Entecavir Dr.Reddy’s 0.5 mg film-coated tablets

Country: Մալթա

language: անգլերեն

source: Medicines Authority

MAH:

Reddy Pharma Iberia S.A. Avinguda De Josep Tarradellas 38 Barcelona, 08029, Spain

ATC_code:

J05AF10

INN:

ENTECAVIR 0.5 mg

pharmaceutical_form:

FILM-COATED TABLET

composition:

ENTECAVIR 0.5 mg

prescription_type:

POM

therapeutic_area:

ANTIVIRALS FOR SYSTEMIC USE

authorization_status:

Authorised

authorization_date:

2023-08-22

PIL

PACKAGE LEAFLET: INFORMATION FOR THE USER
Entecavir Dr. Reddy’s 0.5 mg film-coated tablets
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 Dr. Reddy’s 0.5 mg film-coated tablets is and what it
is used for
2.
What you need to know before you take Entecavir Dr. Reddy’s 0.5 mg
film-coated
tablets
3.
How to take Entecavir Dr. Reddy’s 0.5 mg film-coated tablets
Possible side effects
4.
How to store Entecavir Dr. Reddy’s 0.5 mg film-coated tablets
5.
Contents of the pack and other information
1.
WHAT ENTECAVIR DR. REDDY’S 0.5 MG FILM-COATED TABLETS IS AND WHAT IT
IS USED FOR
ENTECAVIR DR. REDDY’S 0.5 MG FILM-COATED TABLETS ARE ANTI-VIRAL
MEDICINES, USED TO TREAT
CHRONIC (LONG TERM) HEPATITIS B VIRUS (HBV) INFECTION IN ADULTS.
Entecavir Dr. Reddy’s 0.5 mg film-coated 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 DR. REDDY’S 0.5 MG FILM-COATED TABLETS ARE ALSO USED TO
TREAT CHRONIC (LONG
TERM) HBV INFECTION IN CHILDREN AND ADOLESCENTS AGED 2 YEARS TO LESS
THAN 18 YEARS.
Entecavir Dr. Reddy’s 0.5 mg film-coated 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 Dr. Reddy’s 0.5 mg
film-coated tablets reduces the amount of virus in your body, and
improves the

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Entecavir Dr. Reddy’s 0.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Entecavir Dr. Reddy’s 0.5 mg film-coated tablets
Each tablet contains entecavir monohydrate corresponding to 0.5 mg
entecavir.
Excipients with known effect:
Each 0.5 mg film-coated tablet contains 115 mg lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Entecavir Dr. Reddy’s 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.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Entecavir Dr. Reddy’s 0.5 mg film-coated tablets 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.
Entecavir Dr. Reddy’s 0.5 mg film-coated tablets is also indicated
for the t
reatment 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 c