Harvoni

Package leaflet: Information for the user

Harvoni 90 mg/400 mg film-coated tablets, 45 mg/200 mg film-coated tablets

ledipasvir/sofosbuvir
Please read all of 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

If Harvoni has been prescribed for your child, all the information contained in this
leaflet applies to your child (in this case, read “your child” instead of “you”).

1. What Harvoni is and what it is used for

Harvoni is a medicine that contains the active substances ledipasvir and sofosbuvir. Harvoni is administered to treat chronic (long-term) hepatitis C virus infection in adults and children aged 3 years and older.
Hepatitis C is a liver infection caused by a virus. The active substances in this medicine work together by blocking two different viral proteins needed for the virus to grow and reproduce, thereby enabling the complete elimination of the infection from the body.
Harvoni is sometimes taken together with another medicine, ribavirin.
It is very important to also read the package leaflets of any other medicines you will be taking together with Harvoni. If you have any questions about medicines, consult your doctor or pharmacist.

2. What you should know before taking Harvoni

Do not take Harvoni

• if you are allergic to ledipasvir, sofosbuvir, or any of the other ingredients of this medicine (listed in section 6 of this leaflet);
• if you are 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);
• rosuvastatin (a medicine used to treat high cholesterol).

If any of these conditions apply to you, do not take Harvoni and inform your doctor immediately.
Warnings and precautions
Your doctor knows whether any of the following conditions apply to you and will take them into account before starting treatment with Harvoni.

• other liver problems besides hepatitis C, for example;
• if you are awaiting a liver transplant;
• if you currently have or have had hepatitis B virus infection, as your doctor may wish to monitor you more closely;
• kidney problems or if you are on renal dialysis, as Harvoni has not been thoroughly studied in patients with severe kidney problems;
• if you are being treated for HIV infection, as your doctor may wish to monitor you more closely.

Talk to your doctor or pharmacist before taking Harvoni if:

• you are taking or have taken amiodarone in the past few months, a medicine used to treat irregular heartbeat, as it may cause a slowing of the heart rate that could be fatal. Your doctor may consider alternative treatments if you have taken this medicine. If Harvoni treatment is necessary, you may require additional cardiac monitoring.
• you have diabetes. After starting treatment with Harvoni, closer 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 Harvoni.

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

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

Blood tests
Your doctor will carry out certain blood tests before, during, and after treatment with Harvoni. This will allow:

• your doctor to decide whether you should take Harvoni and for how long;
• your doctor to 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 Harvoni in children under 3 years of age has not yet been studied.
Other medicines and Harvoni
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, 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 how other medicines work (e.g. medicines used to suppress the immune system, etc.). Your doctor may need to monitor these other medicines closely and adjust their dose after starting Harvoni treatment.
If you are unsure whether you can take other medicines, consult your doctor or pharmacist.
Some medicines must not be taken with Harvoni:

• Do not take any other medicine containing sofosbuvir, one of the active ingredients in Harvoni.
• Inform your doctor or pharmacist if you are taking any of the following medicines:
• amiodarone, used to treat irregular heartbeat;
• tenofovir disoproxil fumarate, or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection;
• digoxin, used to treat certain heart conditions;
• dabigatran, used to thin the blood;
• statins, used to treat high cholesterol;
• rifapentine (an antibiotic used to treat infections such as tuberculosis);
• oxcarbazepine (a medicine used to treat epilepsy and prevent seizures);
• tipranavir (used to treat HIV infection).

Taking Harvoni with any of these medicines may reduce their effectiveness or worsen any side effects. Your doctor may need to prescribe a different medicine or adjust the dose of the medicine you are taking.

• Ask your doctor or pharmacist if you are taking medicines used to treat gastric ulcer, heartburn, or acid reflux, including:
• antacids (such as aluminium/magnesium hydroxide or calcium carbonate). These medicines should be taken at least 4 hours before or 4 hours after Harvoni;
• proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole, pantoprazole, and esomeprazole). These medicines should be taken at the same time as Harvoni. Do not take proton pump inhibitors before Harvoni. Your doctor may prescribe a different medicine or adjust the dose of the medicine you are taking;
• H2-receptor antagonists (such as famotidine, cimetidine, nizatidine, or ranitidine). Your doctor may prescribe a different medicine or adjust the dose of the medicine you are taking. These medicines may reduce levels of ledipasvir in the blood. If you are taking one of these medicines, your doctor will prescribe a different medicine for gastric ulcer, heartburn, or acid reflux, or will advise you on how and when to take the medicine.

Pregnancy and contraception
The effects of Harvoni 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.
If Harvoni is taken together with ribavirin, pregnancy must be avoided. It is very important to read carefully the “Pregnancy” section of the ribavirin package leaflet.
Ribavirin can be very harmful to the unborn baby. Therefore, special precautions must be taken regarding sexual activity if there is any possibility of pregnancy.

• You or your partner must use an effective method of contraception during and for some time after treatment with Harvoni in combination with ribavirin. It is very important to read carefully the “Pregnancy” section of the ribavirin package leaflet. Ask your doctor which effective contraceptive method is suitable for you.
• If you or your partner becomes pregnant during treatment with Harvoni and ribavirin, or in the months following, you must contact your doctor immediately.

Breast-feeding
Do not breast-feed during treatment with Harvoni. It is not known whether ledipasvir or sofosbuvir, the two active ingredients in Harvoni, pass into breast milk.
Driving and using machines
If you feel tired after taking Harvoni, do not carry out activities that require concentration, such as driving, cycling, or operating machinery.
Harvoni 90 mg/400 mg film-coated tablets and 45 mg/200 mg film-coated tablets contain lactose

• If your doctor has diagnosed you with an intolerance to certain sugars, inform your doctor before taking this medicine.

Harvoni 90 mg/400 mg film-coated tablets contain sunset yellow FCF (E110), which may cause allergic reactions

• Inform your doctor if you are allergic to sunset yellow FCF, also known as “E110”, before taking this medicine.

Harvoni contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Harvoni

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Recommended dose
Harvoni must be taken as directed by your doctor. The recommended dose of Harvoni in adults is one 90 mg/400 mg film-coated tablet once daily. Your doctor will tell you for how many weeks you need to take Harvoni.
The recommended dose of Harvoni in children aged 3 years and older is based on body weight. Take Harvoni as directed by your doctor.
Swallow the tablets whole, with or without food. Do not chew, split, or crush the tablets, as they have a very bitter taste. Inform your doctor or pharmacist if you have difficulty swallowing the tablets.
If you are taking an antacid, take it at least 4 hours before or at least 4 hours after taking Harvoni.
If you are taking a proton pump inhibitor, take it at the same time as Harvoni. Do not take it before Harvoni.
If you vomit after taking Harvoni, the amount of Harvoni in your blood may be altered. The effectiveness of Harvoni may therefore be reduced.

• If you vomit within 5 hours of taking Harvoni, take another dose.
• If you vomit more than 5 hours after taking Harvoni, do not take another dose until your next scheduled dose.

If you take more Harvoni 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 Harvoni
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 Harvoni:

• 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 or more hours have passed since your usual dosing 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 Harvoni
Do not stop treatment with this medicine unless your doctor tells you to. It is very important to complete the full course of treatment to give the medicine the chance to fight the hepatitis C virus infection.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects. If you take Harvoni,
one or more of the following side effects may occur:
Very common side effects
(may affect more than 1 in 10 people)

• headache
• feeling tired

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

• rash

Other side effects that may occur during treatment with Harvoni
The frequency of the following side effects is unknown (frequency cannot be estimated from the
available data).

• 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, blisters in the mouth, eyes and/or genital area (Stevens-Johnson syndrome).

Reporting of side effects
If you experience any side effect, 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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Harvoni

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 refers to the last day of that month.
This medicine requires no 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 Harvoni contains

• The active substances are ledipasvir and sofosbuvir. Each film-coated tablet contains 90 mg of ledipasvir and 400 mg of sofosbuvir or 45 mg of ledipasvir and 200 mg of sofosbuvir.
• The other components are
  Tablet core: Copovidone, monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate

Coating:
Polyvinyl alcohol, titanium dioxide, macrogol, talc and, only for the 90 mg/400 mg tablet,
Sunset Yellow FCF (E110)

Description of the appearance of Harvoni and contents of the pack
Harvoni 90 mg/400 mg film-coated tablets are orange, rhomboid-shaped tablets with the inscription “GSI” on one side and “7985” on the other side. The tablet is approximately 19 mm long and 10 mm wide.
Harvoni 45 mg/200 mg film-coated tablets are white, capsule-shaped tablets with the inscription “GSI” on one side and “HRV” on the other side. The tablet is approximately 14 mm long and 7 mm wide.
Each bottle contains a silica gel desiccant, which must remain in the bottle to protect the tablets. The silica gel desiccant is contained in a sachet or a separate container and must not be ingested.
The following pack sizes are available:

• outer cartons containing 1 bottle with 28 film-coated tablets of 90 mg/400 mg and film-coated tablets of 45 mg/200 mg.
• outer cartons containing 3 bottles with 28 (84) film-coated tablets, only for the 90 mg/400 mg film-coated tablets. Not all pack sizes may be marketed.

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 113700

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

Package leaflet: information for the user

Harvoni 33.75 mg/150 mg coated granules in sachet, 45 mg/200 mg coated granules in sachet

ledipasvir/sofosbuvir
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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

If Harvoni has been prescribed for your child, all the information contained in this
leaflet applies to your child (in this case, read “your child” instead of “you”).

1. What Harvoni is and what it is used for

Harvoni granules is a medicine that contains the active substances ledipasvir and sofosbuvir in granule form.
Harvoni is given to treat chronic (long-term) hepatitis C virus infection in adults and children aged 3 years and older.
Hepatitis C is a liver infection caused by a virus. The active substances in this medicine work together by blocking two different proteins that the virus needs to grow and reproduce, thereby enabling the infection to be permanently cleared from the body.
Harvoni is sometimes taken together with another medicine, ribavirin.
It is very important to also read the package leaflets of any other medicines you will be taking together with Harvoni. If you have any questions about medicines, consult your doctor or pharmacist.

2. What you need to know before taking Harvoni

Do not take Harvoni

• if you are allergic to ledipasvir, sofosbuvir, or any of the other ingredients of this medicine (listed in section 6 of this leaflet)
• if you are 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);
  • rosuvastatin (a medicine used to treat high cholesterol).

If any of these apply to you, do not take Harvoni and inform your doctor immediately.
Warnings and precautions
Your doctor will know if any of the following conditions apply to you and will take them into account before starting treatment with Harvoni.

• other liver problems besides hepatitis C, for example
• if you are awaiting a liver transplant
• if you currently have or have had hepatitis B virus infection, as your doctor may wish to monitor you more closely;
• kidney problems or if you are on kidney dialysis, as Harvoni has not been thoroughly studied in patients with severe kidney problems;
• if you are being treated for HIV infection, as your doctor may want to monitor you more closely.

Talk to your doctor or pharmacist before taking Harvoni if:

• you are taking or have taken amiodarone in the past few months, a medicine used to treat irregular heartbeat, as it may cause a slowing of the heart rate that could be fatal. Your doctor may consider alternative treatments if you have taken this medicine. If treatment with Harvoni is necessary, you may require additional cardiac monitoring.
• you have diabetes. After starting treatment with Harvoni, closer 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 Harvoni.

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

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

Blood tests
Your doctor will carry out certain blood tests before, during, and after treatment with Harvoni. This will allow:

• your doctor to decide whether you should take Harvoni and for how long;
• your doctor to confirm that the treatment has been effective and that 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 Harvoni in children under 3 years of age has not yet been studied.
Other medicines and Harvoni
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, used to thin the blood. Your doctor may increase the frequency of blood tests to ensure your blood is clotting properly.
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 other medicines you are taking closely and may adjust their dose after starting Harvoni treatment.
If you are unsure about taking other medicines, consult your doctor or pharmacist.
Some medicines must not be taken with Harvoni:

• Do not take any other medicine containing sofosbuvir, one of the active substances in Harvoni.
• Inform your doctor or pharmacist if you are taking any of the following medicines:
  • amiodarone, used to treat irregular heartbeat;
  • tenofovir disoproxil fumarate, or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection;
  • digoxin, used to treat certain heart conditions;
  • dabigatran, used to thin the blood;
  • statins, used to treat high cholesterol;
  • rifapentine (an antibiotic used to treat infections such as tuberculosis);
  • oxcarbazepine (a medicine used to treat epilepsy and prevent seizures);
  • tipranavir (used to treat HIV infection).

Taking Harvoni together with any of these medicines may reduce their effectiveness or worsen side effects. Your doctor may need to prescribe a different medicine or adjust the dose of the medicine you are taking.

• Ask your doctor or pharmacist if you are taking medicines used to treat gastric ulcer, heartburn, or acid reflux, including:
  • antacids (such as aluminium/magnesium hydroxide or calcium carbonate). These medicines should be taken at least 4 hours before or 4 hours after Harvoni;
  • proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole, pantoprazole, and esomeprazole). These medicines should be taken at the same time as Harvoni. Do not take proton pump inhibitors before Harvoni. Your doctor may prescribe a different medicine or adjust the dose of the medicine you are taking;
  • H2-receptor antagonists (such as famotidine, cimetidine, nizatidine, or ranitidine). Your doctor may prescribe a different medicine or adjust the dose of the medicine you are taking. These medicines may reduce levels of ledipasvir in the blood. If you are taking one of these medicines, your doctor will prescribe a different medicine for gastric ulcer, heartburn, or acid reflux, or advise you on how and when to take it.

Pregnancy and contraception
The effects of Harvoni 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.
If Harvoni is taken together with ribavirin, pregnancy must be avoided. It is very important to read carefully the “Pregnancy” section of the ribavirin package leaflet.
Ribavirin can be very harmful to the unborn baby. Therefore, special precautions must be taken regarding sexual activity if there is any possibility of pregnancy.

• You or your partner must use an effective method of contraception during treatment with Harvoni plus ribavirin and for some time after treatment. It is very important to read carefully the “Pregn游戏副本

3. How to take Harvoni

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Recommended dose
Harvoni must be taken as directed by your doctor. Your doctor will tell you how long you need to take Harvoni and how many sachets you should take.
The recommended dose of Harvoni is the entire contents of one sachet taken once daily, with or without food.

Taking Harvoni granules with food to aid swallowing:

1. Hold the sachet with the perforation line facing upwards
2. Gently shake the sachet to settle the contents
3. Open the sachet by tearing along the perforation line or by using scissors to cut along the line
4. Pour the entire contents of the sachet onto one or more spoonfuls of non-acidic food such as chocolate syrup, mashed potatoes, or ice cream, at room temperature or lower
5. Make sure no granules remain inside the sachet
6. Take all the granules within 30 minutes after gently mixing them with food
7. Swallow the food-granule mixture without chewing to avoid a bitter taste. Be sure to eat all of the food.

Taking Harvoni granules without food or water, or with water to aid swallowing:

1. Hold the sachet with the perforation line facing upwards
2. Gently shake the sachet to settle the contents
3. Open the sachet by tearing along the perforation line or by using scissors to cut along the line
4. The granules can be poured directly into the mouth and swallowed without chewing to avoid a bitter taste, or can be taken with non-acidic liquids such as water. Do not use fruit juices, for example apple, blueberry, grape, orange, or pineapple juice, as they are acidic and must not be used
5. Make sure no granules remain inside the sachet
6. Swallow all the granules completely.

If you are taking an antacid, take it at least 4 hours before or at least 4 hours after taking Harvoni.
If you are taking a proton pump inhibitor, take it at the same time as Harvoni.
Do not take it before Harvoni.
If you vomit after taking Harvoni, the amount of Harvoni in your blood may be altered.
The effectiveness of Harvoni may therefore be reduced.

• If you vomit within 5 hours of taking Harvoni, take another dose.
• If you vomit more than 5 hours after taking Harvoni, do not take another dose; wait and take the next dose at your usual scheduled time.

If you take more Harvoni 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 outer carton with you so you can clearly explain what you have taken.

If you forget to take Harvoni
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 Harvoni:

• 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 Harvoni
Do not stop taking this medicine unless your doctor tells you to.
It is very important to complete the full course of treatment to give the medicine the best chance to fight the hepatitis C virus infection.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects. If you take Harvoni,
one or more of the following side effects may occur:
Very common side effects
(may affect more than 1 in 10 people)

• headache
• feeling of tiredness

Common side effects
(may affect up to 1 in 10 people)

• rash

Other effects that may be observed during treatment with Harvoni
The frequency of the following side effects is unknown (frequency cannot be estimated from the
available data).

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

Other effects that may be observed 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, and blisters in the mouth, eyes and/or genital area (Stevens-Johnson syndrome).

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

5. How to store Harvoni

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 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 Harvoni contains
The active substances are ledipasvir and sofosbuvir.

• Harvoni 33.75 mg/150 mg granules for oral suspension in sachet contains 33.75 mg of ledipasvir and 150 mg of sofosbuvir.
• Harvoni 45 mg/200 mg granules for oral suspension in sachet contains 45 mg of ledipasvir and 200 mg of sofosbuvir.
• The other components are copovidone, monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol, yellow iron oxide, red iron oxide, methacrylic acid-ammonium methacrylate copolymer.

Description of the appearance of Harvoni and the contents of the pack
The granules are orange in colour and contained in a sachet.
The following pack sizes are available:

• Outer carton 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 113700

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