Generic Emtricitabine/Tenofovir Disoproxil Fumarate

This product is a combination of two different drugs, emtricitabine and tenofovir. This product is used to treat HIV infection. It works by slowing the growth of the virus. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir is called a nucleotide reverse transcriptase inhibitor. They are often referred to as NRTIs. NRTIs are usually used in combination with other HIV medications (e.g., protease inhibitor). Consult your doctor or pharmacist for more details. This product and other anti-HIV drugs may help to control your HIV infection, thereby improving your quality of life and lowering your risk of getting complications from HIV (e.g., opportunistic infections, cancer). This product is not a cure for HIV infection, and it does not prevent the spread of HIV to others through sexual contact or blood contamination (e.g., sharing used needles).

Read the Patient Information Leaflet provided by your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth, usually once daily with or without food or as directed by your doctor. The dosage is based on your kidney function, medical condition, and response to treatment. This product is taken with other medicines to 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. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects. Order your refills early to make sure you do not run out of medication.

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. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease (e.g., requiring dialysis). 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 (e.g., 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. Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, caution is advised when using this drug in older adults because they may be more sensitive to the effects of the drug. This medication should be used only when clearly needed during pregnancy. However, it is now normal to prescribe HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of passing HIV to the baby. This medication may be part of that treatment. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

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.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. This drug should not be used with the following medication because very serious interactions may occur: adefovir. If you are currently using the medication listed above, tell your doctor or pharmacist before starting emtricitabine/tenofovir. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: certain other HIV medicines (e.g., didanosine, lopinavir/ritonavir). Tell your doctor or pharmacist if you are also using other drugs that may be harmful to the kidneys such as: aminoglycosides (e.g., gentamicin, amikacin), amphotericin B, cyclosporine, non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen), tacrolimus, vancomycin. Tenofovir can decrease the effectiveness of another medication, atazanavir (by decreasing blood levels). If you take both of these drugs, your condition may worsen. 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. Some drugs may also change the way your body gets rid of tenofovir (e.g., cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir). If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this product. 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 without checking with your doctor first. Other medications may also contain a drug (lamivudine) that is similar to a drug in this medication. Consult your doctor before taking lamivudine with this medication. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

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 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 immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression, anxiety), loss of appetite, stomach/abdominal pain. Tell your doctor immediately if any of these rare but very serious side effects occur: bone pain, pink/bloody urine, change in the amount of urine. Changes in body fat may occur while you are taking this product (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. 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, seek immediate medical attention 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.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.