IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

EMTRICITABINE - ORAL

(em-tri-SITE-ah-bean)

COMMON BRAND NAME(S): Emtriva

WARNING: Rarely, emtricitabine has caused severe (sometimes fatal) liver and blood acid-base problems (lactic acidosis). Immediately notify your doctor if you develop dark urine, unusual fatigue, yellowing of the skin or eyes, rapid breathing, drowsiness, muscle aches, or stomach/abdominal pain.

USES: Emtricitabine is a nucleoside reverse transcriptase inhibitor antiviral agent used in combination with other antivirals for the treatment of human immunodeficiency virus (HIV) infection. It works by slowing the growth of the virus. This medication is not a cure for HIV, nor does it prevent the passing of HIV to others.

HOW TO USE: Take this medication by mouth, usually once daily with or without food; or as directed by your doctor. Do not take more or less of this drug than prescribed, or stop taking it (or other HIV medicines), even for a brief time, unless directed to do so by your doctor. This may cause the amount of the virus to increase or may make the virus more difficult to treat (develop resistance). This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, use it at the same time each day. Do not skip any doses.

SIDE EFFECTS: See also Warning section. Headache, diarrhea, nausea, vomiting, dizziness, trouble sleeping, unusual dreams, cough, runny nose, change in the color of the skin on the palms or soles of feet, joint or muscle pain, and rash may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: depression, tingling of the hands or feet, severe weakness. Changes in body fat may occur while you are taking this medication (e.g., increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes is unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, Hepatitis B infection, any allergies. This drug may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

DRUG INTERACTIONS: Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: other HIV medications (e.g., abacavir, delavirdine, nevirapine). Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately.

NOTES: This medication does not cure HIV. Patients treated with emtricitabine may continue to acquire "opportunistic" infections associated with HIV. This medication also does not prevent transmission of HIV to others through sexual contact or blood. Do not share this medication with others. Laboratory and/or medical tests should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is within 2 hours of the next dose, skip the missed dose and resume your usual dosing schedule. It is important not to miss doses of this drug.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59 and 86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854- 1166 (USA) or 1-800-668-1507 (Canada).

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Copyright 2004 by First DataBank, Inc.