Epclusa

Package leaflet: Information for the user

Epclusa 400 mg/100 mg film-coated tablets, 200 mg/50 mg film-coated tablets

sofosbuvir/velpatasvir
Please 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 others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 the information
contained in this package 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 is a medicine that contains the active substances sofosbuvir and velpatasvir. Epclusa is administered for the long-term treatment of chronic hepatitis C virus infection in adults and children aged 3 years and older.
The active substances in this medicine work together by blocking two different viral proteins necessary for the virus to grow and reproduce, thereby enabling permanent elimination of the infection from the body.
It is very important to also read the package leaflets of any other medicines you will be taking together with Epclusa. If you have any doubts 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 or rifabutin (antibiotics used to treat infections such as tuberculosis);
• St John’s wort (a herbal medicine used to treat depression);
• carbamazepine, phenobarbital, or phenytoin (medicines used to treat epilepsy and prevent seizures).

Warnings and precautions
Consult your doctor if:

• for example, you have liver problems other than hepatitis C;
• you have an ongoing or past infection with the hepatitis B virus, as your doctor may decide to monitor you more closely;
• you have undergone a liver transplant;
• you have kidney problems or are on kidney dialysis, as Epclusa has not been thoroughly studied in patients with severe kidney problems;
• you are receiving treatment for human immunodeficiency virus (HIV) infection, as your doctor may wish to monitor you more closely.

Talk to your doctor or pharmacist before taking Epclusa if:

• you are taking or have taken amiodarone in the past few months, a medicine used to treat irregular heartbeats, as it may cause a slowing of the heartbeat, a potentially life-threatening event. Your doctor may consider alternative treatments if you have taken this medicine. If treatment with Epclusa is necessary, you may require additional cardiac monitoring.
• you have diabetes. After starting treatment with Epclusa, closer monitoring of blood glucose levels and/or adjustment of your antidiabetic therapy may be needed. Some diabetic patients have experienced low blood sugar levels (hypoglycaemia) after starting treatment with medicines such as Epclusa.

Inform your doctor immediately if you are taking or have taken in the past few months medicines for
heart problems and if you experience any of the following during treatment:

• slow or irregular heartbeat, or heart rhythm disorders;
• shortness of breath or worsening of an existing breathing condition;
• chest pain;
• mild confusion;
• palpitations;
• near-fainting or fainting.

Blood tests
Your doctor will perform blood tests before, during, and after treatment with Epclusa.
This way

• 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 the hepatitis C virus is no longer present.

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 increase the frequency of blood tests to ensure that blood clotting is properly controlled.
Liver function may change during hepatitis C treatment, which could affect other medicines (e.g., medicines used to suppress the immune system, etc.). Your doctor may need to monitor these medicines you are taking closely and adjust their dose after starting treatment with Epclusa.
If you are unsure, speak to your doctor or pharmacist.
Some medicines must not be taken with Epclusa.

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

Inform your doctor or pharmacist if you are taking any of the following medicines:

• amiodarone, used to treat irregular heartbeats;
• rifapentine (an antibiotic used to treat infections such as 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 certain 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 medicines may make them less effective or lead to worsening of any side effects. Your doctor may need to prescribe a different medicine or adjust the dose of the medicine you are taking. This adjustment may involve Epclusa or another medicine you are taking.

• Ask your doctor or pharmacist if you are taking medicines used to treat stomach ulcer, heartburn, or acid reflux, as 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 4 hours after taking 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 require high doses of these medicines, your doctor may prescribe a different medicine or adjust the dose of the medicine you are taking.

These medicines may reduce velpatasvir levels in the blood. If you are taking any of these medicines, your doctor will prescribe a different medicine for stomach ulcer, heartburn, or acid reflux, or will advise you on how and when to take the medicine in question.
Pregnancy and contraception
The effects of Epclusa during pregnancy are unknown. If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
Epclusa is sometimes used in combination with ribavirin. Ribavirin can harm the unborn child. It is therefore very important that you (or your partner) avoid pregnancy during treatment and for a period of time after treatment has ended. Read the “Pregnancy” section in 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 while taking Epclusa. It is not known whether sofosbuvir or velpatasvir, the two active substances in Epclusa, pass into breast milk.
Driving and using machines
Epclusa has no influence on the ability to drive or use tools and machines.
Epclusa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Epclusa

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Recommended dose
In adults, the recommended dose of Epclusa is one 400 mg/100 mg tablet once daily for 12 weeks.
In patients aged 3 to less than 18 years, the recommended dose of Epclusa is based on body weight. Take Epclusa as prescribed by your doctor.

Swallow the tablet(s) whole, with or without food. Do not chew, split, or crush the tablet(s), as they have a very bitter taste.

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 taking the proton pump inhibitor.

If you vomit after taking Epclusa, the amount of Epclusa in your blood may be affected. The effectiveness of Epclusa may therefore be reduced.

• If you vomit within 3 hours of taking Epclusa, take another dose.
• If you vomit more than 3 hours after taking Epclusa, do not take another dose; wait for your next scheduled dose.

If you take more Epclusa than you should
If you accidentally take more than the recommended dose, contact your doctor or the nearest emergency department immediately. Take the bottle containing the tablets with you so that you can easily explain what you have taken.

If you forget to take Epclusa
It is important not to miss any doses of this medicine. If you forget a dose, consider how much time has passed since you last took Epclusa:

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

Do not stop treatment with Epclusa
Do not stop taking this medicine unless your doctor tells you to. It is very important to complete the full course of treatment to allow the medicine to effectively treat the hepatitis C virus infection.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Very common adverse reactions
(may affect more than 1 in 10 people)

• vomiting (observed in paediatric patients aged between 3 and < 6 years)

Common adverse reactions
(may affect up to 1 in 10 people)

• skin rash

Uncommon adverse reactions
(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 reactions is unknown (frequency cannot be estimated from the available data).

• Severe, widespread skin rash with skin peeling, which may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes and/or genital area (Stevens-Johnson syndrome).

If you experience any adverse reactions, tell your doctor.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system referred to in Annex V. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

to provide further information on the safety of this medicinal product.

5. How to store 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 the 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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Epclusa contains

• The active substances are sofosbuvir and velpatasvir. Each film-coated tablet contains 400 mg of sofosbuvir and 100 mg of velpatasvir or 200 mg of sofosbuvir and 50 mg of velpatasvir.
• The other components are
  Tablet core: Copovidone (E1208), microcrystalline cellulose (E460), croscarmellose sodium (E468) (see section 2 of this leaflet), magnesium stearate (E470b)

Film coating:
Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron
oxide red (E172)
Description of the appearance of Epclusa and the contents of the pack
Epclusa 400 mg/100 mg film-coated tablets are pink, rhomboidal-shaped tablets,
with the imprint “GSI” on one side and “7916” on the other side. The tablet is 20 mm long and 10 mm wide.
Epclusa 200 mg/50 mg film-coated tablets are pink, oval-shaped film-coated tablets, 14 mm x 7 mm in size, with the imprint “GSI” on one side and “S/V” on the other side.
The following packs are available for both film-coated tablets 400 mg/100 mg and 200 mg/50 mg:

• Pack containing 1 bottle with 28 film-coated tablets

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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Gilead Sciences Belgium SRL-BV Gilead Sciences Ireland UC
Tél/Tel: + 32 (0) 24 01 35 50 Tel: + 353 (0) 1 686 1888
България Luxembourg/Luxemburg
Gilead Sciences Ireland UC Gilead Sciences Belgium SRL-BV
Тел.: + 353 (0) 1 686 1888 Tél/Tel: + 32 (0) 24 01 35 50
Česká republika Magyarország
Gilead Sciences s.r.o. Gilead Sciences Ireland UC
Tel: + 420 910 871 986 Tel: + 353 (0) 1 686 1888
Danmark Malta
Gilead Sciences Sweden AB Gilead Sciences Ireland UC
Tlf: + 46 (0) 8 5057 1849 Tel: + 353 (0) 1 686 1888
Deutschland Nederland
Gilead Sciences GmbH Gilead Sciences Netherlands B.V.
Tel: + 49 (0) 89 899890-0 Tel: + 31 (0) 20 718 36 98
Eesti Norge
Gilead Sciences Ireland UC Gilead Sciences Sweden AB
Tel: + 353 (0) 1 686 1888 Tlf: + 46 (0) 8 5057 1849
Ελλάδα Österreich
Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences GesmbH
Τηλ: + 30 210 8930 100 Tel: + 43 1 260 830
España Polska
Gilead Sciences, S.L. Gilead Sciences Poland Sp. z o.o.
Tel: + 34 91 378 98 30 Tel: + 48 22 262 8702
France Portugal
Gilead Sciences Gilead Sciences, Lda.
Tél: + 33 (0) 1 46 09 41 00 Tel: + 351 21 7928790
Hrvatska România
Gilead Sciences Ireland UC Gilead Sciences (GSR) S.R.L.
Tel: + 353 (0) 1 686 1888 Tel: + 40 31 631 18 00
Ireland Slovenija
Gilead Sciences Ireland UC Gilead Sciences Ireland UC
Tel: +353 (0) 214 825 999 Tel: + 353 (0) 1 686 1888
Ísland Slovenská republika
Gilead Sciences Sweden AB Gilead Sciences Slovakia s.r.o.
Sími: + 46 (0) 8 5057 1849 Tel: + 421 232 121 210
Italia Suomi/Finland
Gilead Sciences S.r.l. Gilead Sciences Sweden AB
Tel: + 39 02 439201 Puh/Tel: + 46 (0) 8 5057 1849
Κύπρος Sverige
Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences Sweden AB
Τηλ: + 30 210 8930 100 Tel: + 46 (0) 8 5057 1849
Latvija United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888 Tel: + 44 (0) 8000 113 700
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Patient Information Leaflet: Information for the User

Epclusa 200 mg/50 mg granulated coated particles in sachet, 150 mg/37.5 mg granulated coated particles in sachet

sofosbuvir/velpatasvir
Please read this leaflet carefully before 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 their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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
contained in this package leaflet is addressed 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 in a granule formulation. Epclusa is administered for the long-term treatment of chronic hepatitis C virus infection in adults and children aged 3 years and older.
The active substances in this medicine work together by blocking two different proteins that the virus needs to grow and reproduce, thereby enabling the permanent elimination of the infection from the body.
It is very important to also read the package leaflets of any other medicines you will be taking together with Epclusa. If you have any questions about your medicines, consult your doctor or pharmacist.

2. What you should 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 such as 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
Consult your doctor if:

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

Talk to your doctor or pharmacist before taking Epclusa if:

• you are taking or have taken amiodarone in the past few months, a medicine used to treat irregular heartbeats, as it may cause a life-threatening slowing of the heartbeat. Your doctor may consider alternative treatments if you have taken this medicine. If treatment with Epclusa is necessary, you may require additional cardiac monitoring.
• you have diabetes. After starting treatment with Epclusa, more frequent monitoring of blood glucose levels and/or adjustment of antidiabetic therapy may be needed. Some diabetic patients have experienced low blood sugar levels (hypoglycaemia) after starting treatment with medicines such as Epclusa.

Inform your doctor immediately if you are taking or have taken in the past few months medicines for
heart conditions and experience any of the following during treatment:

• slow or irregular heartbeat, or heart rhythm disturbances;
• shortness of breath or worsening of pre-existing breathing difficulties;
• chest pain;
• mild confusion;
• palpitations;
• near-fainting or fainting.

Blood tests
Your doctor will perform blood tests before, during, and after treatment with Epclusa.
This way

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

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
Inform 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 frequency of blood tests to ensure that blood clotting remains within the correct range.
Liver function may change during hepatitis C treatment, which could affect other medicines (e.g., medicines used to suppress the immune system, etc.). Your doctor may need to monitor these medicines closely and may adjust their dose 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 any other medicine containing sofosbuvir, one of the active substances in Epclusa.

Inform your doctor or pharmacist if you are taking any of the following medicines:

• amiodarone, used to treat irregular heartbeats;
• rifapentine (an antibiotic used to treat infections such as 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 infection and chronic hepatitis B;
• efavirenz, used to treat HIV infection;
• digoxin, used to treat certain 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 medicines may reduce their effectiveness or increase the risk of side effects. Your doctor may need to prescribe a different medicine or adjust the dose of the medicine you are taking. This adjustment may involve Epclusa or another medicine you are taking.

• Ask your doctor or pharmacist if you are taking medicines used to treat stomach ulcer, heartburn, or acid reflux, as 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 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 require high doses of these medicines, your doctor may prescribe a different medicine or adjust the dose of the medicine you are taking.

These medicines may reduce velpatasvir levels in the blood. If you are taking any of these medicines, your doctor will prescribe a different medicine for stomach ulcer, heartburn, or acid reflux, or will advise you on how and when to take the medicine.
Pregnancy and contraception
The effects of Epclusa during pregnancy are unknown. If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
Epclusa is sometimes used in combination with ribavirin. Ribavirin may harm the unborn baby. It is therefore very important that you (or your partner) avoid pregnancy during treatment and for a period of time after treatment ends. Read the “Pregnancy” section in the ribavirin package leaflet very carefully. Ask your doctor which effective contraceptive method is suitable for you and your partner.
Breastfeeding
Do not breastfeed while taking Epclusa. It is not known whether sofosbuvir or velpatasvir, the two active ingredients in Epclusa, pass into breast milk.
Driving and use of machines
Epclusa has no effect on the ability to drive or use tools or machines.
Epclusa granules contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Epclusa granules contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e., essentially ‘sodium-free’.

3. How to take Epclusa

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Recommended dose
Epclusa must be taken as directed by your doctor. Your doctor will inform you of how long you need to take Epclusa and how many sachets you should take.
The recommended dose is the entire contents of the sachet(s), once daily, with or without food.
How to administer Epclusa granules mixed with food to aid swallowing:

1. Hold the sachet with the tear line facing upwards
2. Gently shake the sachet to settle the contents
3. Open the sachet by tearing along the tear line, or use scissors to cut along the line
4. Carefully pour the entire contents of the sachet into one or more teaspoons 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 mousse or sorbet, as they are acidic
5. Ensure no granules remain in the sachet
6. Take all the granules within 15 minutes after mixing with food
7. The food-granule mixture must be swallowed without chewing, to avoid the bitter taste. Make sure the entire mixture has been consumed.

How to administer Epclusa granules without food or water, or with water to aid swallowing:

1. Hold the sachet with the tear line facing upwards
2. Gently shake the sachet to settle the contents
3. Open the sachet by tearing along the tear line, or use scissors to cut along the line
4. The granules can be poured directly into the mouth and swallowed without chewing, to avoid the bitter taste, or taken with non-acidic liquids such as water. Do not use fruit juices, such as apple, blueberry, grape, orange, or pineapple juice, as they are acidic
5. Ensure 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 taking the proton pump inhibitor.
If you vomit after taking Epclusa, the amount of Epclusa in your blood may be altered. The effectiveness of Epclusa may therefore be reduced.

• If you vomit within 3 hours of taking Epclusa, take another dose.
• If you vomit more than 3 hours after taking Epclusa, do not 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, contact your doctor or the nearest emergency department immediately. Bring the sachet and the package with you so you can clearly explain what you have taken.
If you forget to take Epclusa
It is important not to miss any doses of this medicine.
If you forget a dose, consider how much time has passed 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 your next dose at the usual time.
• If 18 hours or more have passed since your usual Epclusa intake time, wait and take the next dose at the usual time. Do not take a double dose (two doses close together).

Do not stop treatment with Epclusa
Do not stop treatment with this medicine unless instructed by your doctor. It is very important to complete the full course of treatment to allow the medicine to effectively combat the hepatitis C virus infection.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Very common side effects
(may affect more than 1 in 10 people)

• vomiting (observed in paediatric patients aged between 3 and < 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 side effects that may occur during treatment with sofosbuvir:
The frequency of the following side effects is unknown (frequency cannot be estimated from the available data).

• severe widespread rash with skin peeling, which may be accompanied by fever, flu-like symptoms, mouth blisters, and/or blisters in the eyes and/or genital area (Stevens-Johnson syndrome).

If you experience any side effects, tell your doctor.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

to provide further information on the safety of this medicinal product.

5. How to store 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 bottle and the 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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Epclusa contains
The active substances are sofosbuvir and velpatasvir.

• Epclusa 150 mg/37.5 mg granules for oral suspension in sachet contains 150 mg of sofosbuvir and 37.5 mg of velpatasvir.
• Epclusa 200 mg/50 mg granules for oral suspension in sachet contains 200 mg of sofosbuvir and 50 mg of velpatasvir.
• Other components: copovidone (E1208), lactose monohydrate (see section 2 of this leaflet), microcrystalline cellulose (E460), sodium croscarmellose (E468) (see section 2 of this leaflet), anhydrous colloidal silica (E551), magnesium stearate (E470b), hypromellose (E464), titanium dioxide (E171), macrogol (E1521), basic butylated methacrylate copolymer (E1205), talc (E553b), stearic acid (E570), L-tartaric acid (E334).

Description of the appearance of Epclusa and contents of the pack
The granules are white to off-white and contained in a sachet.
The following pack is available:

• Pack 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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Gilead Sciences Belgium SRL-BV Gilead Sciences Ireland UC
Tél/Tel: + 32 (0) 24 01 35 50 Tel: + 353 (0) 1 686 1888

България Luxembourg/Luxemburg
Gilead Sciences Ireland UC Gilead Sciences Belgium SRL-BV
Тел.: + 353 (0) 1 686 1888 Tél/Tel: + 32 (0) 24 01 35 50

Česká republika Magyarország
Gilead Sciences s.r.o. Gilead Sciences Ireland UC
Tel: + 420 910 871 986 Tel: + 353 (0) 1 686 1888

Danmark Malta
Gilead Sciences Sweden AB Gilead Sciences Ireland UC
Tlf: + 46 (0) 8 5057 1849 Tel: + 353 (0) 1 686 1888

Deutschland Nederland
Gilead Sciences GmbH Gilead Sciences Netherlands B.V.
Tel: + 49 (0) 89 899890-0 Tel: + 31 (0) 20 718 36 98

Eesti Norge
Gilead Sciences Ireland UC Gilead Sciences Sweden AB
Tel: + 353 (0) 1 686 1888 Tlf: + 46 (0) 8 5057 1849

Ελλάδα Österreich
Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences GesmbH
Τηλ: + 30 210 8930 100 Tel: + 43 1 260 830

España Polska
Gilead Sciences, S.L. Gilead Sciences Poland Sp. z o.o.
Tel: + 34 91 378 98 30 Tel: + 48 22 262 8702

France Portugal
Gilead Sciences Gilead Sciences, Lda.
Tél: + 33 (0) 1 46 09 41 00 Tel: + 351 21 7928790

Hrvatska România
Gilead Sciences Ireland UC Gilead Sciences (GSR) S.R.L.
Tel: + 353 (0) 1 686 1888 Tel: + 40 31 631 18 00

Ireland Slovenija
Gilead Sciences Ireland UC Gilead Sciences Ireland UC
Tel: +353 (0) 214 825 999 Tel: + 353 (0) 1 686 1888

Ísland Slovenská republika
Gilead Sciences Sweden AB Gilead Sciences Slovakia s.r.o.
Sími: + 46 (0) 8 5057 1849 Tel: + 421 232 121 210

Italia Suomi/Finland
Gilead Sciences S.r.l. Gilead Sciences Sweden AB
Tel: + 39 02 439201 Puh/Tel: + 46 (0) 8 5057 1849

Κύπρος Sverige
Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences Sweden AB
Τηλ: + 30 210 8930 100 Tel: + 46 (0) 8 5057 1849

Latvija United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888 Tel: + 44 (0) 8000 113 700

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.