EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- emtricitabine and tenofovir disoproxil fumarate tablet, film coated 
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Medication Guide

Emtricitabine and Tenofovir Disoproxil Fumarate

(em’’ trye sye’ ta been and ten of’ oh vir dye’’ soe prox’ il fue’ ma rate) Tablets

Read this Medication Guide before you start taking emtricitabine and tenofovir disoproxil fumarate tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

This Medication Guide provides information about two different ways that emtricitabine and tenofovir disoproxil fumarate tablets may be used. See the section “What are emtricitabine and tenofovir disoproxil fumarate tablets?” for detailed information about how emtricitabine and tenofovir disoproxil fumarate tablets may be used.

What is the most important information I should know about emtricitabine and tenofovir disoproxil fumarate tablets?

Emtricitabine and tenofovir disoproxil fumarate tablets can cause serious side effects, including:

For more information about side effects, see the section “What are the possible side effects of emtricitabine and tenofovir disoproxil fumarate tablets?”. Other important information for people who take emtricitabine and tenofovir disoproxil fumarate tablets to help reduce their risk of getting human immunodeficiency virus-1 (HIV-1) infection, also called pre-exposure prophylaxis or “PrEP”:

Before taking emtricitabine and tenofovir disoproxil fumarate tablets to reduce your risk of getting HIV-1:

  • tiredness
  • vomiting or diarrhea
  • fever
  • rash
  • joint or muscle aches
  • night sweats
  • headache
  • enlarged lymph nodes in the neck or groin
  • sore throat

While you are taking emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP:

If you have HIV-1 and take only emtricitabine and tenofovir disoproxil fumarate tablets, over time your HIV-1 may become harder to treat.

What are emtricitabine and tenofovir disoproxil fumarate tablets?

Emtricitabine and tenofovir disoproxil fumarate tablets are a prescription medicine that may be used in two different ways. Emtricitabine and tenofovir disoproxil fumarate tablets is used:

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

Emtricitabine and tenofovir disoproxil fumarate tablet contains the prescription medicines emtricitabine and tenofovir disoproxil fumarate.

It is not known if emtricitabine and tenofovir disoproxil fumarate tablets for treatment of HIV-1 infection are safe and effective in children who weigh less than 37 pounds (17 kg).

It is not known if emtricitabine and tenofovir disoproxil fumarate tablets are safe and effective in reducing the risk of HIV-1 infection in people who weigh less than 77 pounds (35 kg).

For people taking emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP:

Do not take emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP if:

Emtricitabine and tenofovir disoproxil fumarate tablets can only help reduce your risk of getting HIV-1 before you are infected.

What should I tell my healthcare provider before taking emtricitabine and tenofovir disoproxil fumarate tablets?

Before taking emtricitabine and tenofovir disoproxil fumarate tablets, tell your healthcare provider about all of your medical conditions, including if you:

Pregnancy Registry: There is a pregnancy registry for people who take emtricitabine and tenofovir disoproxil fumarate tablets during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may interact with emtricitabine and tenofovir disoproxil fumarate tablets. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take emtricitabine and tenofovir disoproxil fumarate tablets?

What are the possible side effects of emtricitabine and tenofovir disoproxil fumarate tablets?

Emtricitabine and tenofovir disoproxil fumarate tablets may cause serious side effects, including:

The most common side effects of emtricitabine and tenofovir disoproxil fumarate tablets for treatment of HIV-1 include:

  • diarrhea
  • depression
  • nausea
  • problems sleeping
  • tiredness
  • abnormal dreams
  • headache
  • rash
  • dizziness

Common side effects in people who take emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP include:

  • headache
  • stomach-area (abdomen) pain
  • decreased weight

These are not all the possible side effects of emtricitabine and tenofovir disoproxil fumarate tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store emtricitabine and tenofovir disoproxil fumarate tablets?

Keep emtricitabine and tenofovir disoproxil fumarate tablets and all other medicines out of reach of children.

General information about emtricitabine and tenofovir disoproxil fumarate tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use emtricitabine and tenofovir disoproxil fumarate tablets for a condition for which it was not prescribed. Do not give emtricitabine and tenofovir disoproxil fumarate tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about emtricitabine and tenofovir disoproxil fumarate tablets that is written for health professionals.

What are the ingredients in emtricitabine and tenofovir disoproxil fumarate tablets?

Active Ingredients: emtricitabine and tenofovir disoproxil fumarate.

Inactive Ingredients: calcium stearate, croscarmellose sodium, hypromellose, microcrystalline cellulose, pregelatinized starch, titanium dioxide and triacetin.

For more information, call toll-free 1-855-361-3993 or go to www.avkare.com.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

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Pulaski, TN 38478

Manufactured by:

Amneal Pharmaceuticals LLC

Brookhaven, NY 11719

Rev. 11-2020-00 AV 11/20

Revised: 3/2021
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