OLANZAPINE

Main information

  • Trade name:
  • OLANZAPINE CH ODT olanzapine 10 mg orally disintegrating tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • OLANZAPINE CH ODT olanzapine 10 mg orally disintegrating tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212896
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212896

OLANZAPINE CH ODT olanzapine 10 mg orally disintegrating tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

26/08/2014

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. OLANZAPINE CH ODT olanzapine 10 mg orally disintegrating tablet blister pack

Product Type

Single Medicine Product

Effective date

20/03/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For the treatment of schizophrenia and related psychoses. Alone or in combination with lithium or valproate is indicated for the short-term treatment of

acute manic episodes associated with Bipolar I Disorder. 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

2 Years

Store below 25

degrees Celsius

Child resistant closure

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. OLANZAPINE CH ODT olanzapine 10 mg orally disintegrating tablet blister pack

Dosage Form

Tablet, orally disintegrating

Route of Administration

Oral

Visual Identification

Yellow coloured, circular, flat faced beveled edge tablets debossed with 'C'

on one side and '52' 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 26.11.2017 at 11:54:48 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

APL-OLANZAPINE ODT

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 1 of 5

APL-OLANZAPINE ODT 5, 10, 15 & 20

Olanzapine

Consumer Medicine Information

What is in this leaflet

This leaflet is designed to provide

you with answers to some common

questions

about

this

medicine.

does

contain

available

information and does not take the

place of talking with your doctor.

The information in this leaflet was

last updated on the date shown on

final

page.

More

recent

information about this medicine may

be available.

Make

sure

speak

your

pharmacist or doctor to obtain the

most up to date information on this

medicine. The updated leaflet may

contain important information about

APL-OLANZAPINE

use that you should be aware of.

medicines

have

risks

benefits.

Your doctor has 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 to make an expert

judgement to 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 APL-OLANZAPINE

ODT is used for

APL-OLANZAPINE

belongs

group

medicines

called

antipsychotics.

helps

correct

chemical

imbalances

brain,

which may cause mental illness.

APL-OLANZAPINE ODT is used to

treat symptoms of schizophrenia and

related psychoses. Schizophrenia is a

mental illness with disturbances in

thinking, feelings and behaviour.

APL-OLANZAPINE ODT alone, or

combination

with

lithium

valproate, is used for the short-term

treatment

acute

manic

episodes

associated with Bipolar I Disorder.

APL-OLANZAPINE ODT is also a

mood stabiliser that prevents further

occurrences

disabling

high

(depressed)

extremes

mood

associated

with

Bipolar

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 and sometimes severe

irritability.

Your

doctor

have

prescribed

APL-OLANZAPINE

another reason.

Ask your doctor if you have any

questions

about

why

APL-

OLANZAPINE

ODT

has

been

prescribed for you.

This medicine is available only with

a doctor's prescription.

APL-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

APL-OLANZAPINE ODT

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 it

Do not take

APL-OLANZAPINE ODT:

if

you

have

had

an

allergic

reaction

to

any

type

of

APL-

OLANZAPINE ODT 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

or

wafers

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

APL-

OLANZAPINE ODT, talk to your

doctor or pharmacist.

Before you start to take it

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 of the pituitary gland (a

small gland at the base of the

brain)

disease

blood

with

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 or a

family history of diabetes

breast cancer or a family history

of breast cancer

paralytic ileus, a condition where

the small bowel does not work

properly

epilepsy (seizures or fits)

glaucoma, a condition in which

there is usually a build up of fluid

in the eye

APL-OLANZAPINE ODT

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 2 of 5

heart disease, including irregular

heart rhythm

neuroleptic malignant syndrome,

reaction

some

medicines

with a sudden increase in body

temperature,

extremely

high

blood

pressure

severe

convulsions

tardive dyskinesia, a reaction to

some

medicines

with

uncontrollable

twitching

jerking movements of the arms

and legs.

Tell

your

doctor

if

you

are

pregnant

or

intend

to

become

pregnant.

Like most antipsychotic medicines,

APL-OLANZAPINE

recommended

during

pregnancy.

there

need

consider APL-OLANZAPINE ODT

during your pregnancy, your doctor

will discuss with you the benefits

and risks of using it.

Tell

your

doctor

if

you

are

breastfeeding

or

plan

to

breast-

feed.

It is recommended that you do not

breast-feed

while

taking

APL-

OLANZAPINE ODT.

Tell your doctor if you suffer from

phenylketonuria

(because

APL-

OLANZAPINE

ODT

orally

disintegrating

tablets

contain

aspartame).

Tell your doctor if you will be in a

hot

environment

or

do

a

lot

of

vigorous exercise.

APL-OLANZAPINE

make you sweat less, causing your

body to overheat.

Tell your doctor if you smoke.

Smoking

affect

APL-

OLANZAPINE ODT 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

APL-OLANZAPINE

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 and to 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 or avoid while taking

APL-OLANZAPINE ODT.

Tell your doctor about these things

before

you

take

APL-

OLANZAPINE ODT.

How to take

APL-OLANZAPINE ODT

Follow all directions given to you

by

your

doctor

or

pharmacist

carefully.

These

differ

from

information contained in this leaflet.

How much to take

Your doctor will tell you how much

of medicine you 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

increase

decrease your dose in order to find

appropriate

dose

your

condition.

lower

starting

dose

prescribed for elderly patients over

the age of 65 years.

How to take it

Do

not

handle

the

APL-

OLANZAPINE

ODT

orally

disintegrating

tablets

with

wet

hands as the tablets may break up.

APL-OLANZAPINE

orally

disintegrating tablets break easily, so

you should handle them carefully.

APL-OLANZAPINE

orally disintegrating tablet in your

mouth. It will dissolve directly in

your mouth, so that it can be easily

swallowed.

also

place

APL-

OLANZAPINE

orally

disintegrating tablet in a full glass or

water,

orange

juice,

apple

juice, milk or coffee, and stir.

Drink it straight away.

With some drinks, the mixture may

change colour and possibly become

cloudy.

Do

not

place

the

APL-

OLANZAPINE

ODT

orally

disintegrating

tablet

in

cola

drinks.

When to take it

APL-OLANZAPINE

ODT

orally

disintegrating

tablets

should

be

taken once a day as advised by

your doctor.

Take

your

prescribed

dose

same time each day.

APL-OLANZAPINE

orally

disintegrating

tablets

taken

with or without food.

How long do I take it

Do

not

stop

taking

APL-

OLANZAPINE ODT just because

you feel better. It is important that

you

do

NOT

stop

taking

APL-

OLANZAPINE ODT unless your

doctor tells you.

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

then

back

taking

APL-OLANZAPINE ODT

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 3 of 5

your

medicine

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

Immediately

telephone

your

doctor or the Australian Poisons

Information Centre (telephone 13

11

26)

or

go

to

Accident

and

Emergency

at

your

nearest

hospital, if you think that you or

anyone else has taken too much

APL-OLANZAPINE ODT. Do this

even

if

there

are

no

signs

of

discomfort or poisoning.

If you have taken too much APL-

OLANZAPINE

ODT,

most

common signs are fast heart beat,

agitation/

aggression,

difficulty

speaking, uncontrollable movements

and sedation.

While you are taking

APL-OLANZAPINE ODT

Things you must do

It is important that you remember

to take APL-OLANZAPINE ODT

daily and at the dose prescribed by

your doctor.

Tell

all

doctors,

dentists

and

pharmacists who are treating you

that

you

are

taking

APL-

OLANZAPINE ODT.

While

you

are

taking

APL-

OLANZAPINE

ODT,

tell

your

doctor or pharmacist before you

start any new medicine.

If

you

become

pregnant

while

taking APL-OLANZAPINE ODT,

tell your doctor.

Keep

all

of

your

doctor's

appointments

so

that

your

progress can be checked.

Your

doctor

should

monitor

your

weight while you are taking APL-

OLANZAPINE ODT.

Patients with diabetes or who have a

higher chance of 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

APL-

OLANZAPINE ODT, or lower the

dosage,

even

if

you

are

feeling

better, without checking with your

doctor.

Do not give APL-OLANZAPINE

ODT to anyone else, even if their

symptoms

seem

similar

or

they

have the same condition as you.

Your

doctor

prescribed

APL-

OLANZAPINE

your condition.

Things to be careful of

Be

careful

driving

or

operating

machinery

until

you

know

how

APL-OLANZAPINE ODT affects

you.

APL-OLANZAPINE

cause drowsiness in some people.

Be careful when drinking alcohol

while taking APL-OLANZAPINE

ODT.

The effects of alcohol could be made

worse

while

taking

APL-

OLANZAPINE ODT.

Your doctor may suggest you avoid

alcohol while you are being treated

with APL-OLANZAPINE ODT.

If

APL-OLANZAPINE

ODT

makes you feel lightheaded, 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.

APL-OLANZAPINE

cause your skin to be much more

sensitive

sunlight

than

normally.

Exposure to sunlight may cause a

skin rash, itching, redness, or 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.

APL-OLANZAPINE

affect the way your body reacts to

temperature changes

Side Effects

medicines

have

some

unwanted

side

effects.

Sometimes

they are serious, but most of the time

they

not.

Your

doctor

weighed

risks

using

this

medicine

against

benefits

they

expect it will have for you.

Like

other

medicines,

APL-

OLANZAPINE

cause

some unwanted side effects. These

are likely to vary from patient to

patient. Some side effects may be

related

dose

APL-

OLANZAPINE ODT. Accordingly,

important

that

tell

your

doctor as soon as possible about any

unwanted effects. Your doctor may

then

decide

adjust

dose

APL-OLANZAPINE ODT you are

taking.

Tell your doctor if you notice any

of the following side effects and

they worry you:

drowsiness

unusual tiredness or weakness

fever

restlessness

difficulty

sitting

still

increased appetite, weight gain

constipation, bloating

dry mouth

swelling of your hands, feet and

ankles

aching joints

nose bleeds

APL-OLANZAPINE ODT

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 4 of 5

dizziness, confusion,

forgetfulness.

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

APL-

OLANZAPINE ODT 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

APL-OLANZAPINE

ODT.

Tell

your

doctor

as

soon

as

possible if you notice any of the

following side effects:

symptoms of sunburn (such as

redness,

itching,

swelling

blistering

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

urine,

excessive

thirst,

having

mouth and skin and weakness).

These may indicate the onset or

worsening of diabetes

reaction

following

abrupt

discontinuation

(profuse

sweating, nausea or vomiting)

absence

menstrual

periods

and changes in the regularity of

menstrual periods

involuntary passing of urine or

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

allergic

reaction

such

skin

rash,

itching, shortness of breath or

swelling

face,

lips

tongue.

frequent

infections

such

fever, severe chills, sore throat

or mouth ulcers

bleeding or bruising more easily

than normal

seizures, fits or convulsions

yellowing

skin

and/or

eyes

nausea,

vomiting,

loss

appetite,

generally

feeling

unwell, fever, itching, yellowing

of the skin and/or eyes

severe upper stomach pain often

with

nausea

vomiting

(inflammation of the pancreas)

worm-like

movements

tongue,

other

uncontrolled

movements

tongue,

mouth,

cheeks,

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

blood,

sudden

shortness

breath

pain/tenderness

calf

muscle area

muscle pain, muscle weakness

and brown urine

heart palpitations and dizziness,

which may lead to collapse.

These are very serious side effects.

need

urgent

medical

attention or hospitalisation.

these

side

effects

very

rare.

The following additional side effects

may occur in some groups of people

taking APL-OLANZAPINE ODT:

Elderly patients with dementia-

related psychosis

Elderly

patients

with

dementia-

related

psychosis

notice

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.

APL-OLANZAPINE

ODT

in

combination

with

lithium

or

valproate

Patients with bipolar mania taking

APL-OLANZAPINE

combination

with

lithium

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.

experience

them.

Other side effects not listed above

may also occur in some patients.

Tell

your

doctor

if

you

notice

anything else that is making you

feel unwell.

APL-OLANZAPINE ODT

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 5 of 5

After taking

APL-OLANZAPINE ODT

Storage

Keep

your

APL-OLANZAPINE

ODT orally disintegrating tablets

in the blister pack until it is time to

take them.

Keep

your

APL-OLANZAPINE

ODT orally disintegrating tablets

in

a

cool,

dry

place

where

the

temperature stays below 25°C.

APL-OLANZAPINE

ODT

orally

disintegrating

tablets

should

be

stored in the original package in

order

to

protect

from

light

and

moisture.

Do not store APL-OLANZAPINE

ODT or any other medicine in the

bathroom or near a sink.

Do

not

leave

your

tablets

and

wafers in the car on hot days or on

window sills.

Heat

dampness

destroy

some medicines.

All

medicines

should

be

kept

where

young

children

cannot

reach them.

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

APL-OLANZAPINE

find that the tablets have passed their

expiry

date,

please

return

leftover tablets to your pharmacist.

Product Description

What it looks like

APL-OLANZAPINE ODT 5, 10, 15

& 20 (containing olanzapine 5 mg,

&

orally

disintegrating tablets are supplied in

pack sizes of 7 and 28 tablets in

blister packs.

APL-OLANZAPINE ODT 5

(AUST R 212901)

Yellow coloured, circular, flat faced

beveled edge tablets debossed with

‘C’ on one side and ‘51’ on the other

side.

APL-OLANZAPINE ODT 10

(AUST R 212896)

Yellow coloured, circular, flat faced

beveled edge tablets debossed with

‘C’ on one side and ‘52’ on the other

side.

APL-OLANZAPINE ODT 15

(AUST R 212902)

Yellow coloured, circular, flat faced

beveled edge tablets debossed with

‘C’ on one side and ‘53’ on the other

side.

APL-OLANZAPINE ODT 20

(AUST R 212893)

Yellow coloured, circular, flat faced

beveled edge tablets debossed with

‘C’ on one side and ‘54’ on the other

side.

Ingredients

Active ingredient

Each

APL-OLANZAPINE

orally disintegrating tablets contains

either 5 mg, 10 mg, 15 mg or 20 mg

olanzapine

active

ingredient.

Inactive ingredients

mannitol

polacrilin potassium

crospovidone

microcrystalline cellulose

aspartame

colloidal anhydrous silica

sodium stearyl fumarate

artificial pineapple FL SD #883

Name and Address of the Sponsor

Aurobindo Pharma Australia Pty Ltd

Unit 3, Macquarie Link

277-283 Lane Cove Road

Macquarie Park

NSW 2113

Australia

Date of Approval

19 August 2014