Uses of Retrovir:

• It is used to treat HIV infection.
• It is used to keep the HIV infection from passing from the mother to the newborn during delivery. The newborn will also be given Retrovir (zidovudine syrup) after birth.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Retrovir?

• If you have an allergy to zidovudine or any other part of Retrovir (zidovudine syrup).
• If you are allergic to Retrovir (zidovudine syrup); any part of Retrovir (zidovudine syrup); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are taking any of these drugs: Doxorubicin, ribavirin, or stavudine.
• If you are breast-feeding. Do not breast-feed while you take Retrovir (zidovudine syrup).

This is not a list of all drugs or health problems that interact with Retrovir (zidovudine syrup).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Retrovir (zidovudine syrup) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Retrovir?

For all patients taking Retrovir (zidovudine syrup):

• Tell all of your health care providers that you take Retrovir (zidovudine syrup). This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors.
• If you have hepatitis C and HIV, talk with your doctor. Liver function has gotten worse in people who were taking Retrovir (zidovudine syrup) and interferon alfa with or without ribavirin. Sometimes, this has been deadly.
• Loss of body fat in the legs, arms, buttocks, and face can happen with Retrovir (zidovudine syrup). This may not go back to normal. It is not known how this loss of body fat may affect health over a long time. You will need to be checked for any changes in body fat while you take Retrovir (zidovudine syrup). If you have questions, talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Retrovir (zidovudine syrup) while you are pregnant.

For patients taking Retrovir (zidovudine syrup) to treat HIV infection:

• This medicine is not a cure for HIV. Stay under the care of your doctor.
• Changes in your immune system can happen when you start taking drugs to treat HIV. If you have an infection that you did not know you had, it may show up when you take Retrovir (zidovudine syrup). Tell your doctor right away if you have any new signs after you start Retrovir (zidovudine syrup), even after taking it for several months. This includes signs of infection like fever, sore throat, weakness, cough, or shortness of breath.

How is this medicine (Retrovir) best taken?

Use Retrovir (zidovudine syrup) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking Retrovir (zidovudine syrup) as you have been told by your doctor or other health care provider, even if you feel well.
• It is important that you do not miss or skip a dose of Retrovir (zidovudine syrup) during treatment.
• Measure liquid doses carefully. Use the measuring device that comes with Retrovir (zidovudine syrup). If there is none, ask the pharmacist for a device to measure Retrovir (zidovudine syrup).

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of too much lactic acid in the blood (lactic acidosis) like fast breathing, fast heartbeat, a heartbeat that does not feel normal, very bad upset stomach or throwing up, feeling very sleepy, shortness of breath, feeling very tired or weak, very bad dizziness, feeling cold, or muscle pain or cramps.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of a very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
• Feeling very tired or weak.
• Muscle pain or weakness.
• Any unexplained bruising or bleeding.

What are some other side effects of Retrovir?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Constipation.
• Headache.
• Not hungry.
• Upset stomach or throwing up.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Retrovir?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Retrovir (zidovudine syrup), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.