LETROZOLE ACTAVIS 2.5mg

Main information

  • Trade name:
  • LETROZOLE ACTAVIS 2.5mg
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • LETROZOLE ACTAVIS 2.5mg
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 176276
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

176276

LETROZOLE ACTAVIS 2.5mg letrozole 2.5mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

22/09/2011

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. LETROZOLE ACTAVIS 2.5mg

Product Type

Single Medicine Product

Effective date

22/09/2011

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of postmenopausal women with hormone receptor positive breast cancer (see Clinical trials).

The safety and efficacy of neoadjuvant use of letrozole has not been established. Letrozole is not indicated in hormone receptor negative disease.

Additional Product 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

100 tablets

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Round, yellow, lenticular film-coated tablet

Active Ingredients

Letrozole

2.5 mg

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

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

Public Summary

Page 1 of

Produced at 29.11.2017 at 01:11:57 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

LetrozoleActavis/102011/CMI-1

Letrozole Actavis

contains the active ingredient letrozole

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about LETROZOLE

ACTAVIS.

It does not contain all of the

available information. It does not

take the place of talking to your

doctor or pharmacist.

All medicines have benefits and

risks. Your doctor has weighed the

risks of you taking LETROZOLE

ACTAVIS against the benefits they

expect it will have for you.

If you have any concerns about

taking this medicine, talk to your

doctor or pharmacist.

Keep this leaflet with your

medicine. You may need to read it

again.

What LETROZOLE ACTAVIS

is used for

LETROZOLE ACTAVIS is used to

treat breast cancer in women who

are post-menopausal that is,

women who no longer have

periods, either naturally due to

their age or after surgery or

chemotherapy.

LETROZOLE ACTAVIS belongs to a

group of medicines called

aromatase inhibitors also called

‘antioestrogens’. These medicines

work by reducing the production of

oestrogen in your body.

Oestrogen stimulates the growth of

certain types of breast cancer.

These cancers are called

"oestrogen-dependent." Reducing

the production of oestrogen may

help to keep the cancer from

growing.

This may be the first time you are

taking an "antioestrogen" such as

letrozole or you may have taken

another "antioestrogen" such as

tamoxifen in the past.

Your doctor may have prescribed

LETROZOLE ACTAVIS for another

reason. Ask your doctor if you have

any questions about why

LETROZOLE ACTAVIS has been

prescribed for you.

LETROZOLE ACTAVIS is available

only with a doctor's prescription.

There is no evidence that

LETROZOLE ACTAVIS is addictive.

Before you take

LETROZOLE ACTAVIS

When you must not take it

Do not take LETROZOLE ACTAVIS

if you are allergic to medicines

containing letrozole or any of the

ingredients listed at the end of

this leaflet.

Some of the symptoms of an

allergic reaction may include skin

rash, itching or hives, swelling of

the face, lips or tongue which may

cause difficulty in swallowing or

breathing, wheezing, shortness of

breath or troubled breathing.

Do not take LETROZOLE ACTAVIS

if you are still having periods.

This medicine is only used in

women who are no longer having

periods.

Women of child bearing age who

recently became postmenopausal

or peri menopausal should use a

proven method of birth control to

avoid pregnancy, until your post

menopausal status is fully

established.

Do not take LETROZOLE ACTAVIS

if you are pregnant.

LETROZOLE ACTAVIS may affect

your developing baby if you take it

during pregnancy.

Do not take LETROZOLE ACTAVIS

if you are breastfeeding.

Do not take LETROZOLE ACTAVIS

if the expiry date (Exp.) printed

on the pack has passed.

Do not take LETROZOLE ACTAVIS

if the packaging is torn or shows

signs of tampering.

Before you start to take it

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.

Tell your doctor if you have

severe kidney or liver disease.

Your doctor may want to take

special precautions while you are

taking this medicine

Tell your doctor if you plan to

become pregnant or breastfeed

If you have not told your doctor

about any of the above, tell them

before you start taking

LETROZOLE ACTAVIS.

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 may be affected

by LETROZOLE ACTAVIS, or may

affect how well it works.

Your doctor and pharmacist have

information on medicines to be

careful with or avoid while taking

LETROZOLE ACTAVIS.

How to take LETROZOLE

ACTAVIS

How much to take

LetrozoleActavis/102011/CMI-1

The usual dose is one LETROZOLE

ACTAVIS tablet.

Follow all directions given to you

by your doctor and pharmacist

carefully.

How to take LETROZOLE ACTAVIS

Swallow the tablets with a glass

of water.

If your stomach is upset after

taking the tablet, take it with a

meal or after a snack.

If you forget to take LETROZOLE

ACTAVIS

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 the missed dose

as soon as you remember, and

then go back to taking your

tablets as you would normally.

Do not take a double dose to

make up for the dose you missed.

If you are not sure what to do,

ask your doctor or pharmacist.

How long to take LETROZOLE

ACTAVIS for

Your doctor will check your

progress to make sure the medicine

is working and will decide how long

your treatment should continue.

If you are unsure, talk to your

doctor.

If you take too much LETROZOLE

ACTAVIS (overdose)

Immediately telephone your

doctor, or the Poisons

Information Centre (telephone 13

11 26), or go to Accident and

Emergency at the nearest

hospital, if you think you or

anyone else may have taken too

much LETROZOLE ACTAVIS. Do

this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

While you are taking

LETROZOLE ACTAVIS

Things you must do

Before starting any new

medicine, tell your doctor or

pharmacist that you are taking

LETROZOLE ACTAVIS.

Tell all the doctors, dentists and

pharmacists who are treating you

that you are taking LETROZOLE

ACTAVIS.

If you become pregnant while

taking LETROZOLE ACTAVIS, tell

your doctor immediately.

You should not take this medicine

while you are pregnant.

Follow your doctor’s instructions

carefully.

If you do not follow your doctor’s

instructions, your treatment may

not help or you may have

unwanted side effects.

Be sure to keep all of your

doctor’s appointments so your

progress can be checked.

Your doctor may want you to have

blood tests from time to time to

check on your progress and detect

unwanted side effects. Your

doctor may also decide to monitor

your bone health as this medicine

may cause thinning or wasting of

your bones (osteoporosis).

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking LETROZOLE ACTAVIS.

Tell any other doctor, dentist or

pharmacist who treats you that

you are taking LETROZOLE

ACTAVIS.

Things you must not do

Do not use LETROZOLE ACTAVIS

to treat any other conditions

unless your doctor tells you to.

Do not give LETROZOLE ACTAVIS

to anyone else, even if they have

the same condition as you.

Things to be careful of

Be careful driving or operating

machinery until you know how

LETROZOLE ACTAVIS affects you.

This medicine may cause

drowsiness and dizziness in some

people. If these occur, do not

drive, operate machinery or do

anything else that could be

dangerous.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

LETROZOLE ACTAVIS.

Like all other medicines,

LETROZOLE ACTAVIS may have

unwanted side effects in some

people. 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 this list 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:

swelling of the feet, ankles or

other parts of the body due to

fluid build up

skin rash, itching or dry skin

pain in the muscles, joints or

bones; joint stiffness, arthritis

vaginal spotting or bleeding

whitish, thick vaginal discharge,

vaginal dryness

headache

fever

LetrozoleActavis/102011/CMI-1

tiredness, sleepiness, weakness

or dizziness

difficulty sleeping

numbness or tingling in hands or

feet

mood changes such as anxiety,

nervousness, irritability and

depression (sad mood)

forgetfulness

change in sense of taste

blurred vision or eye irritation

stomach upset, nausea (feeling

sick) or vomiting, pain in the

abdomen

constipation

diarrhoea

dry mouth, sore mouth, mouth

ulcers and cold sores

increased thirst

breast pain

hot flushes

increased sweating

appetite or weight changes

hair thinning

urgent need to urinate (pass

water)

pain or burning sensation when

urinating, which may be a sign of

an infection

fast or irregular heartbeats

thinning of bones (osteoporosis),

bone fractures.

Tell your doctor immediately or

go to Accident and Emergency at

the nearest hospital if you notice

any of the following:

signs that blood clots may have

formed, such as sudden severe

headache, sudden loss of

coordination, blurred vision or

sudden loss of vision, slurred

speech, numbness or tingling in

an arm or leg, painful swelling in

the calves or thighs, chest pain,

difficulty breathing, coughing

blood

constant ‘flu-like’ symptoms

(chills, fever, sore throat, sores

in mouth, swollen glands,

tiredness or lack of energy) that

could be sign of blood problems.

These side effects may be serious.

You may need urgent medical

attention or hospitalisation.

Tell your doctor if you notice

anything that is making you feel

unwell.

Other side effects not listed

above may also occur in some

patients. Some of these can only

be found by laboratory testing.

After using LETROZOLE

ACTAVIS

Storage

Keep LETROZOLE ACTAVIS 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.

Keep your tablets in the pack

until it is time to take them.

If you take the tablets out of the

pack they may not keep well.

Keep your tablets in a cool dry

place where the temperature

stays below 25

C.

Do not store LETROZOLE ACTAVIS

or any other medicine in the

bathroom or near a sink.

Do not leave LETROZOLE ACTAVIS

in the car or on window sills.

Heat and dampness can destroy

some medicines.

Disposal

If your doctor tells you to stop

taking LETROZOLE ACTAVIS, or

your tablets have passed their

expiry date, ask your pharmacist

what to do with any that are left

over.

Product description

What it looks like

LETROZOLE ACTAVIS is a round,

yellow lenticular film-coated

tablet.

Each pack contains 30 and 100

tablets.

Ingredients

The active ingredient in

LETROZOLE ACTAVIS is letrozole.

Each LETROZOLE ACTAVIS tablet

contains 2.5 mg of letrozole.

The tablets also contain:

lactose

maize starch

sodium starch glycollate

microcrystalline cellulose

magnesium stearate

Opadry II 85F32410 Yellow

(ARTG 107176).

The tablets do not contain gluten,

sucrose, tartrazine or any other

azo dyes.

Supplier

Actavis Australia Pty Ltd

Upper Ground Floor

183 Melbourne Street

North Adelaide SA 5006

Australia

Tel: 1300 881 893

Australian registration numbers:

LETROZOLE ACTAVIS - AUST R

176276

Date of preparation:

October 2011.