BARACLUDE 1 MG TABLET, Packaging Type : Plastic Bottle

Listing ID #4202582

• chronic hepatitis B treatment

BARACLUDE® (entecavir) is a chronic hepatitis B treatment that works to fight the hepatitis B virus (HBV) and may help to improve the condition of your liver.

BARACLUDE is a prescription medicine used to treat chronic hepatitis B virus (HBV) in adults who have active virus and liver damage.

Currently there is no cure for HBV. BARACLUDE will not cure HBV

BARACLUDE MAY :

• lower the amount of HBV in the body
• lower the ability of HBV to multiply and infect new liver cells
• improve the condition of your liver
• It is not known whether BARACLUDE will reduce the chances of getting liver cancer or liver damage (cirrhosis), which may be caused by chronic HBV infection
• It is not known if BARACLUDE is safe and effective for use in children

This chronic hepatitis B treatment works to help fight HBV and may reduce the amount of the virus in your blood. BARACLUDE is taken once a day by mouth. BARACLUDE does not stop you from spreading the hepatitis B virus (HBV) to others by sex, sharing needles, or being exposed to your blood. Talk with your healthcare provider about safe sexual practices that protect your partner. Never share needles. Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades. A shot (vaccine) is available to protect people at risk from becoming infected with HBV.

Read the sections below to learn more about choosing a chronic hepatitis B treatment, and to see how BARACLUDE may help to improve the condition of your liver. Ask your doctor if BARACLUDE is right for you. Remember, not all people who have HBV need treatment.

How BARACLUDE Works:

HBV attacks your healthy liver cells where it multiplies and infects more liver cells. As a chronic hepatitis B treatment, BARACLUDE works to fight HBV and may lower the amount of HBV in the body.

All medicines have benefits and risks. BARACLUDE® (entecavir) may cause the following serious side effects:

Your hepatitis B virus infection may get worse if you stop taking BARACLUDE. This usually happens within 6 months after stopping BARACLUDE.

• Take BARACLUDE exactly as prescribed.
• Do not run out of BARACLUDE.
• Do not stop BARACLUDE without talking to your healthcare provider.
• Your healthcare provider should monitor your health and do regular blood tests to check your liver if you stop taking BARACLUDE.
• Tell your healthcare provider right away about any new or unusual symptoms that you notice after you stop taking BARACLUDE.

If you have or get HIV that is not being treated with medicines while taking BARACLUDE, the HIV virus may develop resistance to certain HIV medicines and become harder to treat. You should get an HIV test before you start taking BARACLUDE and anytime after that when there is a chance you were exposed to HIV.

BARACLUDE can cause serious side effects including:

Lactic acidosis (buildup of acid in the blood). Some people who have taken BARACLUDE or medicines like BARACLUDE (a nucleoside analogue) have developed a serious condition called lactic acidosis. Lactic acidosis is a serious medical emergency that can cause death. Lactic acidosis must be treated in the hospital. Reports of lactic acidosis with BARACLUDE generally involved patients who were seriously ill due to their liver disease or other medical condition.

Call your healthcare provider right away if you get any of the following signs or symptoms of lactic acidosis:

• You feel very weak or tired.
• You have unusual (not normal) muscle pain.
• You have trouble breathing.
• You have stomach pain with nausea and vomiting.
• You feel cold, especially in your arms and legs.
• You feel dizzy or light-headed.
• You have a fast or irregular heartbeat.
• Serious liver problems. Some people who have taken medicines like BARACLUDE have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Hepatomegaly with steatosis is a serious medical emergency that can cause death.

Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:

• Your skin or the white part of your eyes turns yellow (jaundice).
• Your urine turns dark.
• Your bowel movements (stools) turn light in color.
• You don’t feel like eating food for several days or longer.
• You feel sick to your stomach (nausea).
• You have lower stomach pain. You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight, or have been taking nucleoside analogue medicines, like BARACLUDE, for a long time.

The most common side effects of BARACLUDE include:

• headache
• tiredness
• dizziness
• nausea.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of BARACLUDE. For more information, ask your healthcare provider or pharmacist