ENTECAVIR-GH entecavir (as monohydrate) 1mg film coated tablets

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

entecavir monohydrate, Quantity: 1.064 mg

Available from:

Cipla Australia Pty Ltd

INN (International Name):

entecavir monohydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; lactose monohydrate; hyprolose; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400

Administration route:

Oral

Units in package:

30, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ENTECAVIR-GH 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 lamivudine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease.

Product summary:

Visual Identification: pink coloured, triangular shaped, biconvex, film coated tablet, debossed with 'E' on one side and "1" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-12-19

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
ENTECAVIR-GH
(ENTECAVIR MONOHYDRATE) FILM-COATED TABLETS
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking Entecavir-GH. This leaflet
answers some common
questions about Entecavir-GH.
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-GH 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-GH IS
USED FOR
Entecavir-GH contains entecavir
(as monohydrate) and belongs
to a group of medicines called
antiviral medicines.
Entecavir-GH is used to treat
adults infected with hepatitis B
virus.
_ _
_HOW ENTECAVIR-GH WORKS _
_ _
Infection by the hepatitis B virus
can lead to damage to the liver.
Entecavir-GH 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-GH is when taken for
long periods.
_ _
Your doctor may have
prescribed Entecavir-GH for
another reason. Ask your doctor
if you have any questions about
why Entecavir-GH has been
prescribed for you.
ENTECAVIR-GH IS NOT ADDICTIVE.
THIS MEDICINE IS AVAILABLE
ONLY WITH A DOCTOR'S
PRESCRIPTION.
Entecavir-GH 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-GH
IT IS IMPORTANT THAT YOU CHECK
THE INFORMATION BELOW BEFORE
YOU TAKE ENTECAVIR-GH.
_WHEN YOU MUST NOT TAKE IT _
YOU MUST NOT TAKE ENTECAVIR-
GH IF YOU HAVE A HISTORY OF
SEVERE ALLERGIC REACTIONS TO:
•
ENTECAVIR;
•
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;
•
swelling of

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – ENTECAVIR-GH
(ENTECAVIR MONOHYDRATE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Entecavir monohydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Entecavir-GH film-coated tablets are available for oral administration
in strengths of 0.5 mg and 1 mg of
entecavir (as monohydrate).
List of excipients with known effect: sugars as lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Entecavir-GH 0.5 mg film-coated tablet: white to off-white,
triangular-shaped, biconvex, film-coated
tablet, debossed with “E” on one side and plain on other side.
Entecavir-GH 1 mg film-coated tablet: pink coloured,
triangular-shaped, biconvex, film-coated tablet,
debossed with “E” on one side and “1” on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Entecavir-GH 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 DOSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE
Entecavir-GH should be taken orally, on an empty stomach (at least 2
hours after a meal and at least
2 hours before the next meal).
The recommended oral dose of Entecavir-GH 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.
Entecavir-GH v3
Page 2 of 24
(entecavir monohydrate) film-coated tablets
RENAL IMPAIRMENT
In patients with renal impairment, the apparent oral clearance of
entecavir decreased as creatinine
clearance decreased (see SECTION 5.2 PHARMACOKINETIC PROPERTIES –
SPECIAL POPULATIONS