Emtricitabine (patient information)

IMPORTANT WARNING
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; light-headedness; 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 this medication is prescribed
Emtricitabine is used with other medications to treat HIV infection in patients with or without AIDS. Emtricitabine is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). This medication works by slowing the spread of HIV in the body. Emtricitabine does not cure HIV infection and may not prevent you from developing HIV-related illnesses. Emtricitabine does not prevent you from spreading HIV to other people.

How this medication should be used
Emtricitabine comes as a capsule 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.

Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special precautions
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 breastfeed 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.

Special dietary instructions
Unless your doctor tells you otherwise, continue your normal diet.

What to do if you forget 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.

Minor side effects
Emtricitabine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:


 * headache
 * diarrhea
 * change in skin color, especially on the palms of the hands or the soles of the feet
 * indigestion
 * joint pain
 * unusual dreams
 * depression
 * trouble falling asleep or staying asleep
 * numbness, burning, or tingling in the hands, arms, feet, or legs
 * runny nose

Severe side effects
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
 * rash

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 http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for 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.

In case of emergency/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.

Other information
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

 * Emtriva®

Brand names of combination products

 * Atripla ® containing Efavirenz, Emtricitabine, and Tenofovir
 * Truvada® containing Emtricitabine and Tenofovir Disoproxil Fumarate