Emtricitabine and Tenofovir disoproxil fumarate

pronounced as (em tri sit' uh bean) (ten of′ oh vir dye″ soe prox′ il fue′ ma rate)

Brand Name(s): Truvada®, also available generically

Why is this medicine prescribed?

The combination of emtricitabine and tenofovir DF is used to treat HIV. Emtricitabine and tenofovir DF is also used along with practicing safer sex (e.g., condom use) to reduce the risk of HIV infection. Emtricitabine and tenofovir DF are in a class of medications called nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs). They work by slowing the spread of HIV in the body.

Although emtricitabine and tenofovir DF will not cure HIV, these medications may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses. Taking these medications and making other lifestyle changes may decrease the risk of getting or giving the HIV virus to other people.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

The combination of emtricitabine and tenofovir DF comes as a tablet to take by mouth. It is usually taken, with or without food, once a day. Take emtricitabine and tenofovir DF at around the same time every day.

Take emtricitabine and tenofovir DF exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If your child is taking emtricitabine and tenofovir DF, swallow the tablet whole. Tell your doctor if your child is unable to swallow the tablets.

Continue to take emtricitabine and tenofovir DF even if you feel well. Do not stop taking emtricitabine and tenofovir DF without talking to your doctor. If you stop taking emtricitabine and tenofovir disoproxil fumarate even for a short time, or if you skip doses, the virus may become resistant to medications and may be harder to treat.

What special precautions should I follow?

Before taking emtricitabine and tenofovir DF,

  • tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take while taking emtricitabine and tenofovir DF. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • you should know that the following nonprescription products may interact with emtricitabine and tenofovir DF: aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil ®
  • , Motrin ® ) and naproxen (Aleve
  • ®
  • , Naprosyn ® ). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking emtricitabine and tenofovir DF. Do not start any of these medications while taking emtricitabine and tenofovir DF without discussing with your healthcare provider.
  • tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section, bone problems including osteoporosis (a condition in which the bones become thin and weak and break easily) or bone fractures, any type of infection that does not go away or that comes and goes such as tuberculosis (TB; a type of lung infection) or cytomegalovirus (CMV; a viral infection that may cause symptoms in people with weak immune systems), or liver or kidney disease.
  • tell your doctor if you are pregnant, or plan to become pregnant. If you become pregnant while taking emtricitabine and tenofovir DF, call your doctor.
  • tell your doctor if you are breastfeeding or plan to breastfeed. Some of the medication and HIV may be passed to your baby in your breast milk. Talk to your doctor about the risks of breastfeeding your baby if you are taking emtricitabine and tenofovir disoproxil fumarate.
  • you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms during your treatment with emtricitabine and tenofovir DF, be sure to tell your doctor.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget to take a dose?

Take the missed dose as soon as you remember it that day. Do not take more than one dose in a day. Do not take a double dose to make up for a missed one.

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222

. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What side effects can this medicine cause?

Emtricitabine and tenofovir DF may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • depression
  • anxiety
  • difficulty falling asleep or staying asleep
  • unusual dreams
  • pain, burning or tingling in the hands or feet
  • heartburn
  • weight loss

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs; hoarseness; difficulty swallowing or breathing
  • decreased urination, frequent urination, muscle pain, bone pain, drinking more than usual
  • nausea, vomiting, pain in upper right part of stomach, loss of appetite, flu-like symptoms, unusual bleeding or bruising, dark yellow or brown urine, light-colored bowel movements, yellowing of the skin or eyes
  • feeling cold, especially in the arms or legs; fast or irregular heartbeat; dizziness; lightheadedness; stomach pain with nausea and vomiting

Emtricitabine and tenofovir DF may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone (

1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What other information should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of emtricitabine and tenofovir DF on hand. Do not wait until you run out of medication to refill your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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