Label: information for the user

Harvoni 90 mg/400 mg film-coated tablets

Harvoni 45 mg/200 mg film-coated tablets

ledipasvir/sofosbuvir

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. How to take Harvoni
2. Possible adverse effects
3. Storage of Harvoni

1. Contents of the pack and additional information

If Harvoni has been prescribed for your child, please note that all the information in this label is directed at your child (in that case, read «your child» instead of «you»).

Harvoni is a medication that contains the active ingredients ledipasvir and sofosbuvir. Harvoni is administered to treat chronic (long-term) infection by the hepatitis C virus inadultsandchildren aged 3 years or older.

Hepatitis C is a viral infection of the liver. The active ingredients in the medication act together by blocking two different proteins that the virus needs to grow and reproduce, allowing for permanent elimination of the infection from the body.

Harvoni is sometimes taken with another medication: ribavirin.

It is very important that you also read the leaflets for any other medications you are taking with Harvoni. If you have any doubts about your medications, consult your doctor or pharmacist.

Do not take Harvoni

• If you are allergicto ledipasvir, sofosbuvir, or any of the other ingredients in thismedication (listed in section 6 of this leaflet).

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

Warnings and precautions

Your doctor will know if you have any of the following conditions. They will be taken into account before starting treatment with Harvoni.

• Other liver problemsapart from hepatitis C, for example

• • If you have or have had a hepatitis B virus infection,as your doctor may want to monitor you more closely;
• Liver or kidney problems, or if you are undergoing dialysis,as Harvoni has not been fully studied in patients with severe kidney problems;

• Current treatment for HIV infection,as your doctor may want to monitor you more closely.

Consult your doctor or pharmacist before starting to take Harvoni if:

• You are currently taking or have stopped taking amiodarone in the past few months to treat irregular heart rhythm, as it may cause a potentially fatal decrease in heart rate. Your doctor may consider alternative treatments if you have taken this medication. If you need treatment with Harvoni, you may need additional cardiac monitoring.

• You have diabetes. After starting Harvoni, you may need a strict control of your blood glucose levels and/or adjust your antidiabetic medication. Some diabetic patients have experienced low blood sugar (hypoglycemia) after starting treatment with medications like Harvoni.

Consult your doctor immediatelyif you are currently taking or have taken in the past few months any medication 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;

• Dizziness;

• Palpitations;

• Fainting or near-fainting.

Blood tests

Your doctor will perform blood tests before, during, and after treatment with Harvoni. This is to:

• Allow your doctor to decide if you should take Harvoni and for how long;

• Confirm that the treatment has worked and you no longer have the hepatitis C virus.

Children and adolescents

Do not give this medication to children under 3 years of age. Harvoni has not yet been studied in children under 3 years of age.

Other medications and Harvoni

Inform your doctor or pharmacistif you are taking, have taken recently, or may need to take any other medication.

Warfarin and other medications similar to warfarin, known as vitamin K antagonists, 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 this may affect other medications (e.g., medications used to suppress your immune system, etc.). Your doctor may need to closely monitor these other medications you are taking and make adjustments after starting treatment with Harvoni.

If you are unsure about whether you should take any other medication, consult your doctor or pharmacist.

Some medications should not be taken with Harvoni.

• Do not take any other medication that contains sofosbuvir, one of the active ingredients in Harvoni.

• Inform your doctor or pharmacistif you are taking any of the following medications:

Taking Harvoni with any of these medications may prevent them from working properly or worsen their potential side effects. Your doctor may need to give you a different medication or adjust the dose you are taking.

• Consult a doctor or pharmacistif you are taking medications used to treatstomach ulcers, heartburn, or acid reflux.These include:
• • Antacids (such as aluminum hydroxide/magnesium hydroxide or calcium carbonate). These medications should be taken at least 4 hours before or 4 hours after Harvoni;

These medications may reduce the amount of ledipasvir present in the blood. If you are taking any of these medications, your doctor will give you a different medication for stomach ulcers, heartburn, or acid reflux or recommend how and when to take it.

Pregnancy and contraception

The effects of Harvoni during pregnancy are unknown. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Pregnancy should be avoided if Harvoni is taken with ribavirin. It is very important that you read the "Pregnancy" section of the ribavirin leaflet carefully. Ribavirin can be very harmful to the fetus. Therefore, special precautions should be taken in sexual activity if there is any possibility of pregnancy.

• You or your partner should use an effective contraceptive method during treatment with Harvoni and ribavirin, and for some time after. It is very important that you read the "Pregnancy" section of the ribavirin leaflet carefully. Ask your doctor for an effective contraceptive method that is suitable for you.

• If you or your partner become pregnant during treatment with Harvoni and ribavirin, or in the months that follow, contact your doctor immediately.

Breastfeeding

Do not breastfeed during treatment with Harvoni.The active ingredients in Harvoni, ledipasvir and sofosbuvir, are unknown to pass into human breast milk.

Driving and operating machinery

If you feel tired after taking Harvoni, do not perform activities that require concentration, such as driving, cycling, or operating machinery.

Harvoni 90 mg/400 mg and 45 mg/200 mg film-coated tablets contain lactose

• If your doctor has told you that you have intolerance to some sugars, inform them before taking this medication.

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

• Inform your doctor if you are allergicto FCF yellow-orange, also known as "E110", beforetaking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

Recommended dose

You should take Harvoni as indicated by your doctor.The recommended dose of Harvoniin adultsisa 90 mg/400 mg film-coated tablet once a day. Your doctor will tell you for how many weeks you should take Harvoni.

The recommended dose of Harvoni in children 3 years of age or older is based on weight.

Take Harvoni as indicated by your doctor.

Swallow the tablet(s) whole, with or without food. Do not chew, crush, or break the tablet, as it has a very bitter taste. Inform your doctor or pharmacist if you have trouble swallowing the tablets.

If you are taking an antacid,take it at least 4 hours before or at least 4 hours after Harvoni.

If you are taking a proton pump inhibitor,take the proton pump inhibitorat the same time as Harvoni. Do not take it before Harvoni.

If you vomit after taking Harvonithis may affect the amount of Harvoni in the blood. Thismay make Harvoni work less effectively.

• If you vomit withinless than 5 hours aftertaking Harvoni, take another dose.

• If you vomit more than5 hours aftertaking Harvoni, you do not need to take another dose until your next scheduled dose.

If you take more Harvoni than you should

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

If you forget to take Harvoni

It is essential not to miss any dose of this medication.

If you miss a dose, calculate how long it has been since you took the last Harvoni:

• If you realize within 18 hoursof the time you normally take Harvoni,take the dose as soon as possible. Then, take the next dose at the usual time.
• If more than 18 hours have passedsince the time you normally take Harvoni, wait andtake the next dose at the usual time. Do not take a double dose (two doses in a short interval).

Do not interrupt Harvoni treatment

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

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects. If you take

Harvoni, you may experience one or more of the following adverse effects:

Very Common Adverse Effects

(may affect more than 1 in 10 people)

• Headache

• Fatigue

Common Adverse Effects

(may affect up to 1 in 10 people)

• Dermatological eruption

Other effects that may be observed during treatment with Harvoni

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

• Severe generalized skin eruption with peeling that may be accompanied by fever, pseudogripal symptoms, blisters in the mouth, eyes, and/or genitals (Stevens Johnson syndrome).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the bottle and the box after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Harvoni Composition

• The active ingredients areledipasvir and sofosbuvir. Each film-coated tabletcontains 90 mg of ledipasvir and 400 mg of sofosbuvir or 45 mg of ledipasvir and 200 mg of sofosbuvir.

• The other components are:Core of the tablet:

Copovidone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, anhydrous colloidal silica, magnesium stearate

Film coating:

Polvinyl alcohol, titanium dioxide, macrogol, talc, and only for the 90 mg/400 mg tablet; Sunset Yellow FCF (E 110)

Appearance of the product and contents of the pack

Harvoni 90 mg/400 mg film-coated tablets are orange-coloured, rhomboid-shaped tablets, engraved with "GSI" on one side and "7985" on the other. The tablet is approximately 19 mm in length and 10 mm in width.

Harvoni 45 mg/200 mg film-coated tablets are white, capsule-shaped tablets, engraved with "GSI" on one side and "HRV" on the other. The tablet is approximately 14 mm in length and 7 mm in width.

Each bottle contains a silica gel desiccant (moisture-absorbing agent) that should be kept in the bottle to help protect the tablets. The silica gel desiccant is packaged in a separate sachet or container and should not be taken.

The following pack sizes are available:

• 1 bottle of 28 film-coated tablets for 90 mg/400 mg and 45 mg/200 mg film-coated tablets.

• 3 bottles of 28 (84) film-coated tablets only for 90 mg/400 mg film-coated tablets. Some pack sizes may only be marketed.

Marketing Authorisation Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Responsible Person

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

For information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

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