Ledipasvir/Sofosbuvir Gilead 90 mg/400 mg film-coated tablets (previously known as Harvoni)

• 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.

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

If Ledipasvir/Sofosbuvir Gilead has been prescribed for your child, please note that all the information in this leaflet is applicable to your child (in this case please read “your child” instead of “you”).

• 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’s 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 take Ledipasvir/Sofosbuvir Gilead and tell your doctor immediately.

Your doctor will know if any of the following conditions apply to you. These will be considered before treatment with Ledipasvir/Sofosbuvir Gilead 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 or if you are on kidney dialysis, since Ledipasvir/Sofosbuvir Gilead 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 Ledipasvir/Sofosbuvir Gilead if:

• you currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats, as it may result in a life-threatening slowing of your heart beat. Your doctor may consider different treatments if you have taken this medicine. If treatment with Ledipasvir/Sofosbuvir Gilead is needed, you may require additional heart monitoring.
• you have diabetes. You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Ledipasvir/Sofosbuvir Gilead. Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Ledipasvir/Sofosbuvir Gilead.

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

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

Your doctor will test your blood before, during and after your treatment with Ledipasvir/Sofosbuvir Gilead. This is so that:

• Your doctor can decide if you should take Ledipasvir/Sofosbuvir Gilead and for how long;
• Your doctor can confirm that your treatment has worked and you are free of the hepatitis C virus.

Do not give this medicine to children under 3 years of age. The use of Ledipasvir/Sofosbuvir Gilead in children under 3 years of age has not yet been studied.

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 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 affect other medications (e.g. medicines used to suppress your immune system, etc.). Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Ledipasvir/Sofosbuvir Gilead.

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

Some medicines should not be taken with Ledipasvir/Sofosbuvir Gilead.

• Do not take any other medicine that contains sofosbuvir, one of the active substances in Ledipasvir/Sofosbuvir Gilead.
• 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
  • 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 Ledipasvir/Sofosbuvir Gilead 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 Ledipasvir/Sofosbuvir Gilead;
  • proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole). These should be taken at the same time as Ledipasvir/Sofosbuvir Gilead. Do not take proton pump inhibitors before Ledipasvir/Sofosbuvir Gilead. 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.

The effects of Ledipasvir/Sofosbuvir Gilead 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 Ledipasvir/Sofosbuvir Gilead 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 chance for pregnancy to occur.

• You or your partner must use an effective birth control method during treatment with Ledipasvir/Sofosbuvir Gilead 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 an effective contraceptive method suitable for you.
• If you or your partner become pregnant during Ledipasvir/Sofosbuvir Gilead and ribavirin treatment or in the months that follow, you must contact your doctor immediately.

Do not breast-feed during treatment with Ledipasvir/Sofosbuvir Gilead. It is not known whether ledipasvir or sofosbuvir, the two active substances of Ledipasvir/Sofosbuvir Gilead, pass into human breast milk.

If you feel tired after taking Ledipasvir/Sofosbuvir Gilead you should not take part in activities that require concentration, for example, do not drive, ride a bike or operate machines.

• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Ledipasvir/Sofosbuvir Gilead is to be taken as advised by your doctor. The recommended dose of Ledipasvir/Sofosbuvir Gilead in adults is one 90 mg/400 mg film-coated tablet once a day. Your doctor will tell you for how many weeks you should take Ledipasvir/Sofosbuvir Gilead.

The recommended dose of Ledipasvir/Sofosbuvir Gilead in children aged 3 years and above is based on weight. Take Ledipasvir/Sofosbuvir Gilead as advised by your doctor.

Swallow the tablet(s) 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 Ledipasvir/Sofosbuvir Gilead.

If you are taking a proton pump inhibitor, take the proton pump inhibitor at the same time as Ledipasvir/Sofosbuvir Gilead. Do not take it before Ledipasvir/Sofosbuvir Gilead.

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

• If you are sick (vomit) less than 5 hours after taking Ledipasvir/Sofosbuvir Gilead, take another dose.
• If you are sick (vomit) more than 5 hours after taking Ledipasvir/Sofosbuvir Gilead, you do not need to take another dose until your next scheduled dose.

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.

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 Ledipasvir/Sofosbuvir Gilead:

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

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.

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).

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

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

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

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

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

• 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
  Film-coating:
  Polyvinyl alcohol, titanium dioxide, macrogol, talc, and for the 90 mg/400 mg tablet only;
  sunset yellow FCF (E110)

Ledipasvir/Sofosbuvir Gilead 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.

Ledipasvir/Sofosbuvir Gilead 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 14 mm long and 7 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 for the 90 mg/400 mg and the 45 mg/ 200 mg film-coated tablets.
• outer cartons containing 3 bottles of 28 (84) film-coated tablets for the 90 mg/400 mg film-coated tablets only. Not all pack sizes may be marketed.