What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because information technology may take been updated since your medicine was packaged.

Black triangle. This medicinal product is subject to additional monitoring. This volition allow quick identification of new safety information.

Beneath is a text only representation of the Patient Information Leaflet. The original leaflet tin can be viewed using the link in a higher place.

The text only version may be available in large print, Braille or audio CD. For further data call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB11972/0041.

Harvoni 45 mg/200 mg film-coated tablets

ledipasvir/sofosbuvir

▼This medicine is subject to boosted monitoring. This will permit quick identification of new safe information. You lot can help past reporting any side furnishings you may get. See the end of department iv for how to report side effects.

  • Go on this leaflet. You may need to read it once again.
  • If y'all have any farther questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for y'all only. Do not laissez passer it on to others. Information technology may harm them, even if their signs of illness are the same equally yours.
  • If you go whatsoever side effects talk to your doctor or pharmacist. This includes whatsoever possible side effects not listed in this leaflet. Encounter section 4.

i. What Harvoni is and what information technology is used for
2. What you demand to know before y'all have Harvoni
three. 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, please notation that all the data in this leaflet is applicative to your child (in this instance delight read "your child" instead of "you lot").

Harvoni is a medicine that contains the agile substances ledipasvir and sofosbuvir. Harvoni is given to treat chronic (long-term) hepatitis C virus infection in adults and children 3 years of age and older.

Hepatitis C is a virus that infects the liver. The active substances in the medicine work together by blocking ii dissimilar proteins that the virus needs to grow and reproduce itself, assuasive the infection to be permanently eliminated from the torso.

Harvoni is sometimes taken with another medicine, ribavirin.

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

  • 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 currently taking any of the following medicines:
    • rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis);
    • St. John'due south wort (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 accept Harvoni and tell your doctor immediately.

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

  • other liver problems apart from hepatitis C, for example
    • if you are pending a liver transplant;
    • if y'all have a current or previous infection with the hepatitis B virus, since your doc may want to monitor you more closely;
  • kidney issues or if you are on kidney dialysis, since Harvoni has not been fully tested in patients with astringent kidney problems;
  • ongoing handling for HIV infection, since your doctor may want to monitor you more closely.

Talk to your physician or chemist before taking Harvoni if:

  • you currently take, or take taken in the last few months, the medicine amiodarone to treat irregular heartbeats, as information technology may event in a life-threatening slowing of your heart crush. Your medico may consider unlike treatments if you accept taken this medicine. If treatment with Harvoni is needed, you may require additional heart monitoring.
  • you accept diabetes. You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication afterward starting Harvoni. Some diabetic patients have experienced low saccharide levels in the blood (hypoglycaemia) later on starting treatment with medicines like Harvoni.

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

  • dull or irregular heartbeat, or eye rhythm problems;
  • shortness of jiff or worsening of existing shortness of breath;
  • breast-pain;
  • light-headedness
  • palpitations
  • virtually fainting or fainting

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

  • Your doctor can decide if yous should take Harvoni and for how long;
  • Your physician can confirm that your treatment has worked and you are gratuitous of the hepatitis C virus.

Exercise not give this medicine to children nether three years of age. The use of Harvoni in children under 3 years of age has not yet been studied.

Tell your doctor or pharmacist if you are taking, take recently taken or might take any other medicines.

Warfarin and other similar medicines chosen 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.

Your liver function may change with treatment of hepatitis C and therefore may touch on other medications (due east.g. medicines used to suppress your immune organization, etc.). Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Harvoni.

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

  • Practice non take any other medicine that contains sofosbuvir, one of the agile substances in Harvoni.
  • Tell your medico or pharmacist if you are taking any of the medicines beneath:
    • amiodarone used to treat irregular heartbeats
    • tenofovir disoproxil fumarate or any medicine containing tenofovir disoproxil fumarate, used to care for HIV infection
    • digoxin used to care for heart conditions
    • dabigatran used to thin the claret
    • statins used to treat loftier cholesterol
    • rifapentine (antibiotic used to treat infections, including tuberculosis)
    • oxcarbazepine (a medicine used to treat epilepsy and prevent seizures)
    • tipranavir (used to treat HIV infection).

Taking Harvoni with any of these may stop your medicines from working properly, or make whatsoever side effects worse. Your doctor may demand to requite y'all a dissimilar medicine or adjust the dose of medicine you are taking.

  • Get advice from a doc or pharmacist if you lot take medicines used to treat stomach ulcers, heartburn or acrid reflux. This includes:
    • antacids (such as aluminium/magnesium hydroxide or calcium carbonate). These should be taken at least iv 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 physician may give you a different medicine or adjust the dose of the medicine yous 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 yous a different medicine for stomach ulcers, heartburn or acid reflux, or recommend how and when yous accept that medicine.

The effects of Harvoni during pregnancy are not known. If y'all are pregnant, think you may be pregnant or are planning to take a babe, ask your md for advice before taking this medicine.

Pregnancy must be avoided if Harvoni is taken together with ribavirin. It is very important that you read the "Pregnancy" section in the ribavirin package leaflet very carefully. Ribavirin can be very damaging to an unborn baby. Therefore, special precautions in sexual activity must be taken if there is any adventure for pregnancy to occur.

  • Y'all or your partner must employ an constructive birth control method during treatment with Harvoni together with ribavirin and for some time afterwards. It is very important that yous read the "Pregnancy" department in the ribavirin parcel leaflet very carefully. Ask your doctor for an effective contraceptive method suitable for yous.
  • If you or your partner become pregnant during Harvoni and ribavirin treatment or in the months that follow, you must contact your doctor immediately.

Do not chest-feed during treatment with Harvoni. It is not known whether ledipasvir or sofosbuvir, the two active substances of Harvoni, pass into human chest milk.

If you feel tired later taking Harvoni you should not take part in activities that crave concentration, for instance, do not drive, ride a bike or operate machines.

  • If yous have been told by your doctor that you have an intolerance to some sugars, contact your dr. before taking this medicinal product.
  • Tell your doctor if you are allergic to sunset yellow FCF, also called "E110" earlier taking this medicine.

This medicine contains less than ane mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-gratuitous'.

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

Harvoni is to be taken as brash by your doctor. The recommended dose of Harvoni in adults is i 90 mg/400 mg picture-coated tablet once a twenty-four hours. Your md will tell y'all for how many weeks you should have Harvoni.

The recommended dose of Harvoni in children aged three years and above is based on weight. Take Harvoni as advised past your medico.

Swallow the tablet(s) whole with or without food. Do not chew, crush or separate the tablet as it has a very bitter taste. Tell your doctor or chemist if you have problems swallowing tablets.

If you are taking an antacid, take information technology at least 4 hours earlier or at least 4 hours later on Harvoni.

If you are taking a proton pump inhibitor, take the proton pump inhibitor at the same time every bit Harvoni. Do not have it before Harvoni.

If you are sick (vomit) afterwards taking Harvoni it may touch the amount of Harvoni in your claret. This may make Harvoni work less well.

  • If you are sick (vomit) less than 5 hours later on taking Harvoni, take another dose.
  • If you are sick (vomit) more 5 hours after taking Harvoni, y'all exercise not need to take some other dose until your next scheduled dose.

If yous accidentally take more than the recommended dose yous should contact your doctor or nearest emergency department immediately for communication. Proceed the tablet bottle with y'all and then that you can easily draw what yous have taken.

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

If you do miss a dose, work out how long information technology is since you last took your Harvoni:

  • If you notice within 18 hours of the time you ordinarily take Harvoni, you must have the dose as soon as possible. So accept the next dose at your usual time.
  • If it'southward xviii hours or more later the time you normally take Harvoni, wait and take the adjacent dose at your usual time. Do not take a double dose (two doses close together).

Do not stop taking this medicine unless your dr. tells you to. It is very important that you complete the full course of treatment to requite the medicine the all-time chance to treat your hepatitis C virus infection.

If y'all have any further questions on the apply of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects. If you accept Harvoni you lot may get one or more than of the side effects beneath:

Very common side effects

(may touch more than 1 in 10 people)

  • headache
  • feeling tired

Common side effects

(may affect upwardly to 1 in 10 people)

  • rash

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

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

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

  • a wide-spread severe rash with peeling peel which may be accompanied past fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson syndrome).

If you get whatsoever side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also written report side effects directly via the

Xanthous Card Scheme

Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Carte in the Google Play or Apple App Store

By reporting side furnishings you can help provide more information on the safety of this medicine.

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

Do non utilize this medicine after the expiry date which is stated on the canteen and carton after "EXP". The expiry date refers to the last day of that month.

This medicine does non require any special storage weather.

Practise non throw away whatsoever medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you lot no longer use. These measures will help protect the surround.

What Harvoni contains

  • The active substances are ledipasvir and sofosbuvir. Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir or 45 mg ledipasvir and 200 mg sofosbuvir.
  • The other ingredients are
    Tablet core:
    Copovidone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate
    Pic-blanket:
    Polyvinyl booze, titanium dioxide, macrogol, talc, and for the 90 mg/400 mg tablet simply; sunset yellowish FCF (E110)

Harvoni 90 mg/400 mg film-coated tablets are orange, diamond-shaped tablets debossed with "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, debossed with "GSI" on one side and "HRV" on the other side. The tablet is approximately fourteen mm long and vii mm wide.

Each canteen 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 exist swallowed.

The following pack sizes are available:

  • outer cartons containing 1 bottle of 28 film-coated tablets for the 90 mg/400 mg and the 45 mg/ 200 mg moving picture-coated tablets.
  • outer cartons containing 3 bottles of 28 (84) film-coated tablets for the 90 mg/400 mg film-coated tablets simply. Non all pack sizes may be marketed.

Gilead Sciences Ltd
280 High Holborn
London
WC1V 7EE
Great britain

Gilead Sciences Ireland UC
IDA Business & Applied science Park
Carrigtohill
County Cork
Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Gilead Sciences Ltd

Tel: + (0) 8000 113 700

This leaflet was final revised in 09/2021