Entecavir Reddy Pharma 0,5 mg, filmomhulde tabletten

Krajina: Holandsko

Jazyk: holandčina

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

Aktívna zložka:

ENTECAVIR 1-WATER SAMENSTELLING overeenkomend met ; ENTECAVIR

Dostupné z:

Reddy Pharma SAS 9 avenue Edouard Belin 92500 RUEIL-MALMAISON (FRANKRIJK)

ATC kód:

J05AF10

INN (Medzinárodný Name):

ENTECAVIR 1-WATER COMPOSITION corresponding to ; ENTECAVIR

Forma lieku:

Filmomhulde tablet

Zloženie:

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),

Spôsob podávania:

Oraal gebruik

Terapeutické oblasti:

Entecavir

Prehľad produktov:

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);

Dátum Autorizácia:

2017-07-03

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
ENTECAVIR REDDY 0,5 MG, FILMOMHULDE TABLETTEN
ENTECAVIR REDDY 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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC
(LONG TERM)
HEPATITIS B VIRUS (HBV) INFECTION IN ADULTS.
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).
TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV
INFECTION IN
CHILDREN AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS.
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.
reduces the
amount of virus in your body, and improves the condition of the liver.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE
-
if you are allergic 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 taking
-

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Entecavir Reddy 0,5 mg, filmomhulde tabletten
Entecavir Reddy 1 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
0.5 mg film-coated tablets
Each tablet contains 0.5 mg entecavir (as monohydrate).
1 mg film-coated tablets
Each tablet contains 1 mg entecavir (as monohydrate).
Excipients with known effect:
Each 0.5 mg film-coated tablet contains 115 mg lactose (as lactose
monohydrate).
Each 1 mg film-coated tablet contains 230 mg lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
0.5 mg film-coated tablets
White oval shaped tablet with a size of about 10.1 mm x 3.7 mm with
break line on both sides.
The tablet can be divided into equal halves.
1 mg film-coated tablets
Pink oval shaped tablet with a size of about 12.8 mm x 4.8 mm with
break line on both sides.
The
tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
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.
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