Patient Information Sheet
Entecavir (marketed as Baraclude)
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This is a summary of the most important information
about Baraclude. For details, talk to your healthcare professional.
What is the
most important information about Baraclude?
-
Lactic acidosis (buildup of an acid in
the blood). Lactic acidosis is a medical emergency and must be
treated in the hospital. Call your healthcare professional right
away if you get any of the following signs of lactic acidosis:
-
You feel very weak or tired.
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You have unusual (not normal) muscle pain.
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You have trouble breathing.
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You have stomach pain with nausea and vomiting.
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You feel cold, especially in your arms and legs.
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You feel dizzy or light-headed.
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You have a fast or irregular heartbeat.
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Serious liver problems called hepatotoxicity,
with liver enlargement (hepatomegaly) and fat in the liver (steatosis).
Call your healthcare professional right away if you get any of the
following signs 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.
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You feel sick to your stomach (nausea).
-
You have lower stomach pain.
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Stopping Baraclude may worsen your hepatitis B
infection. Therefore:
-
Take Baraclude exactly as prescribed.
-
Do not run out of Baraclude.
-
Do not stop Baraclude without talking to your
healthcare professional.
What is Baraclude?
Baraclude is a prescription medicine used for
chronic infection with hepatitis B virus (HBV) in adults who also
have active liver damage.
-
Baraclude will not cure HBV.
-
Baraclude does not stop you from spreading HBV to
others by having sex, sharing needles, or being exposed to your
blood.
-
Baraclude may lower the amount of HBV in the body.
-
Baraclude may lower the ability of HBV to multiply
and infect new liver cells.
-
Baraclude may improve the condition of your liver.
It is important to stay under your healthcare
professional’s care while taking Baraclude. Your healthcare
professional will test the level of the hepatitis B virus in your
blood regularly.
Who Should Not Use Baraclude?
What are The Risks?
See “What is the most important information about
Baraclude?”
What Should I Tell My Health Care
Professional?
Before you start taking Baraclude, tell your
health care professional if you:
Are There Any Interactions With
Drugs or Foods?
Baraclude may interact with certain other medicines
that leave the body through the kidneys. Know the medicines that you
take including prescription and non-prescription medicines,
vitamins, and herbal supplements. Keep a list of them to show your
healthcare professional and pharmacist.
How should I take Baraclude?
-
Take Baraclude exactly as prescribed. Your dose will
depend on whether you have been treated for HBV infection before and
what medicine you took. Your dose may be lower if you have kidney
problems.
-
Take Baraclude once a day on an empty stomach to
help it work better. Empty stomach means at least 2 hours after a
meal and at least 2 hours before the next meal.
-
Do not change your dose or stop taking Baraclude
without talking to your healthcare professional. After you stop
taking Baraclude, it is important to stay under your healthcare
professional’s care.
Your healthcare provider will need to do
regular blood tests to check your liver.
Baraclude FDA Approved 03/2005
Patient Information Sheet Revised 04/2005
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Date created: May 27, 2005 |