Epivir (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, the virus that can cause acquired immunodeficiency syndrome (AIDS). Lamivudine is not a cure for HIV or AIDS.

Epivir-HBV is for treating hepatitis B. It should not be used in people who are infected with both hepatitis B and HIV.

Read the Patient Information Leaflet provided by your pharmacist before you start using lamivudine-HBV and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Take lamivudine-HBV by mouth with or without food, usually once a day or as directed by your doctor.

Use this medicine regularly in order to get the most benefit from it. This medication works best when the amount of drug in your body is kept at a constant level. Remember to use it at the same time each day. Do not skip any doses. Dosage is based on your medical condition and response to therapy.

Do not stop taking this medication without consulting your doctor. Worsening of your condition, decreased response to medication, or development of drug-resistant types of the virus may occur during or after treatment. Promptly report any new symptoms that occur during or after treatment to your doctor.

You should not take Epivir-HBV (for treating hepatitis B) if you also take other medicine that contains lamivudine or emtricitabine. This includes Atripla, Combivir, Complera, Emtriva, Epzicom, Stribild, Trizivir, and Truvada.

Epivir may cause a serious condition called lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

Epivir can also 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 Epivir. You may need frequent liver function tests for several months.

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

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 breast-feed 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.

Epivir is not approved for use by anyone younger than 2 years old.

Nausea, vomiting, diarrhea, dizziness, headache, fatigue, or infections of the ear/nose/throat may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, lamivudine-HBV has caused severe (sometimes fatal) liver problems and a buildup of lactic acid in the blood (lactic acidosis). These serious side effects may occur more often in women and obese patients. Get medical help right away if you have any very serious side effects, including: symptoms of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), symptoms of lactic acidosis (such as deep/rapid breathing, drowsiness, nausea/vomiting).

Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes, muscle/joint pain.

Tell your doctor right away if any of these rare but very serious side effects occur: tingling/numbness in hands or feet.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

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
• HIV infection
• kidney disease
• liver disease
• pancreatitis
• an unusual or allergic reaction to lamivudine, 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. Take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the hepatitis B virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years old for selected conditions, precautions do apply.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.