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What you should know before using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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.

Pediatrics

Appropriate studies have not been performed on the relationship of age to the effects of efavirenz, emtricitabine, and tenofovir combination in children up to 18 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of efavirenz, emtricitabine, and tenofovir combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems which may require caution in patients receiving efavirenz, emtricitabine, and tenofovir.

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

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.

Drug Interactions

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Astemizole
  • Bepridil
  • Cisapride
  • Dihydroergotamine
  • Ergoloid Mesylates
  • Ergonovine
  • Ergotamine
  • Methylergonovine
  • Methysergide
  • Midazolam
  • Pimozide
  • St John's Wort
  • Triazolam
  • Voriconazole

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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:

  • Alcohol or drug abuse—May increase the side effect of this medicine, such as dizziness or drowsiness.
  • Infections—When you start taking HIV medicines, your immune system may get stronger. If you have certain infections, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor.
  • Bone problems or
  • Kidney problems or
  • Liver disease (especially hepatitis B infection) or
  • Mental illness (severe depression) or
  • Seizure history—Use with caution. Condition may worsen.