FAMLO

Main information

  • Trade name:
  • FAMLO
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FAMLO
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 176995
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

176995

FAMLO famciclovir 250 mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Southern Cross Pharma Pty Ltd

Postal Address

PO Box 2037,MALUA BAY, NSW, 2536

Australia

ARTG Start Date

14/08/2012

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. FAMLO

Product Type

Single Medicine Product

Effective date

11/02/2013

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Famciclovir is indicated for:

òTreatment 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.

òTreatment of recurrent episodes of genital herpes in adults and adolescents 12 years of age and older.

òSuppression of recurrent genital herpes.

òTreatment of recurrent herpes labialis (cold sores) in immunocompetent adult patients.,Famciclovir is also indicated in immunocompromised patients

for:

òTreatment of uncomplicated herpes zoster.

òTreatment of recurrent herpes simplex.

òSuppression of recurrent herpes simplex.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

56 tablets

(S4) Prescription Only Medicine

21 tablets

(S4) Prescription Only Medicine

20 tablets

(S4) Prescription Only Medicine

14 tablets

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White round film coated tablets with FM on one side and 250 on the other

side

Active Ingredients

Famciclovir

250 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 29.11.2017 at 12:05:23 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

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FAMLO for shingles

Famciclovir

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about FAMLO.

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 ensure that you speak to

your pharmacist or doctor to obtain

the most up to date information on

the medicine.

All medicines have risks and benefits.

Your pharmacist or doctor has weighed

the risks of you taking FAMLO 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 FAMLO is used for

FAMLO is an antiviral medicine that is

used to treat shingles in adults and

adolescents.

Shingles is a condition that is caused

by a herpes virus called varicella

zoster, the same virus that causes

chicken pox. The virus can become

active again in the body, even after

many years, resulting in shingles. The

main symptom is a rash that can cause

pain, burning and blisters.

Although FAMLO does not cure the

viral infection, it helps to 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.

FAMLO is only available with a

doctor's prescription. It is not addictive.

This medicine is not recommended for

use in children under 12 years of age.

Before you take FAMLO

When you must not take it

Do not take FAMLO if you have an

allergy to:

famciclovir, the active ingredient

penciclovir, a related antiviral

medicine

any of the other ingredients of

FAMLO 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 doctor if you have a

problem with:

your body's immune system,

which helps to fight off infections

your kidneys

your 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.

FAMLO should not be used during

pregnancy unless necessary. Your

doctor will discuss with you the

potential risks of taking FAMLO

during pregnancy, and will also advise

you if you should take FAMLO while

breast-feeding, based on the benefits

and risks of your particular situation.

FAMLO

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 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 FAMLO 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

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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

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 FAMLO

Swallow the tablets whole with a full

glass of water.

The tablets may be taken with or

without food.

Follow all directions given to you by

your doctor and pharmacist

carefully.

These instructions may 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 no later than 72 hours after

the rash appears.

Your doctor may have prescribed a

different dose.

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.

Follow your doctor's instructions on

how many FAMLO 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 FAMLO every day

for the full course of treatment.

To help clear up your infection, you

must take the full course of treatment,

even if your symptoms begin to clear

up 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 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 FAMLO. 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 FAMLO 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

FAMLO

Things you must do

If you become pregnant while taking

FAMLO, 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

FAMLO.

Tell any other doctor, dentist or

pharmacist who treats you that you

are taking FAMLO.

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 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

FAMLOaffects you.

This medicine can cause dizziness,

sleepiness or confusion in some

people.

Things that may help your condition

Take the following precautions to

help manage your condition:

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Keep the areas affected by the

virus as clean and dry as possible.

Wear loose-fitting clothing to

avoid irritating the rash.

Avoid touching or scratching the

sore area as you may spread the

virus on your fingers.

Side effects

Tell your pharmacist or doctor as

soon as possible if you do not feel

well while you are taking FAMLO.

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

doctor or pharmacist to answer any

questions you may have.

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 that is separate from the

shingles rash

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.

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 (eg 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 may 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 or

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.

After using FAMLO

Storage

Keep your medicine in the

original container until it is time

to take it.

Store your 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. FAMLO 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 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 it looks like

FAMLO 250 mg tablets are white,

round film-coated tablets, marked with

"FM" on one side and "250" on the

other.

FAMLO 500 mg tablets are white,

oval, film-coated tablets with "FM" on

one side and “500” on the reverse side.

Ingredients

Active Ingredient

FAMLO 250 contain 250 mg

famciclovir per tablet

FAMLO 500 contain 500 mg

famciclovir per tablet.

Inactive ingredients

Microcrystalline cellulose,

crospovidone, colloidal anhydrous

silica, copovidone, sodium

stearylfumarate and Opadry White YS-

22-18096.

Sponsor

Southern Cross Pharma Pty Ltd

56 Illabunda Drive

Malua Bay NSW 2536

ABN 47 094 447 677

Distributor

Ranbaxy Australia Pty Ltd

Ground Floor 9-13 Waterloo Road

North Ryde

NSW 2113

Date of Information:

6 September

2013

Australian Registration Number

FAMLO 250 mg

Blister pack 176994

Bottle 176995

FAMLO 500 mg

Blister pack 176996

Bottle 176997