Each film coated tablet of HARVIX® contains:

• Sofosbuvir 400 mg & Ledipasvir  90 mg

• HARVIX® is given to treat chronic (long-term) hepatitis C virus infection in adults and children 3  years of age and older.
• HARVIX® 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 HARVIX®.
• If you have any questions about your medicines, please ask your doctor or pharmacist.

Do not take HARVIX®:
* If you are allergic to ledipasvir, sofosbuvir or any of the other ingredients of this medicine
* 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 HARVIX® and tell your doctor
  immediately.

• 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 HARVIX®.
• If you are not sure about taking any other medicines, talk to your doctor or pharmacist.
• Some medicines should not be taken with HARVIX®.
• Do not take any other medicine that contains sofosbuvir, one of the active substances in HARVIX®. 

• The effects of HARVIX® during pregnancy are not known. Pregnancy must be avoided if HARVIX® 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.
• You or your partner must use an effective birth control method during treatment with HARVIX® together with ribavirin and for some time afterwards.
• Do not breast-feed during treatment with HARVIX®. It is not known whether ledipasvir or sofosbuvir, the two active substances of HARVIX®, pass into human breast milk. 

¤ Like all medicines, this medicine may cause side effects. If you take HARVIX® 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 HARVIX® 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). 
Other effects that may be seen during treatment with sofosbuvir: 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). 

¤ Always take this medicine exactly as your doctor has told you.Recommended dose HARVIX® is to be taken as advised by your doctor.

¤ The recommended dose of HARVIX® 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 HARVIX®.

¤ How to use:

• 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 of swallowing tablets.
• If you are taking an antacid, take it at least 4 hours before or at least 4 hours after HARVIX®. 
• If you are taking a proton pump inhibitor, take the proton pump inhibitor at the same time as HARVIX®. Do not take it before HARVIX®.
• If you are sick (vomit) after taking HARVIX® it may affect the amount of HARVIX® in your blood. This may make HARVIX® work less well.
• If you are sick (vomit) less than 5 hours after taking HARVIX®, take another dose.
• If you are sick (vomit) more than 5 hours after taking HARVIX®, you do not need to take another dose until your next scheduled dose.
• The recommended dose of HARVIX® in children aged 3 years and above is based on weight. Take HARVIX® as advised by your doctor.
• If you forget to take HARVIX® 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 HARVIX®
• If you notice within 18 hours of the time you usually take HARVIX®, 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 HARVIX®, wait and take the next dose at your usual time.Do not take a double dose (two doses close together).

Do not stop taking HARVIX®:

• 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

¤ Your doctor will know if any of the following conditions apply to you. These will be considered before treatment with HARVIX® 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 HARVIX® 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.

¤ 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.

• Blister of 5 tablets, pack of 6 blisters. 
   

• Store below 25ºC, and protect away from light and moisture.