Emtricitabine; Tenofovir disoproxil fumarate tablets

What is this medicine?

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE (em tri SIT uh bean; te NOE fo veer) is 2 antiretroviral medicines in 1 tablet. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. This medicine can lower, but not fully prevent, the risk of spreading HIV to others. This medicine can also be used with safe sex practices to prevent HIV infection in high-risk persons.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Swallow tablets whole; do not cut, crush or chew. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• bone pain

• breathing difficulties

• changes in vision

• dizziness

• fast, irregular heartbeat

• muscle pain

• nausea, vomiting, unusual upset stomach or stomach pain

• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• signs of infection - fever or chills, cough, sore throat, pain or trouble passing urine

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• abnormal dreams

• cough

• depressed mood

• diarrhea

• headache

• skin discoloration

• trouble sleeping

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• adefovir

• any medicine that contains lamivudine

• any medicine that contains emtricitabine or tenofovir

This medicine may also interact with the following medications:

• atazanavir

• didanosine, ddI

• lopinavir; ritonavir

• medicines for viral infections like cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir

• saquinavir

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.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bone problems

• kidney disease

• liver disease

• an unusual or allergic reaction to emtricitabine, tenofovir, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

If you have hepatitis B, talk to your doctor if you plan to stop this medicine. The symptoms of hepatitis B may get worse if you stop this medicine.