EXEMESTANE

Main information

  • Trade name:
  • EXEMESTANE PFIZER
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EXEMESTANE PFIZER
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 176215
  • Last update:
  • 14-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

176215

EXEMESTANE PFIZER exemestane 25mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

38-42 Wharf Road,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

22/02/2011

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. EXEMESTANE PFIZER

Product Type

Single Medicine Product

Effective date

14/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

EXEMESTANE PFIZER is indicated for the sequential adjuvant treatment of estrogen receptor-positive early breast cancer in post-menopausal women

who have received prior adjuvant tamoxifen therapy.,EXEMESTANE PFIZER is indicated for the treatment of estrogen receptor-positive advanced breast

cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-estrogen therapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Not recorded

3 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

90 tablets

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, sugar coated

Route of Administration

Oral

Visual Identification

Round, biconvex, off white to slightly greyish tablets, about 6mm in

diameter. The tablets are printed on one side "7663" in black.

Active Ingredients

Exemestane

25 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 01:14:24 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

EXEMESTANE PFIZER

®

Exemestane

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about EXEMESTANE

PFIZER.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking

EXEMESTANE PFIZER against the

benefits it is expected to have for

you.

If you have any concerns about this

medicine, ask your doctor or

pharmacist.

Keep this leaflet.

You may need to read it again.

What EXEMESTANE

PFIZER is used for

EXEMESTANE PFIZER is used to

treat breast cancer in women who no

longer have their menstrual periods,

either naturally due to their age (after

menopause) or because they have

had their ovaries surgically removed.

EXEMESTANE PFIZER is used to

reduce the risk of recurrence or

spreading of the breast cancer. It is

also used when the cancer has not

responded or has returned after

treatment with another medicine or

medicines.

How EXEMESTANE PFIZER

works

EXEMESTANE PFIZER is an

aromatase inactivator. It works by

significantly reducing the supply of

oestrogen to cancer cells.

This stops the growth of those cancer

cells which need oestrogen, a natural

female sex hormone, to grow.

Ask your doctor if you have any

questions about why

EXEMESTANE PFIZER has been

prescribed for you.

Your doctor may have prescribed it

for another purpose.

EXEMESTANE PFIZER is only

available with a doctor's prescription.

It is not addictive.

Before you take

EXEMESTANE PFIZER

When you must not take it

Do not take EXEMESTANE

PFIZER and talk to your doctor if

you think you may have an allergy

to:

exemestane, the active ingredient

in EXEMESTANE PFIZER

any of the other ingredients in

EXEMESTANE PFIZER listed at

the end of this leaflet.

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 EXEMESTANE

PFIZER if you are pregnant or

intend to become pregnant.

EXEMESTANE PFIZER may affect

your developing baby if you take it

during pregnancy.

Do not breastfeed while taking

EXEMESTANE PFIZER.

There is a possibility that your baby

may be affected.

EXEMESTANE PFIZER is not

recommended for use in children.

Do not take EXEMESTANE

PFIZER after the expiry date

printed on the pack.

Do not take EXEMESTANE

PFIZER if the packaging is torn or

shows signs of tampering.

If your EXEMESTANE PFIZER

has expired or is damaged return it

to your pharmacist for disposal.

If you are not sure whether you

should start taking

EXEMESTANE PFIZER, talk to

your doctor.

Before you start to take it

Tell your doctor if you have an

allergy to:

any medicine

other substances, such as foods,

preservatives or dyes.

Tell your doctor if you:

are still having your monthly

period

have or have had kidney

problems

have or have had liver problems

have osteoporosis (disease which

causes bones to be more brittle

and likely to break)

have a vitamin D deficiency

If you have not told your doctor

about any of the above, tell your

doctor before you start taking

EXEMESTANE PFIZER.

EXEMESTANE PFIZER

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including medicines

that you buy without a

prescription from a pharmacy,

supermarket or health food shop.

Some medicines should not be used

with EXEMESTANE PFIZER.

These include:

medicines which contain

oestrogen, such as hormone

replacement therapy (HRT)

oral contraceptives

Some health food products for

menopausal symptoms contain

natural oestrogens.

Tell your doctor or pharmacist if

you are taking any medicines or

health food products containing

oestrogens.

Talk to your doctor or pharmacist

if you have any concerns or

questions about taking

EXEMESTANE PFIZER.

How to take

EXEMESTANE PFIZER

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

The recommended dose is one 25 mg

tablet taken once daily.

When to take it

Take the tablet once daily after a

meal at approximately the same

time each day.

How long to take it

Your doctor or pharmacist will tell

you how long to take

EXEMESTANE PFIZER.

Do not stop taking EXEMESTANE

PFIZER unless your doctor tells

you to, even if you feel better.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to. Otherwise, take it as

soon as you remember, and then go

back to taking EXEMESTANE

PFIZER as you would normally.

Do not take a double dose to make

up for the one that you missed.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or Poisons Information Centre

(Phone Australia 13 11 26 or New

Zealand 0800 POISON or 0800 764

766) for advice or go to Accident

and Emergency at your nearest

hospital, if you think you or

anyone else may have taken too

much EXEMESTANE PFIZER.

Do this even if there are no signs of

discomfort or poisoning.

Keep the telephone numbers for

these places handy.

While you are using

EXEMESTANE PFIZER

Things you must do

Use EXEMESTANE PFIZER

exactly as your doctor has

prescribed.

Be sure to keep all your doctor's

appointments so your progress can

be checked.

If you feel that your medicine is

not helping your condition, talk to

your doctor.

Tell all doctors, dentists and

pharmacists who are treating you

that you are taking

EXEMESTANE PFIZER.

If you go into hospital whilst taking

EXEMESTANE PFIZER, let the

medical staff know that you are

taking EXEMESTANE PFIZER.

If you are about to be started on

any new medicine, tell your doctor,

dentist or pharmacist that you are

taking EXEMESTANE PFIZER.

Things you must not do

Do not give EXEMESTANE

PFIZER to anyone else, even if

they have the same condition as

you.

Do not take EXEMESTANE

PFIZER to treat any other

complaints unless your doctor tells

you to.

Do not stop taking EXEMESTANE

PFIZER or change the dosage

without checking with your doctor.

Things to be careful of

Be careful driving or operating

machinery, until you know how

EXEMESTANE PFIZER affects

you.

EXEMESTANE PFIZER may cause

tiredness or dizziness in some people.

If you experience these effects

whilst taking EXEMESTANE

PFIZER, you should not attempt to

drive or operate machinery.

If EXEMESTANE PFIZER makes

you feel dizzy, be careful when

getting up from a sitting or lying

position.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

EXEMESTANE PFIZER.

EXEMESTANE PFIZER

EXEMESTANE PFIZER, like other

medicines, may cause unwanted side

effects in some people. Many women

can take EXEMESTANE PFIZER

without any problems, but some

women may have mild to moderate

side effects.

Tell your doctor or pharmacist as

soon as possible if you have any of

the following side effects or other

effects that you think may be

related to your treatment:

hot flushes

nausea, vomiting, loss of appetite,

indigestion, pain (including

stomach ache)

constipation

diarrhoea

tiredness

swelling in your legs

dizziness and headache

increased sweating

difficulty sleeping

depression

disturbed vision such as

blurriness

pain in your muscle or joints

increase in weight

skin rash or itching

hair loss

bleeding or bruising more easily

than normal

pain and/or numbness of hands,

loss of feeling in fingers/thumb

frequent infections such as fever,

severe chills, sore throat or mouth

ulcers.

symptoms of gastric ulcer such as

blood in stools, black tarry stools

or vomiting of blood.

abnormal vaginal bleeding

hepatitis, yellowing of the skin or

eyes, also called jaundice.

Other side effects not listed above

may occur in some people. Some of

these side effects can only be found

when your doctor does tests from

time to time to check your progress.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

After using

EXEMESTANE PFIZER

Storage

Keep your tablets in their blister

pack until it is time to take them.

If you take the tablets out of the

blister pack they may not keep well.

Keep EXEMESTANE PFIZER in

a cool dry place where the

temperature stays below 30°C.

Do not leave EXEMESTANE

PFIZER or any other medicine in

the car or on window sills.

Do not store EXEMESTANE

PFIZER or any other medicines in

a bathroom or near a sink.

Heat and dampness can destroy some

medicines.

Keep EXEMESTANE PFIZER

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 EXEMESTANE PFIZER or

the tablets have passed their expiry

date, ask your pharmacist what to

do with any tablets that are left

over.

Product description

What it looks like

EXEMESTANE PFIZER is available

as 25 mg tablets. The tablets are

round and off-white to slightly

greyish in colour marked with '7663'

on one side in black ink.

EXEMESTANE PFIZER 25 mg

tablets are available in blister packs

of 30 tablets.

Ingredients

Active Ingredient

EXEMESTANE PFIZER tablets

contain 25 mg of exemestane as the

active ingredient.

Other Ingredients

The tablets also contain:

silicon dioxide

crospovidone

hypromellose

light magnesium carbonate

magnesium stearate

mannitol

microcrystalline cellulose

methyl hydroxybenzoate

macrogol 6000

polysorbate 80

polyvinyl alcohol

simethicone emulsion

sodium starch glycollate

sucrose

titanium dioxide

cetyl esters wax

purified talc

carnauba wax

black printing ink.

Supplier

EXEMESTANE PFIZER is supplied

in Australia by:

Pfizer Australia Pty Ltd

ABN 50 008 422 348

38-42 Wharf Road

West Ryde NSW 2114

Toll Free Number 1800 675 229

It is supplied in New Zealand by:

Pfizer New Zealand Ltd

PO Box 3998

Auckland

Toll Free Number 0800 736 363

EXEMESTANE PFIZER

Australian Registration

Number

EXEMESTANE PFIZER 25 mg

tablets can be identified by the

Australian Register Number on the

box:

AUST R 176215

Date of preparation

This leaflet was revised November

2015.

© Pfizer Australia Pty Ltd

= Registered trademark

EXEMESTANE PFIZER