AURO-FAMCICLOVIR 125 famciclovir 125 mg tablets blister pack

Main information

  • Trade name:
  • AURO-FAMCICLOVIR 125 famciclovir 125 mg tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AURO-FAMCICLOVIR 125 famciclovir 125 mg tablets blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 195180
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

195180

AURO-FAMCICLOVIR 125 famciclovir 125 mg tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Aurobindo Pharma Australia Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088

Australia

ARTG Start Date

19/02/2013

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

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

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

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

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

Products

1. AURO-FAMCICLOVIR 125 famciclovir 125 mg tablets blister pack

Product Type

Single Medicine Product

Effective date

14/08/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

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 in immunocompromised patients for:-

treatment of uncomplicated herpes zoster, - treatment of recurrent herpes simplex, - suppression of recurrent herpes simplex

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. AURO-FAMCICLOVIR 125 famciclovir 125 mg tablets blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to pale yellow colored, round film-coated, biconvex tablets with

beveled edges, debossed with 'X' on one side and '48' on the other side

Active Ingredients

Famciclovir

125 mg

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

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

Public Summary

Page 1 of

Produced at 28.11.2017 at 05:06:57 AEDT

This is not an ARTG Certificate document.

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

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

AURO-FAMCICLOVIR

CONSUMER MEDICINE INFORMATION

Ver 1.4

Page 1 of 5

AURO-FAMCICLOVIR 125, 250 & 500

Famciclovir

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions

about

AURO-

FAMCICLOVIR.

It does not contain all the available

information.

does

take

place of talking to your pharmacist

or doctor.

medicines

have

risks

benefits. Your pharmacist or doctor

have weighed the risks of you taking

AURO-FAMCICLOVIR 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

AURO-FAMCICLOVIR

is used for

Shingles

AURO-FAMCICLOVIR

antiviral

medicine

that

used

treat

shingles

adults

adolescents.

Shingles is a condition that is caused

herpes

virus

called

varicella

zoster,

same

virus

that

causes

chicken pox. The virus can become

active again in the body, even after

many

years,

resulting

shingles,

The main symptom is a rash that can

cause pain, burning and blisters.

Although

AURO-FAMCICLOVIR

does not cure the viral infection, it

helps to relieve the symptoms and

shorten their duration.

The best results are obtained if the

medicine

started

soon

possible

after

first

symptoms

begin to appear.

Genital herpes

AURO-FAMCICLOVIR is used to

treat outbreaks of genital herpes and

also to suppress (prevent) recurrent

outbreaks of the condition.

Genital

herpes

a viral

infection

caused by herpes simplex 1 or herpes

simplex 2. It is usually transmitted

through sexual contact.

Symptoms include tingling, burning

or itching of the genitals, followed

by blisters that may be painful.

People who have frequent episodes

genital

herpes

also

take

AURO-FAMCICLOVIR

help

prevent the attacks.

Taking

AURO-FAMCICLOVIR

does not prevent you from spreading

the 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.

AURO-FAMCICLOVIR

only

available

with

doctor's

prescription. It

is not addictive.

AURO-FAMCICLOVIR

recommended

children

under 12 years of age.

Before you take

AURO-FAMCICLOVIR

When you must not take it

Do

not

take

AURO-

FAMCICLOVIR

if

you have

an

allergy to:

famciclovir, the active ingredient

penciclovir,

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 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.

that

case,

return

your

pharmacist.

Before you start to take it

Tell your doctor if:

have

problem

with

your

body's

immune

system,

which

helps to fight off infections

have

problem

with

your

kidneys or liver

Your doctor may want to take extra

precautions in that case.

Tell

your

doctor

if

you

are

pregnant,

intend

to

become

pregnant

or

if

you

are

breast

feeding.

AURO-FAMCICLOVIR should not

used

during

pregnancy

unless

necessary. Your doctor will discuss

with you the potential risks of taking

AURO-FAMCICLOVIR

during

pregnancy, and will also advise you

should

take

AURO-

FAMCICLOVIR

while

breast-

feeding, based on the benefits and

risks of your particular situation.

Tell your doctor if you are lactose

intolerant.

AURO-FAMCICLOVIR

tablets

contain lactose.

Tell your pharmacist or 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

AURO-FAMCICLOVIR

CONSUMER MEDICINE INFORMATION

Ver 1.4

Page 2 of 5

and

inform

your

doctor

or

pharmacist 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

AURO-

FAMCICLOVIR may interfere with

each other. These include:

probenecid,

prescription

medicine

used

treat

gout

disease

with

painful,

swollen

joints,

caused

uric

acid

crystals)

increase

blood

levels of penicillin-type antibiotics

raloxifene,

medicine

used

treat osteoporosis (a disease which

causes

bones

become

less

dense,

gradually

making

them

weaker, more brittle and likely to

break)

medicines

that

affect

your

kidneys.

need

take

different

amounts of these medicines or you

need

take

different

medicines.

Your

pharmacist

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

AURO-FAMCICLOVIR

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.

Follow all directions given to you

by

your

doctor

and

pharmacist

carefully.

These instructions may differ from

information

contained

this

leaflet.

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

AURO-

FAMCICLOVIR tablets to take.

These instructions may differ from

information

contained

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.

Follow the instructions that they give

you.

For people whose immune system

does not work as well as it should,

the dose and duration of treatment

may be increased.

For people who have reduced kidney

function, the dose may be reduced.

When to take it

For Shingles

The usual dose is one 250 mg tablet

three times each day for seven days,

beginning

later

than

hours

after the rash appears.

Your doctor may have prescribed a

different dose.

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.

For Genital Herpes

There

different

ways

take

AURO-FAMCICLOVIR

depending

on 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.

The tablets are best taken within 6

hours

first

symptoms

genital herpes appearing.

There

three

ways

take

AURO-FAMCICLOVIR

treat

an outbreak of genital herpes and

your doctor will tell you which

regimen is best for you:

AURO-

FAMCICLOVIR tablets twice

daily for one day

or

AURO-

FAMCICLOVIR

tablets

start with, followed by one 250

mg tablet every 12 hours for

the next 3 doses

or

AURO-

FAMCICLOVIR

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 the late

morning or early afternoon, you

take

next

dose

before

going to bed, but do not take any

doses less than 6 hours apart.

During

normal

waking

hours,

take any remaining doses at 12

hourly intervals.

Your doctor may 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

AURO-FAMCICLOVIR

prescription filled.

Take

one

250

mg

AURO-

FAMCICLOVIR

tablet

twice

each day.

Continue

to

take

one

250

mg

AURO-FAMCICLOVIR

tablet

AURO-FAMCICLOVIR

CONSUMER MEDICINE INFORMATION

Ver 1.4

Page 3 of 5

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 but does not cure it.

Your

doctor

will

tell

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. It

will also help you remember when to

take the tablets.

How long to take it

Continue

taking

AURO-

FAMCICLOVIR every day for as

long as your doctor tells you.

To help clear up your infection, you

must keep taking this medicine, even

if your symptoms begin to clear up

after a few 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 you

getting an 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

AURO-FAMCICLOVIR.

Do this even if there are no signs of

discomfort or poisoning. Keep the

telephone numbers for these places

handy.

Taking

much

AURO-

FAMCICLOVIR

affect

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

AURO-FAMCICLOVIR

Things you must do

If

you

become

pregnant

while

taking

AURO-FAMCICLOVIR,

tell your doctor.

Your doctor can discuss with you the

risks

taking

while

pregnant.

If you are about to be started on

any

new

medicine,

remind

your

doctor

and

pharmacist

that

you

are

taking

AURO-

FAMCICLOVIR.

Tell any other doctor, dentist or

pharmacist

who

treats

you

that

you

are

taking

AURO-

FAMCICLOVIR.

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.

If you stop your tablets suddenly,

your condition may worsen or you

may have unwanted side effects.

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

AURO-

FAMCICLOVIR affects you.

This medicine can cause dizziness,

sleepiness or confusion.

Practice "safer sex", including the

use of condoms, when symptoms

are

present,

even

if

you

have

started

taking

AURO-

FAMCICLOVIR

for

genital

herpes.

This

important

prevent

passing the infection on to others.

Things that may help your

condition

For Shingles

Take

the

following

precautions

to

avoid spreading the virus:

Keep

areas

affected

virus as dean and dry as possible.

Wear

loose-fitting

clothing

avoid irritating the rash.

Avoid touching or scratching the

sore area as you may spread the

virus on your fingers.

For Genital Herpes

Take the following precautions to

help manage your condition:

Use condoms between episodes to

reduce the risk of infecting your

partner

Keep

areas

affected

virus as clean and dry as possible

Wear

loose-fitting

clothing

avoid irritating the blisters

Avoid touching or 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

AURO-FAMCICLOVIR

CONSUMER MEDICINE INFORMATION

Ver 1.4

Page 4 of 5

well while you are taking AURO-

FAMCICLOVIR.

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.

experience

them.

Tell your doctor if you notice any

of the following side effects and

they worry you:

headache

dizziness

nausea (feeling sick) or vomiting

diarrhoea

itching or an itchy rash (urticaria)

abnormal

liver

function

test

results.

The above side effects are 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 or confusion,

usually in older people

hallucinations (seeing or hearing

things that are not really there)

painful or swollen joints

aching

muscles

muscle

tenderness or weakness that is not

caused by exercise.

above

side

effects

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)

bruising 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

signs of a serious skin or mouth

reaction,

which

include

widespread

red,

raised

areas,

blisters or sores

signs of a possible liver problem

such as persistent pain in the upper

right abdomen, yellowing of the

skin

and/or

eyes,

dark

urine

pale bowel motions.

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 using

AURO-FAMCICLOVIR

Storage

Keep your medicine in the original

container until it is time to take it.

Store

your

AURO-

FAMCICLOVIR tablets in a dry

place where the temperature stays

below 25°C.

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

dampness

destroy

some

medicines.

AURO-

FAMCICLOVIR

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-anda-

half metres above the ground is a

good place to store medicines.

Disposal

If

your

doctor

tells

you

to

stop

taking this medicine or the expiry

date

has

passed,

ask

your

pharmacist what to do with any

medicine that you have left over.

Product Description

What

AURO-FAMCICLOVIR

looks like

AURO-FAMCICLOVIR is available

as tablets containing 125, 250 & 500

mg of famciclovir.

AURO-FAMCICLOVIR 125 tablets

supplied

blister

packs

containing 10, 40 & 56 tablets, each

containing famciclovir 125 mg.

AURO-FAMCICLOVIR 250 tablets

supplied

blister

packs

containing 20, 21, 30 & 56 tablets,

each containing famciclovir 250 mg.

AURO-FAMCICLOVIR 500 tablets

supplied

blister

packs

containing 20, 30 & 56 tablets, each

containing famciclovir 500 mg.

AURO-FAMCICLOVIR 125

(AUST R 195180)

White to pale yellow colored, round

film-coated,

biconvex

tablets

with

beveled edges, debossed with 'X' on

one side and '48' on the other side.

AURO-FAMCICLOVIR 250

(AUST R 195176)

White to pale yellow colored, round

film-coated,

biconvex

tablets

with

beveled edges, debossed with ‘X’ on

one side and ‘49’ on the other side.

AURO-FAMCICLOVIR 500

(AUST R 195182)

White to pale yellow colored, oval

film-coated,

biconvex

tablets,

debossed with 'X' on one side and

'34' on the other side.

Ingredients

Active ingredient

Famciclovir

Inactive ingredients

sodium starch glycollate

lactose anhydrous

hydroxypropylcellulose

magnesium stearate

hypromellose

macrogol 400

AURO-FAMCICLOVIR

CONSUMER MEDICINE INFORMATION

Ver 1.4

Page 5 of 5

titanium dioxide

Name and Address of the Sponsor

Aurobindo Pharma Australia Pty Ltd

Unit 3, North Rydelink

277-283 Lane Cove Road

Macquarie Park

NSW 2113

Australia

Date of Approval

5 February 2013

Date of Most Recent Amendment

7 August 2014