AURO-OLANZAPINE 10 olanzapine 10 mg tablets blister pack

Main information

  • Trade name:
  • AURO-OLANZAPINE 10 olanzapine 10 mg tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AURO-OLANZAPINE 10 olanzapine 10 mg tablets blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 179918
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

179918

AURO-OLANZAPINE 10 olanzapine 10 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

15/11/2011

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. AURO-OLANZAPINE 10 olanzapine 10 mg tablets blister pack

Product Type

Single Medicine Product

Effective date

30/10/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Olanzapine is indicated for the treatment of schizophrenia and related psychoses. ,Olanzapine alone or in combination with lithium or valproate is

indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. ,Olanzapine is indicated for preventing recurrence of

manic, mixed or depressive episodes in Bipolar I Disorder.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Other composite

material

24 Months

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. AURO-OLANZAPINE 10 olanzapine 10 mg tablets blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

Yellow coloured, circular, biconvex uncoated tablets, debossed with "C" on

one side and "48" on the other side

Active Ingredients

Olanzapine

10 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 08:36:40 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-OLANZAPINE

CONSUMER MEDICINE INFORMATION

Ver 1.2

Page 1 of 5

AURO-OLANZAPINE 2.5, 5, 7.5 & 10

Olanzapine

Consumer Medicine Information

What is in this leaflet

This leaflet is designed to provide you

with

answers

some

common

questions about this medicine. It does

contain

available

information

does

take

place of talking with your doctor.

All medicines have risks and benefits.

Your

doctor

more

information

about this medicine than is contained

in this leaflet. Also, your doctor has

had the benefit of taking a full and

detailed history from you and is in the

best

position

make

expert

judgement

meet

your

individual

needs.

If

you

have

any

concerns

about

taking this medicine, talk to your

doctor or pharmacist.

Keep this leaflet with this medicine.

You may need to read it again.

What

AURO-OLANZAPINE used

for

AURO-OLANZAPINE belongs to a

group

medicines

called

antipsychotics.

helps

correct

chemical

imbalances

brain,

which may cause mental illness.

AURO-OLANZAPINE

used

treat symptoms of schizophrenia and

related psychoses. Schizophrenia is a

mental

illness

with

disturbances

thinking, feelings and behaviour.

AURO-OLANZAPINE

alone,

combination

with

lithium

valproate, is used for the short-term

treatment

acute

manic

episodes

associated

with

Bipolar

Disorder.

AURO-OLANZAPINE

also

mood stabiliser that prevents further

occurrences of the disabling high and

(depressed)

extremes

mood

associated with Bipolar I Disorder.

Bipolar I Disorder is a mental illness

with

symptoms

such

feeling

“high”, having excessive amounts of

energy, needing much less sleep than

usual,

talking

very

quickly

with

racing

ideas

sometimes

severe

irritability.

Your

doctor

have

prescribed

AURO-OLANZAPINE

another

reason.

Ask your doctor if you have any

questions

about

why

AURO-

OLANZAPINE has been prescribed

for you.

This medicine is available only with a

doctor’s prescription.

AURO-OLANZAPINE

recommended

children

under the age of 18 years as there is

not enough information on its effects

in this age group.

Before you take

AURO-OLANZAPINE

Tell your doctor if you have any of

the following conditions or if you

have ever experienced any of these

conditions

When

you

must

not

take

AURO-OLANZAPINE

Do not take

AURO-OLANZAPINE:

if

you

have

had

an

allergic

reaction

to

AURO-

OLANZAPINE or to any of the

ingredients listed at the end of

this

leaflet

(see

‘Product

Description’).

Signs of an allergic reaction may

include

skin

rash,

itching,

shortness of breath or swelling of

the face, lips or tongue.

if the packaging is torn or shows

signs of tampering or the tablets

do not look quite right.

if the expiry date on the pack has

passed.

If you take this medicine after the

expiry date has passed it may not

work as well.

If

you

are not

sure

whether

you

should

start

taking

AURO-

OLANZAPINE, talk to your doctor

or pharmacist.

Before

you

start

to

take

AURO-OLANZAPINE

Tell your doctor if you have had an

allergic

reaction

to

any

medicine

which you have taken previously to

treat your current condition.

Tell your doctor if you have or have

had

any

medical

conditions,

especially the following:

tumour

pituitary

gland

small gland at the base of the brain)

- disease of the blood with a reduced

number of white or red blood cells

- disease of the blood vessels of the

brain, including stroke

- prostate problems

- kidney or liver disease

high

blood

sugar,

diabetes

family history of diabetes

- breast cancer or a family history of

breast cancer

- paralytic ileus, a condition where

small

bowel

does

work

properly

- epilepsy (seizures or fits)

- glaucoma,

condition

which

there is usually a build up of fluid

in the eye

heart

disease,

including

irregular

heart rhythm

- neuroleptic malignant syndrome, a

reaction to some medicines with a

sudden

increase

body

temperature, extremely high blood

pressure and severe convulsions

tardive

dyskinesia,

reaction

some

medicines

with

AURO-OLANZAPINE

CONSUMER MEDICINE INFORMATION

Ver 1.2

Page 2 of 5

uncontrollable twitching or jerking

movements of the arms and legs.

Tell your doctor if you are pregnant

or intend to become pregnant.

Like

most

antipsychotic

medicines,

AURO-OLANZAPINE

recommended

during

pregnancy.

there

need

consider

AURO-OLANZAPINE

during your pregnancy, your doctor

will discuss with you the benefits and

risks of using it.

Tell your doctor if you are breast-

feeding or plan to breast-feed.

It is recommended that you do not

breast-feed

while

taking

AURO-

OLANZAPINE.

Tell your doctor if you suffer from

lactose intolerance

(because AURO-

OLANZAPINE contains lactose).

Tell your doctor if you will be in a

hot

environment

or

do

a

lot

of

vigorous exercise.

AURO-OLANZAPINE

make

you sweat less, causing your body to

overheat.

Tell your doctor if you smoke.

Smoking

affect

AURO-

OLANZAPINE or may affect how it

works.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a prescription

from your pharmacy, supermarket

or health food shop.

Some medicines may be affected by

AURO-OLANZAPINE or may affect

how it works. These include:

medicines used to treat a fast or

irregular heart beat (arrhythmia)

medicines taken for anxiety or to

help you sleep

medicines taken for depression

carbamazepine, a medicine used for

mood

stabilisation

treat

epilepsy

other

centrally

acting

medicines

(eg. tranquillisers)

ciprofloxacin, a medicine used to

treat bacterial infections

medicines that lower blood pressure

medicines

used

Parkinson’s

disease

medicines

that

change

heart’s electrical activity or make it

more likely to change.

Your doctor or pharmacist has more

information

medicines

careful

with

avoid

while

taking

AURO-OLANZAPINE.

Tell your doctor about these things

before

you

take

AURO-

OLANZAPINE.

How to take

AURO-OLANZAPINE

Follow all directions given to you by

your

doctor

or

pharmacist

carefully.

These

differ

from

information contained in this leaflet.

How

much

to

take

AURO-

OLANZAPINE

Your doctor will tell you how many

AURO-OLANZAPINE

tablets

should take. The dose your doctor will

prescribe for you will usually be in

the range 5 mg to 20 mg per day.

Your doctor may increase or decrease

your

dose

order

find

appropriate dose for your condition.

lower

starting

dose

prescribed

elderly

patients

over

the age of 65 years.

How

to

take

AURO-

OLANZAPINE

AURO-OLANZAPINE

should

swallowed

whole

with

glass

water.

When

to

take

AURO-

OLANZAPINE

AURO-OLANZAPINE

should

be

taken once a day as advised by your

doctor.

Take your prescribed dose at the same

time each day.

AURO-OLANZAPINE can be taken

with or without food.

How

long

do

I

take

AURO-

OLANZAPINE

Do

not

stop

taking

AURO-

OLANZAPINE

just

because

you

feel better. It is important that you

do

NOT

stop

taking

AURO-

OLANZAPINE unless your doctor

tells you.

If you forget to take AURO-

OLANZAPINE

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

soon

remember then go back to taking your

medicine as you would normally.

Do not take a double dose to make

up for the dose that you missed.

If you are not sure what to do, ask

your doctor or pharmacist.

If

you

take

too

much

(overdose)

Immediately telephone your doctor

or

the

Australian

Poisons

Information

Centre

(telephone

13

11 26) or the New Zealand National

Poisons Centre (0800 POISON or

0800 764 766), or go to Accident

and

Emergency

at

your

nearest

hospital, if you think that you or

anyone

else

has

taken

too

much

AURO-OLANZAPINE

Do

this

even

if

there

are

no

signs

of

discomfort or poisoning.

If you have taken too much AURO-

OLANZAPINE,

most

common

signs

fast

heart

beat,

agitation/aggression,

difficulty

speaking,

uncontrollable

movements

and sedation.

While you are taking

AURO-OLANZAPINE

Things you must do

It is important that you remember

to

take

AURO-OLANZAPINE

daily and at the dose prescribed by

your doctor.

AURO-OLANZAPINE

CONSUMER MEDICINE INFORMATION

Ver 1.2

Page 3 of 5

Tell

all

doctors,

dentists

and

pharmacists who are treating you

that

you

are

taking

AURO-

OLANZAPINE.

While

you

are

taking

AURO-

OLANZAPINE,

tell your doctor or

pharmacist

before

you

start

any

new medicine.

If

you

become

pregnant

while

taking

AURO-OLANZAPINE,

tell

your doctor.

Keep

all

of

your

doctor’s

appointments so that your progress

can be checked.

Your doctor should monitor your

weight

while

taking

AURO-OLANZAPINE.

Patients with diabetes or who have

higher

chance

developing

diabetes

should

have

their

blood

sugar checked often.

If you are over 65, your doctor may

measure your blood pressure from

time to time.

Tell your doctor if you are female

and

your

monthly

periods

are

absent for six months or more.

Talk

to

your

doctor

or

mental

health

professional

if

you

have

thoughts

or

talk

about

death

or

suicide; or thoughts or talk about

self-harm or doing harm to others.

These may be signs of changes or

worsening in your mental illness.

Things you must not do

Do

not

stop

taking

AURO-

OLANZAPINE,

or

lower

the

dosage,

even

if

you

are

feeling

better, without checking with your

doctor.

Do not give AURO-OLANZAPINE

to

anyone

else,

even

if

their

symptoms

seem

similar

or

they

have the same condition as you.

Your doctor has prescribed AURO-

OLANZAPINE

your

condition.

Things to be careful of

Be

careful

driving

or

operating

machinery

until

you

know

how

AURO-OLANZAPINE affects you.

AURO-OLANZAPINE

cause

drowsiness in some people.

Be careful when drinking alcohol

while

taking

AURO-

OLANZAPINE.

The effects of alcohol could be made

worse

while

taking

AURO-

OLANZAPINE.

Your doctor may suggest you avoid

alcohol while you are being treated

with AURO-OLANZAPINE.

If

AURO-OLANZAPINE

makes

you feel light-headed, dizzy or faint,

be careful when getting up from a

sitting or lying position.

Getting up slowly may help.

If

outdoors,

wear

protective

clothing

and

use

at

least

a

30

+

sunscreen.

AURO-OLANZAPINE

cause

your skin to be much more sensitive

to sunlight than it is normally.

Exposure to sunlight may cause a skin

rash,

itching,

redness,

severe

sunburn.

If

your

skin

does

appear

to

be

burning, tell your doctor.

Make

sure

you

keep

cool

in

hot

weather

and

keep

warm

in

cool

weather.

AURO-OLANZAPINE

affect

your

body

reacts

temperature changes.

Side Effects

medicines

have

some

unwanted

side

effects.

Sometimes

they are serious, but most of the time

they are not. Your doctor has weighed

risks

using

this

medicine

against the benefits they expect it will

have for you.

Like

other

medicines,

AURO-

OLANZAPINE

cause

some

unwanted

side

effects.

These

likely to vary from patient to patient.

Some side effects may be related to

dose

AURO-OLANZAPINE.

Accordingly, it is important that you

tell your doctor as soon as possible

about

unwanted

effects.

Your

doctor may then decide to adjust the

dose

AURO-OLANZAPINE

are taking.

Tell your doctor if you notice any of

the following side effects and they

worry you:

drowsiness

unusual tiredness or weakness.

restlessness or difficulty sitting still

increased appetite, weight gain

constipation

dry mouth

swelling

your

hands,

feet

ankles

dizziness

Some people may feel dizzy in the

early stages of treatment, especially

when

getting

from

lying

sitting

position.

This

side

effect

usually

passes

after

taking

AURO-

OLANZAPINE for a few days.

Tell your doctor if you notice any of

the

above

side

effects

and

they

worry you.

These

more

common

side

effects of AURO-OLANZAPINE.

Tell your doctor as soon as possible

if you notice any of the following

side effects:

symptoms

sunburn

(such

redness,

itching,

swelling

blistering of the skin) which occur

more quickly than normal

rash or allergic reaction

slow heart beat

changes in sexual functioning or

sex drive in men or women

prolonged and/or painful erection

unusual secretion of breast milk

breast

enlargement

women

symptoms of high sugar levels in

the blood (including passing large

amounts of urine, excessive thirst,

AURO-OLANZAPINE

CONSUMER MEDICINE INFORMATION

Ver 1.2

Page 4 of 5

having a dry mouth and skin and

weakness). These may indicate the

onset or worsening of diabetes

reaction

following

abrupt

discontinuation

(profuse

sweating,

nausea or vomiting)

absence of menstrual periods and

changes

regularity

menstrual periods

involuntary

passing

urine

difficulty in initiating urination

unusual hair loss or thinning.

These side effects are uncommon but

may require medical attention.

Tell your doctor immediately or go

to Accident and Emergency

at your

nearest hospital if you notice any of

the following:

Sudden signs of an allergic reaction

such

skin

rash,

itching,

shortness of breath or swelling of

the face, lips or tongue.

frequent infections such as fever,

severe chills, sore throat or mouth

ulcers

bleeding

bruising

more

easily

than normal

seizures, fits or convulsions

yellowing of the skin and/or eyes

nausea, vomiting, loss of appetite,

generally

feeling

unwell,

fever,

itching,

yellowing

skin

and/or eyes

severe

upper

stomach

pain

often

with nausea and vomiting

(inflammation of the pancreas)

worm-like

movements

tongue,

other

uncontrolled

movements of the tongue, mouth,

cheeks, or jaw which may progress

to the arms and legs

sudden

increase

body

temperature,

sweating,

fast

heart

beat, muscle stiffness, high blood

pressure and convulsions

sharp chest pain, coughing of blood,

or sudden shortness of breath

pain/tenderness in the calf muscle

area

muscle pain, muscle weakness and

brown urine

heart

palpitations

dizziness,

which may lead to collapse.

These are very serious side effects.

need

urgent

medical

attention or hospitalisation.

All of these side effects are very rare.

The following additional side effects

may occur in some groups of people

taking AURO-OLANZAPINE:

Elderly

patients

with

dementia-

related psychosis

Elderly patients with dementia-related

psychosis may notice the following

side effects:

unusual manner of walking

falls

pneumonia

involuntary passing of urine.

Parkinson’s disease psychosis

Some

patients

with

Parkinson’s

disease may hallucinate (see, feel or

hear

things

that

there)

develop

worsening

symptoms

Parkinson’s disease.

AURO-OLANZAPINE

in

combination

with

lithium

or

valproate

Patients

with

bipolar

mania

taking

AURO-OLANZAPINE

combination with lithium or valproate

may notice the following additional

side effects:

tremors

speech disorder.

Tell

your

doctor

if

you

notice

anything

unusual

or

if

you

are

concerned about any aspect of your

health,

even

if

you

think

the

problems

are

not

connected

with

this medicine and are not referred

to in this leaflet.

Also,

some

side

effects,

such

changes to liver function, cholesterol

or triglycerides can occur. These 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

side effects.

You may not experience any of them.

Other

side

effects

listed

above

may also occur in some patients.

Tell

your

doctor

if

you

notice

anything

else

that

is

making

you

feel unwell.

After Taking

AURO-OLANZAPINE

Storage

Keep

your

tablets

in

the

blister

pack until it is time to take them

Keep

your

tablets

in

a

cool,

dry

place where the temperature stays

below 25°C and is protected from

light.

All medicines should be kept where

young children cannot reach them.

There will be an expiry date (month,

year) on your AURO-OLANZAPINE

container.

The medicine should not

be taken after this date

because it

may have lost some of its strength.

Disposal

If your doctor tells you to stop taking

AURO-OLANZAPINE

find

that

tablets

have

passed

their

expiry date,

please return any left

over tablets to your pharmacist.

Product Description

What

AURO-OLANZAPINE

looks like

AURO-OLANZAPINE 2.5, 5, 7.5 &

10 (2.5, 5, 7.5 & 10 mg olanzapine)

presented

pack

size

tablets

blister

tablets

bottle.

AURO-OLANZAPINE 2.5

Yellow

coloured,

circular,

biconvex

uncoated tablets, debossed with ‘C’

on one side and ‘45’ on the other side.

AURO-OLANZAPINE 5

Yellow

coloured,

circular,

biconvex

uncoated tablets, debossed with ‘C’

on one side and ‘46’ on the other side.

AURO-OLANZAPINE

CONSUMER MEDICINE INFORMATION

Ver 1.2

Page 5 of 5

AURO-OLANZAPINE 7.5

Yellow

coloured,

circular,

biconvex

uncoated tablets, debossed with ‘C’

on one side and ‘47’ on the other side.

AURO-OLANZAPINE 10

Yellow

coloured,

circular,

biconvex

uncoated tablets, debossed with ‘C’

on one side and ‘48’ on the other side.

Ingredients

Active Ingredient:

Olanzapine

Each

tablet

contain

either

olanzapine.

Other Ingredients:

Lactose

Crospovidone

Hydroxypropylcellulose

Magnesium stearate

Please

read

this

leaflet

carefully

before

start

taking

AURO-

OLANZAPINE. You may wish to

keep it to read again.

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

8 November 2011

Date of Most Recent Amendment

4 December 2012