Emtricitabine/rilpivirine/tenofovir (By mouth)

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant, have kidney problems, liver disease, hepatitis B infection, weak bones (osteoporosis), or depression.
• You should not breast feed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
• This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.
• This medicine may cause a rare, but serious, unwanted effect called lactic acidosis (too much acid in the blood). Stop using this medicine and call your doctor right away if you have more than one of these symptoms: abdominal or stomach discomfort; a decreased appetite; diarrhea; fast, shallow breathing; a general feeling of discomfort; muscle pain or cramping; nausea; shortness of breath; sleepiness; or unusual tiredness or weakness.
• This medicine may cause rare, but serious, liver problems. Stop using this medicine and check with your doctor right away if you have more than one of these symptoms: clay-colored stools; dark urine; a decreased appetite; fever; headache; itching; nausea and vomiting; skin rash; stomach pain or tenderness; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.
• Tell your doctor right away if you start to feel depressed and have thoughts about hurting yourself. Report any unusual thoughts or behavior that troubles you, especially if they are new or get worse quickly.
• This medicine may cause your bones to get thin. This could increase your risk for broken bones (fractures). Ask your doctor about this if you have any concerns.
• This medicine may cause you to have extra body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from your legs, arms, or face.
• When you start taking HIV medicines, your immune system may get stronger. If you already have pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight the infections. If this occurs, be sure to tell your doctor.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood and urine tests may be needed to check for unwanted effects.

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.
• Extreme weakness, tiredness, or confusion.
• Feeling sad or depressed, anxious, or restless.
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
• Lightheadedness or fainting.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Unusual tiredness or weakness.

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

• Abnormal dreams.
• Diarrhea.
• Headache or dizziness.
• Skin rash.
• Trouble sleeping.

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

Introduction

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 human immunodeficiency virus (HIV) infection. HIV causes acquired immune deficiency syndrome (AIDS). 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

You should not use this medicine if you have had an allergic reaction to emtricitabine, rilpivirine, tenofovir, Atripla®, Emtriva®, Edurant®, Truvada®, or Viread®. Do not use this medicine if you are also taking adefovir (Hepsera®), lamivudine (Combivir®, Epivir®, Epivir-HBV®, Epzicom?, Trizivir®), other medicines that contain emtricitabine, rilpivirine, or tenofovir (such as Atripla®, Emtriva®, Edurant®, Truvada®, or Viread®), a seizure medicine (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, or Trileptal®), medicine to treat tuberculosis (such as rifabutin, rifampin, rifapentine, Mycobutin®, Priftin®, Rifadin®, or Rimactane®), certain stomach medicines (such as esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, Aciphex®, Nexium®, Prevacid®, Prilosec®, or Protonix®), dexamethasone (Decadron®), or St. John's wort.

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• It is best to take this medicine with food or milk.
• Keep taking this medicine for the full time of treatment, even if you begin to feel better. Do not change or stop using this medicine without checking first with your doctor.
• You should take this medicine every day and try not to miss any doses. When your supply is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of medicine.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• 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 and take your next dose at the normal time. If you miss a dose or forget to use it, 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.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

• Make sure your doctor knows if you are using other medicines to treat HIV/AIDS such as acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, Cytovene®, Valcyte?, Valtrex®, Vistide®, or Zovirax®.
• Tell your doctor if you are using arsenic trioxide (Trisenox®), cisapride (Propulsid®), dofetilide (Tikosyn®), methadone (Dolophine®), medicine for depression (such as amitriptyline, fluoxetine, nortriptyline, Elavil®, Pamelor®, Prozac®, Sarafem®, or Vivactil®), or certain antibiotics (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, sparfloxacin, troleandomycin, Avelox®, Biaxin®, Ery-Tab®, Levaquin®, Tao®, or Zagam®).
• Make sure your doctor knows if you are using medicine for a fungus infection (such as fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole, Diflucan®, Nizoral®, Noxafil®, Sporanox®, or Vfend®) or medicine for a mental illness (such as haloperidol, mesoridazine, pimozide, prochlorperazine, quetiapine, thioridazine, ziprasidone, Compazine®, Geodon®, Haldol®, Mellaril®, Orap®, Serentil®, or Seroquel®).
• If you are taking antacids that contain aluminum, magnesium, or calcium, take the antacid at least 2 hours before or 4 hours after this medicine.
• If you are taking a stomach medicine for heartburn or ulcers (such as cimetidine, famotidine, nizatidine, ranitidine, Axid®, Pepcid®, Tagamet®, or Zantac®), take the heartburn medicine at least 12 hours before or 4 hours after this medicine.