Label: information for the user

Epclusa 400 mg/100 mg film-coated tablets

Epclusa 200 mg/50 mg film-coated tablets

sofosbuvir/velpatasvir

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 section 4 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

If you have been prescribed Epclusa for your child, please note that all the information in this label is directed at your child (in that case, read «your child» instead of «you»).

Epclusa is a medication that contains the active ingredients sofosbuvir and velpatasvir in a single tablet. It is administered to treat a chronic (long-term) viral infection of the liver called hepatitis C in patients aged 6 years and older and weighing at least 17 kg.

The active ingredients of this medication act in combination by blocking two different proteins that the virus needs to grow and reproduce, allowing for the permanent elimination of the infection from the body.

Epclusa is sometimes taken with another medication: ribavirin.

It is very important that you also read the prospectuses of the other medications you will be taking with Epclusa. If you have any doubts about your medications, consult your doctor or pharmacist.

Do not take Epclusa

• If you are allergicto sofosbuvir, velpatasvir, or any of the other components of this

medication (listed in section 6 of this leaflet).

→If this is the case,do not take Epclusa and inform your doctor immediately.

• If you are currently takingany of the following medications:

• Rifampicin and rifabutin(antibiotics used to treat infections, including tuberculosis);
• St. John's Wort(a plant-based medication used to treat depression);

• Carbamazepine, phenobarbital, and phenytoin(medications used to treat epilepsy and prevent seizures).

epilepsy and prevent seizures).

Warnings and precautions

Consult your doctor if:

• • You have liver problemsother than hepatitis C, for example
• If you haveor have had in the past a hepatitis B virus infection, as your doctor may want to monitor you more closely;
• • If you have undergone a liver transplant
• You have kidney problems or are undergoing dialysis,as Epclusa has not been fully studied in patients with severe kidney problems;
• • You are taking HIV treatment,as your doctor may want to monitor you more closely.

Consult your doctor or pharmacist before starting Epclusa 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 medication. If Epclusa treatment is needed, you may require additional cardiac monitoring.
• You have diabetes. After starting Epclusa, you may need to have your blood glucose levels closely monitored and/or adjust your antidiabetic medication. Some diabetic patients have experienced hypoglycemia after starting treatment with medications like Epclusa.

Consult your doctor immediatelyif you are currently taking or have taken in the past few months any medication 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;
• Dizziness;
• Palpitations;
• Fainting or near-fainting.

Blood tests

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

• Allow your doctor to decide if you should take Epclusa and for how long;
• Confirm that the treatment has been effective and you no longer have the hepatitis C virus.

Children and adolescents

Do not give this medication to children under 6 years of age or weighing less than 17 kg. Epclusa has not yet been studied in patients under 6 years of age.

Other medications and Epclusa

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

Warfarin and other medications called vitamin K antagonists are used to thin the blood. Your doctor may increase the number of blood tests to check how your blood clots.

Your liver function may change with hepatitis C treatment, which may affect other medications (e.g., medications used to suppress your immune system, etc.). Your doctor may need to closely monitor these other medications you are taking and make adjustments after starting Epclusa treatment. This change may be Epclusa or another medication you are taking.

Consult your doctor or pharmacist if you are unsure.

Some medications should not be taken with Epclusa.

• Do not take any other medication that contains sofosbuvir, one of the active ingredients of Epclusa.

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

• Amiodarone, used to treat irregular heart rhythm;

• Rifapentine(an antibiotic used to treat infections, including tuberculosis);

• Oxcarbazepine(a medication used to treat epilepsy and prevent seizures);

• Tenofovir disoproxil fumarateor any medication containing tenofovir disoproxil fumarate, used to treat HIV;
• Efavirenz, used to treat HIV;
• Digoxin, used to treat heart problems;
• Dabigatran, used to thin the blood;
• Modafinilused to treat sleep disorders;
• Rosuvastatinorother statins, used to treat high cholesterol.

Taking Epclusa with any of these medications may prevent them from working correctly or worsen their potential side effects. Your doctor may need to give you a different medication or adjust the dose of the one you are taking. This change may be Epclusa or another medication you are taking.

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

• Antacids (such as aluminum/magnesium hydroxide or calcium carbonate). These medications should be taken at least 4 hours before or 4 hours after Epclusa;
• Inhibitors of the proton pump (such as omeprazole, lansoprazole, rabeprazole, pantoprazole, and esomeprazole). Epclusa should be taken with food 4 hours before using a proton pump inhibitor;
• H2 receptor antagonists (such as famotidine, cimetidine, nizatidine, or ranitidine). If you need high doses of these medications, your doctor may give you a different medication or adjust the dose of the one you are taking.

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

Pregnancy and contraception

The effects of Epclusa during pregnancy are unknown. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Epclusa is sometimes used with ribavirin. Ribavirin can harm the fetus. Therefore, it is very important that you (or your partner) do not become pregnant during treatment or for a certain time after completing treatment. You should read the "Pregnancy" section of the ribavirin leaflet carefully. Ask your doctor what effective contraceptive method is suitable for you and your partner.

Breastfeeding

Do not breastfeed during treatment withEpclusa. The active ingredients of Epclusa, sofosbuvir and velpatasvir, are unknown to pass into human breast milk.

Driving and using machines

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

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

Recommended dose

The recommended dose of Epclusain adultsisone 400 mg/100 mg tablet once a day for 12 weeks.

The recommended dose of Epclusain patients aged 6 years to less than 18 years and weighing at least 17 kg is based on weight. Take Epclusa as instructed by your doctor.

Swallow the tablet(s) whole, with or without food. Do not chew, crush, or break the tablet, as it has a very bitter taste.

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

If you are taking a proton pump inhibitor, take Epclusa with food 4 hours before using a proton pump inhibitor.

If you vomit after taking Epclusathis may affect the amount of Epclusa in the blood. This may make Epclusa less effective.

• If you vomit withinless than 3 hours aftertaking Epclusa, take another tablet.

• If you vomit more than3 hours aftertaking Epclusa, do not take another tablet until your next scheduled dose.

If you take more Epclusa than you should

If you accidentally take a higher dose than recommended, contact your doctor or the nearest emergency service immediately for advice.Bringthe tablet container with you to easily describe what you have taken.

If you forget to take Epclusa

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 Epclusa tablet:

• If you realize within 18 hoursof your usual Epclusa time, take the tablet as soon as possible. Then, take the next dose at your usual time.
• If more than 18 hours have passedsince your usual Epclusa time, wait and take the next dose at your usual time. Do not take a double dose (two doses together).

Do not interrupt Epclusa treatment

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

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

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

Frequent Adverse Effects

(may affect up to 1 in 10 patients)

• eruption

Less Frequent Adverse Effects

(may affect up to 1 in 100 people)

• 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).

→If you experience any type of adverse effect, inform your doctor.

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 appearin this prospectus. You can also report them directly through thenational notification system included in theAppendixV.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.

No special storage conditions are required.

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

Composition of Epclusa

• The active ingredients aresofosbuvir and velpatasvir. Each film-coated tablet contains either 400 mg of sofosbuvir and 100 mg of velpatasvir or 200 mg of sofosbuvir and 50 mg of velpatasvir.

• The other components are

Core of the tablet:

Copovidone, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Film coating:

Polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol, talc, iron oxide red (E172).

Appearance of the product and contents of the pack

Epclusa 400 mg/100 mg film-coated tablets are pink, rhomboid-shaped tablets with "GSI" engraved on one side and "7916" on the other. The tablet measures 20 mm in length and 10 mm in width.

Epclusa 200 mg/50 mg film-coated tablets are pink, oval-shaped tablets with "GSI" engraved on one side and "S/V" on the other. The tablet measures 14 mm in length and 7 mm in width.

The following pack sizes are available for both film-coated tablets:

• 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

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

The detailed information about this medicine is available on the website of the European Medicines Agency:

http://www.ema.europa.eu