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 rilpivirine.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. Take this medicine with a meal.
• Take all of the medicines your doctor has prescribed at the right time of day and in the correct order. Do not change your dose or stop using any of your medicines without talking to your doctor.
• Contact your doctor or pharmacist when your supply of medicine is running low. Do not allow yourself to run out of medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If it is within 12 hours of your regular time, take a dose with a meal as soon as you can. If your next dose is less than 12 hours away, wait until then and take a regular dose. Do not use extra medicine to make up for a missed dose.
• 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.

• Do not use this medicine if you are also using St John's wort, dexamethasone, seizure medicine (including carbamazepine, oxcarbazepine, phenobarbital, phenytoin), medicine to treat tuberculosis (including rifampin, rifapentine), or stomach medicine (including esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole).
• Many other drugs can affect how rilpivirine works. Tell your doctor about all other medicines you are using.
• Take didanosine on an empty stomach and at least 2 hours before or 4 hours after you take rilpivirine.
• Take antacids that contain aluminum, magnesium, or calcium at least 2 hours before or 4 hours after you take rilpivirine.
• Take medicine for heartburn or ulcers (including cimetidine, famotidine, nizatidine, ranitidine) at least 12 hours before or 4 hours after you take rilpivirine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or if you have kidney problems, liver disease (including hepatitis B or C), or a history of depression.
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause the following problems:
  
  • Serious skin reactions
  • Drug reaction with eosinophilia and systemic symptoms (DRESS), which may damage organs such as the liver, kidney, or heart
  • Depression, unusual thoughts or behavior
  • Severe liver problems
• Your immune system may get stronger when you start taking HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
• This medicine will not keep you from giving HIV to others. Always practice safe sex, even if your partner also has HIV. Do not share needles or other items that may have blood or body fluids on them.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• 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
• Blistering, peeling, red skin rash
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Depression, unusual changes in behaviors or moods, thoughts of hurting yourself
• Fever, swollen glands in your armpits, neck, or groin, mouth sores, redness or swelling around your eye

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

• Headache, tiredness, sleepiness
• Mild nausea
• Trouble sleeping
• Weight gain around your neck, upper back, breast, or waist

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