Truvada 200-300mg Tablets - 30 Count Bottle

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

EMTRICITABINE/TENOFOVIR - ORAL

(EM-trye-SYE-ta-been/ten-OF-oh-vir)

COMMON BRAND NAME(S): Truvada

WARNING: Rarely, this medication can cause severe (sometimes fatal) liver and blood problems (lactic acidosis). Immediately tell your doctor if you develop symptoms of liver problems (such as persistent nausea, light-colored stools, stomach/abdominal pain, dark urine, yellowing eyes/skin) or lactic acidosis (such as rapid breathing, drowsiness, fast/irregular heartbeat, unusual weakness, feeling cold especially in the arms/legs). If you have hepatitis B infection as well as HIV, your hepatitis symptoms may get worse or become very serious if you stop taking this medication. Talk with your doctor before stopping this medication. Your doctor will perform liver function tests for several months after you stop. If you are taking this product to prevent HIV infection, you must first get tested to be sure you are HIV-negative. Your doctor will perform laboratory tests before starting this medication and periodically during treatment to make sure that you do not have HIV infection. Using this product will not always prevent HIV infection. To get the most benefit from it, take this product exactly as directed, and follow all prevention actions. (See also Uses section.) Tell your doctor right away if you have any signs of HIV infection (such as tiredness, fever, persistent sore throat, night sweats, diarrhea, joint/muscle aches, enlarged lymph nodes).

USES: This product is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. This product is a combination of two different drugs: emtricitabine and tenofovir. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir is called a nucleotide reverse transcriptase inhibitor. They are often called NRTIs. This product should not be used by itself to help control HIV infection. Doing so can make your treatment less effective. Combination treatment with at least one other HIV medication should be used. This product is also approved in the US to help prevent HIV infection in people who have a high risk for infection. Some things that increase risk include having a partner infected with HIV, having unprotected sex, having multiple sex partners, infection with a sexually transmitted disease-STD, or use/abuse of drugs or alcohol. Emtricitabine/tenofovir is not a cure for HIV infection. Also, it will not always prevent HIV infection. To help prevent becoming infected with HIV and to decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This product may also be used alone or in combination with other HIV medications to reduce the risk of getting HIV infection after contact with the virus (for example, due to an accidental needle stick injury). Consult your doctor for more details.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once daily with or without food. The dosage is based on your kidney function, medical condition, and response to treatment. When used to treat HIV infection, this product is taken with other medicines that treat HIV. If you are also taking didanosine enteric-coated tablets, take both products either on an empty stomach or with a light meal. If you are taking the didanosine buffered tablets, take both drug products on an empty stomach. Continue taking this medication (and your other anti-HIV medications) exactly as prescribed by your doctor. This medication works best when the amount of drugs in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day. Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

SIDE EFFECTS: See also Warning section. Nausea, vomiting, diarrhea, headache, dizziness, trouble sleeping, back pain, or change in the color of skin on your palms or soles of your feet may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Some people with HIV infection may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech). Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety), loss of appetite, stomach/abdominal pain, bone pain, pink/bloody urine, change in the amount of urine. Changes in body fat may occur while you are taking this product (such as 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. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect. Tenofovir may increase the risk of bone loss. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of calcium and vitamin D to reduce this side effect. If you are at risk for bone loss, your doctor may monitor your bone mineral density. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking emtricitabine/tenofovir, tell your doctor or pharmacist if you are allergic to either of the medications; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: pancreatitis, liver problems (hepatitis B, hepatitis C, cirrhosis), alcohol use, bone problems (such as osteopenia, osteoporosis, broken bone), kidney disease. This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. However, HIV medicines are now usually given to pregnant women with HIV. Treatment can decrease the risk of passing the HIV infection to your baby. This medication may be part of that treatment. Discuss the risks and benefits with your doctor. This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Also, if you have HIV infection, do not breast-feed because breast milk can transmit HIV.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: adefovir, didanosine, other drugs that may harm the kidneys (including amphotericin B, cyclosporine, tacrolimus, vancomycin, aminoglycosides such as amikacin/gentamicin, nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen). Tenofovir can decrease the effectiveness of another medication, atazanavir (by decreasing blood levels). If you are taking atazanavir with this product, you may need to also take another medication (ritonavir). Consult your doctor or pharmacist for more details. Other medications can affect the removal of tenofovir from your body, which may affect how tenofovir works. Examples include cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, among others. Check the labels on all your medicines for HIV infection because they may contain the same ingredients (tenofovir, emtricitabine) found in this product. Do not take 2 medications that both contain the same ingredient. Other medications may also contain a drug (lamivudine) that is similar to a drug in this medication. Do not take lamivudine with this medication.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as kidney tests, liver tests, viral load, T-cell counts, blood mineral levels, bone density tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Keep all medical and laboratory appointments. Calcium and vitamin D supplements may help with the bone problems that may occur with HIV infection (osteopenia or osteoporosis). Consult your doctor or pharmacist for more details. (See also Side Effects section.)

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised August 2012. Copyright(c) 2012 First Databank, Inc.