| IMPORTANT WARNING
| WHY is this medicine prescribed?
| HOW should this medicine be used?
| Are there OTHER USES for this medicine?
| What SPECIAL DIETARY instructions should I follow?
| What should I do IF I FORGET to take a dose?
| What SIDE EFFECTS can this medicine cause?
| What should I know about STORAGE and DISPOSAL of this medication?
| What should I do in case of OVERDOSE?
| What OTHER INFORMATION should I know?
- Atripla®(as a combination product containing Efavirenz, Emtricitabine, Tenofovir)
Medications that are similar to emtricitabine have caused serious damage to the liver and a life-threatening condition called lactic acidosis (buildup of lactic acid in the blood) when they were used alone or in combination with other medications that treat human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). Tell your doctor if you have or have ever had liver disease. If you experience any of the following symptoms, call your doctor immediately: upset stomach; vomiting; stomach pain; loss of appetite; extreme tiredness; weakness; dizziness; lightheadedness; fast or irregular heartbeat; trouble breathing; dark yellow or brown urine; light-colored bowel movements; yellowing of the skin or eyes; feeling cold, especially in the arms or legs; or muscle pain that is different than any muscle pain you usually experience.
Emtricitabine should not be used to treat hepatitis B virus infection (HBV; an ongoing liver infection). Tell your doctor if you have or think you may have HBV. Your doctor may test you to see if you have HBV before you begin your treatment with emtricitabine. If you have HBV and you take emtricitabine, your condition may suddenly worsen when you stop taking emtricitabine. Your doctor will examine you and order lab tests regularly for several months after you stop taking emtricitabine to see if your HBV has worsened.
Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to emtricitabine. Talk to your doctor about the risks of taking emtricitabine.
WHY is this medicine prescribed?
Emtricitabine is used along with other medications to treat human immunodeficiency virus (HIV) infection. Emtricitabine is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by decreasing the amount of HIV in the blood. Although emtricitabine does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other life-style changes may decrease the risk of transmitting (spreading) the HIV virus to other people.
HOW should this medicine be used?
Emtricitabine comes as a capsule, a tablet, and a solution (liquid) to take by mouth. It is usually taken once a day with or without food. Take emtricitabine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take emtricitabine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Emtricitabine controls HIV infection but does not cure it. Continue to take emtricitabine even if you feel well. Do not stop taking emtricitabine without talking to your doctor. When your supply of emtricitabine starts to run low, get more from your doctor or pharmacist. If you miss doses or stop taking emtricitabine, your condition may become more difficult to treat.
Ask your doctor or pharmacist for a copy of the manufacturer's information for the patient.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking emtricitabine,
- tell your doctor and pharmacist if you are allergic to emtricitabine or any other medications.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
- tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section, any type of infection that does not go away or that comes and goes such as tuberculosis (TB; a type of lung infection) or cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems) or kidney disease.
- tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking emtricitabine, call your doctor. Tell your doctor if you are breast-feeding. You should not breast-feed if you are infected with HIV or if you are taking emtricitabine.
- you should know that your body fat may increase or move to different areas of your body such as your breasts and upper back.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take more than one dose of emtricitabine in one day and do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Emtricitabine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- change in skin color, especially on the palms of the hands or the soles of the feet
- joint pain
- unusual dreams
- trouble falling asleep or staying asleep
- numbness, burning, or tingling in the hands, arms, feet, or legs
- runny nose
Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:
- fever, chills, sore throat, cough, or other signs of infection
Emtricitabine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at
] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the capsules at room temperature and away from excess heat and moisture (not in the bathroom). Store the solution in the refrigerator, but do not freeze it. If you prefer not to refrigerate the solution, you may store it at room temperature for up to 3 months. Throw away any medication that is outdated or no longer needed, and any unused solution that has not been refrigerated after 3 months. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What OTHER INFORMATION should I know?
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: November 15, 2012.