Entecavir Fomed 0,5 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ENTECAVIR 1-WATER 0,53 mg/stuk SAMENSTELLING overeenkomend met ; ENTECAVIR 0,5 mg/stuk

Beschikbaar vanaf:

Fomed Pharmaceuticals SL Gabriel Garcia Marquez 4, Las Rozas MADRID (SPANJE)

ATC-code:

J05AF10

INN (Algemene Internationale Benaming):

ENTECAVIR 1-WATER 0,53 mg/stuk SAMENSTELLING overeenkomend met ; ENTECAVIR 0,5 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Entecavir

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); POLYSORBAAT 80 (E 433); TITAANDIOXIDE (E 171);

Autorisatie datum:

2017-10-13

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENTECAVIR FOMED 0,5 MG FILMOMHULDE TABLETTEN
ENTECAVIRFOMED1 MG FILMOMHULDETABLETTEN
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 EntecavirFomed is and what it is used for
2.
What you need to know before you take EntecavirFomed
3.
How to take EntecavirFomed
4.
Possible side effects
5.
How to store EntecavirFomed
6.
Contents of the pack and other information
1. WHAT ENTECAVIRFOMED IS AND WHAT IT IS USED FOR
ENTECAVIRFOMED TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC
(LONG TERM) HEPATITIS B
VIRUS (HBV) INFECTION IN ADULTS.EntecavirFomed 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).
ENTECAVIRFOMED TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV
INFECTION IN CHILDREN
AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS.EntecavirFomed 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.
EntecavirFomed reduces the
amount of virus in your body, and improves the condition of the liver.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENTECAVIRFOMED
DO NOT TAKE ENTECAVIRFOMED
IF YOU ARE ALLERGIC (HYPERSENSITIVE) to entecavir or any of the other
ingredients of this
medicine (listed in section 6).
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before tak

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
ENTECAVIR FOMED 0,5 MG FILMOMHULDE TABLETTEN
ENTECAVIR FOMED 1 MG FILMOMHULDE TABLETTEN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.5 mg entecavir (as monohydrate).
Each film-coated tablet contains 1 mg entecavir (as monohydrate).
Excipients with known effect:
Each 0,5 mg film-coated tablet contains 120.5 mg lactose monohydrate.
Each 1 mg film-coated tablet contains 241.0 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White triangular shaped film coated tablets debossed 'A' on one side
and '88' on the other side of
8.7 x 8.4 mm.
Pink triangular shaped film coated tablets debossed 'A' on one side
and '89' on the other side of
10.9 x 10.5 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 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 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 hepati