Hepsera

Hepsera is used for:

Treating chronic hepatitis B virus (HBV) infection.

Hepsera is a nucleotide analog. It works by slowing the growth of the virus. It is not a cure for hepatitis B.

Do NOT use Hepsera if:

• you are allergic to any ingredient in Hepsera
• you have an enlarged liver or high levels of lactic acid in the blood (lactic acidosis)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hepsera :

Some medical conditions may interact with Hepsera . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of kidney problems, liver problems, abnormal liver function tests, or a liver transplant
• if you have HIV infection, are at risk for HIV infection, or are very overweight
• if you have taken lamivudine to treat HBV infection and it stopped working well (lamivudine-resistant HBV)

Some MEDICINES MAY INTERACT with Hepsera . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Nucleoside analogs (eg, didanosine, lamivudine) because risk of lactic acidosis or severe liver problems may be increased
• Medicines that may harm your kidneys (eg, aminoglycosides [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of severe kidney problems may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hepsera may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hepsera :

Use Hepsera as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Hepsera may be taken with or without food.
• Hepsera comes with an additional patient leaflet. Read it carefully and reread it each time you get Hepsera refilled.
• Take Hepsera on a regular schedule to get the most benefit from it.
• Continue to use Hepsera even if you feel well. Do not miss any doses.
• If you miss a dose of Hepsera , take it as soon as possible if you remember that same day. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If more than one dose is missed, contact your health care provider.

Ask your health care provider any questions you may have about how to use Hepsera .

Important safety information:

• Hepsera will not cure chronic hepatitis B. It may help reduce the amount of hepatitis B virus in your body.
• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Hepsera , even for a short period of time. If you do, the virus may grow resistent to the medicine and become harder to treat.
• Do NOT stop taking Hepsera or change your dose without checking with your doctor. The risk of severe liver problems may be greater if you suddenly stop Hepsera .
• Hepsera does not stop the spread of HBV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HBV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
• You should be tested for HIV before taking Hepsera and anytime there is a chance that you are exposed to HIV. If you have or contract HIV that is not being treated, Hepsera may stop usual HIV medicines from controlling your HIV infection.
• Hepsera may infrequently cause a buildup of lactic acid in the blood. Tell your doctor right away if you notice new or unusual weakness, muscle pain, trouble breathing, stomach pain with nausea and vomiting, cold arms and legs, dizziness, lightheadedness, or fast or irregular heartbeat.
• Worsening of your condition, decreased response to Hepsera , or development of resistant strains of the virus may occur during or after treatment. Tell your doctor immediately if any new symptoms occur during or after treatment.
• Lab tests, including liver and kidney function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Hepsera with caution in the ELDERLY; they may be more sensitive to its effects.
• Hepsera should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hepsera while you are pregnant. It is not known if Hepsera is found in breast milk. Do not breast-feed while taking Hepsera .

Possible side effects of Hepsera :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Store Hepsera at 77 degrees F (25 degrees C) in the original container. Store away from heat, moisture, and light. Do not use if the seal over the bottle opening is broken or missing. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Hepsera out of the reach of children and away from pets.

General information:

• If you have any questions about Hepsera , please talk with your doctor, pharmacist, or other health care provider.
• Hepsera is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Hepsera . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.