Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate Oral tablet

What is this medicine?

EMTRICITABINE; RILPIVIRINE; TENOFOVIR DISOPROXIL FUMARATE (em tri SIT uh bean; ril pi VIR een; te NOE fo veer) is three antiretroviral medicines in one tablet. It is used to treat HIV. This medicine is not a cure for HIV. It will not stop the spread of HIV to others.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

• heart disease

• kidney disease

• liver disease

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water and food. Follow the directions on the prescription label. 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 children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

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?

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

• certain medicines for seizures like carbamazepine, oxcarbazepine, phenobarbital, phenytoin

• certain medicines for stomach problems like esomeprazole, pantoprazole, omeprazole, lansoprazole, rabeprazole

• dexamethasone

• lumacaftor; ivacaftor

• rifampin

• rifapentine

• St. John's wort; Hypericum perforatum

This medicine may also interact with the following medications:

• certain antibiotics like clarithromycin, erythromycin, rifabutin, troleandomycin

• certain medicines for fungal infections like fluconazole, voriconazole, posaconazole, ketoconazole, itraconazole

• certain medicines for stomach problems like aluminum hydroxide, magnesium hydroxide, calcium carbonate, cimetidine, famotidine, nizatidine, ranitidine

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

• methadone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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.

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

• breathing difficulties

• dark urine

• fast, irregular heartbeat

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• suicidal thoughts or other mood changes

• trouble passing urine or change in the amount of urine

• yellowing of the eyes or skin

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

• diarrhea

• dizziness

• headache

• skin discoloration on the hands or feet

• nausea, vomiting

• stomach pain

• weight gain around waist, back, or thinning of face, arms, legs

• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.