EZOVIR famciclovir 250 mg tablet blister pack

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Active ingredient:
famciclovir
Available from:
Neo Health (OTC) Pty Ltd
Authorization status:
Registered
Authorization number:
343761

Read the complete document

EZOVIR – for Cold Sores

famciclovir

Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some

common questions about

EZOVIR.

It does not contain all the

available information. It does not

take the place of talking to your

pharmacist or doctor.

The information in this leaflet

was last updated on the date

listed on the final page. Some

more recent information on the

medicine may be available.

You should speak to your

pharmacist or doctor to obtain

the most up to date

information on the medicine.

Those updates may contain

important information about the

medicine and its use of which

you should be aware.

All medicines have risks and

benefits. Your pharmacist or

doctor has weighed the risks of

you taking EZOVIR against the

benefits it can provide.

If you have any concerns about

this medicine, ask your

pharmacist or doctor.

Keep this leaflet with the

medicine.

You may need to read it again.

WHAT EZOVIR IS USED

FOR

EZOVIR is an antiviral medicine

used to treat recurrent outbreaks

of cold sores in adults 18 years

of age and over who have a

normal immune system (the

body system which fights

against harmful bacteria,

viruses and fungi).

Cold sores are an infection

caused by a virus called

herpes simplex type 1 (HSV-

1). The infection is most

commonly acquired as a baby

or child from contact with

parents or relatives, often

from kissing.

Cold sores usually begin on

or around the lips, mouth, and

nose as small red bumps that

turn into fluid- filled blisters.

Cold sores can be tender and

painful. Many people who get

cold sores know when one is

coming by a tingling,

burning, itchy or painful

sensation or redness in the

area.

This can happen very rapidly.

After redness and swelling

develop, blisters form. The

blisters may weep or burst

and this can be painful. Then

a shallow ulcer and yellow

crust form as the cold sore

dries. The crust eventually

falls off, exposing new pink-

coloured skin. Generally the

sores heal without scarring.

After the initial infection has

healed, the virus becomes

dormant in nerve cells.

Cold sores can be

unpredictable. The virus can

become active again in the

body, even after many years,

resulting in recurrent

outbreaks.

Even after many years, some

people may experience

recurring cold sores due to viral

reactivation.

Some common triggers to a cold

sore may include:

sun exposure

stress

fatigue

menstrual periods

fever

illness

dry chapped lips

skin trauma

a cold.

Although EZOVIR does not cure

the viral infection, it helps to

relieve the symptoms and shorten

the duration of an outbreak.

The best results are obtained if

the medicine is started as soon as

possible after the onset of

symptoms of a cold sore, such as

tingling, itching or burning, or

the appearance of the first signs,

such as redness or swelling. This

is when the virus is reproducing

rapidly.

Ask your pharmacist or

doctor if you have any

questions about why this

medicine has been

recommended for you.

EZOVIR is only available from

your pharmacist and does not

require a prescription. It is not

addictive.

This medicine is not

recommended for use in infants,

children or adolescents under 18

years of age.

BEFORE YOU TAKE

EZOVIR

When you must not take it

Do not take EZOVIR if you

have a problem with your

body's immune system, which

helps to fight off infections.

Your pharmacist will refer you

to your doctor in that case.

Do not take EZOVIR if you

have an allergy to:

famciclovir, the active

ingredient

penciclovir, a related antiviral

medicine

any of the other ingredients of

EZOVIR listed at the end of

this leaflet.

Some of the symptoms of an

allergic reaction may include:

shortness of breath, wheezing

or difficulty breathing

swelling of the face, lips,

tongue or other parts of the

body

rash, itching or hives on the

skin

Do not take this medicine after

the expiry date printed on the

pack, or if the packaging is

torn or shows signs of

tampering.

In that case, return it to your

pharmacist.

Before you start to take it

Tell your pharmacist or doctor

if you are over 50 years of age,

or if you have:

a problem with your body's

immune system, which helps to

fight off infections

a problem with your kidneys

diabetes, high blood

pressure, heart problems,

liver problems or other

medical conditions

signs of an infection other

than your cold sore.

Your pharmacist may want to

take extra precautions or refer

you to a doctor to determine

if this medicine is suitable for

you.

Tell your pharmacist or

doctor if you are pregnant,

intend to become pregnant

or if you are breast- feeding.

EZOVIR should not be used

during pregnancy unless

necessary.

Your pharmacist or doctor

will discuss with you the

potential risks of taking

EZOVIR during pregnancy,

and will also advise you if

you should

take EZOVIR while breast-

feeding, based on the benefits

and risks of your particular

situation.

Tell your pharmacist or

doctor if you are allergic to

any other medicines, foods,

dyes or preservatives.

He/she will want to know if

you are prone to allergies.

If you experience an allergic

reaction, inform your

pharmacist or doctor

immediately.

Taking other medicines

Tell your pharmacist or

doctor if you are taking any

other medicines, including

any that you buy without a

prescription from a

pharmacy, supermarket or

health food shop.

Some medicines and

EZOVIR may interfere with each

other.

These include:

probenecid, a prescription

medicine used to treat gout (a

disease with painful, swollen

joints, caused by uric acid

crystals) and to increase blood

levels of penicillin-type

antibiotics raloxifene, a

medicine used to treat

osteoporosis (a disease which

causes bones to become less

dense, gradually making them

weaker, more brittle and likely

to break)

medicines that can affect your

immune system

medicines that can affect your

kidneys.

You may need to take different

amounts of these medicines or

you may need to take different

medicines. Your pharmacist and

doctor have more information.

If you have not told your

pharmacist or doctor about

any of these things, tell him/her

before you start taking this

medicine.

HOW TO TAKE EZOVIR

Follow all directions given to

you by your pharmacist or

doctor carefully.

These instructions may differ

from the information contained

in this leaflet.

If you do not understand the

instructions on the label, ask

your pharmacist or doctor

for help.

How much to take

The usual dose is three 500 mg

tablets taken together as a

single dose.

However, if you have problems

with your kidneys and your

pharmacist has referred you to

your doctor to see if this

medicine is suitable for you,

your doctor may have

recommended a different dose.

Ask your pharmacist or

doctor if you are unsure of

the correct dose for you.

He/she will tell you exactly

how much to take.

When to take it

Take EZOVIR as soon as

possible after

the first symptoms (e.g.

tingling, itching or burning)

or signs (e.g. redness or

swelling) of a cold sore

appear.

Do not take the tablets if a

hard crust has already

formed on the cold sore.

Keep the tablets for the next

episode.

How to take it

Swallow the tablets whole with

a full glass of water.

They may be taken with or

without food. It is not necessary

to chew or crush the tablet.

How long to take it

A single dose of EZOVIR is all

that is necessary for treating

each episode of cold sores. Each

pack of EZOVIR contains

enough medicine for one dose. A

repeat dose during this episode is

not recommended. If another

episode of cold sores recurs,

another dose may be taken.

However, treatment should

not be repeated within 7 days.

If you take too much

(Overdose)

Immediately telephone your

doctor or the Poisons

Information Centre

(telephone number 13 11

26), or go to Accident and

Emergency at your nearest

hospital if you think that

you or anyone else may

have taken too much

EZOVIR.

Show them your pack of

tablets. Do this even if there

are no signs of discomfort

or poisoning.

Keep the telephone

numbers for these places

handy.

Taking too much EZOVIR

may affect the kidneys. In

people who already have

kidney problems it may,

rarely, lead to kidney failure

if their dose is not correctly

lowered.

WHILE YOU ARE

TAKING EZOVIR

Things you must do

Tell your pharmacist or

doctor if your cold sore

symptoms do not improve

within a few days, or if they

become worse.

If you become pregnant

while taking EZOVIR, tell

your pharmacist or doctor.

If you are about to be

started on any new

medicine, remind

your doctor and pharmacist

that you periodically take this

medicine to treat recurring

episodes of cold sores.

Tell any other doctor, dentist

or pharmacist who treats you

that you periodically take this

medicine.

Things you must not do

Do not take less than the

recommended dose of 3 tablets,

unless advised by your doctor.

Do not give this medicine to

anyone else even if their

condition seems to be the same

as yours.

Do not use it to treat any other

complaints unless your doctor

tells you to.

Things to be careful of

If you are pregnant or

breastfeeding, ask your doctor

or pharmacist for advice before

taking any medicine.

Be careful driving, operating

machinery or doing jobs that

require you to be alert until

you know how EZOVIR affects

you.

This medicine can cause

dizziness, sleepiness or

confusion.

Things that may help your

Condition

Cold sores are contagious and

the virus can be passed on from

person to person through close

physical contact or saliva, even

when blisters are not present. The

risk is much higher when the

cold sore is visible, as the virus

can be shed, making it easy to

infect other people.

Take the following

precautions to avoid

spreading the virus:

Keep the areas affected by the

virus as clean and dry as

possible

Avoid touching or scratching

the sore area as you may spread

the virus on your fingers

Do not share any objects that

have been in contact with a

cold sore (e.g. drinking glasses,

eating utensils, or towels)

Avoid direct skin-to-skin

contact of the area with other

people (e.g. kissing) until the

cold sore has healed.

SIDE EFFECTS

Tell your pharmacist or

doctor as soon as possible if

you do not feel well while you

are taking EZOVIR .

All medicines can have side

effects. Sometimes they are

serious, most of the time they

are not. You may need medical

treatment if you get some of the

side effects.

Do not be alarmed by these

lists of possible side effects.

You may not experience any

of them. Ask your pharmacist

or doctor to answer any

questions you may have.

Tell your pharmacist or

doctor if you notice any of the

following and they worry you:

headache

dizziness

nausea (feeling sick) or

vomiting

abdominal pain

diarrhoea

itching or an itchy rash

(urticaria)

The above side effects are

usually mild.

Tell your pharmacist or

doctor as soon as possible if

you notice

any of the following:

a rash elsewhere on the

body, that is separate from

the cold sore

extreme sleepiness or

confusion, usually in older

people

hallucinations (seeing or

hearing things that are not

really there)

painful or swollen joints

aching muscles or muscle

tenderness or weakness that

is not caused by exercise.

yellowing of the skin or

eyes (signs of jaundice)

palpitations (signs of

abnormal heart beat)

The above side effects may

need medical attention.

Tell your pharmacist or

doctor immediately or go to

Accident and Emergency at

your nearest hospital if any

of the following side effects

happen:

swelling below the surface

of the skin (e.g. swelling

around the face, eye, eyelid

or throat)

unexplained bruising,

reddish or purplish patches

on the skin or bleeding more

easily than usual, as it may

indicate that the number of

platelets (a type of blood

cell responsible for blood

clotting) in your blood are

reduced

severe blistering of the skin

or mucous membranes of

the lips, eyes, mouth, nasal

passages or genitals (signs

of a serious skin reaction)

purple patches, itching,

burning of the skin (signs of

inflamed blood vessels)

seizures or fits

difficulty breathing or

swallowing, wheezing or

cough, light-headedness,

changes in alertness, skin

reddening, facial/throat

swelling, blue discoloration of

the lips, tongue or skin (signs of

severe allergic reaction).

The above side effects are very

rare.

Tell your pharmacist or doctor

if you notice anything else that

is making you feel unwell.

Other side effects not listed here

or not yet known may happen in

some people.

AFTER TAKING EZOVIR

Storage

Keep your medicine in the

original container until it is time

to take it.

Store your EZOVIR tablets in

a dry place at room

temperature.

Do not store your medicines in

the bathroom or near a sink.

Do not leave the tablets in the

car or on window sills.

Heat and dampness can destroy

some medicines. EZOVIR

tabletswill keep best if they are

stored cool and dry.

Keep the 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 the

expiry pharmacist what to do

with any medicine that you

have left over.

Product description

What it looks like

EZOVIR 500 mg tablets are

white, oval, film-coated tablets

with "FM" on one side and

"500" on the other. Each carton

contains 3 tablets.

Ingredients

Active Ingredient

EZOVIR

250 - contain 250

mg famciclovir per tablet.

EZOVIR 500 - contain 500

mg famciclovir per tablet.

Inactive ingredients

All EZOVIR tablets

contain the following inactive

ingredients:

microcrystalline cellulose

crospovidone

silicone dioxide

copovidone

sodium stearylfumarate

OPADRY II complete film

coating system YS-22-18096

White

Supplier

Neo Health (OTC) Pty Ltd

Suite 3, 380 Pennant Hills Road,

Pennant Hills, NSW 2120,

Australia

Australian Registration

Numbers

EZOVIR:

500 mg - AUST R 343762

250 mg – AUST R 343761

This leaflet was prepared in

October 2020.

EZOVIR

for genital herpes

famciclovir

Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This

leaflet

answers

some

common

questions

about

EZOVIR.

does

contain

available

information.

does

not take the place of talking to

your doctor or pharmacist.

The information in this leaflet

last

updated

date

listed on the final page.

Some more recent information on

the medicine may be available.

You

should

ensure

that

you

speak to your pharmacist or

doctor to obtain the most up to

date

information

on

the

medicine.

Those

updates

contain

important information about the

medicine and its use of which

you should be aware.

medicines

have

risks

benefits.

Your

doctor

weighed the risks of you taking

EZOVIR against the benefits it

can provide.

If you have any concerns about

this medicine, ask your doctor

or pharmacist.

Keep

this

leaflet

with

the

medicine.

You may need to read it again.

WHAT EZOVIR IS USED FOR

EZOVIR is an antiviral medicine

for adults and adolescents. It is

used to treat outbreaks of genital

herpes

also

suppress

(prevent)

recurrent

outbreaks

the condition. Genital herpes is a

viral infection caused by herpes

simplex 1 or herpes simplex 2. It

usually

transmitted

through

sexual contact.

Symptoms

include

tingling,

burning or itching of the genitals,

followed by blisters that may be

painful.

People

have

frequent

episodes

genital

herpes

also

take

EZOVIR

help

prevent the attacks.

Although EZOVIR does not cure

viral

infection,

helps

relieve the symptoms and shorten

their duration.

The best results are obtained if

the medicine is started as soon as

possible after the first symptoms

begin to appear.

Taking EZOVIR does not prevent

from

spreading

herpes

virus to another person.

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.

EZOVIR is only available

with a doctor's prescription. It is

not addictive.

This

medicine

recommended for use in children

under 12 years of age.

BEFORE YOU TAKE EZOVIR

When you must not take it

Do not take EZOVIR if you

have an allergy to:

famciclovir,

active

ingredient

penciclovir, a related antiviral

medicine

any of the other ingredients

listed at the end of this leaflet

Some of the symptoms of an

allergic reaction may include:

shortness of breath, wheezing

or difficulty breathing;

swelling

face,

lips,

tongue

other

parts

body;

rash, itching or hives on the

skin.

Do

not

take

EZOVIR

after

the expiry date printed on the

pack

or

if

the packaging

is

torn or if it shows signs of

tampering.

In that case, return it to your

pharmacist.

Before you start to take it

Tell your doctor if you have a

problem with:

your

body's

immune

system,

which

helps

fight

infections

your kidneys

your liver

Your

doctor

want

take

extra precautions in that case.

Tell

your

doctor

if

you

are

pregnant,

intend

to

become

pregnant or if you are breast-

feeding.

EZOVIR

should

used

during

pregnancy

unless

necessary.

Your

doctor

will

discuss

with

potential

risks of taking EZOVIR during

pregnancy, and will also advise

you if you should take EZOVIR

while breast- feeding, based on

benefits

risks

your

particular situation.

Tell

your

doctor

if

you

are

allergic to any other medicines,

foods, dyes or preservatives.

Your doctor will want to know if

you are prone to allergies.

If

you

experience

an

allergic

reaction,

stop

using

the

medicine

and

inform

your

doctor

or

pharmacist

immediately.

Taking other medicines

Tell

your

doctor

if

you

are

taking

any

other

medicines,

including

any

that

you

buy

without a prescription from a

pharmacy,

supermarket

or

health food shop.

Some

medicines

EZOVIR may interfere with each

other. These include:

probenecid,

prescription

medicine used to treat gout (a

disease

with

painful,

swollen

joints

caused

uric

acid

crystals) and to increase blood

levels

penicillin-type

antibiotics

raloxifene, a medicine used to

treat

osteoporosis

disease

which causes bones to become

less

dense,

gradually

making

them weaker, more brittle and

likely to break)

medicines that can affect your

kidneys.

You may need to take different

amounts of these medicines or you

need

take

different

medicines.

Your

doctor

pharmacist

have

more

information.

If

you

have

not

told

your

doctor

about

any

of

these

things, tell him/her before you

start taking this medicine.

HOW TO TAKE EZOVIR

Swallow the tablets whole with

a full glass of water.

The tablets may be taken with or

without food. It is not necessary

to chew or crush the tablet.

If you do not understand the

instructions

on

the

label,

ask

your doctor or pharmacist for

help.

How much to take

Follow your doctor's instructions on

how many EZOVIR tablets to take.

These

instructions

differ

from the information contained

in this leaflet.

Do

not

change

the

dose

yourself, without your doctor's

advice, regardless of how well

you may feel.

Ask your doctor or pharmacist

if you are unsure of the correct

dose for you.

They will tell you exactly how

much to take.

people

whose

immune

system does not work as well

should,

dose

duration of treatment may need

to be increased.

people

have

kidney

problems,

your

doctor

decide to give you a lower dose.

When to take it

There are different ways to take

EZOVIR

depending

your

condition.

1.

TO

TREAT

AN

OUTBREAK OF GENITAL

HERPES

To

treat

an

outbreak,

take

the

tablets

as

soon

as

possible

after

the

first

symptoms of genital herpes

appear.

tablets

best

taken

within

hours

first

symptoms

genital

herpes

appearing.

There are three ways to take

EZOVIR to treat an outbreak

genital

herpes

your

doctor

will

tell

which

regimen is best for you:

Two 500 mg EZOVIR tablets

twice daily for one day

or

Two 250 mg EZOVIR tablets

to start with, followed by one

250 mg tablet every 12 hours

for the next 3 doses

or

One 125 mg EZOVIR tablet

every 12 hours for 5 days

Take the second dose (and

subsequent

doses,

if

applicable) 12 hours after

the first dose, or as close

as

possible

to

12

hours

during waking hours.

If you take the first dose in

late

morning

early

afternoon, you can take the

next dose before going to

bed,

take

doses

less

than

hours

apart.

During

normal

waking

hours,

take

any

remaining

doses

at

12

hourly intervals.

Your

doctor

have

prescribed a different dose.

2.

TO

SUPPRESS

(PREVENT)

OUTBREAKS

OF

RECURRENT

GENITAL HERPES

Start

suppressive

treatment

to

prevent

outbreaks

of

recurrent

genital herpes as soon as

possible

after

you

have

your

EZOVIR

prescription filled.

Take one 250 mg EZOVIR

tablet twice each day.

Continue to take one 250

mg

EZOVIR

tablet

twice

each

day

for

as

long

as

your doctor tells you to. Do

this even if you do not have

an outbreak.

This

medicine

helps

control

your

condition

does not cure it. Your doctor

will tell you when you can

stop.

Fill

your

next

repeat

prescription before using all of

the

tablets

in

your

current

carton.

This

will

ensure

that

your

treatment can be continued and

give you the best results.

Try to take the tablets at about

the

same

times

each

day,

as

directed

by

your

doctor

or

pharmacist.

Taking your tablet at the same

times each day will have the best

effect.

will

also

help

remember

when

take

tablets.

How long to take it

Continue

taking

EZOVIR

every day for as long as your

doctor tells you.

To help clear up your infection,

must

keep

taking

this

medicine, even if your symptoms

begin

clear

after

days.

To

prevent

recurrent

episodes

of

genital

herpes,

you

must

take

the

tablets

each day, even if you have no

symptoms.

It is important to keep taking

your medicine even if you feel

well.

If you forget to take it

Take a dose as soon as you

remember.

Take

your

next

tablet at the usual time, and

then go back to taking it as

you would normally.

Do not take two doses within a

time

frame

of

less

than

one

hour.

In

that

case,

skip

the

missed dose.

Do not take a double dose to

make up for the one that you

missed.

This may increase the chance of

getting

unwanted

side

effect.

If

you

have

trouble

remembering

when

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

number 13 11 26), or go to

Accident

and

Emergency

at

your

nearest

hospital

if

you

think that you or anyone else

may

have

taken

too

much

EZOVIR.

Show

them

your

pack of tablets. Do this even if

there

are

no

signs

of

discomfort or poisoning. Keep

the

telephone

numbers

for

these places handy.

Taking too much EZOVIR may

affect the kidneys. In people who

already have kidney problems it

may, rarely, lead to kidney failure

their

dose

correctly

lowered.

WHILE YOU ARE TAKING

EZOVIR

Things you must do

If you become pregnant while

taking

EZOVIR,

tell

your

doctor.

Your doctor can discuss with you

the risks of taking it while you

are pregnant.

If you are about to be started

on any new medicine, remind

your doctor and pharmacist

that you are taking EZOVIR.

Tell any other doctor, dentist

or

pharmacist

who

treats

you

that

you

are

taking

EZOVIR.

Things you must not do

Do

not

give

this

medicine

to

anyone

else

even

if

their

condition seems to be the same

as yours.

Do

not

use

it

to

treat

any

other complaints unless your

doctor tells you to.

Do

not

stop

taking

your

tablets or change the dosage

without

checking

with

your

doctor first.

stop

your

tablets

suddenly, your condition may

worsen

have

unwanted side effects.

Things to be careful of

If

you

are

pregnant

or

breast-

feeding,

ask

your

doctor

or

pharmacist

for

advice

before

taking

any

medicine.

Be careful driving, operating

machinery or doing jobs that

require you to be alert until

you

know

how

EZOVIR

affects you.

This

medicine

cause

dizziness,

sleepiness

confusion.

Practice "safer sex", including

the

use

of

condoms,

when

symptoms are present, even if

you

have

started

taking

EZOVIR.

This is important to prevent you

passing

infection

others.

Things

that

may

help

your

condition

Take

the

following

precautions

to

help

manage

your condition:

Use condoms between episodes

to reduce the risk of infecting

your partner

Keep the areas affected by the

virus

clean

possible

Wear loose-fitting clothing to

avoid irritating the blisters

Avoid

touching

scratching

the sore area as you may spread

the virus on your fingers.

SIDE EFFECTS

Tell

your

doctor

or

pharmacist

as

soon

as

possible

if

you

do

not

feel

well

while

you

are

taking

EZOVIR.

medicines

have

side

effects.

Sometimes

they

serious, most of the time they are

not.

need

medical

treatment if you get some of the

side effects.

Do

not

be

alarmed

by

these

lists of possible side effects.

You may not experience any of

them.

Tell your doctor if you notice

any of the following side effects

and they worry you:

headache

dizziness

nausea

(feeling

sick)

vomiting

abdominal pain

diarrhoea

itching

itchy

rash

(urticaria)

abnormal liver function test

results

above

side

effects

usually mild.

Tell

your

doctor

as

soon

as

possible if you notice any of the

following:

a rash on other parts of your

body

extreme

sleepiness

confusion,

usually

older

people

hallucinations

(seeing

hearing

things

that

really there)

painful or swollen joints

aching

muscles

muscle

tenderness or weakness that is

not caused by exercise

yellowing of the skin or eyes

(signs of jaundice)

palpitations (signs of abnormal

heart beat)

The above side effects may need

medical attention.

Tell your doctor immediately or

go to Accident and Emergency

at your nearest hospital if any

of

the

following

side

effects

happen to you:

swelling below the surface of

the skin (e.g. swelling around

the face, eye, eyelid or throat)

unexplained

bruising,

reddish

or purplish patches on the skin

or bleeding more easily than

usual as it may indicate that the

number of platelets (a type of

blood

cell

responsible

blood clotting) in your blood

are reduced

severe blistering of the skin or

mucous membranes of the lips,

eyes, mouth, nasal passages or

genitals (signs of a serious skin

reaction)

purple

patches,

itching,

burning of the skin (signs of

inflamed blood vessels)

seizures or fits

difficulty

breathing

swallowing,

wheezing

coughing,

light-headedness,

changes

alertness,

skin

reddening,

facial/throat

swelling, blue discoloration of

the lips, tongue or skin (signs

of severe allergic reaction).

The above side effects are very

rare.

Tell your doctor if you notice

anything else that is making

you feel unwell.

Other side effects not listed here

or not yet known may happen in

some people.

Ask your doctor or pharmacist

to

answer

any

questions

you

may have.

AFTER TAKING EZOVIR

Storage

Keep

your

medicine

in

the

original container until it is time

to take it.

Store your EZOVIR tablets in a

dry place at room temperature.

Do not store your medicines in

the bathroom or near a sink.

Do not leave the tablets in the

car or on window sills.

Heat and dampness can destroy

some medicines. EZOVIR tablets

will keep best if they are stored

cool and dry.

Keep

the

medicine

where

children cannot reach it.

A locked cupboard at least one-

and-

a-half

metres

above

ground is a good place to store

medicines.

Disposal

If your doctor tells you to stop

taking

this

medicine

or

the

expiry pharmacist what to do

with

any

medicine

that

you

have left over.

Product description

What it looks like

EZOVIR comes in three tablet

strengths

treatment

genital herpes:

EZOVIR 125 mg tablets are

white,

round,

film-coated

tablets, marked with "FM" on

side

"125"

other. Each carton contains 2,

10, 40 or 56 tablets.

EZOVIR 250 mg tablets are

white,

round,

film-coated

tablets, marked with "FM" on

side

"250"

other.

Each

carton

contains

either 20, 30 or 56 tablets.

EZOVIR 500 mg tablets are

white, oval, film-coated tablets

with

"FM"

side

"500"

other.

Each

carton contains 3, 4, 12, 14,

16, 20 or 56 tablets.

Some

pack

sizes

and/or

pack

types

marketed.

Ingredients

Active Ingredient

EZOVIR 125 - contain 125 mg

famciclovir per tablet

EZOVIR 250 - contain 250 mg

famciclovir per tablet.

EZOVIR 500 - contain 500 mg

famciclovir per tablet.

Inactive ingredients

All EZOVIR tablets contain the

following inactive ingredients:

microcrystalline cellulose

crospovidone

silicone dioxide

copovidone

sodium stearylfumarate

OPADRY

complete

film

coating system YS-22-18096

White

Supplier

Neo Health (OTC) Pty Ltd

Suite 3, 380 Pennant Hills Road,

Pennant

Hills,

2120,

Australia

Australian

Registration

Numbers

EZOVIR:

125 mg - AUST R 343760

250 mg - AUST R 343761

500 mg - AUST R 343762

This

leaflet

prepared

October 2020.

EZOVIR

for shingles

famciclovir

Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This

leaflet

answers

some

common

questions

about

EZOVIR.

does

contain

available information. It does not

take the place of talking to your

doctor or pharmacist.

information

this

leaflet

last

updated

date

listed on the final page.

Some more recent information on

the medicine may be available.

You

should

ensure

that

you

speak

to

your

pharmacist

or

doctor to obtain the most up to

date

information

on

the

medicine.

medicines

have

risks

benefits.

Your

doctor

weighed the risks of you taking

EZOVIR against the benefits it

can provide.

If you have any concerns about

this medicine, ask your doctor

or pharmacist.

Keep

this

leaflet

with

the

medicine.

You may need to read it again.

WHAT EZOVIR IS USED FOR

EZOVIR is an antiviral medicine

that is used to treat shingles in

adults and adolescents.

Shingles

condition

that

caused by a herpes virus called

varicella zoster, the same virus

that

causes

chicken

pox.

virus can become active again in

the body, even after many years,

resulting in shingles.

The main symptom is a rash that

cause

pain,

burning

blisters.

Although EZOVIR does not cure

viral

infection,

helps

relieve the symptoms and shorten

their duration.

The best results are obtained if

the medicine is started as soon as

possible after the first symptoms

begin to appear.

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.

EZOVIR is only available with a

doctor's

prescription.

addictive.

This

medicine

recommended for use in children

under 12 years of age.

BEFORE

YOU

TAKE

EZOVIR

When you must not take it

Do not take EZOVIR if you

have an allergy to:

famciclovir,

active ingredient

penciclovir,

related

antiviral medicine

any of the other ingredients

EZOVIR

listed

end of this leaflet

Some of the symptoms of an

allergic reaction may include:

shortness

breath,

wheezing

difficulty

breathing

swelling of the face, lips,

tongue or other parts of the

body

rash, itching or hives on the

skin.

Do

not

take

EZOVIR

after

the expiry date printed on the

pack or if the packaging is

torn

or

shows

signs

of

tampering.

In that case, return it to your

pharmacist.

Before you start to take it

Tell your doctor if you have a

problem with:

your

body's

immune

system,

which

helps

fight off infections

your kidneys

your liver

Your

doctor

want

take

extra precautions in that case.

Tell

your

doctor

if

you

are

pregnant,

intend

to

become

pregnant or if you are breast-

feeding.

EZOVIR

should

used

during

pregnancy

unless

necessary.

Your

doctor

will

discuss

with

potential

risks of taking EZOVIR during

pregnancy, and will also advise

you if you should take EZOVIR

while breast- feeding, based on

benefits

risks

your

particular situation.

Tell

your

doctor

if

you

are

allergic to any other medicines,

foods, dyes or preservatives.

Your doctor will want to know if

you are prone to allergies.

If

you

experience

an

allergic

reaction,

stop

using

the

medicine

and

inform

your

doctor

or

pharmacist

immediately.

Taking other medicines

Tell

your

doctor

if

you

are

taking

any

other

medicines,

including

any

that

you

buy

without a prescription from a

pharmacy,

supermarket

or

health food shop.

Some

medicines

EZOVIR may interfere with each

other. These include:

probenecid, a prescription

medicine used to treat gout

disease

with

painful,

swollen joints caused

uric acid crystals) and to

increase

blood

levels

penicillin-type antibiotics

raloxifene,

medicine

used to treat osteoporosis

disease

which

causes

bones

become

less

dense,

gradually

making

them weaker, more brittle

and likely to break)

medicines that can affect

your kidneys.

You may need to take different

amounts

these

medicines

you may need to take different

medicines.

Your

doctor

pharmacist

have

more

information.

If

you

have

not

told

your

doctor

about

any

of

these

things, tell him/her before you

start taking this medicine.

HOW TO TAKE EZOVIR

Swallow the tablets whole with

a full glass of water.

They

taken

with

without

food.

necessary to chew or crush the

tablet.

Follow all directions given to

you

by

your

doctor

and

pharmacist carefully.

These

instructions

differ

from the information contained

in this leaflet.

If you do not understand the

instructions on the label, ask

your doctor or pharmacist for

help.

How much to take

The usual dose is one 250 mg

tablet three times each day for

seven

days,

beginning

later

than

hours

after

rash

appears.

Your doctor may have prescribed

a different dose.

people

whose

immune

system does not work as well

should,

dose

duration of treatment may be

increased.

people

have

reduced

kidney function, the dose may be

reduced.

Follow

your

doctor's

instructions

on

how

many

EZOVIR tablets to take.

Ask your doctor or pharmacist

if you are unsure of the correct

dose for you.

They will tell you exactly how

much to take.

Follow

the

instructions

that

they give you.

When to take it

Unless your doctor tells you

otherwise,

take

one

tablet

when

you

get

up

in

the

morning,

one

in

the

afternoon and one just before

going to bed at night.

Try

to

take

the

tablets

at

about the same time each day.

How long to take it

Continue taking EZOVIR every

day for the full course of

treatment.

To help clear up your infection,

you must take the full course of

treatment,

even

your

symptoms

begin

clear

after a few days.

If you forget to take it

Take a dose as soon as you

remember.

Take

your

next

tablet at the usual time, and

then go back to taking it as

you would normally.

Do not take two doses within

a time frame of less than one

hour. In that case, skip the

missed dose.

Do not take a double dose to

make up for the one that you

missed.

This may increase the chance of

getting

unwanted

side

effect.

If

you

have

trouble

remembering

when

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 number 13 11 26),

or go to Accident and

Emergency at your nearest

hospital if you think that you

or anyone else may have taken

too

much

EZOVIR. Show them your

pack of tablets. Do this even if

there are no signs of

discomfort or poisoning. Keep

the telephone numbers for

these places handy.

Taking too much EZOVIR may

affect the kidneys. In people who

already have kidney problems it

may, rarely, lead to kidney failure

their

dose

correctly

lowered.

WHILE

YOU

ARE

TAKING

EZOVIR

Things you must do

If you become pregnant while

taking

EZOVIR,

tell

your

doctor.

Your doctor can discuss with you

the risks of taking it while you

are pregnant.

If

you

are

about

to

be

started on any new medicine,

remind

your

doctor

and

pharmacist

that

you

are

taking EZOVIR.

Tell

any

other

doctor,

dentist

or

pharmacist

who

treats

you

that

you

are

taking EZOVIR.

Things you must not do

Do

not

give

this

medicine

to

anyone

else

even

if

their

condition seems to be the same

as yours.

Do not use it to treat any other

complaints unless your doctor

tells you to.

Do not stop taking your tablets

or change the dosage without

checking

with

your

doctor

first.

stop

your

tablets

suddenly,

your

condition

worsen

have

unwanted side effects.

Things to be careful of

If you are pregnant or breast-

feeding,

ask

your

doctor

or

pharmacist for advice before

taking any medicine.

Be

careful

driving,

operating

machinery or doing jobs that

require

you

to

be

alert

until

you know how EZOVIR affects

you.

This

medicine

cause

dizziness, sleepiness or confusion

in some people.

Things

that

may

help

your

condition

Take the following precautions

to avoid spreading the virus:

Keep the areas affected by

the virus as clean and dry as

possible.

Wear

loose-fitting

clothing to avoid irritating

the rash.

Avoid

touching

scratching the sore area as

you may spread the virus on

your fingers.

SIDE EFFECTS

Tell your doctor or pharmacist

as soon as possible if you do

not

feel

well

while

you

are

taking EZOVIR.

medicines

have

side

effects.

Sometimes

they

serious, most of the time they are

not.

need

medical

treatment if you get some of the

side effects.

Do not be alarmed by these lists

of possible side effects. You may

not experience any of them. Ask

your

doctor

or

pharmacist

to

answer any questions you may

have.

Tell your doctor if you notice

any of the following and they

worry you:

headache

dizziness

nausea

(feeling

sick)

vomiting

abdominal pain

diarrhoea

itching

itchy

rash

(urticaria)

abnormal liver function

test results

above

side

effects

usually mild.

Tell

your

doctor

as

soon

as

possible if you notice any of the

following:

a rash that is separate from

the shingles rash

extreme

sleepiness

confusion, usually in older

people

hallucinations

(seeing

hearing things that are not

really there)

painful or swollen joints

aching muscles or muscle

tenderness or weakness that

is not caused by exercise.

yellowing of the skin or

eyes (signs of jaundice)

palpitations

(signs

abnormal heart beat)

The above side effects may

need medical attention.

Tell your doctor immediately

or

go

to

Accident

and

Emergency

at

your

nearest

hospital

if

any

of

the

following side effects happen:

swelling below the surface

of the skin (e.g. swelling

around the face, eye, eyelid

or throat)

unexplained

bruising,

reddish or purplish patches

skin

bleeding

more easily than usual as it

indicate

that

number of platelets (a type

of blood cell responsible for

blood

clotting)

your

blood are reduced

severe

blistering

skin

mucous

membranes

lips,

eyes,

mouth,

nasal

passages

genitals

(signs of a serious skin

reaction)

purple

patches,

itching,

burning of the skin (signs

inflamed

blood

vessels)

Seizures or fits

Difficulty

breathing

swallowing, wheezing or

cough,

light-headedness,

changes in alertness, skin

reddening,

facial/throat

swelling,

blue

discoloration of the lips,

tongue or skin (signs of

severe allergic reaction).

The above side effects are very

rare.

Tell

your

doctor

if

you

notice anything else that is

making you feel unwell.

Other side effects not listed

here or not yet known may

happen in some people.

AFTER TAKING EZOVIR

Storage

Keep

your

medicine

in

the

original container until it is time

to take it.

Store your EZOVIR tablets in a

dry place at room temperature.

Do not store your medicines in

the bathroom or near a sink.

Do not leave the tablets in the

car or on window sills.

Heat and dampness can destroy

some medicines. EZOVIR tablets

will keep best if they are stored

cool and dry.

Keep

the

medicine

where

children cannot reach it.

A locked cupboard at least one-

and-

a-half

metres

above

ground is a good place to store

medicines.

Disposal

If your doctor tells you to stop

taking

this

medicine

or

the

expiry pharmacist what to do

with

any

medicine

that

you

have left over.

PRODUCT DESCRIPTION

What it looks like

EZOVIR 250 mg tablets are

white, round, film-coated tablets,

marked with "FM" on one side

and "250" on the other. Each

carton contains 14 or 21 tablets.

Available in 3 (herpes zoster

samples), 5 (episodic genital herpes

samples), 14, 20, 21, 30, or 56

tablets. Some of pack sizes and/or

pack types may not be marketed.

EZOVIR 500 mg tablets are

white, oval, film-coated tablets

with "FM" on one side and "500"

on the other. Each carton contains

30 tablets.

Available in 3, 4, 9, 12, 14, 16, 20,

30, or 56 tablets. Some of pack sizes

and/or pack types may not be

marketed.

Ingredients

Active Ingredient

EZOVIR 250 - contain 250 mg

famciclovir per tablet.

EZOVIR 500 - contain 500 mg

famciclovir per tablet.

Inactive ingredients

All EZOVIR tablets contain

the following inactive

ingredients:

microcrystalline cellulose

crospovidone

silicone dioxide

copovidone

sodium stearylfumarate

OPADRY II complete film

coating system YS-22-18096

White

Supplier

Neo Health (OTC) Pty Ltd

Suite 3, 380 Pennant Hills Road,

Pennant Hills, NSW 2120, Australia

Australian Registration Numbers

EZOVIR:

250 mg - AUST R 343761

500 mg - AUST R 343762

This leaflet was prepared in October 2020.

Read the complete document

Version 01

AUSTRALIAN PRODUCT INFORMATION – Ezovir

(famciclovir) tablets

1 NAME OF THE MEDICINE

Famciclovir

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 125 mg, 250 mg or 500 mg of famciclovir as the active ingredient.

For the full list of excipients, see

Section 6.1 List of excipients.

3 PHARMACEUTICAL FORM

Ezovir famciclovir 125 mg Tablets are white, round, film-coated tablets, debossed with “FM”

on one side and “125” on the reverse side.

Ezovir famciclovir 250 mg Tablets are white, round, film-coated tablets, debossed with “FM”

on one side and “250” on the reverse side.

Ezovir famciclovir 500 mg Tablets are white, oval, film-coated tablets, debossed with “FM” on

one side and “500” on the reverse side.

4 CLINICAL PARTICULARS

4.1 THERAPEUTIC INDICATIONS

Ezovir

is indicated for

the treatment of herpes zoster infection in adult patients who commence therapy within

72 hours of the onset of rash. Greatest benefit occurs if the drug is started within 48

hours. Efficacy has not been demonstrated in patients less than 50 years of age, although

the occasional younger patient with severe herpes zoster may benefit from therapy with

famciclovir. Herpes zoster infection is generally a milder condition in younger patients.

the treatment of recurrent episodes of genital herpes in adults and adolescents 12 years

of age and older.

suppression of recurrent genital herpes.

treatment of recurrent herpes labialis (cold sores) in immunocompetent adult patients.

Ezovir is also indicated in immunocompromised patients for:

treatment of uncomplicated herpes zoster

treatment of recurrent herpes simplex

suppression of recurrent herpes simplex

Version 01

4.2 DOSE AND METHOD OF ADMINISTRATION

Famciclovir can be taken without regard to meals (se Section 5.2 Pharmacokinetic Properties-

Effect of Food.

Immunocompetent

Herpes zoster:

The recommended dosage of Ezovir is 250 mg three times daily for seven days. Treatment

should be initiated as soon as possible after herpes zoster is diagnosed. Studies have shown

famciclovir to be of benefit when started within 72 hours of the onset of rash. Greatest

benefit occurs if famciclovir is started within 48 hours.

Recurrent genital herpes infections (HSV):

The recommended dosage is either:

125 mg twice each day for 5 days or

(ii)

500 mg statim, then 250 mg 12 hourly for 3 doses or

(iii)

1000 mg twice daily for 1 day.

Initiation of treatment is recommended during the prodromal period or as soon as possible

after onset of lesions.

Suppression of recurrent genital herpes (HSV):

The recommended dose for the suppression of recurrent genital herpes is 250 mg twice daily.

As studies conducted to date have not extended beyond 12 months, therapy should be re-

evaluated after this period in order to observe possible changes in the natural history of the

disease.

Recurrent herpes labialis (cold sores):

The recommended dosage is 1500 mg as a single dose or 750 mg twice daily at 12 hourly

intervals for one day [see

Section 5.1 Pharmacodynamic Properties - Clinical Trials

herpes labialis (cold sores

)”]. Initiate therapy at the earliest sign or symptom of a cold sore

(e.g. tingling, itching or burning).

Treatment was initiated within 1 hour of symptom onset in the recurrent herpes labialis

clinical study.

Immunocompromised

Herpes zoster:

The recommended dosage of Ezoviris 500 mg three times daily for ten days. Initiation of

treatment is recommended as soon as possible after rash onset. Studies have shown

famciclovir to be of benefit when started within 72 hours of the onset of rash.

Version 01

Recurrent HSV infections:

For treating herpes simplex infections in immunocompromised adults, the recommended dose

is 500 mg twice daily for seven days.

Initiation of treatment is recommended during the prodromal period or as soon as possible

after onset of lesions.

Suppression of recurrent genital herpes (HSV) in HIV:

For suppression of recurrent genital herpes infections, a dose of 500 mg twice a day has been

shown to be efficacious in HIV patients.

Renal impairment

As reduced clearance of penciclovir is related to reduced renal function, as measured by

creatinine clearance, special attention should be given to dosages in patients with impaired

renal function. The following modifications in dosage are recommended:

Immunocompetent

For the treatment of herpes zoster infection:

Creatinine Clearance (mL/min/1.73m

Dosage

No dosage adjustment necessary

10 - 29

250 mg / 24 hours

For the treatment or suppression of recurrent genital herpes infections:

5-day treatment

Creatinine Clearance (mL/min/1.73m

Dosage

No dose adjustment necessary

10 - 29

125 mg / 12 hours

1-day treatment

Creatinine Clearance (mL/min/1.73m

Dosage

No dose adjustment necessary

40 -59

500 mg / 12 hours

20 -39

500 mg / 24 hours

< 20

250 mg / 24 hours

For the treatment of recurrent herpes labialis:

Creatinine Clearance (mL/min/1.73m

Dosage

No dose adjustment necessary

40 - 59

750 single dose

20 - 39

500 single dose

10 - 20

250 single dose

for patients on haemodialysis

250 single dose

Version 01

Immunocompromised

For the treatment of herpes zoster infection:

Creatinine Clearance (mL/min/1.73m

Dosage

No dose adjustment necessary

30 - 49

250 mg / 8 hours

10 - 29

250 mg / 24 hours

For the treatment of recurrent herpes simplex infections:

Creatinine Clearance (mL/min/1.73m

Dosage

No dose adjustment necessary

30 - 49

250 mg / 12 hours

10 - 29

125 mg / 24 hours

For suppression of genital herpes infections:

Creatinine Clearance (mL/min/1.73m

Dosage

No dose adjustment necessary

30 - 49

250 mg / 12 hours

10 - 29

125 mg / 12 hours

As these recommendations are not based on repeated dose data, patients with impaired renal

function should be closely monitored for adverse effects. There are insufficient data to

recommend a dosage for patients with creatinine clearance less than 10 mL/min/1.73m

For a patient on haemodialysis, who has been prescribed famciclovir for conditions other than

herpes labialis, a dosage interval of 48 hours is recommended for periods between dialysis.

Since 4 hours of haemodialysis results in approximately 75 % reduction in plasma

concentrations of penciclovir, the full adjusted dose (for patients with severe renal

impairment) of

famciclovir should be administered immediately following dialysis.

Hepatic impairment

Dosage modification is not required for patients with well compensated hepatic impairment.

Black patients with recurrent genital herpes

A placebo-controlled study in immunocompetent Black patients with recurrent genital herpes

showed no difference in efficacy between patients receiving famciclovir 1 g b.i.d. for 1 day

and placebo. There were no unexpected or new safety findings in this trial in Black patients.

The relevance of these study results to other indications in Black patients is unknown (see

Section 5.1 Pharmacological Properties – Clinical Trials and Section 5.2

Pharmacokinetic Properties

4.3 CONTRAINDICATIONS

Ezovir is contraindicated in patients with known hypersensitivity to famciclovir or other

constituents of Ezovir.

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It is also contraindicated in those patients who have shown hypersensitivity to penciclovir, the

active metabolite of famciclovir.

4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Efficacy has not been studied in ophthalmic zoster, chicken pox or zoster encephalomyelitis

patients.

Use in Hepatic Impairment

No special precautions are

required for elderly patients with normal renal function and

patients with mild or moderate hepatic impairment. Famciclovir has not been studied in

patients with severe hepatic

impairment. Conversion of famciclovir to the active metabolite

penciclovir may be impaired

in these patients resulting in lower penciclovir plasma

concentrations, and thus possibly a

decrease of efficacy of famciclovir (see

Section 5

Pharmacological Properties

Genital herpes is a sexually transmitted disease. The risk of transmission is increased during

acute episodes. Patients should be advised to use condoms between episodes to reduce the

risk of transmission and to avoid sexual intercourse when symptoms are present, even if

treatment with an antiviral has been initiated. Genital herpes can also be transmitted in the

absence of symptoms through asymptomatic viral shedding. Therefore, in addition to therapy

with famciclovir, it is recommended that patients use “safer sex” practices.

Use in Renal Impairment

Special attention should be paid to patients with impaired renal function and dosage

adjustment may be necessary. Appropriate dosage adjustments for renally impaired patients

are provided (see

Section 4.2 Dose and Method of Administration

Paediatric Use

Safety and efficacy in children has not been established.

Use in the Elderly

No special precautions are required for elderly patients with normal renal function and well-

compensated hepatic impairment.

Effects on Laboratory Tests

No data available.

4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF

INTERACTIONS

Effects of other medicinal products on famciclovir

No clinically significant interactions have been identified with famciclovir or penciclovir.

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Probenecid:

Concurrent use of Probenecid may result in increased plasma concentrations of penciclovir

(active metabolite of famciclovir, see

Section 5 Pharmacological Properties).

Other drugs that affect renal physiology:

could affect plasma levels of penciclovir (the

active metabolite of famciclovir, see

Section 5 Pharmacological Properties).

Evidence from preclinical studies has shown no potential for induction of cytochrome P450.

Zidovudine:

In a phase I study, no significant drug interactions were observed after coadministration of

zidovudine and famciclovir.

The conversion of the inactive metabolite 6-deoxy penciclovir to penciclovir is catalysed by

aldehyde oxidase. Interactions with other drugs metabolized by this enzyme and/or inhibiting

this enzyme could potentially occur. Clinical interaction studies of famciclovir with

cimetidine and promethazine,

in vitro

inhibitors of aldehyde oxidase, did not show relevant

effects on the formation of penciclovir. However, raloxifene, the most potent aldehyde

oxidase inhibitor observed

in vitro

, could affect the formation of penciclovir and thus the

efficacy of famciclovir. When raloxifene is co-administered with famciclovir, the clinical

efficacy should be monitored.

Effects of famciclovir on other medicinal products

Although famciclovir is only a weak inhibitor of aldehyde oxidase

in vitro

, interactions with

drugs metabolized by aldehyde oxidase could potentially occur. Evidence from preclinical

studies has shown no potential for induction of cytochrome P450 enzymes or inhibition of

CYP3A4.

4.6 FERTILITY, PREGNANCY AND LACTATION

Effects on fertility

Testicular toxicity was observed in rats, mice and dogs following repeated administration of

famciclovir or penciclovir. Testicular changes included atrophy of seminiferous tubules,

reduction in sperm count and/or increased incidence of sperm with abnormal morphology or

reduced motility. The degree of testicular toxicity was related to dose and duration of

exposure and tended to reverse after the cessation of dosing. In male rats, decreased fertility

was observed after 10 weeks dosing at 500 mg/kg/day, or approximately 3 to 20 times the

human systemic exposure (AUC). Testicular toxicity was also seen in mice and dogs

following chronic administration at exposures to penciclovir ranging from 2 to 14 times the

human systemic exposure (AUC). However, there were no clinically significant effects on

sperm count, morphology and motility in male patients receiving 250 mg famciclovir b.i.d.

for 18 weeks. Famciclovir had no effect on fertility in female rats at doses of up to

1000 mg/kg/day, approximately 4 to 27 times the human systemic exposure (AUC).

Use in Pregnancy (Category B1)

Famciclovir was tested for effects on embryo-foetal development in rats and rabbits at oral

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doses up to 1000 mg/kg/day (approximately 4 to 27 times and 2 to 12 times the human

systemic exposure to penciclovir in rats and rabbits, respectively [AUC]), and intravenous

doses of 360 mg/kg/day in rats (1.9 to 12 times the human dose based on body surface area

[BSA] comparisons) or 120 mg/kg/day in rabbits (1.2 to 7.1 times the human dose [BSA]). No

adverse effects were observed on embryo-foetal development. Similarly, no adverse effects

were observed following intravenous administration of penciclovir to rats (80

mg/kg/day,

0.4 to 2.6 times the human dose [BSA]) or rabbits (60 mg/kg/day, 0.6 to 3.6 times the human

dose [BSA]). Although animal studies have not shown any embryotoxic or teratogenic effects

with famciclovir or penciclovir (the active metabolite of famciclovir), the

safety of famciclovir

in human pregnancy has not been established. Famciclovir should therefore not be used during

pregnancy unless the potential benefits are considered to outweigh the potential risks

associated with treatment.

Use in Lactation

Famciclovir should not be used by nursing mothers unless the potential benefits are

considered to outweigh the potential risks associated with treatment

.

Following oral

administration of famciclovir to lactating rats, penciclovir was excreted in milk at

concentrations higher than those seen in plasma

.

There is no information on excretion in

human milk.

4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Patients who experience dizziness, somnolence, confusion or other central nervous system

disturbances while taking Ezovir should refrain from driving or operating machinery.

4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)

Famciclovir has been well tolerated in human studies. Headache, fatigue and nausea have

been reported in clinical trials. These were generally mild or moderate and occurred at a

similar incidence in patients receiving placebo treatment. Confusion, predominantly in the

elderly, has been reported rarely.

Table 1:

Adverse Events (related, possibly related, unassessable or unknown)

reported by

1% of immunocompetent subjects during clinical trials:

Adverse Event

Famciclovir

(n=3996)

Placebo (n=880)

Headache

5.3 %

4.8 %

Nausea

4.6 %

4.5 %

Dizziness

1.5 %

1.5 %

Diarrhoea

1.5 %

1.3 %

Fatigue

1.2 %

0.9 %

Abdominal pain

1.1 %

1.3 %

Vomiting

1.1 %

0.5 %

Somnolence

0.6 %

1.1 %

Table 2:

Adverse Events (related, possibly related, unassessable or unknown)

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reported by

1% of immunocompetent subjects during clinical trials in Herpes labialis:

Adverse Event

Famciclovir 1500 mg

q.d. N=227

N (%)

Famciclovir 750 mg

b.i.d. N=220

N (%)

Placebo

N=254

N (%)

Patients with AE(s)

63 (27.8)

54 (24.5)

53 (20.9)

AE preferred

term

Headache

22 (9.7)

16 (7.3)

17 (6.7)

Diarrhoea

4 (1.8)

3 (1.4)

2 (0.8)

Nausea

5 (2.2)

5 (2.3)

10 (3.9)

Nasopharyngitis

6 (2.6)

3 (1.4)

2 (0.8)

Table 3:

Adverse Events (related, possibly related, unassessable or unknown)

reported by

1% of immunocompetent subjects during the clinical

trial comparing the 2-day and 5-day recurrent genital herpes

treatments

a

Adverse Event

Famciclovir 2-day course

(n=521 recurrences)

N (%)

Famciclovir 5-day course

(n=517 recurrences)

N (%)

Recurrences with

1 AE(s)

185 (35.5)

176 (34.0)

No. of AEs

MedDRA preferred term

Headache

83 (15.9)

94 (18.2)

Nausea

15 (2.9)

22 (4.3)

Diarrhoea

12 (2.3)

16 (3.1)

Abdominal pain

12 (2.3)

5 (1.0)

Dizziness

10 (1.9)

10 (1.9)

Fatigue

9 (1.7)

13 (2.5)

Where:2-day course:

2-day famciclovir regimen (500 mg loading dose then 250 mg 12-

hourly)

5-day course:

5-day famciclovir regimen (125 mg 12-hourly)

On or for 4 days after date of starting study medication

The denominator is the number of recurrences in the safety recurrence population for

each treatment group

If a patient had more than 1 recurrence of a specific AE during a recurrence, the AE is counted

only once for that recurrence

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Table 4:

Adverse Events (related, possibly related, unassessable or unknown)

reported by

1% of immunocompetent subjects during a clinical trial of 1 g b.i.d. for 1

day vs placebo in recurrent genital herpes

Adverse Event

Famciclovir (n=163)

N (%)

Placebo (n=166)

N (%)

Patients with AE(s)

43 (26.4)

40 (24.1)

AE preferred term

Headache

22 (13.5)

9 (5.4)

Diarrhoea

8 (4.9)

2 (1.2)

Nausea

4 (2.5)

6 (3.6)

Insomnia

3 (1.8)

2 (1.2)

Dysmenorrhoea

3 (1.8)

1 (0.6)

Pharyngolaryngeal pain

3 (1.8)

1 (0.6)

Back pain

2 (1.2)

1 (0.6)

Anxiety

2 (1.2)

Dry mouth

2 (1.2)

Palpitations

2 (1.2)

Stomach Discomfort

2 (1.2)

1 (0.6)

Vomiting

2 (1.2)

1 (0.6)

Abdominal pain upper

1 (0.6)

4 (2.4)

Dizziness

4 (2.4)

Abdominal pain

2 (1.2)

Fungal infection

2 (1.2)

Nasopharyngitis

2 (1.2)

Table 5:

Adverse Events reported by

5% of patients receiving Famciclovir

500 mg daily or placebo for >10 months

Adverse Event

Famciclovir (n=154)

Placebo (n=63)

Headache

37.7 %

42.9 %

URTI

31.8 %

31.7 %

Infection (viral)

24.7 %

25.4 %

Injury

18.8 %

23.8 %

Sinusitis

19.5 %

15.9 %

Back pain

12.3 %

14.3 %

Pharyngitis

11.0 %

14.3 %

7.1 %

4.8 %

Dyspepsia

5.2 %

11.1 %

Famciclovir has also been well tolerated in immunocompromised patients. Adverse

effects

reported from clinical studies were similar to those reported in the immunocompetent

population.

Post-marketing Data

In addition to the adverse events reported in the clinical trials, the following Adverse

reactions (Table 6) have been reported in post-marketing surveillance. They are ranked under

headings of frequency, according to the following convention: very common (

1/10);

common (

1/100, < 1/10); uncommon (

1/1,000, <1/100); rare (

10,000, < 1/1,000); very

rare (<1/10,000), including isolated reports.

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Table 6:

Adverse Events reported by patients receiving Famciclovir

Blood and lymphatic system disorders

Very rare

Thrombocytopenia

Psychiatric disorders

Uncommon

Confusional state (predominantly in the elderly)

Rare

Hallucinations

Nervous system disorders

Very common :

Headache

Common

Dizziness

Uncommon

Somnolence (predominantly in the elderly)

Not known : Seizure

Cardiac disorders

Rare

Palpitations

Gastrointestinal disorders

Common

Vomiting, nausea, abdominal pain, diarrhoea

Hepatobiliary disorders

Common

Liver function test abnormal

Rare

Jaundice cholestatic

Immune system disorders

Not known : Anaphylactic shock, anaphylactic reaction

Skin and subcutaneous tissue disorders

Common

Rash, pruritus

Uncommon

Angioedema (e.g. face oedema, eyelid oedema, periorbital oedema,

pharyngeal oedema), urticaria

Very rare

Serious skin reactions (e.g. erythema multiforme, Stevens-Johnson

syndrome, toxic epidermal necrolysis)

Not known

Hypersensitivity vasculitis

Musculoskeletal disorders

Very rare:

arthralgia, myalgia

Reporting Suspected Adverse Effects

Reporting suspected adverse reactions after registration of the medicinal product is important. It

allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-

problems.

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4.9 OVERDOSE

Symptomatic and supportive therapy should be given as appropriate. Acute renal failure has

been reported rarely in patients with underlying renal disease. The famciclovir dosage in

these patients had not been appropriately reduced for the level of renal function.

Penciclovir, the active metabolite of famciclovir, is dialysable; plasma concentrations are

reduced by approximately 75% following 4 hours of haemodialysis.

For information on the management of overdose, contact the Poisons Information Centre on 13

11 26 (Australia).

5 PHARMACOLOGICAL PROPERTIES

5.1 PHARMACODYNAMIC PROPERTIES

Mechanism of Action

Pharmacotherapeutic group: Oral antiviral agent, ATC code: JO5A B09

Virology

Famciclovir is the oral form of the antiviral compound: penciclovir. Famciclovir is rapidly

converted

in vivo

into penciclovir, which has demonstrable

in vitro

activity against herpes

simplex viruses (HSV types 1 and 2) and varicella zoster virus (VZV). The antiviral effect of

orally administered famciclovir has been demonstrated in several animal models: this effect is

due to

in vivo

conversion to penciclovir

.

Penciclovir targets virus-infected cells where it is rapidly converted into penciclovir-

triphosphate (mediated via virus-induced thymidine kinase). The triphosphate inhibits viral

DNA polymerase by competition with deoxyguanosine triphosphate and is incorporated into

the extending DNA chain, preventing significant chain elongation. Consequently, viral DNA

synthesis and, therefore, viral replication are inhibited.

This triphosphate persists in infected cells in excess of 12 hours. The long intracellular half-

life of penciclovir triphosphate ensures prolonged antiviral activity, as demonstrated in cell

cultures with HSV-1 and HSV-2 and in animal studies.

Penciclovir is only readily phosphorylated in virus-infected cells

.

In uninfected cells treated

with penciclovir, concentrations of penciclovir-triphosphate are only barely detectable.

Accordingly, uninfected cells are unlikely to be affected by therapeutic concentrations of

penciclovir.

The most common form of resistance encountered with aciclovir among HSV strains is a

deficiency in the production of the thymidine kinase (TK) enzyme. Such TK deficient strains

would be expected to be cross-resistant to both penciclovir and aciclovir. However,

penciclovir has been shown to be active against a clinically isolated aciclovir-resistant herpes

simplex type 1 strain with an altered DNA polymerase.

The results from penciclovir and famciclovir patient studies, including studies of up to four

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months’ treatment with famciclovir, showed that no resistance occurred as a result of

treatment with either famciclovir or penciclovir. Penciclovir-resistant isolates were found at

the start of treatment or in the placebo groups in 0.25% of the 1976 total isolates from HSV

and VZV (5/1976), and in 0.19% of the 533 virus isolates from immunocompromised patients

(1/533).

CLINICAL TRIALS

Herpes Zoster

Placebo-controlled trial

Famciclovir was studied in a placebo-controlled, double-blind trial of 419 otherwise healthy

patients with uncomplicated herpes zoster who were treated with famciclovir 500 mg t.i.d.

(n=138), famciclovir 750 mg t.i.d. (n=135) or placebo (n=146). Treatment was begun within

72 hours of initial lesion appearance and therapy was continued for 7 days.

Dermatology and virology: The times to full crusting, loss of vesicles, loss of ulcers and loss

of crusts were shorter for famciclovir 500 mg-treated patients than for placebo-treated patients

the overall study population. The median time to full crusting in famciclovir 500 mg-

treated patients was 5 days compared to 7 days in placebo-treated patients. No additional

efficacy

was demonstrated with the higher dose of famciclovir (750 mg t.i.d.) when compared

to famciclovir 500 mg t.i.d. In the total population, 65.2% of patients had a positive viral

culture at some time during their acute infection. Patients treated with famciclovir 500 mg had

a shorter median duration of viral shedding (time to last positive viral culture) than did

placebo-treated

patients (1 day and 2 days, respectively).

Acute pain and postherpetic neuralgia: There were no overall differences in the duration of

acute pain (i.e. pain before rash healing) between famciclovir and placebo-treated groups. In

addition, there was no difference in the incidence of postherpetic neuralgia (i.e. pain after rash

healing) between the treatment groups. In the 186 patients (44.4% of total study population)

who did develop postherpetic neuralgia, the median duration of postherpetic neuralgia was

shorter in patients treated with famciclovir 500 mg than in those treated with placebo (63 days

and 119 days, respectively).

Active-control trial

A second double-blind controlled trial in 545 otherwise healthy patients with uncomplicated

herpes zoster treated within 72 hours of initial lesion appearance compared famciclovir 250 mg

t.i.d. (n=134), famciclovir 500 mg t.i.d. (n=134), famciclovir 750 mg t.i.d. (n=138) and

aciclovir 800 mg 5 times per day (n=139) for 7 days. In this study, patients treated with

famciclovir at each dose and aciclovir had comparable times to full lesion crusting and times to

loss of acute pain. There were no statistically significant differences in the time to loss of

postherpetic

neuralgia between famciclovir and aciclovir-treated groups.

Higher doses of famciclovir (500 mg t.i.d.; 750 mg t.i.d.) have not been shown to confer

greater benefit. The minimum effective dose of famciclovir in the treatment of herpes zoster

has not been established.

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Immunocompromised

A double-blind, controlled clinical trial was conducted in 148 oncology and transplant

patients with herpes zoster infections who received famciclovir 500 mg t.i.d. (n=71) or

aciclovir 800 mg 5 times per day (n=77) for 10 days. Patients started study medication

within 72 hours of rash onset. Overall famciclovir and aciclovir showed comparable efficacy.

The median times to full crusting and complete healing were 8 and 20 days for the

famciclovir group and 9 and 21 days for the aciclovir group. The median times to loss of all

pain were 14 and 17 days for the famciclovir and aciclovir groups, respectively. Withdrawal

due to dissemination of zoster and

continued new lesion formation beyond 10 days of onset

was reported in 7% of the famciclovir group and 9% of the aciclovir group.

Genital Herpes

Placebo-controlled trials (episodic therapy)

5-day treatment:

In two double-blind, placebo-controlled trials, 626 otherwise healthy

patients with a recurrence of genital herpes were treated with famciclovir 125 mg b.i.d.

(n=160), famciclovir 250 mg b.i.d. (n=169), famciclovir 500 mg b.i.d. (n=154) or placebo

(n=143) for 5 days. Treatment was initiated within 6 hours of either symptom onset or lesion

appearance. In the

two studies combined, the median time to healing in famciclovir 125 mg-

treated patients was 4 days compared to 5 days in placebo-treated patients. The median time

to cessation of viral shedding was 1.8 vs 3.4 days in famciclovir 125 mg and placebo

recipients, respectively. The median time to loss of all symptoms was 3.2 days in famciclovir

125 mg-treated patients vs. 3.8 days in placebo-treated patients. When used to treat acute

recurrent genital herpes, no additional efficacy was demonstrated with higher doses of

famciclovir (250 mg b.i.d. or 500 mg b.i.d.) when compared to famciclovir 125 mg b.i.d.

over 5 days.

1-day treatment:

In one double-blind, placebo-controlled trial, 329 immunocompetent

patients with a recurrence of genital herpes were treated with famciclovir 1 g b.i.d. (n=163) or

placebo (n=166) for 1 day. Treatment was initiated within 6 hours of either symptom onset or

lesion appearance. Among patients with non-aborted lesions, the median time to healing in

famciclovir 1 g-treated patients (n=125) was 4.3 days compared to 6.1 days in placebo-treated

patients (n=145). The median difference in time to healing between the placebo- and

famciclovir-

treated groups was 1.2 days (95 % CI: 0.5 – 2.0). 23 % of famciclovir-treated

patients had aborted lesions (no development beyond erythema) compared to 13 % in

placebo-treated patients. The median time to loss of all symptoms (e.g., burning, itching,

pain, tenderness, tingling), was 3.3 days in famciclovir-treated patients vs. 5.4 days in

placebo-treated patients.

In one, randomized (2:1), double-blind, placebo-controlled, double-blind study to assess the

safety and efficacy of patient-initiated, single-day treatment, 304 black immunocompetent

patients with recurrent genital herpes were treated with famciclovir 1 g b.i.d. (n= 206) or

placebo (n=98) 1 g b.i.d. The study was conducted in 43 centres in the USA and South Africa,

in patients with a history of at least four recurrences of genital herpes in the past 12 months and

laboratory confirmation of HSV-2 infection. The median time to healing among patients with

non-aborted lesions was 5.4 days in famciclovir-treated patients (n=152) as compared to

4.8 days in placebo-treated patients (n=78). The median difference in time to healing between

placebo and famciclovir-treated groups was -0.26 days (95% CI: -0.98 – 0.40). There were

no unexpected or new safety findings in this trial.

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Active-control trial (episodic therapy)

2-day treatment:

In a randomised, double-blind, non-inferiority, multi-centre study (59 sites

in Australia and 7 in Canada), famciclovir 500 mg statim then 250 mg bd for 2 days (short-

course) was compared to the standard regimen of 125 mg bd for 5 days in the treatment of

adult patients with recurrent genital herpes. HIV-infected patients were eligible if

CD4 ≥ 500 cells/µL and/or CD4% ≥ 25%.

The study was designed to treat and follow each eligible patient for two complete and

consecutive recurrences. A total of 1038 recurrences occurred in 616 patients that were

randomised and treated. Treatment was initiated by patients within 12 hours of development

of a lesion or onset of symptoms.

Patients attended for assessment within 24 hours and then 5.5 days following initiation of

treatment. A daily diary was used to record treatment compliance, progression of lesions and

symptoms, functional impact and side effects from the treatment.

The primary endpoint was the estimated probability of being not lesion-free at 5.5 elapsed

days (132 hours) after patient self-initiation of therapy. The estimated probability was 24.4%

for recurrences treated with the 2-day regimen and was 27.6 % for recurrences treated with

the 5-day regimen. The upper one-sided 97.5% confidence limit of the treatment difference

was 1.7 % which was within the pre-defined margin for claiming non-inferiority. Non-

inferiority was maintained in five sensitivity analyses, confirming a robust result.

Over the course of treatment, there were no differences between the mean symptom and

functional

impact

scores

either

famciclovir

short-course

standard-course

treatment groups.

The study concluded that the 2-day famciclovir regimen was equivalent to the 5-day regimen

in the treatment of adult patients with recurrent genital herpes.

Placebo-controlled trials (suppressive therapy)

In two placebo controlled suppression studies, immunocompetent patients (n=934) with at

least

six recurrences of genital herpes per year received 125 mg t.i.d. (n=233), 250 mg b.i.d. (n=236),

250 mg t.i.d. (n=232) or placebo (n=233) for 52 weeks. Treatment was initiated during an

asymptomatic period. Among those who received famciclovir 250 mg b.i.d., the proportion of

patients who remained free from virologically confirmed recurrence at the 12

month end point

was 68% in one trial and 72% in the second trial compared with approximately 21% in the

placebo groups. Median days to first clinically confirmed

recurrence for the famciclovir 250 mg

b.i.d. treatment groups were >365 days for the famciclovir 250 mg b.i.d. treatment groups

compared to 67 days for the placebo treated group in one of the studies and 336 days for the

famciclovir groups compared to 47 days for the placebo group in the second study.

Immunocompromised

A randomised, double-blind controlled trial in 293 HIV-infected patients with a recurrence of

genital herpes compared famciclovir 500 mg b.i.d. (n=150) and aciclovir 400 mg 5 times per

day (n=143) for 7 days. Treatment was initiated within 48 hours of lesion onset.

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Famciclovir and aciclovir were equally effective in prevention of new lesion formation while

patients were receiving treatment. Efficacy in the three main time to event parameters were

also comparable. The median times to complete healing of lesions, cessation of viral shedding

and loss of lesion pain were 7 days, 2 days and 3 days for both the famciclovir and aciclovir

treatment groups, respectively.

A further double-blind, placebo-controlled crossover study was conducted in 48 patients with

HIV to assess famciclovir (500 mg b.i.d.) in the suppression of HSV recurrence for 8 weeks.

Famciclovir showed statistically significant superiority over placebo in the efficacy

parameters

measured. There was an approximate 10-fold reduction in the percentage of

days with HSV shedding (p=0.0003) and a 6.7-fold reduction in the proportion of patients

with HSV

shedding from anogenital sites (p=0.0065) in the famciclovir treated group.

There was also an 8.7-fold reduction in the proportion of patients with HSV shedding from

any site. Overall in

the famciclovir group, the proportion of days of asymptomatic,

symptomatic, subclinical or lesional HSV shedding from any site was significantly reduced

compared to placebo (p=0.0012).

In the famciclovir treatment group there was a 2.6-fold reduction in the percentage of days

with lesions (p=0.0101), and a 3.6-fold reduction in the percentage of days with

lesions/symptoms (p=0.0089) over the placebo group.

Herpes Labialis (Cold Sores)

Placebo-controlled trial

In one large placebo-controlled trial, 701 immunocompetent adults with recurrent herpes

labialis were treated with famciclovir 1500 mg once (n=227), famciclovir 750 mg b.i.d.

(n=220) or placebo (n=254) for 1 day. As well, patients also had to be in good general

health, aged at least 18 years, have normal renal and hepatic function, had prior pregnancy

tests if they were females of reproductive age, and have experienced 3 or more episodes of

cold sores in the preceding 12 months. Patients were required to have a history of prodromal

symptoms preceding at least 50% of the recurrent episodes, and at least 50% of these

episodes had to have progressed to the vesicular lesion stage. Women of childbearing

potential had to agree to use reliable birth control measures during the study. Pregnant or

breast-feeding women were excluded. Patients were excluded if they had received an

investigational drug in the 4 weeks prior to the study, had been previously vaccinated against

herpes, or were using a topical immunosuppressive agent on or near the face or a systemic

immunosuppressive agent within 1 month of screening. Patients were also excluded if they

were immunosuppressed due to underlying disease or concomitant treatment had a recent

history of drug or alcohol abuse, were suffering from inflammatory skin diseases (e.g. eczema

or dermatitis) that would

interfere with the assessment of lesions, or were allergic or

hypersensitive to products containing aciclovir, penciclovir, famciclovir or other nucleoside

analogs.

Patients were instructed to take the first dose of study medication within 1 hour of symptom

onset. However, some patients commenced treatment after 1 hour of onset of symptoms.

Both famciclovir regimens significantly reduced time to healing of primary vesicular herpes

labialis lesions (the primary efficacy variable) in the modified ITT population compared with

placebo. The median time to healing in famciclovir 1500 mg single-dose treated patients was

4.4 days compared to 4.0 days in famciclovir 750 mg bid and 6.2 days in placebo-treated

patients.

Version 01

This translates to treatment effects of 1.8 (CI95% 0.9, 2.7) and 2.2 (CI95% 1.3, 3.1) days,

respectively. A single 1500 mg dose of famciclovir reduced the time to resolution of pain and

tenderness (median time 1.7 days versus 2.9 days) compared with placebo and was marginally

more effective than famciclovir 750 mg b.i.d. (median time 2.1 days).

5.2 PHARMACOKINETIC PROPERTIES

Famciclovir is the oral prodrug of penciclovir. Following oral administration, famciclovir is

rapidly and extensively absorbed and converted to the antivirally active compound penciclovir.

The bioavailability of penciclovir after oral famciclovir administration is 77 %.

Mean peak

plasma concentrations (C

) of penciclovir occurred at a median time of 45 minutes following

administration of single oral doses of famciclovir (as shown in Table 7). No data is available

on the pharmacokinetics of 1500 mg famciclovir as a single dose.

Table 7:

Mean peak plasma concentrations (C

max

) of penciclovir after

administration of single oral doses of famciclovir

famciclovir single oral dose (mg)

(µg/mL)

1000

Plasma concentration-time curves of penciclovir are similar following single and repeat (b.i.d.

and t.i.d.) dosing and there is no accumulation of penciclovir on repeated dosing. Penciclovir

and its 6-deoxy precursor are poorly (<20%) bound to plasma proteins. Famciclovir is

eliminated principally as penciclovir and its 6-deoxy precursor, which are excreted in urine.

No unchanged famciclovir has been detected in urine. Tubular secretion and glomerular

filtration contribute to renal elimination of the compound. The terminal plasma half-life of

penciclovir after both single and repeat dosing with famciclovir is approximately 2.0 hours.

There is no accumulation of penciclovir on repeated dosing with famciclovir.

Effect of food

Penciclovir C

was decreased by approximately 50 % and T

was delayed by 1.5 hour

when a capsule formulation of famciclovir was administered 30 minutes after food. When

famciclovir tablets were administered 30 minutes after food, penciclovir C

was reduced by

approximately 20 % and T

was delayed by 0.75 hour. The systemic availability (AUC) of

penciclovir following either preparation was unaffected. The clinical consequences of these

effects on plasma concentration are unknown.

Characteristics in special populations

Patients with Herpes Zoster

Uncomplicated Herpes virus does not significantly alter the pharmacokinetics of penciclovir

measured after the oral administration of famciclovir.

Version 01

Renal impairment

Plasma clearance, renal clearance and plasma elimination rate constant decreased linearly

with reductions in renal function. A dosage interval adjustment is recommended for patients

with renal impairment (see

Section 4.2 Dose and Method of Administration

Hepatic impairment

Well-compensated chronic liver disease (chronic hepatitis [n=6], chronic ethanol abuse [n=8]

or biliary cirrhosis [n=1]) has no effect on the extent of availability (AUC) of penciclovir

following a single dose of 500 mg famciclovir. No dose adjustment is recommended for

patients with well-compensated hepatic impairment (see section

Section 4.2 Dose and Method

of Administration

– Hepatic impairment

” and

Section 4.4 Special Warnings and Precautions

for Use

). However, there was a 43% decrease in penciclovir mean maximum plasma

concentration and the time to maximum plasma concentration was increased by a median of

0.75 hour in patients with hepatic impairment compared to normal volunteers. The

pharmacokinetics have not been

evaluated in patients with severe uncompensated hepatic

impairment.

Elderly patients

Based on cross-study comparisons of single dose studies, the mean penciclovir AUC was

approximately 30 % higher, half-life 23 % longer and penciclovir body weight adjusted renal

clearance reduced by 19% in healthy elderly male volunteers (n=18, aged 65 to 79 years)

compared to younger volunteers. Some of this difference may be due to differences in renal

function between the two groups. No dose adjustment based on age is recommended unless

renal function is impaired (see section

Section 4.2 Dose and Method of Administration

HIV patients

Extrapolated data from a study (n=8) where famciclovir was given as a single dose resulted in

a mean AUC of 24 microgram.h/mL, which is similar to that obtained in healthy subjects.

Race

A retrospective evaluation was performed to compare the pharmacokinetic parameters obtained

in Black and Caucasian subjects after single and repeat once-daily, twice-daily, or three times-

daily administration of famciclovir 500 mg. Data from a study in healthy

volunteers (single

dose), a study in subjects with varying degrees of renal impairment (single and repeat dose)

and a study in subjects with hepatic impairment (single dose) did not indicate any relevant

differences in the pharmacokinetics of penciclovir between Black and

Caucasian subjects.

Transplant patients

In a study of allogeneic bone marrow transplant or peripheral blood stem cell transplant or

allogeneic renal transplant patients (n=21), intravenous penciclovir for one month was

followed by oral use of famciclovir. The doses of penciclovir and famciclovir were adjusted

according to creatinine clearance. During repeat dosing with famciclovir, the AUC of

penciclovir was found to be 66 microgram.h/mL in subjects with creatinine clearance greater

than 50 mL/min. No safety concerns were identified despite the higher than normal AUCs

reported, and additional dosage adjustment in renal transplant patients is not recommended.

Version 01

5.3 PRECLINICAL SAFETY DATA

Data presented below include reference to area under the plasma concentration curve (24 hour

AUC) for penciclovir in humans following the lowest and highest recommended doses for

famciclovir (i.e. penciclovir AUC of 4.5 microgram.h/mL at 125 mg b.i.d. for acute recurrent

genital herpes, and a penciclovir AUC of 27 microgram.h/mL at 500 mg t.i.d. for herpes

infections in immunocompromised patients). This is based on the assumption that the

pharmacokinetics in immunocompetent subjects are similar to the pharmacokinetics in

immunocompromised subjects, as shown in the study on HIV patients (see

Section 5.2

Pharmacokinetic Properties

). If the higher values of AUC obtained in the renal transplant

patients were used as a basis for comparison, the multiples specified here would be decreased.

Exposures in animal studies are expressed as multiples of human exposures at the highest and

lowest dosing schedules based on penciclovir AUC or body surface area.

Carcinogenicity

The carcinogenic potential of famciclovir was evaluated in 2 year dietary studies in rats and

mice. A significant increase in the incidence of mammary adenocarcinoma was seen in

female rats receiving 600 mg/kg/day. No increases in tumour incidences were reported for

male rats treated at doses of up to 240 mg/kg/day or in mice of either sex at doses of up to

600 mg/kg/day. At the no effect levels of 240 and 200 mg/kg/day in male and female rats,

the daily exposures to penciclovir based on AUC were about 40 and 29 microgram.h/mL

respectively, or approximately 1 to 8 times the human systemic exposures at 500 mg t.i.d or

125 mg b.i.d. Systemic exposures at the no effect dose in male and female mice were 65 and

46 microgram.h/mL respectively, or approximately 2 to 12 times the human systemic

exposure (AUC).

Genotoxicity

Famciclovir and penciclovir (the active metabolite of famciclovir) were tested for genotoxic

potential in a series of

in vitro

in vivo

assays. Famciclovir showed no genotoxic potential

in a series of assays for gene mutations, chromosomal damage and DNA damage. Penciclovir

was positive in the L5178Y mouse lymphoma assay for gene mutations/ chromosomal

damage, caused chromosomal aberrations in human lymphocytes

in vitro

and was positive in

a mouse micronucleus assay

in vivo

when administered IV at doses toxic to bone marrow.

6 PHARMACEUTICAL PARTICULARS

6.1 LIST OF EXCIPIENTS

Ezovir film-coated tablets contain microcrystalline cellulose, crospovidone, silicon dioxide,

copovidone, sodium stearylfumarate, OPADRY II complete film coating system YS-22-

18096 White.

6.2 INCOMPATIBILITIES

Incompatibilities were either not assessed or not identified as part of the registration of this

medicine.

6.3 SHELF LIFE

Version 01

In Australia, information on the shelf life can be found on the public summary of the Australian

Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 SPECIAL PRECAUTIONS FOR STORAGE

Store below 25°C in a dry place. Store in the original package in order to protect from

moisture. Keep out of the reach of children.

6.5 NATURE AND CONTENTS OF CONTAINER

Ezovir 125 mg :PVC/Aluminium blisters in pack sizes of 2 (not currently marketed), 10, 40, or

56 tablets.

Ezovir 250 mg :PVC/Aluminium blisters in pack sizes of 3 (herpes zoster samples), 5 (episodic

genital herpes samples), 14, 20, 21, 30, or 56 tablets.

Ezovir 500 mg :PVC/Aluminium blisters in pack sizes of 3, 4, 9, 12, 14, 16, 20, 30, or 56

tablets.

Some strengths, pack sizes and/or pack types may not be marketed.

6.6 SPECIAL PRECAUTIONS FOR DISPOSAL

In Australia, any unused medicine or waste material should be disposed of by taking it to your

local pharmacy.

6.7 PHYSICOCHEMICAL PROPERTIES

Famciclovir is a synthetic guanine derivative. It is a white to pale yellow crystalline solid.

Chemical Structure

Chemical name:

9-[4-acetoxy-3-(acetoxymethyl)but-1-yl]-2-aminopurine

Molecular weight:

321.3

Molecular formula

Version 01

CAS number

104227-87-4

7 MEDICINE SCHEDULE (POISONS STANDARD)

S4 (Prescription Only Medicine)

8 SPONSOR

Neo Health (OTC) Pty Ltd

3 Lydham Place, CASTLE HILL,

NSW, 2154

Australia

9 DATE OF FIRST APPROVAL

6 October 2020

10 DATE OF REVISION

06/10/2020

Read the complete document

Public Summary

Summary for ARTG Entry:

343761

EZOVIR famciclovir 250 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Neo Health (OTC) Pty Ltd

Postal Address

3 Lydham Place, CASTLE HILL, NSW, 2154

Australia

ARTG Start Date

13/10/2020

Product Category

Medicine

Status

Active

Approval Area

Drug Safety Evaluation Branch

Conditions

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

Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods on

the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to substantiate and

support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription Medicines Authorisation

Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

The conditions applying to these goods when they are exported from Australia are given below:

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, other than condition No. 8 and condition No. 9.

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, other than condition No.11

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.

The therapeutic goods grouped in this registration/listing as export only goods under the following names are included in the Australian Register of

Therapeutic Goods and may not be supplied in Australia. Export Name(s) to be added:

Products

1 . EZOVIR famciclovir 250 mg tablet blister pack

Product Type

Single Medicine Product

Effective Date

13/10/2020

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Famciclovir is indicated for the treatment of herpes zoster infection in adult patients who commence therapy within 72 hours of the onset of rash. Greatest

benefit occurs if the drug is started within 48 hours.,Efficacy has not been demonstrated in patients less than 50 years of age, although the occasional

younger patient with severe herpes zoster may benefit from therapy with famciclovir. Herpes zoster infection is generally a milder condition in younger

patients.

Famciclovir is also indicated for the treatment of recurrent episodes of genital herpes in adults and adolescents 12 years of age and older.,Famciclovir is

also indicated for suppression of recurrent genital herpes.,Famciclovir is also indicated for the treatment of recurrent herpes labialis (cold sores) in

immunocompetent adult patients.,Famciclovir is also indicated in immunocompromised patients for:

· treatment of uncomplicated herpes zoster

· treatment of recurrent herpes simplex

· suppression of recurrent herpes simplex

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Public Summary

Page 1 of

Produced at 12.01.2021 at 02:21:09 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

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

5 tablets

(S4) Prescription Only Medicine

3 tablets

(S4) Prescription Only Medicine

56 tablets

(S4) Prescription Only Medicine

20 tablets

(S4) Prescription Only Medicine

14 tablets

(S4) Prescription Only Medicine

21 tablets

(S4) Prescription Only Medicine

Components

1 . EZOVIR famciclovir 250 mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, round, coated tablets debossed with FM on one side and 250 on the other side.

Active Ingredients

famciclovir

250 mg

Other Ingredients (Excipients)

copovidone

crospovidone

hypromellose

macrogol 8000

microcrystalline cellulose

polydextrose

silicon dioxide

sodium stearylfumarate

titanium dioxide

triethyl citrate

© 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 2 of

Produced at 12.01.2021 at 02:21:09 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

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