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VOSEVI 400 MG/100 MG/100 MG FILM-COATED TABLETS

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About the medicine

How to use VOSEVI 400 MG/100 MG/100 MG FILM-COATED TABLETS

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

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

sofosbuvir/velpatasvir/voxilaprevir

This medicinal product is subject to additional monitoring, which will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 or pharmacist.
  • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What is Vosevi and what is it used for

Vosevi is a medicine that contains the active substances sofosbuvir, velpatasvir and voxilaprevir in one tablet. It is given to adults aged 18 years and over to treat a long-term (chronic) viral infection of the liver called hepatitis C.

The active substances in this medicine work together by blocking three different proteins that the hepatitis C virus needs to grow and reproduce, which makes the infection disappear from the body.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you take Vosevi

Do not take Vosevi

  • If you are allergicto sofosbuvir, to velpatasvir, to voxilaprevir or to any of the other ingredients of this medicine (listed in section 6 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, phenobarbitaland phenytoin(medicines used to treat epilepsy and prevent seizures);
  • rosuvastatin(a medicine used to treat high cholesterol levels and the risk of certain cardiovascular events);
  • dabigatran(a medicine used to prevent blood clots);
  • medicines that contain ethinylestradiol, including many oral contraceptives.

Warnings and precautions

Tell your doctor if:

  • you have liver problemsother than hepatitis C, for example
  • if you haveor have had infection with the hepatitis Bvirus, as your doctor may want to monitor you more closely;
  • if you have had a liver transplant.
  • you are taking treatment for infection with the human immunodeficiency virus (HIV),as your doctor may want to monitor you more closely.

Tell your doctor or pharmacist before you start taking Vosevi if:

  • you are currently taking or have recently taken the medicine amiodarone to treat an irregular heartbeat, as it may cause a potentially life-threatening decrease in heart rate. Your doctor may consider alternative treatments if you have taken this medicine. If Vosevi treatment is needed, you may need additional heart monitoring.
  • you have diabetes. After starting Vosevi, you may need close monitoring of your blood glucose levels and/or adjustment of your anti-diabetic medication. After starting treatment with medicines like Vosevi, some diabetic patients have experienced low blood sugar levels (hypoglycaemia).

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

  • slow or irregular heartbeats, or heart rhythm problems;
  • shortness of breath or worsening of existing shortness of breath;
  • chest pain;
  • feeling dizzy;
  • palpitations;
  • fainting or feeling like you are about to faint.

Blood tests

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

  • Your doctor can decide if you should take Vosevi and for how long.
  • Your doctor can confirm that the treatment has worked and you no longer have the hepatitis C virus.

Children and adolescents

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

Other medicines and Vosevi

Tell your doctor or pharmacistif you are taking, have recently taken or might take any other medicines.

If you are not sure, ask your doctor or pharmacist.

Some medicines must not be taken with Vosevi.If you take them with Vosevi, they may not work properly or they may make side effects worse.

  • Rifampicin and rifabutin(antibiotics used to treat infections, including tuberculosis);
  • St John's Wort(a herbal medicine used to treat depression);
  • Carbamazepine, phenobarbitaland phenytoin(medicines used to treat epilepsy and prevent seizures);
  • Rosuvastatin(a medicine used to treat high cholesterol levels or the risk of certain cardiovascular events);
  • Dabigatran(a medicine used to prevent blood clots);
  • Medicines that contain ethinylestradiol, including many oral contraceptives.

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

  • amiodarone,used to treat irregular heartbeat;
  • rifapentine(an antibiotic used to treat infections, including tuberculosis);
  • oxcarbazepine(a medicine used to treat epilepsy and prevent seizures);
  • tenofovir disoproxil fumarateor any medicine that contains tenofovir disoproxil fumarate, used to treat HIV infection;
  • atazanavir, efavirenz or lopinavir, used to treat HIV infection;
  • digoxin, used to treat heart problems;
  • modafinil, used to treat sleep disorders;
  • atorvastatin, pravastatinor other statins, used to treat high cholesterol levels;
  • ciclosporin, which is used to suppress the immune system.

Taking Vosevi with any of these medicines may stop them from working properly or make any side effects worse. Your doctor may need to give you a different medicine or adjust the dose of the one you are taking.

  • Ask your doctor or pharmacist for adviceif you are taking medicines used to treat stomach 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 4 hours before or 4 hours after Vosevi;
  • proton pump inhibitors (such as omeprazol, lansoprazol, rabeprazol, pantoprazol and esomeprazol). If you need to take high doses of these medicines, your doctor may give you a different medicine instead, or adjust the dose of the one you are taking;
  • H2 receptor antagonists (such as famotidine, cimetidine, nizatidine or ranitidine). If you need to take high doses of these medicines, your doctor may give you a different medicine instead or adjust the dose of the one 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 the medicine.

  • Ask your doctor or pharmacist for adviceif you are taking warfarin or other similar medicinesthat are known as vitamin K antagonists, to thin the blood. Your doctor may increase the number of blood tests to check how the blood clots.
  • Your liver function may change with hepatitis C treatment and 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, breast-feeding and fertility

If you are pregnant, think you may be pregnant, are breast-feeding or plan to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

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

Breast-feeding

Do not breast-feed during treatment with Vosevi.Some of the active substances in Vosevi may pass into breast milk.

Driving and using machines

Vosevi is unlikely to affect your ability to drive or use tools or machines.

Vosevi contains lactose

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

3. How to take Vosevi

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Recommended dose

The recommended dose is onetabletoncedailyfor 8 or 12weeks.

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

Kidney problems

If you have kidney problemsor if you are on dialysistell your doctor, as Vosevi has not been fully evaluated in patients with severe kidney problems.

Liver problems

Do not take Vosevi if you have moderate or severe liver problems.

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

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

  • If you vomit less than 4 hoursafter taking Vosevi, take another tablet.
  • If you vomit more than 4 hoursafter taking Vosevi, do not take another tablet until the next one is due.

If you take more Vosevi than you should

If you accidentally take a higher dose than recommended, you may increase the risk of getting side effects from this medicine (see section 4 Possible side effects).

You should contact your doctor or the nearest emergency department immediately for advice. Take the pack with you so that you can show the doctor what you have taken.

If you forget to take Vosevi

It is important that you do not miss any dose of this medicine.

If you miss a dose, calculate how long ago you took the last Vosevi tablet:

  • If you realise within 18 hoursof the time you usually take Vosevi, you should take the tablet as soon as possible. Then take the next dose at the usual time.
  • If it has been 18 hours or moresince the time you usually take Vosevi, wait and take the next dose at the usual time. Do not take a double dose (two doses together).

Do not stop taking Vosevi

Do not stop taking this medicine unless your doctor tells you to. It is very important that you complete the full treatment course so that the medicine can work as well as possible to treat the hepatitis C infection.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects

(may affect more than 1 in 10 people)

  • headache
  • diarrhoea
  • nausea

Common side effects

(may affect up to 1 in 10 people)

  • stomach pain
  • loss of appetite
  • vomiting
  • muscle pain (myalgia)
  • abnormal liver function test (total bilirubin).
  • rash

Uncommon side effects

(may affect up to 1 in 100 people)

  • muscle cramps
  • swelling of the face, lips, tongue or throat (angioedema).

Other side effects that may be seen with sofosbuvir:

The following side effects have not been known to occur with sofosbuvir (frequency cannot be estimated from the available data).

  • widespread severe skin rash with skin peeling, possibly with fever, flu-like symptoms, blistering of the mouth, eyes and/or genitals (Stevens-Johnson syndrome).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist,even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vosevi

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 refers to the last day of that month.

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

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

6. Package Contents and Additional Information

Vosevi Composition

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

Tablet core:

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

Film coating:

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

Product Appearance and Package Contents

The film-coated tablets are beige, 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 closures. All bottles contain a desiccant with silica gel (desiccant) that should 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:

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

Marketing Authorization Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Belgium

Gilead Sciences Belgium SPRL-BVBA

Tel: + 32 (0) 24 01 35 50

Lithuania

Gilead Sciences Poland Sp. z o.o.

Tel: + 48 22 262 8702

Greece

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Luxembourg

Gilead Sciences Belgium SPRL-BVBA

Tel: + 32 (0) 24 01 35 50

Czech Republic

Gilead Sciences s.r.o.

Tel: + 420 910 871 986

Hungary

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Denmark

Gilead Sciences Sweden AB

Tel: + 46 (0) 8 5057 1849

Malta

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Germany

Gilead Sciences GmbH

Tel: + 49 (0) 89 899890-0

Netherlands

Gilead Sciences Netherlands B.V.

Tel: + 31 (0) 20 718 36 98

Estonia

Gilead Sciences Poland Sp. z o.o.

Tel: + 48 22 262 8702

Norway

Gilead Sciences Sweden AB

Tel: + 46 (0) 8 5057 1849

Greece

Gilead Sciences Ελλάς Μ.ΕΠΕ.

Tel: + 30 210 8930 100

Austria

Gilead Sciences GesmbH

Tel: + 43 1 260 830

Spain

Gilead Sciences, S.L.

Tel: + 34 91 378 98 30

Poland

Gilead Sciences Poland Sp. z o.o.

Tel: + 48 22 262 8702

France

Gilead Sciences

Tel: + 33 (0) 1 46 09 41 00

Portugal

Gilead Sciences, Lda.

Tel: + 351 21 7928790

Croatia

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Romania

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Ireland

Gilead Sciences Ireland UC

Tel: +353 (0) 214 825 999

Slovenia

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Iceland

Gilead Sciences Sweden AB

Tel: + 46 (0) 8 5057 1849

Slovakia

Gilead Sciences Slovakia s.r.o.

Tel: + 421 232 121 210

Italy

Gilead Sciences S.r.l.

Tel: + 39 02 439201

Finland

Gilead Sciences Sweden AB

Tel: + 46 (0) 8 5057 1849

Cyprus

Gilead Sciences Ελλάς Μ.ΕΠΕ.

Tel: + 30 210 8930 100

Sweden

Gilead Sciences Sweden AB

Tel: + 46 (0) 8 5057 1849

Latvia

Gilead Sciences Poland Sp. z o.o.

Tel: + 48 22 262 8702

United Kingdom

Gilead Sciences Ltd.

Tel: + 44 (0) 8000 113 700

Date of Last Revision of this Leaflet:

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

Online doctors for VOSEVI 400 MG/100 MG/100 MG FILM-COATED TABLETS

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Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

  • High blood pressure, headaches, dizziness, swelling, palpitations.
  • Diagnosis and management of hypertension, arrhythmias, and tachycardia.
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  • Chronic conditions: diabetes, thyroid disorders.
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Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
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General internal medicine and preventive care:
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Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

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  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
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  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
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Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

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Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

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  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
  • Other issues related to allergology and internal medicine.

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Frequently Asked Questions

Is a prescription required for VOSEVI 400 MG/100 MG/100 MG FILM-COATED TABLETS?
VOSEVI 400 MG/100 MG/100 MG FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in VOSEVI 400 MG/100 MG/100 MG FILM-COATED TABLETS?
The active ingredient in VOSEVI 400 MG/100 MG/100 MG FILM-COATED TABLETS is sofosbuvir, velpatasvir and voxilaprevir. This information helps identify medicines with the same composition but different brand names.
Who manufactures VOSEVI 400 MG/100 MG/100 MG FILM-COATED TABLETS?
VOSEVI 400 MG/100 MG/100 MG FILM-COATED TABLETS is manufactured by Gilead Sciences Ireland Unlimited Company. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of VOSEVI 400 MG/100 MG/100 MG FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether VOSEVI 400 MG/100 MG/100 MG FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to VOSEVI 400 MG/100 MG/100 MG FILM-COATED TABLETS?
Other medicines with the same active substance (sofosbuvir, velpatasvir and voxilaprevir) include EPCLUSA 150 mg/37.5 mg COATED GRANULES IN SACHET, EPCLUSA 200 mg/50 mg COATED GRANULES IN SACHET, EPCLUSA 400 MG/100 MG FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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