Entecavir 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Entecavir monohydrate

Available from:

Dr Reddy's Laboratories (UK

ATC code:

J05AF10

INN (International Name):

Entecavir monohydrate

Dosage:

1mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05030301

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ENTECAVIR 0.5 MG FILM-COATED TABLETS
ENTECAVIR 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 is and what it is used for
2.
What you need to know before you take Entecavir
3.
How to take Entecavir
4.
Possible side effects
5.
How to store Entecavir
6.
Contents of the pack and other information
1.
WHAT ENTECAVIR IS AND WHAT IT IS USED FOR
ENTECAVIR TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC
(LONG TERM) HEPATITIS
B VIRUS (HBV) INFECTION
IN ADULTS.
Entecavir 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 TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV
INFECTION IN CHILDREN AND ADOLESCENTS AGED
2
YEARS TO LESS THAN 18
YEARS.
Entecavir 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 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
DO NOT TAKE ENTECAVIR
-
if you are allergic to entecavir or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Entecavir
-
IF YOU HAVE EVER HAD PROBLEMS WITH YOUR KIDNEYS
, tell your doctor. This is impo

Summary of Product characteristics

OBJECT 1
ENTECAVIR DR. REDDY'S 1 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 08-May-2017 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Entecavir Dr. Reddy's 1 mg Film-Coated Tablets
2. Qualitative and quantitative composition
Each tablet contains entecavir monohydrate corresponding to 1 mg
entecavir.
Excipients with known effect:
Each 1 mg film-coated tablet contains 242 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
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
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 administration
Therapy should be initiated by a physician experienced in the
management of chronic hepatitis B
infection.
Posology
_Compensated liver disease_
_Nucleoside naïve patients: _the recommended dose in adults i