Entecavir

Main information

  • Trade name:
  • Entecavir Apotex entecavir (as monohydrate) 0.5mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Entecavir Apotex entecavir (as monohydrate) 0.5mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217581
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217581

Entecavir Apotex entecavir (as monohydrate) 0.5mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

10/03/2016

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. Entecavir Apotex entecavir (as monohydrate) 0.5mg tablet blister pack

Product Type

Single Medicine Product

Effective date

6/09/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults 16 years or older with evidence of active liver inflammation.,This

indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment naïve and lamivudine-resistant adult patients

with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

36 Months

Store below 30

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. Entecavir Apotex entecavir (as monohydrate) 0.5mg tablet blister pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White colored, triangular shaped film coated tablets, engraved 'APO' on

one side and '0.5' over 'ENT' on the other side

Active Ingredients

Entecavir

.5 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 06:14:01 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Entecavir APOTEX

Contains the active ingredient entecavir monohydrate

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about entecavir. It does not

contain all the available information.

It does not take the place of talking to

your doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is

Entecavir APOTEX tablets. It

contains the active ingredient

entecavir and belongs to a group of

medicines called antiviral medicines.

It is used to treat chronic hepatitis B

virus infection in adults 16 years or

older.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

How it works

Infection by the hepatitis B virus can

lead to damage to the liver. Entecavir

reduces the amount of virus in your

body and has been shown to improve

the condition of the liver.

It is not known how safe entecavir is

when taken for long periods.

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be used in

children under 16 years as safety and

effectiveness have not been

established.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You are hypersensitive to, or

have had an allergic reaction to,

entecavir or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

ENTECAVIR APOTEX TABLETS

You have or have had any

medical conditions, especially the

following:

problems with your kidneys

hepatitis C or D

you have received a liver

transplant

you have HIV and you are not

currently receiving HIV

treatment. Entecavir may affect

your HIV which could impact on

future treatment options for HIV.

You are currently pregnant or you

plan to become pregnant.

Experience is limited with the use

of entecavir in pregnant women.

Do not take this medicine whilst

pregnant until you and your

doctor have discussed the risks

and benefits involved.

You are currently breastfeeding

or you plan to breast-feed. It is

not known whether entecavir

passes into breast milk. Do not

take this medicine whilst

breastfeeding.

You are lactose intolerant.

Entecavir tablets contain lactose.

You are planning to have surgery

or an anaesthetic.

You are currently receiving or are

planning to receive dental

treatment.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Medicines excreted by the kidney or

which affect kidney function may

interact with entecavir. Patients

should be monitored closely for

adverse events when entecavir is

taken with such medicines.

If you are taking any of these

medicines you may need a different

dose or you may need to take

different medicines.

Other medicines not stated above

may also interact with entecavir.

How to take this

medicine

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much to take

Your doctor will tell you how much

of this medicine you should take.

This will depend on your condition

and whether you are taking any other

medicines.

The usual dose of entecavir is 0.5mg

or 1mg once a day.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

How to take it

Swallow the tablet whole with a glass

of water.

When to take it

Take this medicine at the same time

each day. Taking it at the same time

each day will have the best effect and

will also help you remember when to

take it.

Entecavir should be taken on an

empty stomach (at least 2 hours after

a meal and 2 hours before the next

meal).

How long to take it for

Entecavir helps control your

condition but does not cure it.

Therefore you must continue taking

entecavir for as long as your doctor

tells you to.

Entecavir is a very important

treatment that can improve the

inflammation and scar tissue caused

by the hepatitis B virus in your liver

and may reduce the chance of

developing cirrhosis, liver failure and

liver cancer.

It is extremely important that you do

not stop taking entecavir without

discussing it with your doctor. If

entecavir is stopped suddenly, the

hepatitis B virus can become very

active again and lead to sudden

development of severe liver failure.

There is a high risk of dying if liver

failure develops and liver

transplantation may be necessary to

save your life.

Make sure you have enough to last

over weekends and holidays, or until

you next see your doctor.

If you forget to take it

If it is almost time to take your next

dose, skip the missed dose and take

your next dose at the usual time.

Otherwise, take it as soon as you

remember and then go back to taking

your medicine as you would

normally.

Do not take a double dose to make

up for missed doses.

This may increase the chance of you

experiencing side effects.It is very

important not to miss your doses of

entecavir. If you have trouble

remembering to take your medicine,

ask your pharmacist for some hints to

help you remember.

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively, go to the Accident

and Emergency department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

While you are taking

this medicine

Things you must do

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

ENTECAVIR APOTEX TABLETS

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breast-feed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

Go to your doctor regularly for a

check-up.

Your doctor may want to do tests to

make sure the medicine is working

and to prevent side effects.

When your treatment with entecavir

is stopped, your doctor will continue

to monitor you and take blood tests

for several months.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Things you must not do

Do not:

Give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Take your medicine to treat any

other condition unless your

doctor tells you to.

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Things to be careful of

Be careful when driving or operating

machinery until you know how this

medicine affects you.

There is no evidence that entecavir

reduces the risk of infecting others

with hepatitis B through sexual

contact or body fluids (including

blood contamination).

Therefore it is important to take

appropriate precautions to prevent

others being infected with hepatitis

B. Talk to your doctor about safe

sexual practices that protect your

partner. Never share needles. Do not

share personal items that can have

blood or bodily fluids on them, like

toothbrushes and razor blades. A

vaccine is available to protect those

at risk of becoming infected with

hepatitis B.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking entecavir or if you have any

questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor if you notice any

of the following:

diarrhoea

indigestion

tiredness

headache.

Some people who have taken

entecavir or medicines like entecavir

have developed a serious condition

called lactic acidosis. Lactic acidosis

is a serious medical emergency that

can cause death. Lactic acidosis must

be treated in the hospital. Reports of

lactic acidosis with entecavir

generally involved patients who were

seriously ill due to their liver disease

or other medical condition.

Tell your doctor as soon as possible

if you notice any of the following

signs or symptoms of lactic

acidosis:

feeling very weak or tired

unusual muscle pain

trouble breathing

stomach pain with nausea and

vomiting

feeling cold (especially in your

arms and legs)

feeling dizzy or light-headed

fast or irregular heartbeat.

If you experience any of the

following, stop taking your

medicine and contact your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

These are very serious signs or

symptoms of liver problems and you

may need urgent medical attention or

hospitalisation:

your skin or the white part of

your eyes turns yellow (jaundice)

urine turns dark

bowel movements (stools) turn

light in colour

you don't feel like eating food for

several days or longer

nausea

lower stomach pain.

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to entecavir, do

not take any more of this medicine

and tell your doctor immediately

or go to the Accident and

Emergency department at your

nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will stay

below 30°C.

ENTECAVIR APOTEX TABLETS

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink. Do not leave it on a

window sill or in the car. Heat and

dampness can destroy some

medicines.

Keep this medicine where children

cannot reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop taking

this medicine or it has passed its

expiry date, your pharmacist can

dispose of the remaining medicine

safely.

Product description

What Entecavir APOTEX

Tablet looks like

0.5mg tablet: white colored,

triangular shaped film coated tablets,

engraved "APO" on one side and

"0.5" over "ENT" on the other side.

It is available in blister pack of 30

tablets.

1.0mg tablet: pink colored, triangular

shaped film coated tablets, engraved

"APO" on one side and "1" over

"ENT" on the other side

It is available in blister pack of 30

tablets.

* Not all strengths, pack types and/or

pack sizes may be available.

Ingredients

Each tablet contains 0.5 mg and

1.0mg of entecavir monohydrate as

the active ingredient.

It also contains the following inactive

ingredients:

lactose

cellulose-microcrystalline

copovidone

crospovidone

magnesium stearate

hypromellose

hydroxypropylcellulose

macrogol 8000

titanium dioxide

iron oxide red (1.0mg only)

purified water.

This medicine is gluten-free, sucrose-

free, tartrazine-free and free of other

azo dyes.

Australian Registration

Numbers

Entecavir APOTEX 0.5mg tablet

(blister pack): AUST R 217581

Entecavir APOTEX 1.0mg tablet

(blister pack): AUST R 217583.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was last updated in:

March 2016

ENTECAVIR APOTEX TABLETS

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