Entecavir Medicopharm 0,5 mg filmomhulde tabletten

Land: Holland

Sprog: hollandsk

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

Aktiv bestanddel:

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

Tilgængelig fra:

Medicopharm AG Stangenreiterstraße 4 83131 NUßDORF AM INN (DUITSLAND)

ATC-kode:

J05AF10

INN (International Name):

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

Lægemiddelform:

Filmomhulde tablet

Sammensætning:

CALCIUMCARBONAAT (E 170) ; CARMELLOSE NATRIUM (E 466) ; CITROENZUUR 1-WATER (E 330) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; NATRIUMSTEARYLFUMARAAT ; POLYSORBAAT 80 (E 433) ; SOJAPOLYSACCHARIDEN ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD,

Indgivelsesvej:

Oraal gebruik

Terapeutisk område:

Entecavir

Produkt oversigt:

Hulpstoffen: CALCIUMCARBONAAT (E 170); CARMELLOSE NATRIUM (E 466); CITROENZUUR 1-WATER (E 330); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MACROGOL 400; NATRIUMSTEARYLFUMARAAT; POLYSORBAAT 80 (E 433); SOJAPOLYSACCHARIDEN; TITAANDIOXIDE (E 171); ZETMEEL, GEPREGELATINEERD;

Autorisation dato:

2017-12-04

Indlægsseddel

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENTECAVIR MEDICOPHARM 0.5 MG FILMOMHULDE TABLETTEN
ENTECAVIR MEDICOPHARM 1 MG FILMOMHULDE TABLETTEN
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 Medicopharm is and what it is used for
2.
What you need to know before you take Entecavir Medicopharm
3.
How to take Entecavir Medicopharm
4.
Possible side effects
5.
How to store Entecavir Medicopharm
6.
Contents of the pack and other information
1.
WHAT ENTECAVIR MEDICOPHARM IS AND WHAT IT IS USED FOR
ENTECAVIR MEDICOPHARM TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT
CHRONIC (LONG TERM)
HEPATITIS B VIRUS (HBV) INFECTION IN ADULTS.
Entecavir Medicopharm 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 MEDICOPHARM TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG
TERM) HBV INFECTION IN
CHILDREN AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS.
ENTECAVIR MEDICOPHARM
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 Medicopharm 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 MEDICOPHARM
DO NOT TAKE ENTECAVIR MEDICOPHARM
•
IF YOU ARE ALLERGIC (HYPERSENSITIVE)
to entecavir or any of the

Produktets egenskaber

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Entecavir Medicopharm 0.5 mg filmomhulde tabletten
Entecavir Medicopharm 1 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Entecavir Medicopharm 0.5 mg film-coated tablets
Each tablet contains 0.5 mg entecavir (as monohydrate).
Entecavir Medicopharm 1 mg film-coated tablets
Each tablet contains 1 mg entecavir (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Entecavir Medicopharm 0.5 mg film-coated tablets
White to off white, triangle shaped, approx. 8.7 x 8.40 mm, biconvex
film- coated tablets debossed
with ‘J' on one
side and ‘110’ on other side.
Entecavir Medicopharm 1 mg film-coated tablets
Pink, triangle shaped, approx. 11.0 x 10.60 mm, biconvex film - coated
tablets debossed with 'J' on
one side and '111' on
other side.
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 ADM