Epzicom (as a combination product containing Abacavir, Lamivudine)

Before taking abacavir,

• tell your doctor and pharmacist if you are allergic to any medications or any of the ingredients in abacavir tablets or solution. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the following: methadone (Dolophine, Methadose); and other medications to treat HIV. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• in addition to the condition listed in the IMPORTANT WARNING section, tell your doctor if you have or have ever had depression, diabetes, high blood pressure, high cholesterol, or heart disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking abacavir, call your doctor.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking abacavir.
• talk to your doctor about the safe use of alcohol while taking this medication.
• tell your doctor if you smoke.
• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body, such as pneumonia, herpes virus, tuberculosis, hepatitis, Graves' disease (condition where the body attacks the thyroid gland causing it to be overactive), polymyositis (condition that causes muscle weakness), Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage), or a fungal infection. If you have a fever or new infection symptom after starting treatment with abacavir, be sure to tell your doctor.
• you should know that while you are taking abacavir your body fat may increase or move to different areas of your body, such as the back of your neck and upper shoulders ('buffalo hump'), stomach, and breasts. Your body may lose fat from your arms, legs, face, and buttocks. Talk to your doctor if you notice any of these changes in your body fat.

Abacavir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• depression
• anxiety
• dreams or sleep problems
• ear, nose, throat infections, especially in children

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately:

• blisters or peeling skin
• hives
• itching
• difficulty swallowing or breathing
• chills

Abacavir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom). Store the oral solution at room temperature or in the refrigerator, but do not freeze it.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Lamivudine is also used sometimes in combination with other medications to treat healthcare workers or other individuals exposed to HIV infection after accidental contact with HIV-contaminated blood, tissues, or other body fluids. Talk to your doctor about the possible risks of using this drug for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

• Epivir^®
• Epivir-HBV^®