Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir Tablets

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with a meal.
• Keep taking this medicine (ombitasvir, paritaprevir, ritonavir, and dasabuvir tablets) as you have been told by your doctor or other health care provider, even if you feel well.
• It is important that you do not miss or skip a dose of this medicine during treatment.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Any skin reaction.
• Feeling very tired or weak.
• Very bad and sometimes deadly liver problems have happened with this medicine (ombitasvir, paritaprevir, ritonavir, and dasabuvir tablets). Some people have needed a liver transplant. These problems most often happened within 1 to 4 weeks of starting treatment. Most people who have had them already had liver problems before starting this medicine. Tell your doctor right away if you have signs of liver problems like dark urine, feeling tired or weak, change in thinking clearly and with logic, not hungry, upset stomach or stomach pain, stomach swelling, light-colored stools, throwing up, or yellow skin or eyes.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Itching.
• Upset stomach.
• Feeling tired or weak.
• Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.