Emtricitabine And Tenofovir (Oral Route)

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone problems (eg, fracture, osteomalacia, osteopenia), history of or
• Kidney disease (including Fanconi syndrome), history of or
• Liver disease (especially hepatitis B infection), history of—Use with caution. May make these conditions worse.

• Kidney disease, severe or requiring hemodialysis or
• Unknown or positive HIV-1 status (for Pre-Exposure prophylaxis)—Should not be used in patients with these conditions.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of HIV infection:
    • Adults and children weighing 35 kilograms (kg) or over—One tablet once a day. Each tablet contains 200 milligrams (mg) of emtricitabine and 300 mg of tenofovir.
    • Children weighing 17 kg to less than 35 kg and who are able to swallow a whole tablet—One tablet once a day. Each tablet contains 167 mg of emtricitabine and 250 mg of tenofovir, 133 mg of emtricitabine and 200 mg of tenofovir, or 100 mg of emtricitabine and 150 mg of tenofovir.
    • Children weighing less than 17 kg—Use and dose must be determined by your doctor.
  • For prevention of HIV infection (Pre-exposure prophylaxis):
    • Adults—One tablet once a day. Each tablet contains 200 milligrams (mg) of emtricitabine and 300 mg of tenofovir.
    • Children—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep the bottle tightly closed. Keep the medicine in the original bottle that you were given at the pharmacy.