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|Hepsera

Hepsera

Hepsera is used for:

Treating chronic hepatitis B virus 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, abnormal liver function tests, or blood-acid base balance problems (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 are overweight or have kidney or liver problems, have had liver transplant, or have HIV infection

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 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.
• Hepsera works best if it is taken at the same time each day.
• 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 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:

• When your medicine supply begins to run low, get more from your doctor or pharmacist as soon as possible. This virus may develop resistance to Hepsera if you stop taking it, even for a short period of time or may make the virus harder to treat.
• Hepsera will not cure chronic hepatitis B. It may help reduce the amount of hepatitis B virus in your body.
• Hepsera offers no protection from the transmission of hepatitis B to others through sexual contact or blood contamination. Use barrier forms of contraception (eg, condoms) if you are infected with hepatitis B. Do not share needles or other injection items. Do not share personal items that may have blood or body fluids on them, such as toothbrushes or razor blades.
• 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.
• 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 because they may be more sensitive to its effects.
• Hepsera is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Hepsera during pregnancy. It is unknown if Hepsera is excreted 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:

Diarrhea; fever; gas; headache; increased cough; indigestion; nausea; sore throat; stomach upset; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); buildup of acid in the blood (weakness; unusual muscle pain; difficulty breathing; stomach pain with nausea and vomiting; cold arms and legs; dizziness or lightheadedness; fast or irregular heartbeat); change in the amount of urine you produce; drowsiness; liver toxicity (yellowing of the skin or eyes; dark urine; light-colored bowel movements; loss of appetite; nausea; lower stomach pain); unusual weakness or fatigue.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), or emergency room immediately.

Store this medicine at 77 degrees F (25 degrees C) in the original container. Store away from heat, moisture, and light. Do not use if seal over 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.