Product Details

Description

Chemical Name EFAVIRENZ (eh-FAV-er-enz), EMTRICITABINE (em-trye-SYE-ta-been), and TENOFOVIR DISOPROXIL FUMARATE (te-NOE-fo-veer dye-soe-PROX-ill FYOU-mar-ate)

This medicine is an antiretroviral combination medicine used alone or with other medicines to treat human immunodeficiency virus (HIV) infection in adults.

Directions

Follow the directions for using this medicine provided by your doctor. An additional patient information leaflet is available with this medicine. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. TAKE THIS MEDICINE BY MOUTH ON AN EMPTY STOMACH at least 1 hour before or 2 hours after eating. TAKE THIS MEDICINE WITH water. STORE THIS MEDICINE at room temperature at 77 degrees F (25 degrees C) in the original container, away from heat and light. Brief storage between 59 to 86 degrees F (15 to 30 degrees C) is permitted. Do not use this medicine if the seal over the bottle opening is broken or missing. Take this medicine regularly to receive the most benefit from it. Taking this medicine at the same time each day will help you to remember. CONTINUE TO USE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. DO NOT take 2 doses at once.

Ingredients

EFAVIRENZ (eh-FAV-er-enz), EMTRICITABINE (em-trye-SYE-ta-been), and TENOFOVIR DISOPROXIL FUMARATE (te-NOE-fo-veer dye-soe-PROX-ill FYOU-mar-ate)<

Cautions

SIDE EFFECTS that may occur while taking this medicine include diarrhea, discoloration of the skin, dizziness, drowsiness, gas, headache, heartburn, stomach upset, strange dreams, tiredness, trouble sleeping, trouble concentrating, or vomiting. These side effects tend to go away after a few weeks. If they continue or are bothersome, check with your doctor. Changes in body fat may occur while you are taking this medicine (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 are unknown. Check with your doctor for more information. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience agitation; anxiety; chronic back pain; a change in the frequency of urination or in the amount of urine produced; loss of appetite; loss of coordination; nervousness; muscle or joint pain; signs or infection (such as cough, fever, sore throat, or runny nose); or tingling or numbness of the hands, feet, or skin. CONTACT YOUR DOCTOR IMMEDIATELY if you experience behavior changes (such as angry or aggressive behavior); confusion; hallucinations; memory loss; symptoms of lactic acidosis (such as extreme weakness or tiredness, fast or irregular heartbeat, unusual muscle pain, severe stomach pain with nausea and vomiting, severe dizziness or lightheadedness, or feeling cold in the arms or legs); mood or mental changes (such as depression, delusions, paranoia, or suicidal thoughts or actions); symptoms of liver problems (such as yellowing of the skin or eyes, dark urine, loss of appetite, pale stool, severe or persistent nausea, or unusual fatigue); reddened, blistered or swollen skin; or seizures. An allergic reaction to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. DO NOT EXCEED THE RECOMMENDED DOSE OR CHANGE THE DOSE of this medicine without checking with your doctor. Exceeding the recommended dose of this medicine may not provide additional benefits and may increase the risks of side effects. DO NOT STOP USING THIS MEDICINE without first checking with your doctor. This may cause the amount of the virus to increase or may make the virus harder to treat. Also some conditions (such as Hepatitis B infection) may become worse when the medicine is suddenly stopped. LABORATORY AND/OR MEDICAL TESTS, including liver function, kidney function, and bone density tests may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are taking this medicine. THIS MEDICINE MAY INTERFERE with certain laboratory tests (such as drug tests). Make sure laboratory personnel and your doctors know you use this medicine. THIS MEDICINE IS NOT A CURE FOR HIV INFECTION and will not prevent you from spreading HIV infection to others through blood or sexual contact. Use barrier methods of birth control (such as condoms) if you have HIV infection. THIS MEDICINE MAY IMPROVE IMMUNE SYSTEM FUNCTION. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (such as fever, sore throat, weakness, cough, or shortness of breath) after you start taking this medicine. THIS MEDICINE WILL ADD TO THE EFFECTS OF ALCOHOL and other depressants (such as sleep aids or tranquilizers). Ask your pharmacist if you have questions about which medicines are depressants. This medicine may cause dizziness or drowsiness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. CHECK WITH YOUR DOCTOR to see if you should take a calcium and vitamin D supplement while you are taking this medicine. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. This includes St. Johns wort. FOR WOMEN THIS MEDICINE HAS BEEN SHOWN TO CAUSE HARM to the human fetus. Avoid becoming pregnant while you are taking this medicine. IF YOU SUSPECT THAT YOU COULD BE PREGNANT, contact your doctor immediately. FOR WOMEN USING HORMONAL BIRTH CONTROL (such as birth control pills), this medicine may decrease the effectiveness of your birth control. To prevent pregnancy, always use an additional form of birth control such as a condom or diaphragm. IT IS UNKNOWN if this medicine is excreted in the breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or this medicine to the baby. IF YOU HAVE DIABETES, this medicine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine. MONITOR BLOOD GLUCOSE on a regular basis, as directed by your doctor.