Efavirenz; Emtricitabine; Tenofovir Tablets

What is this medication?

EFAVIRENZ; EMTRICITABINE; TENOFOVIR (e fa VEER ens; em tri SIT uh bean; te NOE fo veer) is 3 antiretroviral medicines in 1 tablet. It is used to treat HIV. This medicine is not a cure for HIV. This medicine can lower, but not fully prevent, the risk of spreading HIV to others.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Atripla

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bone problems
• heart disease
• history of a drug or alcohol abuse problem
• history of depression or other mental illness
• kidney disease
• liver disease
• seizures
• an unusual or allergic reaction to efavirenz, emtricitabine, tenofovir, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 30 minutes before or 2 hours after food. Do not take with food. Take your dose at bedtime. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• any medicine that contains efavirenz, emtricitabine, lamivudine, or tenofovir
• disopyramide
• elbasvir; grazoprevir
• rifapentine
• voriconazole

This medicine may also interact with the following medications:

• amiodarone
• artemether; lumefantrine
• atovaquone; proguanil
• cyclosporine
• certain antibiotics like clarithromycin, gentamicin, rifabutin, rifampin
• female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections
• medicines for heart rate and blood pressure like diltiazem, felodipine, nicardipine, nifedipine, verapamil
• medicines for cholesterol like atorvastatin, pravastatin, simvastatin
• medicines for depression, anxiety, or psychotic disturbances like bupropion, sertraline
• medicines for fungal infections like ketoconazole, itraconazole, and posaconazole
• medicines for seizures like carbamazepine, phenobarbital, phenytoin
• medicines for viral infections like adefovir, boceprevir, simeprevir, ledipasvir; sofosbuvir, pibrentasvir; glecaprevir, velpatasvir; sofosbuvir, velpatasvir; sofosbuvir; voxilaprevir, cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir
• methadone
• NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen
• other medicines for HIV
• red yeast rice
• sirolimus
• tacrolimus
• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor or healthcare provider for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your healthcare provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

If you have hepatitis B, talk to your doctor if you plan to stop this medicine. The symptoms of hepatitis B may get worse if you stop this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Avoid alcohol and mood altering (street) drugs while taking this medicine because they can make these side effects worse.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control. Women who can still have children must use a reliable form of barrier contraception, like a condom or diaphragm.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• bone or muscle pain
• breathing difficulties
• changes in behavior like severe depression, strange thoughts, thoughts of suicide, or angry behavior
• fast, irregular heartbeat
• hallucinations
• nausea, vomiting, unusual stomach upset or pain
• redness, blistering, peeling, or loosening of the skin, including inside the mouth
• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• difficulty sleeping, strange dreams
• dizziness
• headache
• skin discoloration on the hands or feet
• trouble concentrating
• weight gain around waist, back, or thinning of face, arms, legs

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.