When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to emtricitabine or tenofovir. Do not use this medicine to help prevent HIV unless you know for sure that you do not have HIV.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. Try to take your medicine at the same time each day.
• This medicine is used with other medicines to treat HIV infection. Take all other medicines your doctor has prescribed as part of your combination treatment.
• Do not change your dose or stop taking this medicine, even for a short time, without checking first with your doctor.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• 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 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 adefovir or any other medicine that contains tenofovir, emtricitabine, or lamivudine.
• Some foods and medicines can affect how emtricitabine and tenofovir combination works. Tell your doctor if you are using acyclovir, atazanavir, cidofovir, darunavir/ritonavir, didanosine, ganciclovir, lopinavir/ritonavir, valacyclovir, valganciclovir, an antibiotic, or an NSAID pain or arthritis medicine such as aspirin, ibuprofen, or naproxen.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney problems, liver disease (especially hepatitis B), or bone problems (such as osteoporosis). Tell your doctor if you are on dialysis.
• This medicine may cause the following problems:
  
  • Lactic acidosis
  • Severe liver problems
  • Worsening of hepatitis B infection
  • Kidney problems
  • Higher risk of broken bones
  • Weight gain around your neck, upper back, breast, face, or waist
• You may need to be tested for hepatitis B virus. You may need extra monitoring if you have hepatitis B.
• 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.
• When this medicine is used as part of a program to prevent HIV infection, you should be tested at least every 3 months for HIV and also tested regularly for other sexually transmitted infections. This medicine does not always prevent HIV infection.
• 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.
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• 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
• Chest pain, fast or uneven heartbeat
• Dark urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes
• Decrease in how much or how often you urinate
• Fast breathing, trouble breathing, nausea and vomiting, lightheadedness, severe weakness, tiredness, or confusion
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet

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

• Cough, stuffy or runny nose, sore throat
• Depression
• Headache, dizziness
• Mild nausea, vomiting, diarrhea

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