TRUVADA- tenofovir disoproxil fumarate and emtricitabine tablet, film coated 
Cardinal Health

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Medication Guide
TRUVADA ® (tru-VAH-dah)
(emtricitabine and tenofovir disoproxil fumarate)
Tablets

Read this Medication Guide before you start taking TRUVADA 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.

What is the most important information I should know about TRUVADA?

TRUVADA can cause serious side effects, including:

For more information about side effects, see the section "What are the possible side effects of TRUVADA?"

Before taking TRUVADA to help prevent you from getting HIV:

What is TRUVADA?

TRUVADA contains the prescription medicines emtricitabine (EMTRIVA®) and tenofovir disoproxil fumarate (VIREAD®). TRUVADA is used:

It is not known if TRUVADA is safe and effective in children with HIV-1 infection who are under 12 years of age or who weigh less than 77 pounds.

When used with other HIV medicines to treat HIV-1 infection, TRUVADA may help:

TRUVADA does not cure HIV infection or AIDS. If you have HIV infection, you must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.

Avoid doing things that can increase your risk of getting HIV infection or spreading HIV infection to other people:

Ask your healthcare provider if you have any questions on how to prevent getting HIV infection or spreading HIV infection to other people.

Who should not take TRUVADA?

Do not take TRUVADA to prevent HIV infection if you are HIV positive or if your HIV status is not known.

What should I tell my healthcare provider before taking TRUVADA?

See "What is the most important information I should know about TRUVADA?"

Before taking TRUVADA, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. TRUVADA may affect the way other medicines work, and other medicines may affect how TRUVADA works.

Do not take TRUVADA if you also take:

Especially tell your healthcare provider if you take:

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take TRUVADA?

What are the possible side effects of TRUVADA?

TRUVADA may cause the following serious side effects, including:

The most common side effects of TRUVADA in people with HIV-1 infection include:

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

Common side effects in people who take TRUVADA to prevent HIV-1 infection include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TRUVADA. For more information, ask your healthcare provider or pharmacist.

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 TRUVADA?

Keep TRUVADA and all other medicines out of reach of children.

General information about TRUVADA.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TRUVADA for a condition for which it was not prescribed. Do not give TRUVADA to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about TRUVADA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about TRUVADA that is written for health professionals. For more information, call 1-800-445-3235 or go to www.TRUVADA.com.

What are the ingredients in TRUVADA?

Active ingredients: emtricitabine and tenofovir disoproxil fumarate

Inactive ingredients: Croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (gluten free). The tablets are coated with Opadry II Blue Y-30-10701 which contains FD&C Blue #2 aluminum lake, hydroxypropyl methylcellulose 2910, lactose monohydrate, titanium dioxide, and triacetin.

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

Manufactured for and distributed by:
Gilead Sciences, Inc.
Foster City, CA 94404

Issued July 2012

21-752-GS-025

TRUVADA tablets are available from Cardinal Health in unit dose packages of 30 tablets.

Unit dose package of 30 tablets, NDC 55154-4425-4

TRUVADA tablets are available from Cardinal Health in cards of 14 tablets and in cards of 30 tablets.

Cardinal Health

Zanesville, OH 43701

IU39994631012

Revised: 11/2013
 
Cardinal Health