Entecavir Mylan

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

entecavir monohydrate

Available from:

Mylan Pharmaceuticals Limited

ATC code:

J05AF10

INN (International Name):

entecavir

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

Hepatitis B

Therapeutic indications:

Entecavir Mylan is indicated for the treatment of chronic hepatitis B virus (HBV) infection 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.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.Entecavir Mylan is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to

Product summary:

Revision: 6

Authorization status:

Authorised

Authorization date:

2017-09-18

Patient Information leaflet

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENTECAVIR VIATRIS 0.5 MG FILM-COATED TABLETS
ENTECAVIR VIATRIS 1 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 Viatris is and what it is used for
2.
What you need to know before you take Entecavir Viatris
3.
How to take Entecavir Viatris
4.
Possible side effects
5.
How to store Entecavir Viatris
6.
Contents of the pack and other information
1.
WHAT ENTECAVIR VIATRIS IS AND WHAT IT IS USED FOR
ENTECAVIR VIATRIS TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT
CHRONIC (LONG TERM) HEPATITIS B
VIRUS (HBV) INFECTION IN ADULTS.
Entecavir Viatris 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 VIATRIS TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM)
HBV INFECTION IN CHILDREN
AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS.
Entecavir Viatris 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 Viatris 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 VIATRIS
_ _
DO NOT TAKE ENTECAVIR VIATRIS

IF YOU ARE ALLERGIC (HYPERSENSITIVE)
to entecavir or any of the other ingredients of this medicine
(listed in section

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Entecavir Viatris 0.5 mg film-coated tablets
Entecavir Viatris 1 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Entecavir Viatris 0.5 mg film-coated tablets
Each film-coated tablet contains entecavir monohydrate equivalent to
0.5 mg entecavir.
Entecavir Viatris 1 mg film-coated tablets
Each film-coated tablet contains entecavir monohydrate equivalent to 1
mg entecavir.
Excipient with known effect
_Entecavir Viatris 0.5 mg film-coated tablets _
Each film-coated tablet contains 62.5 mg lactose monohydrate.
_ _
_Entecavir Viatris 1 mg film-coated tablets _
Each film-coated tablet contains 125 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Entecavir Viatris 0.5 mg film-coated tablets
White, film-coated, round, biconvex, beveled edge tablet debossed with
“M” on one side and “EA” on
the other side. Diameter: approximately 6.8 mm.
_ _
Entecavir Viatris 1 mg film-coated tablets
_ _
_ _
White, film-coated, round, biconvex, beveled edge tablet debossed with
“M” on one side and “EB” on
the other side. Diameter: approximately 8.8 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Entecavir Viatris 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.
3
Entecavir Viatris is also indicated for the treatment of chronic HBV
infection in nucleoside naive
paediatr