Harvoni (Ledipasvir/Sofosbuvir)

• Take this medicine with or without food.
• Your healthcare professional will determine how long you need to take this medicine. It can be for 8, 12 or 24 weeks.
• If you are taking an antacid, you may need to take HARVONI at a different time than the antacid. Talk to your healthcare professional.
• Do NOT stop taking HARVONI without first talking with your healthcare professional.

Usual adult dose:

• Take one tablet once each day.

Overdose:

If you think you have taken too much HARVONI, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

It is important to take HARVONI each day.

• If you miss a dose of HARVONI and you notice within 18 hours, take a tablet as soon as you can. Then take the next dose at your usual time.
• If you miss a dose of HARVONI and you notice after 18 hours, wait and take the next dose at your usual time. Do NOT take a double dose (two doses close together).

What to do if you vomit (throw up):

• If you vomit less than 5 hours after taking HARVONI, take another tablet.
• If you vomit more than 5 hours after taking HARVONI, wait. Do NOT take another tablet until you are scheduled to take the next tablet.

These are not all the possible side effects you may feel when taking HARVONI. If you experience any side effects not listed here, contact your healthcare professional.

The most common side effects of HARVONI are tiredness and headache.

Slow heart rate (bradycardia). HARVONI treatment may result in slowing of the heart rate along with other symptoms when taken with amiodarone (Cordarone), a medicine used to treat certain heart problems. In some cases the slow heart rate has led to death or the need for a heart pacemaker. Get medical help right away if you take amiodarone with HARVONI and get any of the following symptoms: near-fainting or fainting, dizziness or lightheadedness, not feeling well, weakness, extreme tiredness, shortness of breath, chest pains, confusion or memory problems.

Do not use HARVONI if:

• you are allergic to ledipasvir, sofosbuvir (also called Sovaldi when it is used with other medicines without ledipasvir) or any of the other ingredients in this product. (Read also “What are the ingredients in HARVONI?” above.)

• your doctor says you should use ribavirin with HARVONI and you are pregnant or may become pregnant (or if you are a man whose female partner is pregnant or may become pregnant). Ribavirin may cause birth defects or the death of your unborn baby.

• antacids (like Tums, Rolaids or Alka-Seltzer) or medicines that have an ingredient to protect the stomach, used for heartburn and indigestion

• amiodarone (Cordarone), a drug used to treat certain abnormal heart rhythms

• carbamazepine (Tegretol), a drug used to treat seizures, nerve pain and bipolar disorder

• digoxin (Lanoxin, Toloxin), a drug used to treat congestive heart failure

• tenofovir disoproxil fumarate (ATRIPLA, COMPLERA, STRIBILD, TRUVADA, VIREAD), to treat HIV

• medicines for indigestion, heartburn or ulcers. Examples are nizatidine (Axid), famotidine (Pepcid AC, Peptic Guard, Ulcidine), cimetidine (Tagamet), ranitidine (Zantac), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Losec), rabeprazole (Aciphex) and pantoprazole (Pantoloc)

• oxcarbazepine (Trileptal), a drug used to control seizures

• phenobarbital, a drug used to treat anxiety and to control seizures

• phenytoin (Dilantin), a drug used to control seizures

• rifabutin (Mycobutin), a drug used to treat tuberculosis

• rifampin (Rifadin, Rifater, Rofact), a drug used to treat tuberculosis

• rosuvastatin (Crestor), a drug used to treat high cholesterol and to help prevent heart attacks and strokes

• simeprevir (Galexos), a drug used to treat hepatitis C

• St. John’s wort (Hypericum perforatum), an herbal product used for anxiety or depression

• tipranavir (Aptivus) or tipranavir/ritonavir (Aptivus and Norvir), drugs used to treat HIV