ENTECAVIR RBX entecavir (as monohydrate) 0.5mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

entecavir, Quantity: 0.5 mg

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Entecavir

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; povidone; crospovidone; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Entecavir monohydrate 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 na?ve and lamividine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease.

Product summary:

Visual Identification: White to off-white, triangular shaped film-coated tablets, debossed with 'RL1' on one side and plain on other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-05-19

Patient Information leaflet

ENTECAVIR RBX
CMI v2
Page 1 of 3
ENTECAVIR RBX
ENTECAVIR (AS MONOHYDRATE)
_CONSUMER MEDICINE _
_INFORMATION _
WHAT IS IN THIS LEAFLET
Read
this
leaflet
carefully
before
taking
ENTECAVIR
RBX.
This
leaflet
answers
some common questions about ENTECAVIR
RBX.
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
ENTECAVIR RBX 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 ENTECAVIR RBX IS
USED FOR
ENTECAVIR
RBX
contains
entecavir
(as
monohydrate)
and
belongs
to
a
group
of
medicines called antiviral medicines.
ENTECAVIR
RBX
is
used
to
treat
adults
infected with hepatitis B virus.
_HOW ENTECAVIR RBX WORKS _
Infection by the hepatitis B virus can lead to
damage to the liver.
ENTECAVIR
RBX 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 ENTECAVIR RBX is
when taken for long periods.
Your
doctor
may
have
prescribed
ENTECAVIR RBX for another reason. Ask
your doctor if you have any questions about
why ENTECAVIR RBX has been prescribed
for you.
ENTECAVIR RBX IS NOT ADDICTIVE. THIS
MEDICINE IS AVAILABLE ONLY WITH A DOCTOR'S
PRESCRIPTION.
ENTECAVIR RBX is not recommended for
use in children under 16 years, as there have
been no studies of its effects in children.
BEFORE YOU TAKE
ENTECAVIR RBX
IT
IS
IMPORTANT
THAT
YOU
CHECK
THE
INFORMATION
BELOW
BEFORE
YOU
TAKE
ENTECAVIR RBX
.
_WHEN YOU MUST NOT TAKE ENTECAVIR _
_RBX _
You must not take ENTECAVIR RBX if you
have a history of severe allergic reactions to
ENTECAVIR
RBX
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 swel

Summary of Product characteristics

Entecavir RBX PI v1.2
AUSTRALIAN PRODUCT INFORMATION
ENTECAVIR RBX TABLETS
entecavir (as monohydrate)
1 NAME OF THE MEDICINE
Entecavir monohydrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.5 mg or 1 mg entecavir (a monohydrate)
Excipients with known effects: lactose
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
ENTECAVIR RBX 0.5 mg film-coated tablet is white to white-off,
triangular shaped film coated tablet,
debossed with ‘RL1’ on one side and plain on other side.
ENTECAVIR RBX 1 mg film-coated tablet is light pink to pink,
triangular shaped film coated tablet,
debossed with ‘RL2’ on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Entecavir monohydrate
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 lamividine-resistant adult patients with
HBeAg-positive or
HBeAg-negative chronic
HBV infection with compensated liver disease.
4.2 DOSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE
ENTECAVIR RBX should be taken orally, on an empty stomach (at least 2
hours after a meal and 2 hours
Entecavir RBX PI v1.2
before the next meal).
The recommended oral dose of ENTECAVIR RBX 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
Section
5 . 2
PHARMACOKINETIC PROPERTIES,
SPECIAL POPULATIONS). Dosage adjustment of ENTECAVIR RBX is
recommended for patients with
creatinine clearance <50 mL/min, including patients on hemodi