Uses of Emtricitabine and Tenofovir Disoproxil Fumarate:

• It is used to treat HIV infection.
• It is used in HIV negative patients to lower the chance of getting HIV infection through sex.

What do I need to tell my doctor BEFORE I take Emtricitabine and Tenofovir Disoproxil Fumarate?

For all patients taking emtricitabine and tenofovir disoproxil fumarate:

• If you have an allergy to emtricitabine, tenofovir, or any other part of emtricitabine and tenofovir disoproxil fumarate.
• If you are allergic to emtricitabine and tenofovir disoproxil fumarate; any part of emtricitabine and tenofovir disoproxil fumarate; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have kidney disease or are on dialysis.
• If you are taking another drug that has the same drug in it.
• If you are taking any of these drugs: Adefovir or lamivudine.
• If you are taking any drugs that can raise the chance of kidney problems. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you are breast-feeding or plan to breast-feed.

For HIV negative patients taking emtricitabine and tenofovir disoproxil fumarate to lower the chance of getting HIV through sex:

• If you have not been tested for HIV.

This is not a list of all drugs or health problems that interact with emtricitabine and tenofovir disoproxil fumarate.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take emtricitabine and tenofovir disoproxil fumarate with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Emtricitabine and Tenofovir Disoproxil Fumarate?

For all patients taking emtricitabine and tenofovir disoproxil fumarate:

• Tell all of your health care providers that you take emtricitabine and tenofovir disoproxil fumarate. This includes your doctors, nurses, pharmacists, and dentists.
• Bone problems like bone pain, soft bones, and thin bones have happened. This may lead to broken bones. You may need to have a bone test.
• Take calcium and vitamin D as you were told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have your urine checked as you have been told by your doctor.
• Kidney problems like kidney failure have happened with emtricitabine and tenofovir disoproxil fumarate. Tell your doctor if you have ever had kidney problems.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors.
• Rarely, emtricitabine and tenofovir disoproxil fumarate may cause a swollen liver and a buildup of acid in the blood. Sometimes, this may be deadly. The risk may be higher in women, in overweight people, and in people who have taken drugs like this one for a long time.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using emtricitabine and tenofovir disoproxil fumarate while you are pregnant.

For patients taking emtricitabine and tenofovir disoproxil fumarate to treat HIV infection:

• This medicine is not a cure for HIV. Stay under the care of your doctor.
• If giving emtricitabine and tenofovir disoproxil fumarate to your child and your child's weight changes, talk with the doctor. The dose of emtricitabine and tenofovir disoproxil fumarate may need to be changed.

For HIV negative patients taking emtricitabine and tenofovir disoproxil fumarate to lower the chance of getting HIV through sex:

• This medicine does not always prevent HIV. It needs to be used as part of a program that has other measures to help prevent HIV. This includes safer sex habits, testing for diseases passed by having sex, and talking with sex partners who have HIV about their HIV treatment. Talk with the doctor for more information.

How is this medicine (Emtricitabine and Tenofovir Disoproxil Fumarate) best taken?

Use emtricitabine and tenofovir disoproxil fumarate as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take emtricitabine and tenofovir disoproxil fumarate at the same time of day.
• Take with or without food.
• Keep taking emtricitabine and tenofovir disoproxil fumarate as you have been told by your doctor or other health care provider, even if you feel well.
• It is important that you do not miss or skip a dose of emtricitabine and tenofovir disoproxil fumarate during treatment.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all patients taking emtricitabine and tenofovir disoproxil fumarate:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of too much lactic acid in the blood (lactic acidosis) like fast breathing, fast heartbeat, a heartbeat that does not feel normal, very bad upset stomach or throwing up, feeling very sleepy, shortness of breath, feeling very tired or weak, very bad dizziness, feeling cold, or muscle pain or cramps.
• Low mood (depression).
• Bone pain.
• Muscle pain or weakness.
• Pain in arms or legs.

For patients taking emtricitabine and tenofovir disoproxil fumarate to treat HIV infection:

• Changes in your immune system can happen when you start taking drugs to treat HIV. If you have an infection that you did not know you had, it may show up when you take emtricitabine and tenofovir disoproxil fumarate. Tell your doctor right away if you have any new signs after you start emtricitabine and tenofovir disoproxil fumarate, even after taking it for several months. This includes signs of infection like fever, sore throat, weakness, cough, or shortness of breath.

What are some other side effects of Emtricitabine and Tenofovir Disoproxil Fumarate?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

For patients taking emtricitabine and tenofovir disoproxil fumarate to treat HIV infection:

• Upset stomach.
• Diarrhea.
• Not able to sleep.
• Dizziness.
• Headache.
• Strange or odd dreams.
• Feeling tired or weak.

For HIV negative patients taking emtricitabine and tenofovir disoproxil fumarate to lower the chance of getting HIV through sex:

• Headache.
• Belly pain.
• Weight loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Emtricitabine and Tenofovir Disoproxil Fumarate?

• Store in the original container at room temperature.
• Keep lid tightly closed.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

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