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Harvoni (ledispavir 90 mg / sofosbuvir 400 mg) – Package leaflet - J05AX65

Updated on site: 07-Oct-2017

Medication nameHarvoni
ATC CodeJ05AX65
Substanceledispavir 90 mg / sofosbuvir 400 mg
ManufacturerGilead Sciences International Ltd

Package leaflet: Information for the user

Harvoni 90 mg/400 mg film-coated tablets ledipasvir/sofosbuvir

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 yours.

-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.

What is in this leaflet

1.What Harvoni is and what it is used for

2.What you need to know before you take Harvoni

3.How to take Harvoni

4.Possible side effects

5.How to store Harvoni

6.Contents of the pack and other information

1.What Harvoni is and what it is used for

Harvoni is a medicine that contains the active substances ledipasvir and sofosbuvir in a single tablet. It is given to treat chronic (long-term) hepatitis C virus infection in adults of 18 years and older.

Hepatitis C is a virus that infects the liver. The active substances in the 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.

Harvoni is sometimes taken with another medicine, ribavirin.

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

2. What you need to know before you take 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 this applies to you, do not take Harvoni 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

(Hypericum perforatum – 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).

Warnings and precautions

Your doctor will know if any of the following conditions apply to you. These will be considered before treatment with Harvoni is started.

other liver problems apart from hepatitis C, for instance

if you are awaiting a liver transplant;

if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;

kidney problems, since Harvoni has not been fully tested in patients with severe kidney problems;

ongoing treatment for HIV infection, since your doctor may want to monitor you more closely.

Talk to your doctor or pharmacist before taking Harvoni if:

you currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if you have taken this medicine).

Tell your doctor immediately if you are taking any medicines for heart problems and during treatment you experience:

shortness of breath

light-headedness

palpitations

fainting

Blood tests

Your doctor will test your blood before, during and after your treatment with Harvoni. This is so that:

Your doctor can decide if you should take Harvoni 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 and adolescents under 18 years of age. The use of Harvoni in children and adolescents 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. This includes herbal medicines and medicines obtained without a prescription.

Warfarin and other similar medicines called vitamin K antagonists used to thin the blood. Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot.

If you are not sure about taking any other medicines, talk to your doctor or pharmacist.

Some medicines should not be taken with Harvoni.

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

Do not take any of these medicines with Harvoni:

rifapentine (antibiotic used to treat infections, including tuberculosis);

oxcarbazepine (a medicine used to treat epilepsy and prevent seizures);

simeprevir (a medicine used to treat hepatitis C infection);

tipranavir (used to treat HIV infection).

Taking Harvoni with any of these may make Harvoni work less well or make any side effects of the medicines worse.

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

amiodarone used to treat irregular heartbeats;

tenofovir disoproxil fumarate or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection;

digoxin used to treat heart conditions;

dabigatran used to thin the blood;

statins used to treat high cholesterol.

Taking Harvoni 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.

Get advice from a doctor or pharmacist if you take medicines used to treat stomach ulcers, heartburn or acid reflux. This includes:

antacids (such as aluminium/magnesium hydroxide or calcium carbonate). These 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 should be taken at the same time as Harvoni. Do not take proton pump inhibitors before Harvoni. Your doctor may give you 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 give you a different medicine or adjust the dose of the medicine you are taking.

These medicines can decrease the amount of ledipasvir 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 that medicine.

Pregnancy and contraception

The effects of Harvoni 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.

Pregnancy must be avoided if Harvoni is taken together with ribavirin. Ribavirin can be very damaging to an unborn baby. Therefore, you and your partner must take special precautions in sexual activity if there is any chance for pregnancy to occur.

You or your partner must use an effective birth control method during treatment with Harvoni together with ribavirin and for some time afterwards. It is very important that you read the “Pregnancy” section in the ribavirin package leaflet very carefully. Ask your doctor for effective contraceptive method suitable for you.

If you or your partner become pregnant during Harvoni and ribavirin treatment or in the months that follow, 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 substances of Harvoni, pass into human breast milk.

Driving and using machines

Do not drive or operate machines if you feel tired after taking your medicine.

Harvoni contains lactose

Tell your doctor if you are lactose intolerant or intolerant to other sugars. Harvoni contains lactose monohydrate. If you are lactose intolerant, or if you have been told that you have an intolerance to other sugars, talk to your doctor before taking this medicine.

Harvoni contains sunset yellow FCF aluminium lake (E110)

Tell your doctor if you are allergic to sunset yellow FCF aluminium lake, also called “E110” before taking this medicine.

3.How to take Harvoni

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

Recommended dose

The recommended dose is one tablet once a day. Your doctor will tell you for how many weeks you should take Harvoni.

Swallow the tablet whole with or without food. Do not chew, crush or split the tablet as it has a very bitter taste. Tell your doctor or pharmacist if you have problems swallowing 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 it at the same time as Harvoni. Do not take it before Harvoni.

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

If you are sick (vomit) less than 5 hours after taking Harvoni, take another tablet.

If you are sick (vomit) more than 5 hours after taking Harvoni, you do not need to take another tablet until your next scheduled tablet.

If you take more Harvoni 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 tablet bottle with you so that you can easily describe what you have taken.

If you forget to take Harvoni

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 Harvoni:

If you notice within 18 hours of the time you usually take Harvoni, you must take the tablet 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 Harvoni, wait and take the next dose at your usual time. Do not take a double dose (two doses close together).

Do not stop taking Harvoni

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 use of this medicine, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, this medicine may cause side effects. If you take Harvoni you may get one or more of the side effects below:

Very common side effects

(may affect more than 1 in 10 people)

headache

feeling tired

Common side effects

(may affect up to 1 in 10 people)

rash

Other effects that may be seen during treatment with Harvoni

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

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

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 Harvoni

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 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 medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Harvoni contains

The active substances are ledipasvir and sofosbuvir. Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir.

The other ingredients are

Tablet core:

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

Film-coating:

Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, sunset yellow FCF aluminium lake (E110)

What Harvoni looks like and contents of the pack

The film-coated tablets are orange, diamond-shaped tablets debossed with “GSI” on one side and “7985” on the other side. The tablet is 19 mm long and 10 mm wide.

Each bottle contains a silica gel desiccant (drying agent) that must be kept in the bottle to help protect your tablets. The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.

The following pack sizes are available:

outer cartons containing 1 bottle of 28 film-coated tablets

outer cartons containing 3 bottles of 28 (84) film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Gilead Sciences International Ltd.

Cambridge

CB21 6GT

United Kingdom

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

Lietuva

Gilead Sciences Belgium SPRL-BVBA

Gilead Sciences Poland Sp. z o.o.

Tél/Tel: + 32 (0) 24 01 35 50

Tel: + 48 22 262 8702

България

Luxembourg/Luxemburg

Gilead Sciences International Ltd.

Gilead Sciences Belgium SPRL-BVBA

Тел.: + 44 (0) 20 7136 8820

Tél/Tel: + 32 (0) 24 01 35 50

Česká republika

Magyarország

Gilead Sciences s.r.o.

Gilead Sciences International Ltd.

Tel: + 420 910 871 986

Tel: + 44 (0) 20 7136 8820

Danmark

Malta

Gilead Sciences Sweden AB

Gilead Sciences International Ltd.

Tlf: + 46 (0) 8 5057 1849

Tel: + 44 (0) 20 7136 8820

Deutschland

Nederland

Gilead Sciences GmbH

Gilead Sciences Netherlands B.V.

Tel: + 31 (0) 20 718 36 98

Eesti

Norge

Gilead Sciences Poland Sp. z o.o.

Gilead Sciences Sweden AB

Tel: + 48 22 262 8702

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 International Ltd.

Gilead Sciences International Ltd.

Tel: + 44 (0) 20 7136 8820

Tel: + 44 (0) 20 7136 8820

Ireland

Slovenija

Gilead Sciences Ltd.

Gilead Sciences International Ltd.

Tel: + 353 214 825999

Tel: + 44 (0) 20 7136 8820

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

Gilead Sciences Poland Sp. z o.o.

Gilead Sciences Ltd.

Tel: + 48 22 262 8702

Tel: + 44 (0) 8000 113700

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

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