ENTECAVIR VIATRIS entecavir (as monohydrate) 1 mg film coated tablets blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
21-04-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
entecavir, Quantity: 1 mg
Available from:
Alphapharm Pty Ltd
INN (International Name):
entecavir monohydrate
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; crospovidone; titanium dioxide; hypromellose; polysorbate 80; macrogol 400
Administration route:
Oral
Units in package:
30
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Entecavir 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: A white, film-coated, round, biconvex, beveled edge tablet debossed with 'M' on one side of the tablet and 'EV2' on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2016-04-18
Patient Information leaflet
ENTECAVIR MYLAN
_Entecavir (as monohydrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Entecavir Mylan.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Entecavir Mylan
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ENTECAVIR MYLAN
IS USED FOR
This medicine belongs to a group of
medicines called antiviral medicines.
This medicine is used to treat adults
infected with hepatitis B virus.
Infection by hepatitis B virus can
lead to damage to the liver. This
medicine 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
Mylan is when taken for long
periods.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
This medicine 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 MYLAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ENTECAVIR MYLAN IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
entecavir monohydrate.
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include
•
chills fever
•
fast heart beat
•
wheezing or coughing
•
difficulty breathing
•
dizziness
•
flushing
•
sweating and swelling of the face,
lips, tongue or other parts of the
body
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist f
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Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION
ENTECAVIR MYLAN
_entecavir (as monohydrate) film coated tablets _
1
NAME OF THE MEDICINE
Entecavir (as monohydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ENTECAVIR MYLAN tablet contains 0.5 mg or 1 mg of entecavir (as
monohydrate).
Excipients with known effects: sugars (as lactose).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ENTECAVIR MYLAN
0.5 mg
:
A white, film-coated, round, biconvex, beveled edge tablet debossed
with
‘M’ on one side of the tablet and ‘EV1’ on the other side.
ENTECAVIR MYLAN
1 mg
:
A white, film-coated, round, biconvex, beveled edge tablet debossed
with
‘M’ on one side of the tablet and ‘EV2’ on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Entecavir 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 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 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 decreased as creatinine clearance
decreased (see section 5.1 PHARMACOKINETIC PROPERTIES: Special
Populations). Dosage adjustment
of entecavir is recommended for patients with creatinine clearance <50
mL/min, including patients on
haemodialysis or
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