When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to lamivudine (Epivir®) or zidovudine (Retrovir®). Do not use this medicine if you have severe kidney disease or liver disease. Children who weigh less than 30 kilograms (66 pounds) should not use this medicine.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• You may take this medicine with or without food.
• Combivir® is used with other medicines to treat HIV infection. Take all other medicines your doctor has prescribed as part of your treatment for HIV or AIDS.
• Your doctor may give you an oral liquid if your child has trouble swallowing tablets.

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

• Do not take any other medicine containing emtricitabine, lamivudine, or zidovudine (such as Atripla®, Complera®, Emtriva®, Epivir®, Epzicom®, Retrovir®, Trizivir®, or Truvada®).
• Tell your doctor if you use doxorubicin (Adriamycin®), ganciclovir (Cytovene®), interferon-alfa (Intron®-A, Roferon®-A), ribavirin (Virazole®), stavudine (Zerit®), or zalcitabine (Hivid®). Make sure your doctor knows if you use medicines that weaken your immune system, such as a steroid or cancer treatment.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or if you have kidney disease, hepatitis B or C, bone marrow problems (such as anemia or a low white blood cell count), muscle problems, or pancreas problems.
• 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.
• This medicine may cause a muscle disease called myopathy. Check with your doctor if you have muscle pain, swelling, tenderness, wasting, or weakness while you use this medicine.
• 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.
• Pancreatitis may occur while you use this medicine. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
• 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.
• This medicine may cause changes to your body fat. Tell your doctor right away if you notice changes in your body shape, such as more fat in your neck or upper back or around your chest or stomach area. You may also lose fat from your legs, arms, or face.
• 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. You may need tests for several months after you stop using this medicine if you also have hepatitis.

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
• Dark-colored urine or pale stools
• Fever, chills, cough, sore throat, and body aches
• Muscle pain or tenderness
• Nausea, vomiting, loss of appetite, or pain in the upper stomach
• 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
• Mild skin rash
• Mild tiredness
• Stuffy or runny nose
• 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