This medicine is an antiviral combination of 3 reverse transcriptase inhibitors used to treat HIV infection alone or along with other medicines.
Follow the directions for using this medicine provided by your doctor. AN EXTRA PATIENT 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 a full glass of water (8oz/240 mL). Take this medicine at the same time every day, preferably at bedtime unless otherwise directed by your doctor. DO NOT EXCEED THE RECOMMENDED DOSE, change your dose, or stop taking this medicine without checking with your doctor. Taking more than the recommended dose may not provide additional benefits and may increase the risk of side effects. STORE THIS MEDICINE at 77 degrees F (25 degrees C) in the original container, away from heat, moisture, and light. Brief storage between 59 to 86 degrees F (15 to 30 degrees C) is permitted. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. Do not use this medicine if the seal over the bottle opening is broken or missing. Do not use this medicine if it is past the expiration date on the bottle. CONTINUE TO TAKE 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.
WARNING: Severe and sometimes fatal lactic acidosis (a buildup of lactic acid in the blood) and liver problems have occurred with tenofovir, a part of this medicine. The risk may be greater in women, in overweight patients, or in patients who have been taking nucleoside medicines (eg, emtricitabine, tenofovir) for a long time. TELL YOUR DOCTOR RIGHT AWAY if you develop symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or lightheadedness; fast or irregular heartbeat) or symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, persistent loss of appetite, nausea, stomach pain). THIS MEDICINE IS NOT APPROVED TO TREAT HEPATITIS B (HBV) INFECTION. Safety and effectiveness have not been confirmed in patients who have both HIV and HBV infection. Some patients with HBV infection who took emtricitabine or tenofovir have had severe worsening of HBV infection after they stopped taking them. Patients with both HIV and HBV who take this medicine should have medical exams and liver function tests performed for at least several months after they stop taking this medicine. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are taking adefovir, atazanavir, bepridil, bortezomib, cabazitaxel, cisapride, an ergot derivative (eg, dihydroergotamine, ergotamine), lurasidone, midazolam, nevirapine, pimozide, St. John's wort, ticagrelor, triazolam, vandetanib, voriconazole, a medicine that contains lamivudine, another medicine that contains emtricitabine or tenofovir, or a medicine that may harm your kidneys (eg, aminoglycoside antibiotic, such as gentamicin; amphotericin B; cyclosporine; nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen; tacrolimus; vancomycin). Ask your doctor if you are not sure if any of your medicines might harm the kidneys. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking other prescription and nonprescription medicines (eg, used for aches and pains, anxiety, birth control, blood thinning, cancer, depression or other mental or mood problems, emergency contraception, hepatitis C, high blood pressure, high cholesterol, HIV, immune system suppression, infections, inflammation, irregular heartbeat or other heart problems, narcotic or other substance abuse or dependence, pain, seizures, sleep, stomach problems), multivitamin products, or herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo). Tell your doctor if you take a medicine that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection). Ask your doctor if you are unsure if any of your medicines might harm the liver. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of bone problems (eg, fracture, osteoporosis), seizures, high cholesterol, kidney problems (including dialysis treatment), liver problems (eg, hepatitis), abnormal liver function tests, lactic acidosis, mental or mood problems (eg, depression), suicidal thoughts or actions, injection drug use, alcohol or other substance abuse or dependence, allergies, pregnancy or if you are able to become pregnant, or breast-feeding. Tell your doctor if you are very overweight. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have moderate to severe kidney problems, moderate to severe liver problems, or lactic acidosis. Use of this medicine in CHILDREN under age 12 is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concer
SIDE EFFECTS that may occur while taking this medicine include back pain; cough; darkened skin color on the palms of hands or soles of feet; diarrhea; dizziness; drowsiness; gas or indigestion; headache; loss of appetite; mild sore throat; mild stomach pain; muscle or joint aches; nausea; skin discoloration (small spots or freckles); stomach upset; strange dreams; stuffy or runny nose; tiredness; trouble concentrating; trouble sleeping; or vomiting. If they continue or are bothersome, check with your doctor. CHANGES IN BODY FAT (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking this medicine. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bone pain; change in personality; chest pain; confusion; decreased coordination; delusions; fever, chills, or persistent sore throat; hallucinations; memory problems; mental, mood, or behavior changes (eg, abnormal thoughts, aggression, agitation, anxiety, depression, nervousness, paranoia); muscle pain or weakness; numbness, burning, pain, or tingling of the hands, feet, or skin; red, swollen, blistered, or peeling skin; seizures; severe or persistent stomach pain, nausea, or vomiting; shortness of breath; suicidal thoughts or actions; symptoms of kidney problems (eg, increased or decreased urination, increased thirst); symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or lightheadedness; fast or irregular heartbeat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; persistent loss of appetite). AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips, throat, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms may include hallucinations; muscle twitching; severe dizziness, drowsiness, or coordination problems; trouble concentrating; trouble sleeping.
WHEN YOUR MEDICINE SUPPLY IS LOW, get more from your doctor or pharmacist as soon as you can. Do not stop taking this medicine, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat. KEEP A LIST of all the medicines that you take. Make a new list each time medicines are added or stopped. Find out about medicines that should not be taken while you are using this medicine. Be sure that each of your health care providers knows all the medicines that you are taking. THIS MEDICINE IS NOT A CURE FOR HIV INFECTION. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor. THIS MEDICINE DOES NOT STOP THE SPREAD OF HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your healthcare provider about ways to prevent the spread of HIV to others. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.