Uses of Tenofovir Disoproxil Fumarate Tablets:

• It is used to treat HIV infection.
• It is used to treat hepatitis B infection.

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

• If you have an allergy to tenofovir or any other part of this medicine (tenofovir disoproxil fumarate tablets).
• If you are allergic to this medicine (tenofovir disoproxil fumarate tablets); any part of this medicine (tenofovir disoproxil fumarate tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are taking another drug that has the same drug in it.
• If you are taking adefovir.
• 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.

This is not a list of all drugs or health problems that interact with this medicine (tenofovir disoproxil fumarate tablets).

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 this medicine (tenofovir disoproxil fumarate tablets) 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 Tenofovir Disoproxil Fumarate Tablets?

For all uses of this medicine (tenofovir disoproxil fumarate tablets):

• Tell all of your health care providers that you take this medicine (tenofovir disoproxil fumarate tablets). 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.
• 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.
• Kidney problems like kidney failure have happened with this medicine (tenofovir disoproxil fumarate tablets). Tell your doctor if you have ever had kidney problems.
• Rarely, this medicine (tenofovir disoproxil fumarate tablets) 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.
• This medicine interacts with many other drugs. The chance of side effects may be raised or how well this medicine (tenofovir disoproxil fumarate tablets) works may be lowered. Check with your doctor and pharmacist to make sure that it is safe for you to take this medicine (tenofovir disoproxil fumarate tablets) with all of your other drugs (prescription or OTC, natural products, vitamins).
• If giving this medicine (tenofovir disoproxil fumarate tablets) to your child and your child's weight changes, talk with the doctor. The dose of this medicine (tenofovir disoproxil fumarate tablets) may need to be changed.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (tenofovir disoproxil fumarate tablets) while you are pregnant.

Treating HIV infection:

• This medicine is not a cure for HIV. Stay under the care of your doctor.
• Hepatitis B testing needs to be done as you were told by the doctor. Talk with the doctor.

Hepatitis B infection:

• This medicine is not a cure for hepatitis infection. Stay under the care of your doctor.
• You will need to have an HIV test as you were told by your doctor. Talk with your doctor.

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

Use this medicine (tenofovir disoproxil fumarate tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

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

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 uses of this medicine (tenofovir disoproxil fumarate tablets):

• 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.
• A burning, numbness, or tingling feeling that is not normal.

Treating 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 this medicine (tenofovir disoproxil fumarate tablets). Tell your doctor right away if you have any new signs after you start this medicine (tenofovir disoproxil fumarate tablets), 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 Tenofovir Disoproxil Fumarate Tablets?

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.
• Feeling dizzy, tired, or weak.
• Upset stomach or throwing up.
• Stomach pain or diarrhea.
• Trouble sleeping.
• Anxiety.

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 Tenofovir Disoproxil Fumarate Tablets?

• 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 this medicine (tenofovir disoproxil fumarate tablets), 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.

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