When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to abacavir, lamivudine, or zidovudine or if you have liver disease or severe kidney disease.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Do not let this medicine run out.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you also use atovaquone (Mepron®), cotrimoxazole (Bactrim®, Septra®), doxorubicin (Adriamycin®), fluconazole (Diflucan®), ganciclovir (Cytovene®), interferon-alfa (Intron®-A, Roferon®-A), methadone (Dolophine®), nelfinavir (Viracept®), probenecid (Benemid®, Probalan®), ribavirin (Copegus®, Rebetol®, Virazole®), ritonavir (Norvir®), stavudine (Zerit®), valproic acid (Depakene®), or zalcitabine (Hivid®).
• Do not take any other medicine containing abacavir, emtricitabine, lamivudine, or zidovudine, such as Atripla®, Combivir®, Complera™, Emtriva®, Epivir®, Epivir-HBV®, Epzicom®, Retrovir®, Truvada®, or Ziagen®. Tell your doctor if you also use efavirenz (Sustiva®), rilpivirine (Edurant™), or tenofovir (Viread®).
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or if you have kidney problems, bone marrow disease, hepatitis B or C, a genetic condition (such as a gene variation called HLA-B*5701), muscle weakness, heart problems, high blood pressure, high cholesterol, or diabetes. Tell your doctor if you smoke.
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Call your doctor right away if you have 2 or more of the following groups of symptoms. These may be signs of a life-threatening allergic reaction to the medicine:
  
  • Fever
  • Rash
  • Nausea, vomiting, diarrhea, or stomach pain
  • Severe tiredness, aching, or general ill feeling
  • Sore throat, trouble breathing, or cough
• Carry the Warning card with a list of allergic symptoms with you at all times. You should not use this medicine again if you have had an allergic reaction because it could be life-threatening.
• You should not stop using this medicine unless your doctor tells you to do so. If you stop using this medicine for any reason, do not start using it again without talking to your doctor.
• This medicine may cause a muscle disease called myopathy. Check with your doctor if you have muscle pain, swelling, tenderness, wasting, or weakness.
• Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis.
• Lactic acidosis (too much acid in the blood) and liver toxicity are rare but serious reactions to this medicine. These are more common if you are female, obese, or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have more than one of these symptoms: stomach pain; dark urine; decreased appetite; diarrhea; general feeling of discomfort; light-colored stools; muscle pain; nausea; unusual tiredness or weakness; trouble breathing; vomiting; or yellow eyes or skin.
• This medicine may cause changes to your body fat. Tell your doctor if you notice changes in your body shape, such as more fat in your upper back and neck or around your chest and stomach area. You may also lose fat from the legs, arms, and face.
• This medicine may increase your risk of a heart attack. This is more likely to occur if you smoke or already have heart disease, high blood pressure, or high cholesterol or fats in the blood. Call your doctor right away if you have chest pain or discomfort; nausea; pain or discomfort in the arms, jaw, back or neck; trouble breathing; sweating; or vomiting.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• This medicine will not keep you from giving HIV to others. Always practice safe sex, even if your partner also has HIV. Do not share needles or other items that may have blood or body fluids on them.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Chest pain or pain in your arm, jaw, back, or neck
• Dark-colored urine or pale stools
• Fever, chills, cough, sore throat, runny or stuffy nose, and body aches
• Muscle pain or tenderness
• Stomach pain, nausea, vomiting, or diarrhea
• Trouble breathing
• Unusual bleeding, bruising, tiredness, or weakness
• Yellowing of your skin or the whites of your eyes

If you notice these less serious side effects, talk with your doctor:

• Headache
• Loss of appetite
• Mild nausea, vomiting, diarrhea, or stomach pain
• Mild skin rash or itching
• Weight gain around your neck, upper back, breast, face, or waist

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088