Sofosbuvir, Velpatasvir Oral tablet

What is this medicine?

SOFOSBUVIR ; VELPATASVIR (soe fos' bue vir; vel pat' us veer) is an antiviral medicine. It is used with other medicines to treat hepatitis C. It will not work for colds, flu, or other viral infections.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• HIV or AIDS

• kidney disease

• man with a partner who is pregnant or trying to get pregnant

• organ transplant

• other liver disease

• an unusual or allergic reaction to sofosbuvir, ribavirin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think you are better. Do not skip doses or stop your medicine early.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• amiodarone

• antacids

• certain antibiotics like rifabutin, rifampin, rifapentine

• certain medicines for cholesterol like atorvastatin and rosuvastatin

• certain medicines for seizures like carbamazepine, oxcarbazepine, phenobarbital, phenytoin

• certain medicines for stomach problems like cimetidine, famotidine, omeprazole, lansoprazole

• digoxin

• efavirenz

• St. John's Wort

• tipranavir

• topotecan

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

See your doctor or health care professional for a follow-up visit as directed. You may need blood work while you are taking this medicine. Tell your doctor if your symptoms do not improve or if they get worse.

This medicine may be given with ribavirin. Ribavirin may cause birth defects or death to an unborn child. Women taking this medicine must avoid pregnancy while taking this medicine and for 6 months after stopping this medicine. Men who are taking this medicine must avoid getting a woman pregnant while taking this medicine and for 6 months after stopping this medicine. Use 2 forms of effective birth control. Women who can still have children must have a negative pregnancy test before starting treatment. Take monthly pregnancy tests while you are taking this medicine and for 6 months after this medicine is stopped. Talk to your doctor if you think that you or your partner are pregnant or are trying to become pregnant.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• depressed mood

• dizziness

• unusually weak or tired

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• diarrhea

• headache

• irritable

• nausea

• tiredness

• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature below 30 degrees C (86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.