Label: information for the user

Vosevi 400mg/100mg/100 mg film-coated tablets

sofosbuvir/velpatasvir/voxilaprevir

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

Read this label carefully before starting to take this medicine, as it contains important information for you.

-Keep this label, as you may need to refer to it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section4.

1.What is Vosevi and for what it is used

2.What you need to know before starting to take Vosevi

3.How to take Vosevi

4.Possible adverse effects

5.Storage of Vosevi

6.Contents of the package and additional information

Vosevi is a medication that contains the active ingredients sofosbuvir, velpatasvir, and voxilaprevir in a single tablet. It is administered to adults aged 18 years and older to treat a chronic (long-term) viral infection of the liver called hepatitis C.

The active ingredients of this medication act in combination to block three different proteins that the hepatitis C virus needs to grow and reproduce, which makes the infection eliminated from the body.

Do not take Vosevi

• If you are allergicto sofosbuvir, velpatasvir, voxilaprevir, or any of the other ingredients in this medicine (listed in section6 of this leaflet).

?If this is the case,do not take Vosevi and tell your doctor immediately.

• If you are currently taking any of the following medicines:
• rifampicin and rifabutin(antibiotics used to treat infections, including tuberculosis);
• St. John's Wort(a herbal medicine used to treat depression);
• carbamazepine, phenobarbitalandphenytoin(medicines used to treat epilepsy and prevent seizures);
• rosuvastatin(a medicine used to treat high cholesterol and the risk of certain cardiovascular events);
• dabigatran(a medicine used to prevent blood clots);
• medicines that containethinylestradiol, including many contraceptives.

Warnings and precautions

Consult your doctor if:

• You have liver problemsother than hepatitisC, for example
• if you haveor have had a hepatitisB infection, as your doctor may want to monitor you more closely;
• if you have had a liver transplant.
• you are taking treatment for HIV infection,as your doctor may want to monitor you more closely.

Consult your doctor or pharmacist before starting Vosevi if:

• You are currently taking or have stopped taking amiodarone in the past few months to treat irregular heart rhythm, as it may cause potentially fatal bradycardia. Your doctor may consider alternative treatments if you have taken this medicine. If you need treatment with Vosevi, you may need additional cardiac monitoring.
• You have diabetes. After starting Vosevi, you may need to have your blood glucose levels closely monitored and/or adjust your diabetes medication. Some diabetic patients have experienced hypoglycemia after starting treatment with medicines like Vosevi.

Consult your doctor immediatelyif you are currently taking or have taken in the past few months any medicine for heart problems and, during treatment, experience:

• slow or irregular heartbeats, or heart rhythm problems;
• shortness of breath or worsening of existing shortness of breath;
• chest pain;
• feeling dizzy;
• palpitations;
• loss of consciousness or near loss of consciousness.

Blood tests

Your doctor will perform blood tests before, during, and after treatment with Vosevi. This is to:

• allow your doctor to decide whether you should take Vosevi and for how long;
• confirm that the treatment has worked and you no longer have hepatitisC.

Children and adolescents

Do not give this medicine to children and adolescents under 18years. Vosevi has not yet been studied in children and adolescents.

Other medicines and Vosevi

Inform your doctor or pharmacistif you are taking, have taken recently, or may need to take any other medicine.

If you are unsure, consult your doctor or pharmacist.

Some medicines should not be taken with Vosevi.Vosevi may not work properly or may worsen side effects if taken with them.

• Rifampicin and rifabutin(antibiotics used to treat infections, including tuberculosis);
• St. John's Wort(a herbal medicine used to treat depression);
• Carbamazepine, phenobarbitalandphenytoin(medicines used to treat epilepsy and prevent seizures);
• Rosuvastatin(a medicine used to treat high cholesterol or the risk of certain cardiovascular events);
• Dabigatran(a medicine used to prevent blood clots);

• Medicines that containethinylestradiol, including many contraceptives.

Inform your doctor or pharmacistif you are taking any of the following medicines:

• amiodarone,used to treat irregular heart rhythm;
• rifapentine(an antibiotic used to treat infections, including tuberculosis);
• oxcarbazepine(a medicine used to treat epilepsy and prevent seizures);
• tenofovir disoproxil fumarateor any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection;
• atazanavir, efavirenz, or lopinavir,used to treat HIV infection;
• digoxin, used to treat heart problems;
• modafinilo, used to treat sleep disorders;
• atorvastatin, pravastatinorother statins, used to treat high cholesterol;
• ciclosporina, used to suppress the immune system.

Taking Vosevi with any of these medicines may prevent them from working properly or worsen their side effects. Your doctor may give you a different medicine or adjust the dose you are taking.

• Ask your doctor or pharmacistif you are taking medicines used to treatstomach ulcers, heartburn, or acid refluxas they may reduce the amount of velpatasvir in the blood. These medicines include:

• antacids (such as aluminium/magnesium hydroxide or calcium carbonate). These medicines should be taken at least 4hours before or 4hours after Vosevi;
• proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole, pantoprazole, and esomeprazole). If you need high doses of these medicines, your doctor may give you a different medicine or adjust the dose you are taking;
• H2 receptor antagonists (such as famotidine, cimetidine, nizatidine, or ranitidine). If you need high doses of these medicines, your doctor may give you a different medicine or adjust the dose you are taking.

These medicines may reduce the amount of Vosevi in the blood. If you are taking any of these medicines, your doctor will give you a different medicine for stomach ulcers, heartburn, or acid reflux or recommend how and when to take it.

• Ask your doctor or pharmacist if you are takingwarfarin or other medicines similar to itthat are called vitamin K antagonists to thin the blood. Your doctor may need to increase the number of blood tests to check how your blood is clotting.
• Your liver function may change with hepatitis C treatment and, therefore, may affect other medicines (e.g., medicines used to suppress your immune system, etc.). Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting treatment with Vosevi.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, are breastfeeding, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

Vosevi is not recommended during pregnancy.The effects of Vosevi during pregnancy are unknown.

Breastfeeding

Do not breastfeed during treatment with Vosevi.Some of the active ingredients in Vosevi may pass into breast milk.

Driving and using machines

Vosevi should not affect your ability to drive or use any tools or machinery.

Vosevi contains lactose

• If you are intolerant to lactose or other sugars, inform your doctor.Vosevi contains lactose monohydrate. If you are intolerant to lactose, or if you have been told you are intolerant to other sugars, talk to your doctor before taking this medicine.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Recommended dose

The recommended dose isonetabletoncedailyfor 8 or 12weeks.

Swallow the tablet whole with food. Do not chew, crush, or break the tablet, as it has a very bitter taste.

Renal problems

Ifyou have renal problemsor if you are receivingdialysistell your doctor, because Vosevi has not been fully evaluated in patients with severe renal problems.

Liver problems

You should not use Vosevi if you have moderate or severe liver problems.

If you are taking an antacid, take it at least 4hours before or at least 4hours after Vosevi.

If you vomit after taking Vosevithis may affect the amount of Vosevi in the blood. This may make Vosevi work less effectively.

• If you vomit withinless than 4hoursafter taking Vosevi, take another tablet.
• If you vomit more than4hoursafter taking Vosevi, you do not need to take another tablet until your next scheduled dose.

If you take more Vosevi than you should

If you accidentally take a higher dose than the recommended doseof Vosevi, it may increase the risk of adverse effects of this medication (see section 4 Possible adverse effects).

You should contact your doctor or the nearest emergency service immediately for advice. Bring the tablet container with you to easily describe what you have taken.

If you forget to take Vosevi

It is essential not to miss any dose of this medication.

If you miss a dose, calculate how long it has been since you took the last Vosevi tablet:

• If you realize within 18hoursof the time when you normally take Vosevi, take the tablet as soon as possible. Then, take the next dose at the usual time.

• If more than 18hourshave passed since the time when you normally take Vosevi, wait and take the next dose at the usual time. Do not take a double dose (two doses together).

Do not interrupt Vosevi treatment

Do not interrupt treatment with this medication unless your doctor tells you to. It is very important to complete the entire treatment cycle so that the medication is in the best conditions to treat the hepatitis C virus infection.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very Frequent Adverse Effects

(may affect more than 1 in 10 patients)

• Headache
• Diarrhea
• Unpleasantness (nausea)

Frequent Adverse Effects

(may affect up to 1 in 10 patients)

• Abdominal pain
• Loss of appetite
• Vomiting
• Muscle pain (myalgia)
• Anomaly in a liver function test (total bilirubin).
• Rash

Rare Adverse Effects

(may affect up to 1 in 100 people)

• Muscle cramps
• Swelling of the face, lips, tongue, or throat (angioedema).

Other effects that may be observed during treatment with sofosbuvir:

The frequency of the following adverse effects is unknown (the frequency cannot be estimated from the available data).

-Severe generalized rash with skin peeling that may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson syndrome).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist,even if it is a possible adverse effect that does not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.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 bottle and the box 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. Keep the bottle tightly closed.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This way, you will help protect the environment.

Composition of Vosevi

• The active principles are sofosbuvir, velpatasvir, and voxilaprevir. Each film-coated tablet contains 400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir.

• The other components are

Core of the tablet:

Colloidal anhydrous silica, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose.

Film coating:

Iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), macrogol, polyvinyl alcohol, talc, titanium dioxide (E171).

Appearance of the product and contents of the package:

The film-coated tablets are beige-colored, capsule-shaped tablets with "GSI" engraved on one side and "3" on the other. The tablet measures 20 mm in length and 10 mm in width.

The tablets are presented in plastic bottles with child-resistant caps. All bottles contain a desiccant with silica gel (desiccant) that must remain inside the bottle to protect the tablets. The desiccant with silica gel is in a separate bag or container that should not be swallowed.

The following package sizes are available:

• Cases with 1 bottle of 28 film-coated tablets.

Marketing Authorization Holder:

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Responsible for manufacturing:

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

To obtain more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last revision date of this leaflet:

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