InfoCons Consumer Protection informs you – Epclusa – Package Leaflet

Before anything else

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 signs of illness are the same as your s.
• 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.

ℹ️ 1. What Epclusa is and what it is used for

Epclusa granules are a medicine that contains the active substances sofosbuvir and velpatasvir which are given in a granule formulation. Epclusa is given to treat chronic (long- term) hepatitis C virus infection in adults and children aged 3 years of age and older.

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

It is very important that you also read the leaflets for the other medicine s that you will be taking with Epclusa . If you have any questions about your medicines, please ask your doctor or pharmacist.

⚠️ 2. What you need to know before you take 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 tell 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 (herbal medicine used to treat depression);
• carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures).

87 Warnings and precautions Talk to your doctor if you:

• have liver problems other than from hepatitis C, for instance
• if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
• if you have had a liver transplant
• have kidney problems or if you are on kidney dialysis, since Epclusa has not been fully tested in patients with some severe kidney problems;
• are taking treatment for human immunodeficiency virus (HIV) infection, since your doctor may want to monitor you more closely.

Talk to your doctor or pharmacist before taking Epclusa if:

• you currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats, as it may result in a life -threatening slowing of your heart beat. Your doctor may consider different treatments if you have taken this medicine. If treatment with Epclusa is needed, you may require additional heart monitoring.
• you have diabetes. You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medic ines after starting Epclusa. Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Epclusa.

Tell your doctor immediately if you currently take, or have taken in the last months any medicines for heart problems and during treatment you experience:

• slow or irregular heartbeat, or heart rhythm problems;
• shortness of breath or worsening of existing shortness of breath;
• chest pain;
• light-headedness;
• palpitations ;
• near fainting or fainting.

Blood tests Your doctor will test your blood before, during and after your 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 your treatment has worked and you are free of the hepatitis C virus.

Children and adolescents

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

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 need to incre ase the frequency of your blood tests to check how well your blood can clot.

Your liver function may change with treatment of hepatitis C and therefore may affect other medications (e.g. medicines used to suppress your immune system, etc.). Your doctor ma y need to closely monitor these other medicines you are taking and make adjustments after starting Epclusa.

If you are not sure talk to your doctor or pharmacist.

88 Some medicines should not be taken with Epclusa.

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

Tell your doctor or pharmacist if you are taking any of the medicines below:

• amiodarone used to treat irregular heartbeats;
• rifapentine (antibiotic used to treat infections, including tuberculosis);
• oxcarbazepine (medicine used to treat epilepsy and prevent seizures);
• tenofovir disoproxil fumarate or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection and chronic hepatitis B ;
• efavirenz used to treat HIV infection;
• digoxin used to treat heart conditions;
• dabigatran used to thin the blood;
• modafinil used to treat sleep disorders;
• rosuvastatin or other statins used to treat high cholesterol.

Taking Epclusa with any of these may stop your medicines from working properly, or make any side effects worse. Your doctor may need to give you a different medicine or adjust the dose of medicine you are taking. This change could be to Epclusa or another medicine you are ta king.

• Get advice from a doctor or pharmacist if you take medicines used to treat stomach ulcers, heartburn or acid reflux as they can decrease the amount of velpatasvir in your blood. These medicines include:
• antacids (such as aluminium/magnesium hydroxide or calcium carbonate). These 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.
• H 2-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 medicine you are taking.

These medicines can decrease the amount of velpatasvir in your blood. If you are taking one of these medicines your doctor will either give you a different medicine for stomach ulcers, heartburn or acid reflux, or recommend how and when you take t hat 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 u sed together with ribavirin. Ribavirin can harm your unborn baby. It is therefore very important that you (or your partner) do not become pregnant during this treatment or for a period of time after completing treatment. You must read the “Pregnancy” secti on in the ribavirin package leaflet very carefully. Ask your doctor for effective contraception method suitable for you and your partner.

Breast -feeding Do not breast -feed during treatment with Epclusa. It is not known whether sofosbuvir or velpatasvir, t he two active substances of Epclusa, pass into human breast milk.

Driving and using machines

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

89 Epclusa granules contain lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Epclusa granules contain sodium This medicin e contains less than 1 mmol sodium (23 mg) per sachet , that is to say essentially ‘sodium -free’.

💊 3. How to take Epclusa

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Recommended dose Epclusa is to be taken as advised by your doctor. Your doctor will tell you for how long you should take Epclusa and how ma ny sachets you should take.

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

Giving Epclusa granules with food to aid swallowing:

1. Hold sachet with cut line on top 2. Shake sachet gently to settle co ntents 3. Tear sachet open along cut line, or use scissors to cut across line 4. Carefully pour entire contents of sachet onto one or more spoonfuls of non- acidic soft food such as chocolate syrup or ice -cream at or below room temperature . Do not use fruit -based foods such as apple sauce or sorbet as these are acidic 5. Make sure no granules remain in the sachet

6. Take all the granules within 15 minutes of gently mixing with food

7. Swallow combination of food and granules without chewing to avoi d a bitter taste. Make sure that all the food is eaten.

Giving Epclusa granules without food or water or with water to aid swallowing:

1. Hold sachet with cut line on top 2. Shake sachet gently to settle contents 3. Tear sachet open along cut line, or us e scissors to cut across 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 such as water. Do not use fruit juices, for example apple, cranberry, grape, orange, pineapple as these are acidic 5. Make sure no granules remain in the sachet 6. Swallow all the granules.

If you are taking an antacid (medicin es 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 (medicin es used to reduce acid production) , take Epclusa with food 4 hours before using a proton pump inhibitor.

If you are sick (vomit) after taking Epclusa it may affect the amount of Epclusa in your blood. This may make Epclusa wo rk less well.

• If you are sick (vomit) less than 3 hours after taking Epclusa, take another dose.
• If you are sick (vomit) more than 3 hours after taking Epclusa, you do not need to take another dose until your next scheduled dose.

90 If you take more Epclusa than you should If you accidentally take more than the recommended dose you should contact your doctor or nearest emergency department immediately for advice. Keep the sachet and carton with you so that you can easily describe what you have taken.

If you forget to take Epclusa

It is important not to miss a dose of this medicine.

If you do miss a dose, work out how long it is since you last took your Epclusa:

• If you notice within 18 hours of the time you usually take Epclusa, you must take the dose as soon as possible. Then take the next dose at your usual time.
• If it’s 18 hours or more after the time you usually take Epclusa, wait and take the next dose at your usual time. Do not take a double dose (two doses close 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 course of treatment to give the medicine the best chance to treat your hepatitis C virus infection.

If you have any further questions on the us e 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 paediatric patients aged 3 to < 6 years)

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 effects that may be seen during treatment with sofosbuvir:

The frequency of the following side effects is not known (frequency cannot be estimated from the available data).

• a wide spread severe rash with peeling skin which may be accompanied by fever, flu like symptoms, blisters i n the mouth, eyes, and/or genitals (Stevens Johnson syndrome).

 If you get any side effects 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. How to store Epclusa

Keep this medicine out of the sight and reach of children.

91 Do not use this medicine after the expiry date which is stated on the sa chet and carton after “EXP”.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away med icines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Epclusa contains

The active substances are sofosbuvir and velpatasvir.

• Epclusa 150 mg/37.5 mg coated granules in sachet contains 150 mg sofosbuvir and 37.5 mg velpatasvir.
• Epclusa 200 mg/50 mg coated granules in sachet contains 200 mg sofosbuvir and 50 mg velpatasvir.
• The other ingredients are copovidone (E1208) , lactose monohydrate (see section 2 of this leaflet) , microcr ystalline cellulose (E460) , croscarmellose sodium (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) .

What Epclusa looks like and contents of the pack

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

The following pack size is available:

• outer cartons containing 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 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Gilead Sciences Belgium SRL -BV Tél/Tel: + 32 (0) 24 01 35 50 Lietuva Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888 България Gilead Sciences Ireland UC Тел.: + 353 (0) 1 686 1888 Luxembourg/Luxemburg Gilead Sciences Belgium SRL -BV Tél/Tel: + 32 (0) 24 01 35 50 92 Česká republika Gilead Sciences s.r.o.

Tel: + 420 910 871 986 Magyarország Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888 Danmark Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1849 Malta Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888 Deutschland Gilead Sciences GmbH Tel: + 49 (0) 89 899890 -0 Nederland Gilead Sciences Netherlands B.V.

Tel: + 31 (0) 20 718 36 98 Eesti Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888 Norge Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1849 Ελλάδα Gilead Sciences Ελλάς Μ.ΕΠΕ.

Τηλ: + 30 210 8930 100 Österreich Gilead Sciences GesmbH Tel: + 43 1 260 830 España Gilead Sciences, S.L.

Tel: + 34 91 378 98 30 Polska Gilead Sciences Poland Sp. z o.o.

Tel: + 48 22 262 8702 France Gilead Sciences Tél: + 33 (0) 1 46 09 41 00 Portugal Gilead Sciences, Lda.

Tel: + 351 21 7928790 Hrvatska Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888 România Gilead Sciences (GSR) S.R.L.

Tel: + 40 31 631 18 00 Ireland Gilead Sciences Ireland UC Tel: + 353 (0) 214 825 999 Slovenija Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888 Ísland Gilead Sciences Sweden AB Sími: + 46 (0) 8 5057 1849 Slovenská republika Gilead Sciences Slovakia s.r.o.

Tel: + 421 232 121 210 Italia Gilead Sciences S.r.l.

Tel: + 39 02 439201 Suomi/Finland Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1849 Κύπρος Gilead Sciences Ελλάς Μ.ΕΠΕ.

Τηλ: + 30 210 8930 100 Sverige Gilead Sciences Sweden AB Tel: + 46 (0) 8 5057 1849 Latvija Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888 United Kingdom (Northern Ireland) Gilead Sciences Ireland UC Tel: + 44 (0) 8000 113 700

This leaflet was last revised in

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

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Epclusa (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/16/1116).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.