AccessPak for HIV PEP Expanded with Kaletra

Emtricitabine, lopinavir, ritonavir, and tenofovir are antiviral medicines that prevent human immunodeficiency virus (HIV) from multiplying in your body.

Emtricitabine, lopinavir, ritonavir, and tenofovir is a combination medicine used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS.

Emtricitabine, lopinavir, ritonavir, and tenofovir may also be used for purposes not listed in this medication guide.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

If you also take didanosine (Videx), take it 1 hour before or 2 hours after you take emtricitabine, lopinavir, ritonavir, and tenofovir.

Taking this medicine 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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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.

Call your doctor at once if you have:

• severe dizziness, fainting, fast or pounding heartbeats;

• vision changes;

• increased urination or extreme thirst;

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• penis erection that is painful or lasts longer than 4 hours;

• signs of new infection--fever, chills, skin lesions, or cough with yellow or green mucus;

• liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; 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.

Common side effects may include:

• diarrhea, nausea, vomiting, stomach pain;

• headache, dizziness, feeling tired;

• depressed mood, sleep problems (insomnia), strange dreams;

• mild skin rash; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.