Epclusa (Sofosbuvir/Velpatasvir)

• Take this medicine with or without food.
• This medicine is taken for 12 weeks.
• If you are taking an antacid, you may need to take EPCLUSA at a different time than the antacid. Talk to your doctor or pharmacist.
• Do NOT stop taking EPCLUSA without first talking with your doctor.

Usual adult dose:

• Take one tablet once each day.

Overdose:

If you think you have taken too much EPCLUSA, 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 EPCLUSA each day.

• If you miss a dose of EPCLUSA 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 EPCLUSA 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 3 hours after taking EPCLUSA, take another tablet.
• If you vomit more than 3 hours after taking EPCLUSA, wait. Do NOT take another tablet until you are scheduled to take the next tablet.

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

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

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your doctor.

Talk about any health conditions or problems you may have, including if you:

• have liver problems other than hepatitis C infection.
• have had a recent liver transplant.
• have hepatitis B.
• have HIV.
• have severe kidney disease or you are on dialysis.
• are breastfeeding or plan to breastfeed. Do NOT breastfeed while taking EPCLUSA.
• are taking anything listed in the section
• Your doctor may monitor your liver function during EPCLUSA treatment, under some conditions.

Pregnancy:

• If you are pregnant or plan to become pregnant, ask your doctor for advice before taking this medicine. It is NOT known if EPCLUSA can harm your unborn child.
• You or your partner must not become pregnant while taking EPCLUSA in combination with ribavirin or become pregnant within 6 months after you have stopped taking ribavirin. Ribavirin may cause birth defects and death of the fetus. Extreme care must be taken to avoid becoming pregnant.
• Your doctor will order monthly pregnancy test during treatment with EPCLUSA in combination with ribavirin and for 6 months after treatment has stopped.
• If you or your partner become pregnant while taking EPCLUSA in combination with ribavirin, contact your doctor. Read the package insert for ribavirin for information regarding pregnancy.

Contraception:

• If you are taking EPCLUSA in combination with ribavirin, then you and your partner must use 2 effective methods of birth control during the entire treatment and for 6 months after you stop taking this combination.

Other warnings you should know about:

Because EPCLUSA already contains sofosbuvir, do not take EPCLUSA with any other medicines containing sofosbuvir (e.g. Sovaldi, Harvoni).

Tell your doctor or pharmacist about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with EPCLUSA:

• amiodarone (Cordarone), a drug used to treat certain abnormal heart rhythms. Amiodarone may slow your heartbeat. Get medical help right away if you get symptoms such as fainting, dizziness, lightheadedness, weakness, shortness of breath.
• carbamazepine (Tegretol), a drug used to treat seizures, nerve pain, and bipolar disorder.
• digoxin (Lanoxin, Toloxin), a drug used to treat congestive heart failure and a certain abnormal heart rhythm (atrial fibrillation).
• efavirenz (Sustiva, Atripla), a drug used 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) or antacids (like Tums, Rolaids or Alka-Seltzer) that have an ingredient to protect the stomach.
• 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.
• 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.
• tenofovir disoproxil fumarate (Atripla, Complera, Stribild, Truvada, Viread), to treat HIV.