Entecavir Farma Job 0.5mg film-coated tablets

Country: Մալթա

language: անգլերեն

source: Medicines Authority

active_ingredient:

ENTECAVIR HYDRATE

MAH:

PharOS – Pharmaceutical Oriented Services Limited Lesvou str. (end), Thesi Loggos, Industrial Zone, 144 52 Metamorfossi Attikis,, Greece

ATC_code:

J05AF10

INN:

ENTECAVIR HYDRATE 0.5 mg

pharmaceutical_form:

FILM-COATED TABLET

composition:

ENTECAVIR HYDRATE 0.5 mg

prescription_type:

POM

therapeutic_area:

ANTIVIRALS FOR SYSTEMIC USE

authorization_status:

Withdrawn

authorization_date:

2017-05-18

PIL

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE
USER
ENTECAVIR PHAROS 0.5 MG FILM-COATED
TABLETS
ENTECAVIR PHAROS 1 MG FILM-COATED
TABLETS
Entecavir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS
IMPORTANT INFORMATION FOR
YOU.

Keep this leaflet. You may need to read it
again.

If you have any further questions, ask your doctor or
pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them,
even if their signs of illness are the same as
yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side
effects not listed in this leaflet. See section
4.
WHAT IS IN THIS
LEAFLET
1.
What Entecavir PharOS is and what it is used
for
2.
What you need to know before you take
Entecavir PharOS
3.
How to take
Entecavir PharOS
4.
Possible side
effects
5.
How to store
Entecavir PharOS
6.
Contents of the pack and other
information
1.
WHAT ENTECAVIR PHAROS IS AND WHAT IT IS USED
FOR
ENTECAVIR PHAROS TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT
CHRONIC (LONG TERM) HEPATITIS B
VIRUS
(HBV) INFECTION IN ADULTS. Entecavir PharOS can be used in people
whose liver is damaged
but still
functions
properly (compensated liver disease) and in people whose liver is
damaged and
does not
function
properly (decompensated liver
disease).
ENTECAVIR PHAROS TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM)
HBV INFECTION IN CHILDREN
AND
ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS. Entecavir PharOS can
be used in children
whose liver
is
damaged but still functions properly (compensated liver
disease).
Infection by the hepatitis B virus can lead to damage to the liver.
Entecavir PharOS reduces the
amount
of
virus in your body, and improves the condition of the
liver.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ENTECAVIR PHAROS
DO NOT TAKE
ENTECAVIR PHAROS

IF YOU ARE ALLERGIC (HYPERSENSITIVE) to entecavir or any of the other
ingredients of this
medicine
(listed in section
6).
WARNING AND
PRECAUTIONS
Tal

SPC

Page 1 of 22
SUMMARY OF PRODUCT
CHARACTERISTICS
1.
NAME OF THE MEDICINAL
PRODUCT
Entecavir PharOS 0.5 mg film-coated
tablets
Entecavir PharOS 1 mg film-coated
tablets
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Entecavir PharOS 0.5 mg film-coated tablets
Each film-coated tablet contains 0.5 mg entecavir (as
monohydrate).
Entecavir PharOS 1 mg film-coated tablets
Each film-coated tablet contains 1 mg entecavir (as
monohydrate).
Excipients with known effect:
Each 0.5 mg tablet contains 108 mg
lactose
(as
monohydrate).
Each 1 mg tablet contains 216 mg
lactose
(as
monohydrate).
For the full list of excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet
(tablet)
Entecavir PharOS 0.5 mg film-coated tablets
White to off-white and triangular-shaped film-coated tablet with
“0.5” debossed on one side and plain
on the other, with dimensions 8.4 mm x 8.7 mm.
Entecavir PharOS 1 mg film-coated tablets
Pink and triangular-shaped film coated tablet with “1” debossed on
one side and plain on the other,
with dimensions 10.6 mm x 11.0 mm.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
ADULT INDICATION
Treatment of chronic hepatitis B virus (HBV) infection (see section
5.1)
in adults
with:

compensated liver disease and evidence of active viral replication,
persistently elevated
serum
alanine aminotransferase (ALT) levels and histological evidence of
active inflammation
and/or fibrosis.

decompensated liver disease (see section
4.4)
For both compensated and decompensated liver disease, this indication
is based on clinical trial data
in
nucleoside naive patients with HBeAg positive and HBeAg negative HBV
infection. With respect
Page 2 of 22
to
patients with lamivudine-refractory hepatitis B, see sections 4.2, 4.4
and
5.1.
PAEDIATRIC POPULATION
Treatment of chronic HBV infection in nucleoside naive
paediatric
patients from 2 to 18 years of age
with compensated liver disease who have evidence of active
viral
replication and persistently
elevated serum ALT levels, or histological evidence of moderate t