Product description

INDICATIONS

Epivir-HBV is a nucleoside analogue. It works by reducing the amount of hepatitis B virus in the body by blocking the ability of the virus to multiply and infect new liver cells.

INSTRUCTIONS

Use Epivir-HBV as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Epivir-HBV. Talk to your pharmacist if you have questions about this information.
Take Epivir-HBV by mouth with or without food.
Continue to take Epivir-HBV even if you feel well. Do not miss any doses.
It is important not to miss any doses of Epivir-HBV. Taking Epivir-HBV at the same time each day will help you remember to take it.
If you miss a dose of Epivir-HBV, take it as soon as possible. If it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Epivir-HBV.

DOSAGE

Take exactly as prescribed by your Health Provider.

STORAGE

Store the tablets at room temperature 77 degrees F (25 degrees C) away from light and moisture. Brief storage from 59 to 86 degrees F (15 to 30 degrees C) is permitted. Store the oral solution at room temperature 68 to 77 degrees F (20 to 25 degrees C). Canadian product: Store the tablets between 36 and 86 degrees F (2 and 30 degrees C). Store the oral solution between 59 to 77 degrees F (15 to 25 degrees C). Keep all medicines away from children and pets.

Safety information

Do NOT use Epivir-HBV if:

• you are allergic to any ingredient in Epivir-HBV
• you have HIV infection, abnormal liver function tests, severe liver problems, or lactic acidosis
• you are taking zalcitabine or another medicine containing lamivudine

Some medical conditions may interact with Epivir-HBV. 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 muscle problems, swelling of the pancreas, abnormal blood counts, liver or kidney problems, diabetes, or a nerve disorder

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

• Trimethoprim/sulfamethoxazole because it may increase the risk of Epivir-HBV’s side effects
• Zalcitabine because it may decrease Epivir-HBV’s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Epivir-HBV 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.

Contact your doctor or health care provider right away if any of these apply to you.Epivir-HBV may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Epivir-HBV with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Your doctor will offer you counseling and testing for HIV infection (the virus that causes AIDS) before treatment with Epivir-HBV and periodically during treatment. You should not take Epivir-HBV if you have HIV infection. If you have both hepatitis B virus and HIV, make sure that your doctor knows you have both infections. If you are prescribed lamivudine, you should only use the medicine that is for HIV treatment ( Epivir). The lower dose of lamivudine in Epivir-HBV could make the HIV infection harder to treat.
Epivir-HBV is not a cure for hepatitis B virus infection. It is unknown if Epivir-HBV reduces the risk of liver cancer or cirrhosis that may be caused by hepatitis B virus. Some patients developed hepatitis B virus that is resistant to Epivir-HBV. These patients had less benefit from Epivir-HBV and some experienced worsening of hepatitis after the resistant virus appeared.
Your doctor will perform lab tests for several months after you stop taking Epivir-HBV. Some patients have had worsening hepatitis B virus after stopping use of Epivir-HBV. Tell your doctor about any new or unusual symptoms that you notice after stopping treatment.
Epivir-HBV has not been shown to reduce the risk of passing hepatitis B to other people through sexual contact or blood contamination. Use barrier forms of contraception (eg, condoms) if you are infected with hepatitis B virus.
Diabetes patients – Epivir-HBV contains sucrose and may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Lab tests, including liver and kidney function tests, may be performed while you use Epivir-HBV. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Caution is advised when using Epivir-HBV in CHILDREN with a history of swelling of the pancreas. Epivir-HBV should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Epivir-HBV while you are pregnant. Epivir-HBV is found in breast milk. Do not breast-feed while taking Epivir-HBV.

Side effects

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:

• Changes in body fat; chills; coughing; decreased appetite; diarrhea; difficulty sleeping; dizziness; ear, nose, and throat infection; general body discomfort; headache; indigestion; joint pain; muscle pain; nausea; sinus drainage; sore throat; stomach discomfort; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

• Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; depression(mental or mood changes); enlarged stomach; increased heart rate; numbness or tingling in the arms or legs; persistent sore throat, chills, or fever; severe muscle or joint pain; stomach tenderness or pain; unusual bleeding or bruising; unusual weakness or exhaustion; vomiting; yellowing of the skin or eyes.

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.