May 27, 2017
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Baraclude Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.




WARNING: Your hepatitis B symptoms may get worse or become very serious if you stop taking entecavir. Talk with your doctor before stopping this medication. Your doctor will perform liver function tests for several months after you stop entecavir. Tell your doctor immediately if you develop symptoms of worsening liver disease, including persistent nausea, stomach/abdominal pain, dark urine, or yellowing eyes/skin.

Entecavir has rarely caused serious (possibly fatal) liver enlargement and/or lactic acid build-up in the blood (lactic acidosis). Get medical help right away if you develop any of the following symptoms: unusual tiredness (fatigue), severe drowsiness, muscle pain, difficult or rapid breathing, irregular heartbeat.

Lactic acidosis is more likely to occur in patients who have: kidney or liver disease, conditions that may cause a low level of oxygen in the blood or poor circulation (e.g., severe congestive heart failure, recent heart attack, recent stroke), excessive alcohol use, a lack of body fluids (dehydration), X-ray or scanning procedure drugs (contrast agents), major surgery, or a serious infection.

This medication is not recommended if you have both HIV and hepatitis B and are not receiving effective treatment for HIV. This drug does not treat HIV, and it can cause certain HIV medications to become ineffective. Therefore, have an HIV test before starting this medication, and get tested again anytime you may have become infected. Consult your doctor for more details.

USES: See also Warning section.

This medication is used to treat a chronic viral infection of the liver (hepatitis B). It works by slowing the growth of the virus. Entecavir is a nucleoside analog-type (NRTI) medication.

Entecavir is not a cure for hepatitis B and does not prevent the spread of hepatitis B to others through sexual contact or blood/body fluid contamination (e.g., sharing used needles). A series of shots (vaccine) are available to protect uninfected people from hepatitis B virus.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using entecavir and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Take this medication by mouth on an empty stomach at least 2 hours after a meal and 2 hours before the next meal, usually once daily or as directed by your doctor.

If you are taking entecavir oral liquid, carefully measure your dose with the spoon provided. Hold the spoon in an upright position with the volume marks facing you. Slowly fill the spoon to the mark for your prescribed dose. Swallow the medicine directly from the measuring spoon. Do not dilute or mix the medication with water or other liquids. Rinse the spoon with water after each use.

Take this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. Do not skip any doses. Dosage is based on your medical condition (including the previous use of the drug lamivudine) and response to treatment. In children, the dosage is also based on weight.

Take this medication exactly as prescribed. Do not change your dose or stop taking entecavir without talking to your doctor. (See Warning section)

Inform your doctor of any new symptoms or if your condition worsens.

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