ENTECAVIR

Main information

  • Trade name:
  • ENTECAVIR MYLAN entecavir monohydrate 0.5 mg film coated tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ENTECAVIR MYLAN entecavir monohydrate 0.5 mg film coated tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220090
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220090

ENTECAVIR MYLAN entecavir monohydrate 0.5 mg film coated tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

18/04/2016

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 MYLAN entecavir monohydrate 0.5 mg film coated tablets blister pack

Product Type

Single Medicine Product

Effective date

12/07/2017

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 lamividine-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

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. ENTECAVIR MYLAN entecavir monohydrate 0.5 mg film coated tablets blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

A white, film-coated, round, biconvex, beveled edge tablet debossed with

'M' on one side of the tablet and 'EV1' on the other side.

Active Ingredients

entecavir monohydrate

.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 02:53:20 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 Mylan

contains the active ingredient (Entecavir monohydrate)

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about Entecavir Mylan.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have benefits and

risks. Your doctor has weighed the

risks of you taking Entecavir Mylan

against the benefits expected for you.

If you have any concerns about

taking this medicine, talk to your

doctor or pharmacist.

Keep this leaflet with your

medicine.

You may need to read it again.

What Entecavir Mylan

is used for

This medicine is used to treat adults

infected with hepatitis B virus.

This medicine belongs to a group of

medicines called antiviral medicines.

Infection by hepatitis B virus can

lead to damage to the liver. This

medicine 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

Mylan is when taken for long

periods.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

This medicine is not addictive.

This medicine is available only with

a doctor's prescription.

This medicine is not recommended

for use in children under 16 years, as

there have been no studies of its

effects in children.

Before you take

Entecavir Mylan

When you must not take it

Do not take Entecavir Mylan if you

have an allergy to:

any medicine containing

entecavir monohydrate.

any of the ingredients listed at the

end of this leaflet

Some of the symptoms of an allergic

reaction may include

chills fever

fast heart beat

wheezing and coughing

difficulty breathing

dizziness

flushing

sweating and swelling of the face,

lips, tongue or other parts of the

body

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

It is important to remain under the

care of your doctor during Entecavir

Mylan therapy and after stopping

Entecavir Mylan. You should report

any new symptoms, medication or

any other aspects affecting your

health to your doctor. Your hepatitis

B virus infection may get worse if

you stop taking Entecavir Mylan. If

your doctor advises you to stop

Entecavir Mylan, they will monitor

your health and perform regular

blood tests to monitor your liver.

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

currently experience or have

experienced any medical

conditions especially any

problems with your kidneys.

have HIV and you are not

currently on HIV treatment.

Entecavir Mylan is not recommended

in patients who have both HIV and

Hepatitis B and who are not currently

receiving anti-HIV treatment.

Entecavir Mylan may affect your

HIV virus which could impact on

future treatment options for HIV.

are lactose intolerant. Entecavir

Mylan contains lactose.

Tell your doctor if you are

pregnant or plan to become

pregnant or are breastfeeding.

Experience is limited with the use of

Entecavir Mylan in pregnant women.

Therefore, it should be used during

pregnancy unless it is clearly needed.

If there is an urgent need to consider

Entecavir Mylan during pregnancy,

ENTECAVIR MYLAN

your doctor will discuss with you the

risks and benefits involved.

It is not known whether Entecavir

Mylan passes into breast milk.

Therefore to avoid possible side

effects in the nursing infant, mothers

should stop breast-feeding if they are

taking Entecavir Mylan.

If you have not told your doctor

about any of the above, tell him/

her before you start taking

Entecavir Mylan.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from a

pharmacy, supermarket or health

food shop.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to take Entecavir

Mylan

Follow all directions given to you

by your doctor and pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box/bottle, ask

your doctor or pharmacist for

help.

How much to take

The usual dose of Entecavir Mylan

0.5 mg or 1 mg is once a day.

If you have a medical problem with

your kidneys your doctor may need

to change how often you take your

Entecavir Mylan tablets.

Your doctor will tell you what dose

to take and how often you should

take your Entecavir Mylan tablets.

How to take it

Swallow the tablets whole with a

full glass of water.

The dose of Entecavir Mylan

should be taken on an empty

stomach.

When to take it

Take your medicine any time of

day provided it is on an empty

stomach, for example, at least 2

hours before food or 2 hours after

food.

Talk to your doctor or pharmacist

to work out when it is best for you

to take your dose of Entecavir

Mylan.

How long to take it

Continue taking your medicine for

as long as your doctor tells you to.

This medicine helps to control your

condition, but does not cure it. It is

important to keep taking your

medicine even if you feel well.

Entecavir Mylan is very important

treatment that can improve the

inflammation and scar tissue caused

by the Hepatitis B virus in your liver

and may reduce the change of

developing cirrhosis, liver failure and

liver cancer.

It is extremely important that you do

not stop taking Entecavir Mylan

without discussing it with your

doctor. If Entecavir Mylan is

suddenly stopped, the hepatitis B

virus can become very active again

and lead to sudden development of

severe liver failure. There is high risk

of dying if liver failure develops and

liver transplantation may be

necessary to save your life.

It is important to take Entecavir

Mylan every day or as directed by

your doctor, to not miss medicine

doses, and to make sure you have

enough supply until you next see

your doctor.

Do not stop taking Entecavir

Mylan or change the dose unless

asked to do so by your doctor, even

if you feel better, as it can be very

dangerous.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

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 the dose you missed.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident and Emergency at

the nearest hospital, if you think

that you or anyone else may have

taken too much Entecavir Mylan.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

While you are taking

Entecavir Mylan

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking Entecavir Mylan.

Tell any other doctors, dentists and

pharmacists who treat you that

you are taking this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are taking this medicine.

ENTECAVIR MYLAN

It may affect other medicines used

during surgery.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

If you are about to have any blood

tests, tell your doctor that you are

taking this medicine.

It may interfere with the results of

some tests.

Keep all of your doctor's

appointments so that your progress

can be checked.

Things you must not do

Do not take Entecavir Mylan to

treat any other complaints unless

your doctor tells you to.

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not stop taking your medicine

or change the dosage without

checking with your doctor.

If you stop taking it suddenly, your

condition may worsen.

Things to be careful of

Be careful driving or operating

machinery until you know how

Entecavir Mylan affects you.

This medicine may cause dizziness,

in some people. It is not known if

this was caused by Entecavir Mylan.

If you have this symptom, do not

drive, operate machinery or do

anything else that could be

dangerous.

If you feel light-headed, dizzy or

faint when getting out of bed or

standing up, get up slowly.

Standing up slowly, especially when

you get up from bed or chairs, will

help your body get used to the

change in position and blood

pressure. If this problem continues or

gets worse, talk to your doctor.

Make sure that you visit your doctor

regularly throughout your entire

course of treatment with Entecavir

Mylan.

When your treatment with Entecavir

Mylan is stopped, your doctor will

continue to monitor you and take

blood tests for several months.

There is no evidence that Entecavir

Mylan reduces the risk of infecting

other 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

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.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Entecavir

Mylan.

This medicine helps most people

with hepatitis B infection, but it may

have unwanted side effects in some

people.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

Do not be alarmed by the following

list of side effects.

You may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

diarrhoea

indigestion

tiredness

headache

The above list includes the more

common side effects of your

medicine.

Tell your doctor as soon as possible

if you notice any of the following

signs or symptoms of liver

problems:

skin and the white part of eyes

turns yellow (jaundice)

urine turns dark

bowel movement (stool) turn

light in colour

loss of appetite

nausea

lower stomach pain

lactic acidosis

serious liver problems

The above list includes serious side

effects that may require medical

attention.

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 arms

and legs)

feeling dizzy or light-headed

fast or irregular heartbeat

The above list includes serious side

effects that may require medical

attention.

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital if you notice any of

the following signs of a sudden life-

threatening allergic reaction:

chills

fever

fast heart beat

wheezing or coughing

difficulty breathing

dizziness

flushing

ENTECAVIR MYLAN

sweating and swelling of the face,

tongue or other parts of the body.

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Other side effects not listed above

may also occur in some people.

After taking Entecavir

Mylan

Storage

Keep your tablets until it is time to

take them.

If you take the tablets they may not

keep well.

Keep your tablets in a cool dry

place where the temperature stays

below 25°C.

Do not store Entecavir Mylan 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 it 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 the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

What it looks like

0.5 mg - A white, film-coated, round,

biconvex, beveled edge tablet

debossed with 'M' on one side of the

tablet and 'EV1' on the other side.

Blister pack of 30 tablets.

1 mg - A white, film-coated, round,

biconvex, beveled edge tablet

debossed with 'M' on one side of the

tablet and 'EV2' on the other side.

Blister pack of 30 tablets.

Ingredients

Entecavir Mylan 0.5 mg film coated

tablet contains 0.5 mg of entecavir

monohydrate as the active ingredient.

Entecavir Mylan 1 mg film coated

tablet contains 1 mg of entecavir

monohydrate as the active ingredient.

It also contains the following inactive

ingredients:

lactose

microcrystalline cellulose

crospovidone

magnesium stearate

Opadry White YS-1R-7003

(ARTG No. 1625)

Supplier

Entecavir Mylan is supplied in

Australia by:

Alphapharm Pty Limited

(ABN 93 002 359 739)

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

Phone: (02) 9298 3999

www.alphapharm.com.au

Australian registration numbers:

Entecavir Mylan 0.5 mg:

AUST R 220090

Entecavir Mylan 1 mg:

AUST R 220091

This leaflet was prepared on

6 February 2015.

Entecavir Mylan_cmi\FEB15/00

ENTECAVIR MYLAN

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

27-7-2018

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Active substance: N-acetyl-D-mannosamine monohydrate) - Transfer of orphan designation - Commission Decision (2018)5053 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/228/15/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety