EPCLUSA 400 MG/100 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Epclusa 400 mg/100 mg film-coated tablets

Epclusa 200 mg/50 mg film-coated tablets

sofosbuvir/velpatasvir

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you 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 symptoms 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 Epclusa and what is it used for
2. What you need to know before you take Epclusa
3. How to take Epclusa
4. Possible side effects
5. Storage of Epclusa
6. Contents of the pack and other information

If Epclusa has been prescribed to your child, please note that all the information in this leaflet is intended for your child (in this case, read ‘your child’ instead of ‘you’).

1. What is Epclusa and what is it used for

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

The active substances in this medicine work together by blocking two different proteins that the virus needs to grow and reproduce, allowing the infection to be eliminated from the body permanently.

Epclusa is sometimes taken with another medicine: ribavirin.

It is very important that you also read the package leaflets of any other medicines you are taking with Epclusa. If you have any questions about your medicines, ask your doctor or pharmacist.

2. What you need to know before you take Epclusa

Do not take Epclusa

• If you are allergicto sofosbuvir, to velpatasvir or to any of the other ingredients of this medicine (listed in section 6 of this leaflet).

→If this applies to you, do not take Epclusa and inform your doctor immediately.

• If you are currently takingany 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, phenobarbital and phenytoin(medicines used to treat epilepsy and prevent seizures);

Warnings and precautions

Tell your doctor if:

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

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

• you are currently taking or have recently stopped taking the medicine amiodarone to treat irregular heart rhythm, 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 Epclusa treatment is needed, you may need additional heart monitoring.
• you have diabetes. After starting Epclusa, you may need close monitoring of your blood glucose levels and/or adjustment of your diabetes medication. Some diabetic patients have experienced low blood sugar levels (hypoglycaemia) after starting treatment with medicines like Epclusa.

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 Epclusa. This is to:

• allow your doctor to decide if you should take Epclusa and for how long;
• allow your doctor to confirm that the treatment has worked and that you no longer have the hepatitis C virus.

Children and adolescents

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

Other medicines and Epclusa

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

Warfarin and other similar medicines 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 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 Epclusa.

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

Some medicines must not be taken with Epclusa.

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

Tell 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 that contains tenofovir disoproxil fumarate, used to treat HIV infection;
• efavirenz, used to treat HIV infection;
• digoxin, used to treat heart problems;
• dabigatran, used to thin the blood;
• modafinil, used to treat sleep disorders;
• rosuvastatinor other statins, used to treat high cholesterol levels.

Taking Epclusa with any of these medicines may prevent them from working properly or worsen their possible side effects. Your doctor may need to give you a different medicine or adjust the dose of the one you are taking. This change could be to Epclusa or to another medicine you are taking.

• Ask your doctor or pharmacist for adviceif you are taking medicines used to treat stomach ulcers, heartburn or acid reflux, as they may reduce the amount of velpatasvir in your 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 Epclusa;
• proton pump inhibitors (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 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 velpatasvir in your blood. If you are taking any of these medicines, your doctor may give you a different medicine for stomach ulcers, heartburn or acid reflux or recommend how and when to take the medicine.

Pregnancy and contraception

The effects of Epclusa during pregnancy are not known. 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.

Epclusa is sometimes used in combination with ribavirin. Ribavirin may harm your unborn baby. It is very important that you (or your partner) do not become pregnant during this treatment or for a certain time after completing treatment. You must read the section “Pregnancy” in the ribavirin package leaflet very carefully. Ask your doctor what effective contraceptive method is suitable for you and your partner.

Breast-feeding

Do not breast-feed during treatment withEpclusa. It is not known whether sofosbuvir or velpatasvir, the two active substances of Epclusa, pass into human breast milk.

Driving and using machines

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

3. How to take Epclusa

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

Recommended dose

The recommended dose of Epclusa in adultsis one 400 mg/100 mg tablet once daily for 12 weeks.

The recommended dose of Epclusa in patients aged 6 years to less than 18 years of age and weighing at least 17 kg is based on weight. Take Epclusa as directed 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 Epclusa, this may affect the amount of Epclusa in your blood. This may make Epclusa work less effectively.

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

• If you vomit more than 3 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 department immediately for advice. Take the pack of tablets with you to show the doctor what you have taken.

If you forget to take Epclusa

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

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

• If you realise within 18 hoursof the time you usually take Epclusa, 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 Epclusa, wait and take the next dose at the usual time. Do not take a double dose (two doses together).

Do not stop taking Epclusa

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 effectively to treat the hepatitis C virus infection.

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

4. Possible side effects

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

Common side effects

(may affect up to 1 in 10 people)

• rash

Uncommon side effects

(may affect up to 1 in 100 people)

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

Other side effects that may occur during treatment with sofosbuvir:

The frequency of the following side effects cannot be estimated from the available data.

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

→If you experience any side effect, tell your doctor.

Reporting of side effects

If you experience any side effect, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report side effects directly via 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. Storage of Epclusa

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 the month shown.

No special storage conditions are required.

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. Container Content and Additional Information

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 ingredients are

Core of the tablet:

Copovidone, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Film coating:

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

Appearance of the Product and Container Content

Epclusa 400 mg/100 mg film-coated tablets are pink, diamond-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 package sizes are available for both film-coated tablets; 400 mg/100 mg and 200 mg/50 mg:

• Package of 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

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

Date of the Last Revision of this Leaflet:

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