Entecavir Polpharma 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:

Pharmaceutical Works Polpharma S.A. 19, Pelplinska Street 83-200 STAROGARD GDANSKI (POLEN)

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

Autorisatie datum:

1900-01-01

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Entecavir Polpharma 0,5 mg, filmomhulde tabletten
Entecavir Polpharma 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 Polpharma is and what it is used for
2.
What you need to know before you take Entecavir Polpharma
3.
How to take Entecavir Polpharma
4.
Possible side effects
5.
How to store Entecavir Polpharma
6.
Contents of the pack and other information
1.
WHAT ENTECAVIR POLPHARMA IS AND WHAT IT IS USED FOR
ENTECAVIR POLPHARMA ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC
(LONG TERM) HEPATITIS B VIRUS
(HBV) INFECTION IN ADULTS.
Entecavir Polpharma 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 POLPHARMA ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV
INFECTION IN CHILDREN AND
ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS.
Entecavir Polpharma 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 Polpharma 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 POLPHARMA
DO NOT TAKE ENTECAVIR POLPHARMA:
-
if you are allergic to entecavir or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Tal

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Entecavir Polpharma 0,5 mg, filmomhulde tabletten
Entecavir Polpharma 1 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Entecavir Polpharma 0.5 mg, film-coated tablets
Each tablet contains 0.5 mg entecavir (as monohydrate).
Excipient with known effect: lactose. Each tablet contains 120.97 mg
lactose.
Entecavir Polpharma 1 mg, film-coated tablets
Each tablet contains 1 mg entecavir (as monohydrate).
Excipient with known effect: lactose. Each tablet contains 241.94 mg
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Entecavir Polpharma 0.5 mg, film-coated tablets
White, 10.1 mm x 3.7 mm +/- 0.2 mm, oval shaped tablet with break line
on both sides.
The tablet can be divided into equal doses.
Entecavir Polpharma 1 mg, film-coated tablets
Pink, 12.8 mm x 4.8 mm +/- 0.2 mm,
oval shaped tablet with break line on both sides.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULT INDICATION
Entecavir Polpharma 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.
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
2
serum ALT levels, or histological evidence of moderate to severe
inflam