Lamivudine is an antiviral medicine that prevents human immunodeficiency virus (HIV) or hepatitis B virus from multiplying in your body.

Epivir is for treating HIV in adults and children at least 3 months old. HIV is the virus that can cause acquired immunodeficiency syndrome (AIDS). Epivir is not a cure for HIV or AIDS.

Epivir-HBV is for treating hepatitis B in adults and children at least 2 years old. Epivir-HBV should not be used in people who are infected with both hepatitis B and HIV.

Lamivudine may also be used for purposes not listed in this medication guide.

You should not take Epivir-HBV (for treating hepatitis B) if you also take other medicine that contains lamivudine or emtricitabine.

Lamivudine can cause severe or life-threatening effects on your liver or pancreas. Call your doctor at once if you have: severe pain in your upper stomach spreading to your back, nausea, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

If you've ever had hepatitis B, it may become active or get worse after you stop using lamivudine. You may need frequent liver function tests for several months.

The hepatitis B virus may become resistant to treatment while you are taking Epivir-HBV. Resistant hepatitis B can lead to worsening liver disease or death. Tell your doctor if you have new hepatitis symptoms.

Lamivudine comes as a tablet and oral solution (liquid) to take by mouth. Lamivudine (Epivir) is usually taken once or twice a day with or without food. Lamivudine (Epivir-HBV) is usually taken once a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lamivudine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Lamivudine controls HIV and hepatitis B infection and but does not cure them. Continue to take lamivudine even if you feel well. Do not stop taking lamivudine without talking to your doctor. When your supply of lamivudine starts to run low, get more from your doctor or pharmacist. If you miss doses or stop taking lamivudine, your condition may become more difficult to treat.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. You should not take Epivir (for treating HIV) together with Epivir-HBV (for treating hepatitis B).

You may take lamivudine with or without food.

Lamivudine doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight. Children who weigh more than 30 pounds (14 kilograms) should use the tablet form of lamivudine if possible. Lamivudine liquid may not be as effective.

You may need to break an Epivir tablet in half when giving lamivudine to a child for HIV. Call your doctor if the child has any trouble swallowing the tablet.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

The Epivir brand contains a higher dose of lamivudine than Epivir-HBV brand. Epivir is for treating HIV and Epivir-HBV is for treating hepatitis B. Each time you get a refill of this medication, be sure you have received the correct brand to treat your condition.

You will need frequent medical tests, including frequent HIV testing. If you become infected with HIV while you are taking lamivudine to treat hepatitis B, the HIV could become resistant to antiviral medicines if not treated right away.

The hepatitis B virus can mutate while you are taking Epivir-HBV and may become resistant to treatment. Resistant hepatitis B can lead to worsening liver disease or death. Tell your doctor if you have new or worsening hepatitis symptoms.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

If you've ever had hepatitis B, this virus may become active or get worse in the months after you stop using lamivudine. You may need frequent liver function tests while using this medicine and for several months after your last dose.

You should not take lamivudine if you are allergic to it.

You should not take Epivir-HBV (for treating hepatitis B) if you also take other medicine that contains lamivudine or emtricitabine, which includes Atripla, Biktarvy, Cimduo, Combivir, Complera, Descovy, Emtriva, Epzicom, Genvoya, Odefsey, Stribild, Symfi, Triumeq, Trizivir, and Truvada.

Tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C, or a liver transplant);

• pancreatitis;

• kidney disease; or

• diabetes (liquid lamivudine contains 3 to 4 grams of sucrose per dose).

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you've taken HIV medication for a long time, or if you are a woman. Ask your doctor about your risk.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

You should not breastfeed while you are using lamivudine to treat hepatitis B. Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). The oral solution does not need to be refrigerated; however, it should be stored in a cool place.

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

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.

Avoid taking other medications that contain an ingredient called sorbitol, often used as a sweetener in liquid medicines. Ask your pharmacist if you are not sure a medicine contains this ingredient.

Using lamivudine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Lamivudine may cause serious side effects. Call your doctor at once if you have:

• pancreas problems--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or

• liver problems--swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Lamivudine affects your immune system, which may cause certain side effects (even weeks or months after you've taken lamivudine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of lamivudine may include:

• nausea, diarrhea;

• headache;

• fever, tiredness, general ill feeling;

• ear infection--ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child; or

• nose or throat infection--stuffy nose, sneezing, sore throat, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs can affect lamivudine, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of lamivudine on hand. Do not wait until you run out of medication to refill your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Epzicom® (containing Abacavir, Lamivudine)