When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use if you had an allergic reaction to efavirenz, emtricitabine, or tenofovir, or if you are pregnant.

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 at the same time each day, preferably at bedtime.
• Do not stop using this medicine without checking first with your doctor. If you stop the medicine even briefly, the virus may become harder to treat. Contact your doctor or pharmacist when your supply is running low so you do not run out.
• It is best to take this medicine on an empty stomach.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take 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. Keep the bottle tightly closed. Keep the medicine in the original bottle that you were given at the pharmacy.

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 adefovir, bepridil, cisapride, lamivudine, midazolam, pimozide, triazolam, voriconazole, St John's wort, or an ergot medicine.
• Some foods and medicines can affect how Atripla works. Tell your doctor about any medicine you take to treat HIV/AIDS or hepatitis. Tell your doctor if you are using bupropion, cyclosporine, methadone, rifabutin, rifampin, sertraline, sirolimus, tacrolimus, a blood thinner (such as warfarin), NSAID pain medicine, blood pressure medicine, medicine to lower cholesterol, medicine to treat an infection, or seizure medicine.
• There are many other drugs that can interact with Atripla. Make sure your doctor knows about all other medicines you are using.

Warnings While Using This Medicine:

• Your baby could be harmed if you use this medicine while you are pregnant. Use 2 forms of birth control while you take this medicine and for 12 weeks after you stop it. One method should be a barrier method, such as condoms. Some birth control pills may not work as well while you are using this medicine. Tell your doctor right away if you become pregnant.
• Tell your doctor if you have kidney disease, liver disease (including hepatitis), or bone problems (such as osteoporosis), seizures, mental illness, or drug or alcohol use. Tell your doctor if you drink alcohol.
• This medicine may cause the following problems:
  
  • Lactic acidosis
  • Severe liver problems
  • Worsening of hepatitis B infection
  • Higher risk of mental or behavior problems
  • Kidney problems
  • Lower bone mineral density
• 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 may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• 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.
• 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, or red skin rash
• Bone, joint, or muscle pain
• 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
• Severe depression, confusion, aggressiveness, thoughts of hurting yourself or others
• Seizures

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

• Headache, dizziness
• Mild nausea, vomiting, diarrhea, constipation
• Mild skin rash, change in skin color
• Trouble sleeping, unusual dreams
• 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