ENTECAVIR ARW entecavir (as monohydrate) 1 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

entecavir monohydrate

Available from:

Arrow Pharma Pty Ltd

INN (International Name):

entecavir monohydrate

Authorization status:

Registered

Patient Information leaflet

ENTECLUDE/CMI/2016-03-08/V1.0
1
ENTECLUDE
TABLETS
_Entecavir monohydrate _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
Read this leaflet carefully before
taking Enteclude. This leaflet
answers some common questions
about Enteclude.
It does not contain all the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Enteclude
against the benefits they expect it
will have for you.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
Keep this leaflet with the
medicine. You may need to read it
again.
WHAT ENTECLUDE IS
USED FOR
Enteclude contains entecavir
monohydrate and belongs to a
group of medicines called
antiviral medicines.
Enteclude is used to treat adults
infected with hepatitis B virus.
_HOW ENTECLUDE WORKS_
Infection by the hepatitis B virus
can lead to damage to the liver.
Enteclude reduces the amount of
virus in your body, and has been
shown to improve the condition of
the liver.
It is not known how safe
Enteclude is when taken for long
periods.
Your doctor may have prescribed
Enteclude for another reason. Ask
your doctor if you have any
questions about why Enteclude
has been prescribed for you.
ENTECLUDE IS NOT ADDICTIVE. THIS
MEDICINE IS AVAILABLE ONLY WITH A
DOCTOR'S PRESCRIPTION.
Enteclude is not recommended for
use in children under 16 years, as
there have been no studies of its
effects in children.
BEFORE YOU TAKE
ENTECLUDE
IT IS IMPORTANT THAT YOU CHECK
THE INFORMATION BELOW BEFORE
YOU TAKE ENTECLUDE.
_WHEN YOU MUST NOT TAKE _
_ENTECLUDE_
You must not take Enteclude if
you have a history of severe
allergic reactions to Enteclude or
to any of the ingredients listed at
the end of this leaflet. Symptoms
of a severe allergic reaction may
include; chills, fever, fast heart
beat, wheezing or coughing,
difficulty breathing, dizziness,
flushing, sweating and swelling of
the face, tongue or other parts of
the body.
Do not use Enteclude after t

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – ENTECLUDE (ENTECAVIR
MONOHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Entecavir monohydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ENTECLUDE film-coated tablets are available for oral administration in
strengths of 0.5 mg and 1 mg
of entecavir (as monohydrate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ENTECLUDE (entecavir monohydrate) tablets are presented in the
following strengths:
•
0.5 mg film-coated tablet – White to off-white, round biconvex film
coated tablet marked with
“0.5” on one side, plain on the reverse.
•
1.0 mg film-coated tablet – Pink, round biconvex film coated tablet
marked with “1” on one side,
plain on the reverse.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ENTECLUDE is indicated for the treatment of chronic hepatitis B virus
infection in adults 16 years or
older with evidence of active liver inflammation.
This indication is based on histologic, virologic, biochemical and
serological responses in nucleoside-
treatment naïve and lamivudine-resistant adult patients with
HBeAg-positive or HBeAg-negative
chronic HBV infection with compensated liver disease.
4.2
D
OSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE
Entecavir should be taken orally, on an empty stomach (at least 2
hours after a meal and 2 hours
before the next meal).
2
The recommended oral dose of entecavir in adults and adolescents older
than 16 years is 0.5 mg once
daily. For lamivudine-refractory patients [history of hepatitis B
viremia while receiving lamivudine
therapy
or
known
lamivudine
resistance
(LVD
R
commonly
called
YMDD
mutations)],
the
recommended dose is 1 mg once daily.
RENAL IMPAIRMENT
In patients with renal impairment, the apparent oral clearance of
entecavir monohydrate decreased
as creatinine clearance decreased (see 5.2 PHARMACOKINETIC PROPERTIES:
Special Populations).
Dosage adjustment of entecavir is recommended for patients with
creatinine clearance <50 mL/min,
including patients on hemodialysis o