Epclusa 150 mg/37.5 mg granules in sachet

Patient Information Leaflet

Introduction

Patient Information Leaflet

Epclusa 200 mg/50 mg granules for oral suspension in sachet

Epclusa 150 mg/37.5 mg granules for oral suspension in sachet

sofosbuvir/velpatasvir

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Leaflet Contents

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

If Epclusa has been prescribed for your child, please note that all information in this leaflet applies to your child (in this case, read "your child" instead of "you").

1. What Epclusa is and what it is used for

Epclusa granules is a medicine that contains the active substances sofosbuvir and velpatasvir, administered in granule form. Epclusa is used to treat chronic (long-term) hepatitis C virus infection in adults and children 3 years of age and older.

The active substances in this medicine work together by blocking two different proteins that the virus needs to grow and replicate, thereby enabling the infection to be permanently cleared from the body.

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, consult your doctor or pharmacist.

2. What you need to know before taking Epclusa

Do not take Epclusa

• If you are allergic to sofosbuvir, velpatasvir, or 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 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, phenobarbital, and phenytoin (medicines used to treat epilepsy and prevent seizures).

Warnings and precautions

Talk to your doctor if:

• you have liver problems other than hepatitis C, for example
• you have or have previously had an infection caused by the hepatitis B virus, as your doctor may want to monitor you more closely;
• you have had a liver transplant;
• you have kidney problems or are on dialysis, as Epclusa has not been fully studied in patients with certain severe kidney problems;
• you are receiving treatment for human immunodeficiency virus (HIV) infection, as your doctor may want to monitor you more closely.

Talk to your doctor or pharmacist before starting Epclusa if:

• you are currently taking or have stopped taking amiodarone for irregular heartbeat within the last few months, as it may cause a potentially life-threatening slow heart rate. Your doctor may consider alternative treatments if you have taken this medicine. If treatment with Epclusa is needed, you may require additional cardiac monitoring.
• you have diabetes. You may need close monitoring of your blood glucose levels and/or adjustment of your antidiabetic medicines after starting Epclusa. Some diabetic patients have experienced low blood sugar (hypoglycemia) after starting treatment with medicines like Epclusa.

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

• slow or irregular heartbeat, 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 so that:

• your doctor can decide whether you should take Epclusa and for how long;
• your doctor can confirm that the treatment has been effective and that you no longer have the hepatitis C virus.

Children and adolescents

Do not give this medicine to children under 3 years of age. The use of Epclusa has not been studied in patients under 3 years of age.

Other medicines and Epclusa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 monitor your blood clotting.

Your liver function may change with hepatitis C treatment, which could 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 unsure, consult your doctor or pharmacist.

Some medicines must not be taken with Epclusa.

• Do not take it with any other medicine containing sofosbuvir, one of the active substances in Epclusa.

Tell your doctor or pharmacist if 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 fumarate or any medicine containing tenofovir disoproxil fumarate, used to treat HIV and chronic hepatitis B 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;
• rosuvastatin or 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 may involve Epclusa or another medicine you are taking.

• Seek advice from a doctor or pharmacist if 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 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 taking 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 prescribe a different medicine or adjust the dose you are taking.

These medicines may reduce the amount of velpatasvir in your blood. If you are taking any of these medicines, your doctor will either prescribe a different medicine for your stomach ulcers, heartburn, or acid reflux, or advise you on how and when to take them.

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, talk to your doctor before using this medicine.

Epclusa is sometimes used together with ribavirin. Ribavirin can harm the unborn baby. Therefore, 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 “Pregnancy” section of the ribavirin package leaflet very carefully. Ask your doctor which effective contraceptive method is suitable for you and your partner.

Breast-feeding

Do not breast-feed during treatment with Epclusa. It is unknown whether sofosbuvir or velpatasvir, the two active ingredients in Epclusa, pass into human breast milk.

Driving and using machines

Epclusa is not expected to affect your ability to drive or use tools or machinery.

Epclusa granules contain lactose

• If your doctor has told you that you have an intolerance to certain sugars, talk to him before taking this medicine.

Epclusa granules contain sodium

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; hence, essentially “sodium-free”.

3. How to take Epclusa

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended dose

You should take Epclusa exactly as prescribed by your doctor. Your doctor will inform you how long you should take Epclusa and how many sachets to take.

The recommended dose is the entire contents of the sachet(s) administered once daily, with or without food.

Administration of Epclusa granules with food to facilitate swallowing:

1. Hold the sachet with the cut line facing upwards
2. Gently shake the sachet so that the contents settle
3. Open the sachet along the cut line or use scissors to cut along the line
4. Carefully pour the entire contents of the sachet into one or more spoonfuls of soft, non-acidic food, such as chocolate syrup or ice cream at room temperature or lower. Do not use fruit-based foods such as apple sauce or sorbet, as they are acidic
5. Make sure no granules remain in the sachet
6. Take all the granules within 15 minutes after gently mixing them with food
7. Swallow the food-granule mixture without chewing to avoid a bitter taste. Ensure that all the food is ingested.

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

1. Hold the sachet with the cut line facing upwards
2. Gently shake the sachet so that the contents settle
3. Open the sachet along the cut line or use scissors to cut along the line
4. The granules may be taken directly into the mouth and swallowed without chewing to avoid a bitter taste, or with non-acidic liquids such as water. Do not use fruit juices such as apple, cranberry, grape, orange, pineapple, as they are acidic
5. Make sure no granules remain in the sachet
6. Swallow all the granules.

If you are taking an antacid (medicines used to relieve heartburn), take it at least 4 hours before or at least 4 hours after taking 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 Epclusa this may affect the amount of Epclusa in your blood. This could make Epclusa less effective.

• If you vomit within 3 hours after taking Epclusa, take another dose.
• If you vomit more than 3 hours after taking Epclusa, there is no need to take another dose until your next scheduled dose.

If you take more Epclusa than you should

If you accidentally take more than the recommended dose, you must contact your doctor or the nearest emergency department immediately for advice. Bring the sachet and the box with you to clearly describe what you have taken.

If you forget to take Epclusa

It is important not to miss any doses of this medicine.

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

• If you remember within 18 hours of your usual Epclusa intake time, take the missed dose as soon as possible. Then take the next dose at your usual time.
• If 18 hours or more have passed since your usual Epclusa intake time, wait and take the next dose at your usual time. Do not take a double dose (two doses together).

Do not interrupt treatment with Epclusa

Do not stop treatment with this medicine unless instructed by your doctor. It is very important that you complete the full course of treatment so that the medicine is optimally effective in treating hepatitis C virus infection.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common adverse effects

(may affect more than 1 in every 10 people)

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

Common adverse effects

(may affect up to 1 in every 10 people)

• rash

Uncommon adverse effects

(may affect up to 1 in every 100 people)

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

Other effects that may occur during treatment with sofosbuvir:

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

• severe generalized rash with skin peeling, which 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 of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the bottle and carton after "EXP". The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Epclusa

The active substances are sofosbuvir and velpatasvir.

• Epclusa 150 mg/37.5 mg granules with coating in sachet contains 150 mg of sofosbuvir and 37.5 mg of velpatasvir.
• Epclusa 200 mg/50 mg granules with coating in sachet contains 200 mg of sofosbuvir and 50 mg of velpatasvir.
• The other components are copovidone (E1280), lactose monohydrate (see section 2 of this leaflet), microcrystalline cellulose (E460), sodium croscarmellose (E468) (see section 2 of this leaflet), colloidal anhydrous silica (E551), magnesium stearate (E470b), hypromellose (E464), titanium dioxide (E171), macrogol (E1521), butylated methacrylate copolymer (E1205), talc (E553b), stearic acid (E570), L-tartaric acid (E334).

Appearance of the product and contents of the pack

The granules are white to off-white in colour and are contained in a sachet.

The following pack size is available:

• pack of 28 sachets.

Marketing Authorisation Holder

Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland

Manufacturer

Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

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