Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate, Oral em-tri-SIT-uh-been ril-py-VIR-een teh-NOH-foh-veer

What are other names for this medicine?

Type of medicine: antiretroviral (anti-HIV)

Generic and brand names: emtricitabine/rilpivirine/tenofovir disoproxil fumarate, oral; Complera

What is this medicine used for?

This medicine is taken by mouth to treat HIV infection in adults who have never taken HIV medicines before. This medicine contains 3 medicines combined in 1 tablet. It will not cure HIV or AIDS but may slow the progression of the disease.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• bone problems such as osteoporosis
• depression or thoughts of suicide
• liver disease such as hepatitis B or hepatitis C
• kidney disease

Tell your provider if you also take adefovir (Hepsera). You should not take this medicine if you also take Hepsera to treat hepatitis B.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. Do not run out of this medicine. Your symptoms may get worse if you stop taking this medicine too soon.

You must take this medicine with food. A protein drink does not replace a meal.

What if I miss a dose?

If you miss a dose, and it is more than 12 hours until the next scheduled dose, take it with a meal as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine may cause severe liver problems. Call your healthcare provider right away if you have:

• yellowish skin or eyes
• dark urine
• light-colored bowel movements
• loss of appetite for several days or longer
• nausea
• stomach pain

You may need urine and blood tests regularly to see how this medicine affects you. You may also need bone scans or X-rays to see if the medicine is affecting your bones. You may also need blood tests after you stop taking this medicine. Keep all appointments for tests.

This medicine may cause a severe or life-threatening condition called lactic acidosis (a buildup of acid in your blood). Contact your healthcare provider right away if you develop unexplained symptoms such as:

• feeling weak or tired
• unusual muscle pain
• having trouble breathing
• feeling cold, especially in your arms or legs
• stomach pain with nausea and vomiting
• feeling dizzy or lightheaded
• suddenly developing a fast or irregular heartbeat

This medicine does not reduce the risk of passing HIV to others through sexual contact or blood contamination. Continue to practice safe sex and do not share needles.

Your body fat may change. Your legs and arms may be thin but your chest, belly, back and face may have more fat. Talk with your healthcare provider about this.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away): Decreased urination, pain when urinating, dark urine, light-colored bowel movements, yellowing of your eyes or skin, unexplained fever, unusual muscle pain; unusual tiredness or weakness; severe dizziness or fainting; fast or irregular heartbeat; trouble breathing; severe stomach or back pain; severe nausea or vomiting; tingling or numbness; depression or thoughts of suicide, unusual mood changes.

Other: Nausea, vomiting, diarrhea, gas, stomach pain, changes in body fat, headache, mild rash, dizziness, trouble sleeping, abnormal dreams, tiredness, muscle or joint pain, runny nose, freckles.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these medicines together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• antacids containing aluminum, calcium, or magnesium such as AlternaGEL, Maalox, Mylanta, and Tums (take antacids at least 2 hours before or 4 hours after this medicine)
• antibiotics such as clarithromycin (Biaxin), erythromycin (Ery-Tab, E.E.S.), isoniazid, levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• antidepressants such as amitriptyline, doxepin, fluoxetine (Prozac), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), paroxetine (Paxil), and sertraline (Zoloft)
• antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• antiviral medicines such as abacavir/lamivudine (Epzicom), abacavir/lamivudine/zidovudine (Trizivir), acyclovir (Zovirax), adefovir (Hepsera), atazanavir (Reyataz), delavirdine (Rescriptor), didanosine (Videx), efavirenz (Sustiva), efavirenz/emtricitabine/tenofovir (Atripla), emtricitabine (Emtriva), emtricitabine/tenofovir (Truvada), etravirine (Intelence), fosamprenavir (Lexiva), ganciclovir (Cytovene), indinavir (Crixivan), lamivudine (Epivir, Epivir-HBV), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), rilpivirine (Edurant), ritonavir (Norvir), saquinavir (Invirase), tenofovir (Viread), valacyclovir (Valtrex), valganciclovir (Valcyte), and zidovudine/lamivudine (Combivir)
• antiseizure medicines such as carbamazepine (Tegretol), oxcarbazepine (Trileptal), phenytoin (Dilantin), and phenobarbital
• antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), pimozide (Orap), thioridazine, and ziprasidone (Geodon)
• arsenic trioxide (Trisenox) bosentan (Tracleer)
• chloroquine (Aralen)
• conivaptan (Vaprisol) dexamethasone
• heart medicines such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), flecainide (Tambocor), nicardipine (Cardene), propafenone (Rythmol), procainamide, quinidine, and sotalol (Betapace) imatinib (Gleevec)
• medicines to reduce stomach acid such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), and ranitidine (Zantac) (take these at least 12 hours before or 4 hours after Complera) methadone (Dolophine, Methadose)
• St. Johns wort
• proton pump inhibitors (PPIs) such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (AcipHex)
• vandetanib

Do not drink alcohol while taking this medicine without your healthcare provider's approval.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.