ENTECAVIR 1 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ENTECAVIR MONOHYDRATE

Available from:

Actavis UK Limited

ATC code:

J05AF10

INN (International Name):

ENTECAVIR MONOHYDRATE

Dosage:

1 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Nucleoside and nucleotide reverse transcriptase inhibitors

Authorization status:

Authorised

Authorization date:

2017-10-20

Patient Information leaflet

ENTECAVIR 0.5MG AND 1MG
FILM-COATED TABLETS
entecavir
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
• The full name of this medicine is
Entecavir 0.5mg and 1mg Film-coated
Tablets but within the leaflet it will be
referred to as Entecavir Tablets.
WHAT IS IN THIS LEAFLET
1 WHAT ENTECAVIR TABLETS ARE AND
WHAT THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ENTECAVIR TABLETS
3 HOW TO TAKE ENTECAVIR TABLETS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE ENTECAVIR TABLETS
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT ENTECAVIR TABLETS ARE AND
WHAT THEY ARE USED FOR
ENTECAVIR TABLETS ARE ANTI-VIRAL
MEDICINES, USED TO TREAT CHRONIC (LONG
TERM) HEPATITIS B VIRUS (HBV) INFECTION
IN ADULTS. Entecavir Tablets 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 TABLETS ARE ALSO USED TO TREAT
CHRONIC (LONG TERM) HBV INFECTION IN
CHILDREN AND ADOLESCENTS AGED 2 YEARS TO
LESS THAN 18 YEARS. Entecavir Tablets 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 Tablets
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 TABLETS
DO NOT TAKE ENTECAVIR TABLETS
•
IF YOU ARE ALLERGIC (HYPERSENSITIVE) to
entecavir or any

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Entecavir 1 mg Film-coated Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg entecavir (as monohydrate).
Excipients with known effect:
Each 1 mg film-coated tablet contains 184 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pink, triangular-shaped, film-coated tablet debossed with “ENT” on
one side and “1” on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Entecavir is indicated for the 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 to patients with lamivudine-
refractory hepatitis B, see sections 4.2, 4.4 and 5.1.
Entecavir is also indicated for the 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 to severe
inflammation and/or fibrosis. With respect to the
decision to initiate treatment in paediatric patients, see sections
4.2, 4.4, and 5.1.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of chronic hepatitis B infection.
Posology
_Compensated liver disease_
_Nucleoside naïve patients:_ the recommended dose in adults is 0.5 mg
once daily, with or without food.
_Lamivudine-refractory patients _(i.e. with evidence of viraemia while
on lamivudine or the presence of lamivudine
resistance [LVDr] mutatio