Abacavir Sulfate, Lamivudine, Zidovudine Oral tablet

What is this medicine?

ABACAVIR; LAMIVUDINE, 3TC; ZIDOVUDINE, ZDV (a ba KA vir; la MI vyoo deen; zye DOE vyoo deen) is three antiretroviral medicines in one tablet. It is used with other medicines 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:

• drink alcohol-containing drinks

• heart disease

• kidney disease

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• smoke tobacco

• weigh less than 40 kg or 88 pounds

• an unusual or allergic reaction to abacavir, lamivudine, zidovudine, 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. Follow the directions on the prescription label. You may take this medicine with or without food. 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.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

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. Then take your next dose at the usual scheduled time. Do not take double or extra doses.

What may interact with this medicine?

• alcohol or alcohol containing products

• any other medicine that contains abacavir, lamivudine, or zidovudine

• doxorubicin

• emtricitabine

• fluconazole

• ganciclovir

• interferon

• methadone

• phenytoin

• ribavirin

• stavudine, d4T

• sulfamethoxazole; trimethoprim, SMX-TMP

• trimethoprim

• valproic acid

• zalcitabine, ddC

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.

A small number of people may have a severe allergy to this medicine. Some symptoms are a skin rash, fever, nausea, vomiting, stomach pain, severe tiredness, aches, or generally feeling sick. A list of these symptoms is on the Warning Card given to you by your pharmacist. You should carry this Warning Card with you. If you have these symptoms while taking this medicine, stop the medicine and call your doctor right away.

If you stop this medicine because you ran out of medicine or because you may have had an allergic reaction, talk to your doctor. Do not restart this medicine without your doctor's advice. Severe hypersensitivity reactions can occur within hours and may include life-threatening hypotension and death.

If you have hepatitis B, talk to your doctor if you plan to stop or change your therapy. The symptoms of hepatitis B may get worse after you stop this medicine.

This medicine can cause blood problems. You may have slow healing and a higher risk of infection while on this medicine. Try to avoid cutting or injuring yourself. Be careful not to damage to your teeth and gums when you brush or floss your teeth.

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, cough

• dizziness

• fever, chills, sore throat, infection

• muscle pain or weakness

• nausea, vomiting, diarrhea, stomach pain

• pain or difficulty swallowing

• pain, tingling, numbness in the hands or feet

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

• seizures

• unexplained weight loss

• unusual bleeding or bruising

• unusually weak or tired

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

• constipation

• hair loss

• headache

• loss of appetite

• trouble sleeping

• stomach upset

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

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.