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Emtricitabine/rilpivirine/tenofovir (By mouth)

Emtricitabine (em-trye-SYE-ta-been), Rilpivirine Hydrochloride (ril-pi-VIR-een hye-droe-KLOR-ide), Tenofovir Disoproxil Fumarate (ten-OF-oh-vir dye-soe-PROX-il FUE-ma-rate)

Treats HIV infection. This medicine does not cure HIV or AIDS, but it may slow the progress of the disease.

Brand Name(s):

Complera

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use if you had an allergic reaction to emtricitabine, rilpivirine, or tenofovir.

How to Use This Medicine:

Tablet

  • Take your medicine as directed. Try not to miss any doses.
  • Do not change your dose or stop using this medicine without checking first with your doctor.
  • Contact your doctor or pharmacist when your supply is running low. Do not allow yourself to run out of medicine.
  • 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: If you miss a dose or forget to use your medicine and it is less than 12 hours since your last dose, take it as soon as you can, with food, and take your next dose at the normal time. If you miss a dose and it is more than 12 hours since your last dose, wait and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.
  • Store the medicine in the original bottle at room temperature, away from heat, moisture, and direct light. Keep the bottle tightly closed.

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 together with the following:
    • adefovir
    • other medicines that contain lamivudine, emtricitabine, rilpivirine, or tenofovir
    • medicine to treat seizures (carbamazepine, oxcarbazepine, phenobarbital, phenytoin)
    • medicine to treat tuberculosis (rifabutin, rifampin, rifapentine)
    • stomach medicines (dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole)
    • dexamethasone
    • St John's wort
  • Tell your doctor if you are using the following:
    • other medicines to treat HIV/AIDS such as acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir
    • methadone
    • an NSAID pain or arthritis medicine such as aspirin, ibuprofen, or naproxen
    • antibiotics
    • medicine for a fungal infection
  • If you take antacids that contain aluminum, magnesium, or calcium, take the antacid at least 2 hours before or 4 hours after you take this medicine.
  • If you take a stomach medicine for heartburn or ulcers (such as cimetidine, famotidine, nizatidine, ranitidine), take the heartburn medicine at least 12 hours before or 4 hours after you take this medicine.

Warnings While Using This Medicine:

  • Tell your doctor if you are pregnant or if you have kidney problems, liver disease, hepatitis B or C infection, bone problems (such as osteoporosis), or a history of depression.
  • This medicine may cause the following problems:
    • Lactic acidosis
    • Severe liver problems
    • Worsening of hepatitis B infection
    • Kidney problems
    • Depression, unusual thoughts or behavior
    • Higher risk of broken bones
    • Weight gain around your neck, upper back, breast, or waist
  • Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders such as Graves disease, polymyositis, and Guillain-Barré syndrome may also occur.
  • Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
  • 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
  • Change in how much or how often you urinate
  • Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
  • Fast breathing, trouble breathing, nausea and vomiting, lightheadedness, severe weakness, tiredness, or confusion
  • Feeling sad or depressed, anxious, or restless, unusual thoughts or behavior, thoughts of hurting others or oneself
  • Fever, chills, cough, runny or stuffy nose, sore throat, and body aches

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


Last Updated: 9/4/2014


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