Uses of Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate:

• It is used to treat HIV infection.

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

• If you are allergic to efavirenz, emtricitabine, and tenofovir disoproxil fumarate; any part of efavirenz, 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 had red, blistered, swollen, or peeling skin after taking efavirenz.
• If you have any of these health problems: Kidney disease or liver disease.
• If you weigh less than 88 pounds (40 kilograms). This medicine is not for use in people who weigh less than 88 pounds (40 kilograms).
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with efavirenz, emtricitabine, and tenofovir disoproxil fumarate, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with efavirenz, emtricitabine, and tenofovir disoproxil fumarate.
• If you are using another drug that has the same drug in it.
• 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. Do not breast-feed while you take efavirenz, emtricitabine, and tenofovir disoproxil fumarate.

This is not a list of all drugs or health problems that interact with efavirenz, 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 efavirenz, 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 Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate?

• Tell all of your health care providers that you take efavirenz, 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.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how efavirenz, emtricitabine, and tenofovir disoproxil fumarate affects you.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• 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 efavirenz, emtricitabine, and tenofovir disoproxil fumarate. Tell your doctor right away if you have any new signs after you start efavirenz, 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.
• Nervous system problems are common with efavirenz, emtricitabine, and tenofovir disoproxil fumarate. These may include dizziness, sleepiness, trouble sleeping or focusing, or abnormal dreams. Most of the time, this goes away after 2 to 4 weeks. Taking efavirenz, emtricitabine, and tenofovir disoproxil fumarate at bedtime may help with these effects. If you feel dizzy, sleepy, or have trouble focusing, avoid driving and doing other tasks or actions that call for you to be alert. Call your doctor if these effects last, they bother you, or are severe.
• Rarely, efavirenz, 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.
• A type of abnormal heartbeat (prolonged QT interval) can happen with efavirenz, emtricitabine, and tenofovir disoproxil fumarate. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.
• Kidney problems like kidney failure have happened with efavirenz, emtricitabine, and tenofovir disoproxil fumarate. Tell your doctor if you have ever had kidney problems.
• Liver problems have happened with efavirenz, emtricitabine, and tenofovir disoproxil fumarate. Sometimes these problems have been severe, leading to liver transplant or death. Liver problems may happen in people with or without liver disease. Talk with the doctor.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking efavirenz, emtricitabine, and tenofovir disoproxil fumarate.
• This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start efavirenz, emtricitabine, and tenofovir disoproxil fumarate to show that you are NOT pregnant.
• Women must use birth control while taking efavirenz, emtricitabine, and tenofovir disoproxil fumarate and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.

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

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

• Take on an empty stomach.
• Take with a full glass of water.
• Taking efavirenz, emtricitabine, and tenofovir disoproxil fumarate at bedtime may help with some side effects.
• Keep taking efavirenz, 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 efavirenz, emtricitabine, and tenofovir disoproxil fumarate during treatment.
• 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.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take efavirenz, emtricitabine, and tenofovir disoproxil fumarate.
• This medicine is not a cure for HIV. Stay under the care of your doctor.
• 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.
• This medicine interacts with many other drugs. The chance of efavirenz, emtricitabine, and tenofovir disoproxil fumarate's side effects may be raised or how well efavirenz, emtricitabine, and tenofovir disoproxil fumarate works may be lowered. The chance of the other drugs' side effects may also be raised. This may include very bad, life-threatening, or deadly side effects. Check with your doctor and pharmacist to make sure that it is safe for you to take efavirenz, emtricitabine, and tenofovir disoproxil fumarate with all of your other drugs (prescription or OTC, natural products, vitamins).

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:

• 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 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.
• 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 or symptoms of depression, suicidal thoughts, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life.
• Memory problems or loss.
• Bone pain.
• Muscle pain or weakness.
• Pain in arms or legs.
• Seizures.
• Change in body fat.
• Severe nervous system problems have happened. These may include feeling confused, behavior or mood changes, balance problems, other movement problems, or hallucinations (seeing or hearing things that are not there). Sometimes, this has happened months to years after starting efavirenz, emtricitabine, and tenofovir disoproxil fumarate. Call your doctor right away if you have any of these effects.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Efavirenz, 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:

• Headache.
• Upset stomach or throwing up.
• Diarrhea.
• Change in color of skin.
• Feeling tired or weak.
• Signs of a common cold.

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 Efavirenz, 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.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about efavirenz, emtricitabine, and tenofovir disoproxil fumarate, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.