When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to simeprevir.

How to Use This Medicine:
Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Simeprevir is always used together with other medicine. Take all of the medicines your doctor prescribed. Make sure you understand when to take them during the day.
• Swallow the capsule whole. Do not crush, break, or chew it.
• It is best to take this medicine with food or milk.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose:
  
  • Within 12 hours: Take the capsule as soon as you can.
  • More than 12 hours: Skip the missed dose and take your next dose at the regular time.
  Do not take extra medicine to make up for a missed dose. Call your doctor if you have questions.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Many drugs can interact with simeprevir. Make sure your doctor knows about all other medicines you are using, including amiodarone or medicine to treat HIV.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease or heart disease. Tell you doctor if you have other liver disease or have had a liver transplant.
• This medicine may cause severe sunburn and rash. Stay out of the sun as much as possible. Wear sunscreen, a hat, and protective clothing when you are outside. Do not use sunlamps or tanning beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blisters, swelling, redness, or other signs of sunburn
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Lightheadedness, dizziness, or fainting
• Red or swollen irritated eyes
• Severe skin rash or itching
• Slow or uneven heartbeat
• Sores or ulcers in the mouth

If you notice these less serious side effects, talk with your doctor:

• Headache
• Nausea

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088