Entecavir 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Entecavir monohydrate

Available from:

Actavis UK Ltd

ATC code:

J05AF10

INN (International Name):

Entecavir monohydrate

Dosage:

1mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05030301; GTIN: 5055565741238

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

OBJECT 1
ENTECAVIR 1MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 05-Feb-2018 | Accord-UK Ltd
1. Name of the medicinal product
Entecavir 1mg Film-coated Tablets
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
Film-coated tablet (tablet)
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 naïve 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 naïve 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 patien