Emtricitabine, Oral

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KEY POINTS

• This medicine is taken by mouth to treat HIV infection. It is not a cure for HIV infection. Take it exactly as directed. Do not stop taking this medicine or change your dosage unless directed to do so by your healthcare provider.
• This medicine may cause a buildup of lactic acid in the blood that can be dangerous. This medicine may also cause severe or life-threatening liver problems. It may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Keep all appointments for tests to see how this medicine affects you.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: nucleoside reverse transcriptase inhibitor; antiretroviral (anti-HIV)

Generic and brand names: emtricitabine, oral; Emtriva

What is this medicine used for?

This medicine is taken by mouth to treat HIV infection. This medicine must be taken with other anti-HIV medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Hepatitis B
• Liver or kidney disease

Make sure your healthcare provider knows if you are taking or have ever taken any other anti-HIV or antiviral medicine.

Tell your healthcare provider if you smoke, regularly drink alcohol, or have a history of alcohol abuse.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant while taking this medicine. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more of it or take it more often than directed. Do not stop taking this medicine or change your dosage unless directed to do so by your healthcare provider.

Do not let your medicine run out. The amount of virus in your blood may increase if you stop the medicine, even for a short time.

You may take this medicine with or without food.

The medicine is available in capsules or liquid. If you have the liquid medicine, use the measuring spoon, cup, dropper, or oral syringe that comes with the medicine, or ask your pharmacist for one. Do not use a kitchen spoon because the dose may not be correct liquid.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

If you are also infected with hepatitis B, you need blood tests and checkups for several months after you stop taking this medicine. This medicine may cause flare-ups of hepatitis B.

This medicine may cause a severe or life-threatening condition called lactic acidosis (a buildup of acid in your blood). Contact your healthcare provider right away if you develop unexplained symptoms such as:

• Feeling very tired or weak
• Unusual muscle pain
• Trouble breathing
• Stomach pain with nausea and vomiting
• Feel cold, especially in your arms or legs
• Feel dizzy or lightheaded
• Fast or irregular heartbeat

This medicine may cause severe or life-threatening liver problems. Contact your healthcare provider right away if you have:

• Yellowing of your skin or eyes
• Dark urine or light-colored bowel movements
• Stomach pain or stomach swelling
• Nausea and vomiting
• Loss of appetite

Treatment with this medicine may cause a change in the location of fat in your body. Talk with your healthcare provider about this.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

Your immune system may get stronger and start to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting this medicine.

This medicine is not a cure for HIV infection. This medicine does not reduce the risk of infecting other people through sexual contact or blood contamination. There is no information about the effects of long-term treatments.

You will need to have lab tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Slow, fast, or irregular heartbeat; chest pain; dark urine; severe diarrhea; fever; light-colored bowel movements; unusual loss of appetite; unusual muscle or joint pain; feeling cold; severe nausea or tiredness; pale skin; severe muscle weakness; shortness of breath; severe stomach pain; seizures; severe dizziness; severe back or leg pain; tingling, numbness, or pain in the hands or feet; unexplained fever, cough, or sore throat; unusual bruising or bleeding; sores that don't heal; persistent vomiting; yellowing of your skin or eyes; increasing drowsiness; rash, skin redness, peeling, or blisters.

Other: Headache, dizziness, diarrhea, skin discoloration, abnormal dreams, changes in body fat, runny nose or cough, trouble sleeping, depression, mild nausea or gas, tiredness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antiviral medicines such as abacavir (Ziagen), adefovir (Hepsera), delavirdine (Rescriptor), didanosine (Videx), ganciclovir (Cytovene), lamivudine (Epivir, Epivir-HBV), nelfinavir (Viracept), ribavirin (Copegus, Rebetol, Ribasphere, Virazole), ritonavir (Norvir), stavudine (Zerit), tenofovir (Viread), valganciclovir (Valcyte), and zidovudine (Retrovir)
• Interferon medicines such as interferon alfa-2b (Intron-A), interferon alfa-n3 (Alferon N), interferon beta-1a (Avonex, Rebif), interferon beta-1b (Betaseron, Extavia), peginterferon alfa-2a (Pegasys), peginterferon alfa-2b (Sylatron), and peginterferon beta-1a (Plegridy)
• Other medicines that contain emtricitabine, such as efavirenz/emtricitabine/tenofovir (Atripla), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), emtricitabine/rilpivirine/tenofovir (Complera, Odefsey), and emtricitabine/tenofovir (Truvada), or that contain lamivudine, such as abacavir/lamivudine (Epzicom), abacavir/lamivudine/zidovudine (Trizivir), and lamivudine/zidovudine (Combivir)

Do not drink alcohol while you are taking this medicine. Talk with your healthcare provider about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store the capsule form of this medicine at room temperature. Store the liquid form of this medicine in the refrigerator. Do not let it freeze. You may also store the liquid form of this medicine at room temperature. If kept at room temperature, discard any unused liquid medicine after 3 months. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.