EPCLUSA 200 mg/50 mg COATED GRANULES IN SACHET

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 tell your doctor immediately.

• If you are currently taking any of the following medicines:

• rifampicinand 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).

Warnings and precautions

Tell your doctor if:

• you have liver problemsother than hepatitis C, for example
• if you haveor have had in the past an infection caused by the hepatitis B virus, 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 some 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 stopped taking in the last few months the medicine amiodarone to treat irregular heartbeat, as it may cause a potentially life-threatening decrease in heart rate. Your doctor may consider other 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 anti-diabetic medicines. After starting treatment with medicines like Epclusa, some diabetic patients have presented with low blood sugar levels (hypoglycemia).

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 so that:

• Your doctor can decide if you should take Epclusa 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 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 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 it with 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 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 and chronic hepatitis B infection;
• efavirenz,used to treat HIV infection;
• digoxin,used to treat heart problems;
• dabigatran,used to thin the blood;
• modafinilused 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 correctly 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 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 at least 4 hours after Epclusa;
• proton pump inhibitors (such as omeprazol, lansoprazol, rabeprazol, pantoprazol and esomeprazol). 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 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 that 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 together with ribavirin. Ribavirin may harm the unborn baby. It is very important that you (or your partner) do not become pregnant during this treatment or for some time after completing the 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 with Epclusa.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.

Epclusa granules contain lactose

• If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Epclusa granules contain sodium

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

3. How to take Epclusa

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

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 sachets you should take.

The recommended dose is the entire contents of the sachet(s) taken once a daywith or without food.

Administration of Epclusa granules with food to facilitate swallowing:

1. Hold the sachet with the cut line facing up
2. Gently shake the sachet to settle the contents
3. Open the sachet by tearing along the cut line or using 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 below. Do notuse fruit-based foods like 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 of mixing them gently with food
7. Swallow the food and granule mixture without chewing to avoid a bitter taste. Make sure to swallow all of the food.

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

1. Hold the sachet with the cut line facing up
2. Gently shake the sachet to settle the contents
3. Open the sachet by tearing along the cut line or using scissors to cut along the line
4. The granules 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 apple, cranberry, grape, orange, or 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 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 well.

• If you vomit less than 3 hours aftertaking Epclusa, take another dose.
• If you vomit more than 3 hours aftertaking Epclusa, it is not necessary to take another dose until your next scheduled dose.

If you take more Epclusa than you should

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

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 dose of Epclusa:

• If you realize within 18 hoursof the time you usually take Epclusa, you should take the dose 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 treatment with Epclusa

Do not stop treatment with this medicine unless your doctor tells you to. It is very important that you complete the full treatment cycle so that the medicine is in the best condition to treat the hepatitis C virus infection.

If you have any other questions about 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.

Very common side effects

(may affect more than 1 in 10 people)

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

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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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 sachet after “EXP”. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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

Composition of Epclusa

The active ingredients are sofosbuvir and velpatasvir.

• Epclusa 150 mg/37.5 mg coated granules in a sachetcontains 150 mg of sofosbuvir and 37.5 mg of velpatasvir.
• Epclusa 200 mg/50 mg coated granules in a sachetcontains 200 mg of sofosbuvir and 50 mg of velpatasvir.
• Other componentsare copovidone (E1280), lactose monohydrate (see section 2 of this prospectus), microcrystalline cellulose (E460), sodium croscarmellose (E468) (see section 2 of this prospectus), anhydrous colloidal silica (E551), magnesium stearate (E470b), hypromellose (E464), titanium dioxide (E171), macrogol (E1521), butyl methacrylate copolymer (E1205), talc (E553b), stearic acid (E570), L-tartaric acid (E334).

Appearance of the Product and Package Contents

The granules are white to off-white and are inside a sachet.

The following package size is available:

• package of 28 sachets.

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 Prospectus:

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