Efavirenz, Emtricitabine and Tenofovir tablet

What is this medicine?

EFAVIRENZ, EMTRICITABINE AND TENOFOVIR is an antiviral medication that prevents human immunodeficiency virus (HIV) from reproducing in your body.

This medicine treats HIV in adults and children who are at least 12 years old. HIV causes acquired immunodeficiency syndrome (AIDS). This medication is not a cure for HIV or AIDS.

This medicine may also be used for purposes not listed in this medication guide.

What should my health care professional know before I take this medicine?

You should not take this medicine if you are allergic to efavirenz (Sustiva), emtricitabine (Emtriva), or tenofovir (Viread, trade mark of Gilead

).

Do not take this medicine together with adefovir (Hepsera), or with medications that contain emtricitabine, lamivudine, or tenofovir (Combivir, Complera, Emtriva, Epivir, Epzicom, Stribild, Trizivir, Truvada which is a trade mark of Gilead, Viread which is a trade mark of Gilead).

Some medicines can cause unwanted or dangerous effects when used with this medicine. Your doctor may need to change your treatment plan if you are taking any of the following drugs:

• midazolam or triazolam;
• pimozide;
• St. John's wort;
• voriconazole; or
• an ergot medicine--dihydroergotamine, ergonovine, ergotamine, methylergonovine.

This medication should not be used in children weighing less than 88 pounds.

To make sure this medicine is safe for you, tell your doctor if you have:

• liver or kidney disease;
• a history of mental illness, use of antipsychotic medication, or injection drug use;
• epilepsy or other seizure disorder;
• low bone mineral density; or
• hepatitis B or C infection.

Some people taking this medicine develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

FDA pregnancy category D. Do not use this medicine if you are pregnant. It could harm the unborn baby. Use two forms of birth control, including a barrier form (such as a condom or diaphragm with spermicide) while you are using this medication and for at least 12 weeks after your treatment ends.

How should I take this medicine?

Take this medicine exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medication on an empty stomach at bedtime.

While using this medicine, you may need frequent blood tests. Your liver function may also need to be tested.

This medication can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking this medicine.

Use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store this medicine in the original container at room temperature, away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using this medicine.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

This medicine can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Many drugs can interact with this medicine. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with this medicine, especially:

• a blood thinner--clopidogrel;
• any other HIV medicines--especially atazanavir, didanosine, efavirenz, lopinavir with ritonavir, or tenofovir.

This list is not complete and many other drugs can interact with this medicine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

What should I watch for while taking this medicine?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Taking this medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What side effects may I notice from taking this medicine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Stop using this medicine and call your doctor at once if you have:

• kidney problems--increased thirst and urination, loss of appetite, constipation, little or no urinating; or
• sore throat, flu symptoms, easy bruising or unusual bleeding;
• liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
• unusual thoughts or behavior, anger, severe depression, thoughts of hurting yourself or others, hallucinations, seizure (convulsions); or
• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

This medicine may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with this medicine. Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;
• chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;
• cold sores, sores on your genital or anal area;
• rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;
• trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include

• mild nausea;
• mild depression;;
• headache, dizziness, tired feeling, strange dreams; or
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).