Label: information for the user

Epclusa 200 mg/50 mg granulated coated tablet

Epclusa 150 mg/37.5 mg granulated coated tablet

sofosbuvir/velpatasvir

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

• Keep this label, as you may need to read 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 other people even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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

Epclusa granulated is a medication that contains the active ingredients sofosbuvir and velpatasvir administered in granulated form. Epclusa is administered to treat chronic (long-term) infection by the hepatitis C virus in adults and children 3 years of age or older.

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

It is very important that you also read the prospectuses of the other medications you are going to take 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 taking any of the following medications:

• RifampicinandRifabutin(antibiotics used to treat infections, including tuberculosis);
• St. John's Wort(herbal medicine used to treat depression);
• Carbamazepine,PhenobarbitalandPhenytoin(medications used to treat 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 viral infection caused by the hepatitis B virus, as your doctor may want to monitor you more closely;
• If you have undergone a liver transplant
• You have kidney problems or if you are undergoing dialysis,as Epclusa has not been fully studied in patients with some severe kidney problems;
• You are taking a treatment for HIV infection,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 medications. 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 3 years of age. Epclusa has not been studied in patients under 3 years of age.

Other medications and Epclusa

Inform your doctor or pharmacist if 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, and this 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.

If unsure, consult your doctor or pharmacist.

Some medications should not be taken with Epclusa.

• Do not take it with 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(antibiotic used to treat infections, including tuberculosis);
• Oxcarbazepine(medication used to treat epilepsy and prevent seizures);
• Tenofovir disoproxil fumarateor any medication containing tenofovir disoproxil fumarate, used to treat HIV infection and chronic hepatitis B;
• Efavirenz, used to treat HIV infection;
• Digoxin, used to treat heart problems;
• Dabigatran, used to thin the blood;
• Modafinilused to treat sleep disorders;
• Rosuvastatinorother statins, used to treat high cholesterol levels.

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 present 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 in its place or adjust the dose of the one you are taking.

These medications may reduce the amount of velpatasvir present 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 this treatment or for a certain time after completing the 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 Epclusa treatment.The active ingredients of Epclusa, sofosbuvir and velpatasvir, are unknown to pass into human breast milk.

Driving and operating machinery

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

Epclusa granules contain lactose

• If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Epclusa granules contain sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

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

You should take Epclusa as indicated by your doctor. Your doctor will tell you for how long you should take Epclusa and how many packets you should take.

The recommended dose is theentire content of the packet(s) administered once a daywith or without food.

Administration of Epclusa granule with food to facilitate swallowing:

1. Hold the packet with the cutting line facing upwards
2. Gently shake the packet so that the content settles
3. Open the packet along the cutting line or use scissors to cut it along the line
4. Carefully pour the entire content of the packet into one or more spoonfuls of bland, non-acidic food, such as chocolate syrup or ice cream at room temperature or below.Do notuse fruit-based foods like apple sauce or sorbet, as they are acidic
5. Ensure that no granule remains in the packet
6. Take the entire granule within 15 minutes after mixing it with food
7. Swallow the combination of food and granule without chewing to avoid a bitter taste. Ensure that the entire food is ingested.

Administration of Epclusa granule without food or water or with water to facilitate swallowing:

1. Hold the packet with the cutting line facing upwards
2. Gently shake the packet so that the content settles
3. Open the packet along the cutting line or use scissors to cut it along the line
4. The granule can be taken directly in the mouth and swallowed without chewing to avoid a bitter taste, or with non-acidic liquids like water. Do not use fruit juices like, for example, apple, aronia, grape, orange, or pineapple, as they are acidic
5. Ensure that no granule remains in the packet
6. Swallow the entire granule.

If you are taking an antacid(medicines used to relieve stomach burning), take it at least 4 hours before or at least 4 hours after Epclusa.

If you are taking a proton pump inhibitor(medicines used to reduce acid production) 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 work less effectively.

• If you vomit withinless than 3 hours aftertaking Epclusa, take another dose.
• If you vomit more than3 hours aftertaking Epclusa, do not need to take another dose until your next scheduled dose.

If you take more Epclusa than you should

If you accidentally take a larger amount than the recommended dose, you should immediately contact your doctor or the nearest emergency service for advice. Bring the packet and the box with you to easily describe what you have taken.

If you forget to take Epclusa

It is essential that you do not miss any dose of this medication.

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

• If you realize within 18 hoursof the time you usually take Epclusa, take the dose as soon as possible. Then, take the next dose at the usual time.
• If more than 18 hours have passedsince 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 interrupt Epclusa treatment

Do not interrupt treatment with this medication unless your doctor tells you to. It is very important that you 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 doubts about the use of this medication, ask your doctor or pharmacist.

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

Very Common Adverse Effects

(may affect more than 1 in 10 people)

• nausea (observed in pediatric patients aged 3 to <6)

Common Adverse Effects

(may affect up to 1 in 10 people)

• skin rash

Uncommon 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 skin rash with peeling of the skin 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 not listed in this prospectus. You can also report them directly through thenational reporting system included in theAppendix V. 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 special storage conditions.

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. By doing so, you will help protect the environment.

Composition of Epclusa

The active ingredients are sofosbuvir and velpatasvir.

• Epclusa 150 mg/37.5 mg granulated coated in a blistercontains 150 mg of sofosbuvir and 37.5 mg of velpatasvir.
• Epclusa 200 mg/50 mg granulated coated in a blistercontains 200 mg of sofosbuvir and 50 mg of velpatasvir.
• The other componentsare copovidone (E 1280), lactose monohydrate (see section 2 of this leaflet), microcrystalline cellulose (E 460), sodium croscarmellose (E 468) (see section 2 of this leaflet), anhydrous colloidal silica (E 551), magnesium stearate (E 470b), hypromellose (E 464), titanium dioxide (E 171), macrogol (E 1521), butylated methacrylate copolymer (E 1205), talc (E 553b), stearic acid (E 570), L-tartaric acid (E 334).

Appearance of the product and contents of the pack

The granule is white to off-white and is inside a blister.

The following pack size is available:

• pack of 28 blisters.

Marketing authorisation 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 authorisation holder:

Last update of this leaflet:

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