breast-feeding

If you are breast-feeding or plan to breast-feed, ask your doctor for advice before taking this medicine. Breast-feeding is not recommended while taking PREVYMIS. This is because it is not known whether PREVYMIS passes into breast milk and could pass to your baby.

Driving and using machines

PREVYMIS may have a minor influence on your ability to drive and use machines (see section 4 "Possible side effects" later). Some patients have reported fatigue (feeling very tired) or dizziness (feeling like they are spinning) during treatment with PREVYMIS. If you experience any of these effects, do not drive or use machines until the effect goes away.

PREVYMIS contains lactose

PREVYMIS contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

PREVYMIS contains sodium

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

3. How to take PREVYMIS

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

How much to take

Your dose of PREVYMIS depends on your weight and whether you are also taking cyclosporine. Your doctor will tell you how many tablets to take.

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

The recommended oral doses of PREVYMIS are presented in Table 1 and Table 2.

Table 1: Recommended doses of PREVYMIS film-coated tablets without cyclosporine

Table 2: Recommended doses of PREVYMIS film-coated tablets with cyclosporine

How to take

• Swallow the tablet whole with a little water. Do not break, crush, or chew the tablet because these methods have not been studied.

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 that you do not miss or skip 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 missed doses.
• If you are unsure what to do, contact your doctor or pharmacist.

Do not stop taking PREVYMIS

Do not stop taking PREVYMIS without talking to your doctor first. Do not run out of PREVYMIS. This way, the medicine will be more effective in preventing you from getting sick with CMV after receiving a stem cell or kidney transplant.

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.

Common:may affect up to 1 in 10 people

• diarrhea
• nausea
• vomiting

Uncommon:may affect up to 1 in 100 people

• allergic reaction (hypersensitivity) - the signs may include hives, difficulty breathing, swelling of the face, lips, tongue, or throat, itching
• loss of appetite
• altered taste
• headache
• feeling of spinning (vertigo)
• stomach pain
• abnormal liver function tests (e.g., elevated liver enzymes)
• muscle spasms
• elevated creatinine levels in blood tests
• feeling of tiredness (fatigue)
• swelling of hands or feet

Reporting of side effects

If you experience 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 through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing PREVYMIS

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 blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions. Store in the original package to protect from moisture.

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

6. Packaging Contents and Additional Information

Composition of PREVYMIS

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

The other ingredients are:

Tablet core

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

Film coating

Lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin, yellow iron oxide (E172), red iron oxide (only in 480 mg tablets) (E172), carnauba wax (E903). See section 2 "PREVYMIS contains lactose" and "PREVYMIS contains sodium".

Appearance and Packaging of the Product

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

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

The 28x1 tablets are packaged in a box containing blister cards with a single-dose, pre-cut poliamide/aluminum/PVC-aluminum blister (a total of 28 tablets).

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

Date of the Last Revision of this Leaflet:{MM/YYYY}.

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