ENTAC 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; microcrystalline cellulose; hyprolose; crospovidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400

Administration route:

Oral

Units in package:

10, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ENTAC 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

ENTAC
®
TABLETS
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking Entac. This leaflet
answers some common
questions about Entac.
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
Entac 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 ENTAC IS USED FOR
Entac contains entecavir and
belongs to a group of medicines
called antiviral medicines.
Entac is used to treat adults
infected with hepatitis B virus.
_HOW ENTAC WORKS _
_ _
Infection by the hepatitis B virus
can lead to damage to the liver.
Entac 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 Entac
is when taken for long periods.
_ _
Your doctor may have
prescribed Entac for another
reason. Ask your doctor if you
have any questions about why
Entac has been prescribed for
you.
ENTAC IS NOT ADDICTIVE. THIS
MEDICINE IS AVAILABLE ONLY WITH
A DOCTOR'S PRESCRIPTION.
Entac is not recommended for
use in children under 16 years,
as there have been no studies of
its effects in children.
BEFORE YOU TAKE ENTAC
IT IS IMPORTANT THAT YOU CHECK
THE INFORMATION BELOW BEFORE
YOU TAKE ENTAC.
_WHEN YOU MUST NOT TAKE ENTAC _
You must not take Entac if you
have a history of severe allergic
reactions to Entac 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 Entac after the expiry
date printed on the back of the
pack. If this medicine is taken
after the expiry date has passed,
it may not work as well.
Do not ta

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - ENTAC TABLETS (ENTECAVIR (AS
MONOHYDRATE))
1
NAME OF THE MEDICINE
Entecavir (as monohydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ENTAC film-coated tablets are available for oral administration in
strengths of 0.5 mg and 1 mg
of entecavir (as monohydrate).
Entecavir monohydrate is a white to off-white powder. It is slightly
soluble in water (2.4
mg/mL), and the pH of the saturated solution in water is 7.9 at 25
o
+ 0.5
o
C. Entecavir
monohydrate has a pKa ranging from 2.67 +/- 0.50 at most basic to 9.48
+/- 0.20 at most acidic
at 25
o
C with a partition coefficient of Log P – 0.960 +/- 0.462 at 25
o
C.
List of excipients with known effect: Sugars
Each 0.5 mg film-coated tablet contains 119.468 mg of lactose.
Each 1.0 mg film-coated tablet contains 238.936 mg of lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Film-coated tablets
Entecavir 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 1.0 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
ENTAC 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
ENTAC 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 ENTAC in adults and adolescents older
than 16 years is 0.5 mg
once daily. For lamivudine-refractory patients [history of hep