OLANZAPINE AN ODT olanzapine 15mg orally disintegrating tablet blister pack

Main information

  • Trade name:
  • OLANZAPINE AN ODT olanzapine 15mg orally disintegrating tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • OLANZAPINE AN ODT olanzapine 15mg orally disintegrating tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 179085
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

179085

OLANZAPINE AN ODT olanzapine 15mg 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

12/08/2011

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. OLANZAPINE AN ODT olanzapine 15mg orally disintegrating tablet blister pack

Product Type

Single Medicine Product

Effective date

28/11/2014

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, it 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

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

24 Months

Store below 30

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. OLANZAPINE AN ODT olanzapine 15mg orally disintegrating tablet blister pack

Dosage Form

Tablet, orally disintegrating

Route of Administration

Oral

Visual Identification

Yellow, round biconvex tablets

Active Ingredients

Olanzapine

15 mg

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

Public Summary

Page 1 of

Produced at 29.11.2017 at 09:26:55 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

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

Public Summary

Page 2 of

Produced at 29.11.2017 at 09:26:55 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

Olanzapine AN and Olanzapine AN ODT tablets – Consumer Medicine Information

Olanzapine AN and ODT CMI v2.0

Page 1

Olanzapine AN and Olanzapine AN ODT tablets

Olanzapine film coated and orally disintegrating tablets

Consumer Medicine Information

What is in this leaflet

This

leaflet

designed

provide

with

answers

some common questions about

this medicine. It does not contain

all the available information and

does not take the place of talking

to your doctor.

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

taking

full

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

your

medicine.

You may need to read it again.

What Olanzapine AN

is used for

Olanzapine AN is used to treat

symptoms of schizophrenia and

related

psychoses.

Olanzapine

AN alone, or in combination with

lithium or valproate, is used for

the short-term treatment of acute

manic episodes associated with

Bipolar I Disorder.

Olanzapine AN is also a mood

stabiliser

that

prevents

further

occurrences of the disabling high

and low (depressed) extremes of

mood associated with Bipolar I

Disorder.

Schizophrenia is a mental illness

with

disturbances

thinking,

feelings and behaviour. Bipolar I

Disorder is a mental illness with

symptoms

such

feeling

"high",

having

excessive

amounts

energy,

needing

much less sleep than

usual, talking very quickly with

racing

ideas

sometimes

severe irritability.

Olanzapine

belongs

group

medicines

called

antipsychotics. It helps to correct

chemical

imbalances

brain, which may cause mental

illness.

Your

doctor

have

prescribed

Olanzapine

another reason.

Ask your doctor if you have any

questions about why Olanzapine

AN has been prescribed for you.

This medicine is available only

with a doctor's prescription.

Before taking

Olanzapine AN

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 Olanzapine AN:

if you have had an allergic

reaction to Olanzapine or

to any of the ingredients

listed

at

the

end

of

this

leaflet

(see

'Product

Description').

Signs of an allergic reaction

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.

take

this

medicine

after

expiry

date

passed it may not work as

well.

If

you

are

not

sure whether

you

should

start

taking

Olanzapine

AN,

talk

to

your

doctor or pharmacist

Before you start to take it

You must tell your doctor:

if you have had an allergic

reaction

to

any

medicine

which

you

have

taken

previously

to

treat

your

current condition

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 or a family

history of diabetes

breast

cancer

family

history

breast cancer

paralytic

ileus,

condition where the

bowel does not work

properly

epilepsy, seizures or

fits

glaucoma,

condition

which

there

usually

build

of fluid

the eye

heart

disease,

including

irregular

Olanzapine AN and Olanzapine AN ODT tablets – Consumer Medicine Information

Olanzapine AN and ODT CMI v2.0

Page 2

heart rhythm

neuroleptic

malignant

syndrome,

reaction

some

medicines

with

sudden

increase

body

temperature,

extremely high blood

pressure and severe

convulsions

tardive dyskinesia, a

reaction

some

medicines

with

uncontrollable

twitching

jerking

movements

arms and legs.

If

you

are

pregnant

or

intend to become pregnant

Like

most

antipsychotic

medicines, Olanzapine AB is

recommended

during pregnancy. If there is

need

consider

Olanzapine AN during your

pregnancy, your doctor will

discuss with you the benefits

risks

using

Shaking,

muscle

stiffness

and difficulty in feeding, all

of which are reversible, may

occur

newbrons,

mother uses the medicine in

last

trimester

pregnancy.

Olanzapine

should ne used in pregnancy

only if the anticipated benefit

outweighs the risk and the

administered

dose

duration of treatment should

short

possible.

If you are pregnant or plan

to breast feed

It is recommended that you

breast

feed

while

taking Olanzapine AN.

If you suffer from lactose

intolerance

(because

Olanzapine

AN

tablets

contain lactose).

Olanzapine

recommended

children.

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

affected

Olanzapine

may affect how it works. These

include:

medicines

used

treat

fast or irregular heart beat

(arrhythmia)

medicines taken for anxiety

or to help you sleep

medicines

taken

depression

carbamazepine, a medicine

used for mood stabilisation

and to treat epilepsy

other

centrally

acting

medicines (eg tranquilisers)

ciprofloxacin,

medicine

used

treat

bacterial

infections

medicines that lower blood

pressure

medicines

used

Parkinsons disease

medicines that can change

the hearts electrical activity

make

more

likely

change

Smoking may affect Olanzapine

GA or may affect how it works.

Your doctor or pharmacist has

more information on medicines

carefully

with

avoid

while taking Olanzapine AN.

Tell your doctor about these

things

before

you

take

Olanzapine AN.

How to take

Olanzapine AN

Follow

all

directions

given

toyou

by

your

doctor

or

pharmacist carefully.

These

differ

from

information

contained

this

leaflet.

How much to take

Olanzapine AN film coated or

orally dispersible tablets:

Your

doctor

will

tell

many Olanzapine AN tablets you

should

take.

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.

A lower starting dose may be

prescribed

elderly

patients

over the age of 65 years.

How to take it

Olanzapine AN:

These film coated tablets should

be swallowed whole with a glass

of water.

Olanzapine AN ODT:

These

orally

disintegrating

tablets

will

dissolve

your

mouth, therefore do not require

water.

You can also place these tablets

in a full glass of 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.

The

orally

disintegrating

tablets should not be placed

in cola drinks.

When to take it

Olanzapine AN film coated or

orally disintegrating tablets

should be taken once a day as

advised by your doctor.

Take your prescribed dose at the

same time each day.

Olanzapine AN tablets can be

taken with or without food.

How long to take it

Do not stop taking Olanzapine

AN

just

because

you

feel

better. It is important that you

do

NOT

stop

taking

Olanzapine

AN

unless

your

doctor tells you.

If you forget to take it

If it is almost time for

your

next dose, skip the dose you

Olanzapine AN and Olanzapine AN ODT tablets – Consumer Medicine Information

Olanzapine AN and ODT CMI v2.0

Page 3

missed

and

take

your

next

dose when you are meant to.

Otherwise, take it as soon as

you remember then go back to

taking

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

(overdose)

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

Olanzapine AN. Do this even if

there are no signs of discomfort

or poisoning.

have

taken

much

Olanzapine

most

common

signs

fast

heart

beat,

agitation/aggression,

difficulty

speaking,

uncontrollable

movements

sedation.

While you are taking

Olanzapine AN

Things you must do

It

is

important

that

you

remember to take Olanzapine

AN

daily

and

at

the

dose

prescribed by your doctor.

Tell all doctors, dentists and

pharmacists who are treating

you

that

you

are

taking

Olanzapine AN.

While

you

are

taking

Olanzapine AN, tell your doctor

or pharmacist before you start

any new medicine.

If you become pregnant while

taking Olanzapine AN, 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

Olanzapine AN.

Patients

with

diabetes

have

higher

chance

developing diabetes should have

their blood sugar checked often.

If you are over 65, your doctor

measure

your

blood

pressure from time to time.

Things you must not do

Do not stop taking Olanzapine

AN, or lower the dosage, even

if

you

are

feeling

better,

without

checking

with

your

doctor.

Do not give Olanzapine AN to

anyone

else,

even

if

their

symptoms

seem

similar

or

they have the same condition

as

you.

Your

doctor

prescribed

Olanzapine

you and your condition.

Things to be careful of

Olanzapine AN may cause

drowsiness in some people. Be

careful driving or operating

machinery until you know how

Olanzapine AN affects you.

Be careful drinking alcohol

while taking Olanzapine AN.

The effects of alcohol could be

made worse while taking

Olanzapine AN. Your doctor may

suggest you avoid alcohol while

you are being treated with

Olanzapine AN.

If Olanzapine AN makes you

feel lightheaded, dizzy or faint,

be careful getting up from a

sitting

or

lying

position.

Getting up slowly may help.

If

outdoors,

wear

protective

clothing and use at least a 15+

sunscreen. Olanzapine AN may

cause

your

skin

much

more sensitive to sunlight than it

is 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.

Olanzapine

may affect the way your body

reacts to temperature changes.

Side Effects

Tell your doctor or pharmacist

as

soon

as

possible

if

you

experience

any

undesirable

effect or feel unwell while you

are taking Olanzapine AN.

Like

other

medicines,

Olanzapine AN may cause some

unwanted

side

effects.

These

are likely to vary from patient to

patient. Some side effects may

related

dose

Olanzapine AN. Accordingly, it is

important

that

tell

your

doctor as soon as possible about

unwanted

effects.

Your

doctor may then decide to adjust

the dose of Olanzapine AN you

are taking.

Tell your doctor if you notice

any

of

the

following

side

effects and they worry you:

drowsiness

restlessness

difficulty

sitting still

weight gain

dizziness

increased appetite

constipation

dry mouth

swelling of your hands, feet

and ankles

unusual

tiredness

weakness.

Some people may feel dizzy in

early

stages

treatment,

especially when getting up from

a lying or sitting position. This

side effect usually passes after

taking Olanzapine AN for a few

days.

Elderly patients with dementia-

related psychosis may notice the

following side effects:

unusual manner of walking

falls

Olanzapine AN and Olanzapine AN ODT tablets – Consumer Medicine Information

Olanzapine AN and ODT CMI v2.0

Page 4

pneumonia

involuntary passing of urine

Some patients with Parkinson's

disease

hallucinate

(see,

feel or hear things that are not

there)

develop

worsening

symptoms

Parkinson's

disease.

Patients

with

bipolar

mania

taking

Olanzapine

combination

with

lithium

valproate

notice

following additional side effects:

tremors

speech disorder

Tell your doctor if you notice

any of the above side effects

and they worry you. These are

the more common side effects of

Olanzapine AN.

Tell your doctor if you notice

any

of

the

following

side

effects:

symptoms of sunburn (such

as redness, itching, swelling

or istering of the skin) which

occur

more

quickly

than

normal

rash

allergic reaction

slow heart beat

prolonged

and/or

painful

erection

unusual secretion of breast

milk

breast enlargement

symptoms

high

sugar

levels in the blood (including

passing

large

amounts

urine,

excessive

thirst,

having a dry mouth and skin

and weakness). These may

indicate

onset

worsening

diabetes

reaction

following

abrupt

discontinuation

(profuse

sweating,

nausea

vomiting)

absence

menstrual

periods and changes in the

regularity

menstrual

periods

involuntary passing of urine

difficulty

initiating

urination

unusual hair loss or thinning

Tell

your

doctor

if

your

monthly

periods

are

absent

for six months or more.

These

side

effects

uncommon

require

medical attention.

Tell your doctor immediately

or

go

to

Accident

and

Emergency

at

the

nearest

hospital if you notice any of

the following:

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

appetite,

generally

feeling

unwell,

fever,

itching,

yellowing of the skin and/or

eyes

inflammation

pancreas

severe upper stomach pain

often

with

nausea

vomiting

worm-like movements of the

tongue, or other uncontrolled

movements

tongue,

mouth, cheeks, or jaw which

progress

arms

and legs

sudden

increase

body

temperature,

sweating,

fast

heart beat, muscle stiffness,

high

blood

pressure

convulsions

sharp chest pain, coughing

blood,

sudden

shortness of breath

pain/tenderness

calf

muscle area

muscle

pain,

muscle

weakness and brown urine

heart

palpitations

dizziness, which may lead to

collapse.

above

list

includes

very

serious

side

effects.

need urgent medical attention or

hospitalisation.

All of these side effects are very

rare.

Also, some side effects, such as

changes

liver

function,

cholesterol

triglycerides

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 that is making you

feel unwell.

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.

After taking

Olanzapine AN

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 30°C.

All medicines should be kept

where young children cannot

reach them. A locked cupboard

one and a half metres above the

ground is a good place to store

medicines.

Do not take Olanzapine AN after

the expiry date on the pack has

passed.

Disposal

If your doctor tells you to stop

taking Olanzapine AN or you find

that

tablets

have

passed

their expiry date, please return

any leftover tablets or wafers to

your pharmacist.

Olanzapine AN and Olanzapine AN ODT tablets – Consumer Medicine Information

Olanzapine AN and ODT CMI v2.0

Page 5

Product description

Olanzapine AN

Olanzapine AN film coated

tablets are presented in

PA/Al/PVC/Al blister packs.

2.5 mg (AUST R 178998): white,

round,

biconvex

film

coated

tablets

5 mg (AUST R 178993): white,

round,

biconvex

film

coated

tablets

7.5mg (AUST R 178992): white,

round,

biconvex

film

coated

tablets

10mg (AUST R 179000): white,

round,

biconvex

film

coated

tablets

15mg (AUST R 179002): light

blue,

oblong,

biconvex

film

coated tablets tablets

20mg (AUST R 178982): pink,

oblong,

biconvex

film

coated

tablets

Olanzapine AN ODT

Olanzapine AN Orally

Disintegrating Tablets are

presented in PA/Al/PVC/Al

blister packs.

5 mg (AUST R 179083): yellow,

round,

biconvex

orally

disintegrating tablets

10

mg

(AUST

R

179081):

yellow,

round,

flat

orally

disintegrating tablets

15

mg

(AUST

R

179085):

yellow,

round,

biconvex

orally

disintegrating tablets

20

mg

(AUST

R

179084):

yellow,

round,

flat

orally

disintegrating tablets

Ingredients

Active Ingredient:

Olanzapine AN and Olanzapine

tablets

contain

active ingredient, Olanzapine:

2.5mg – 2.5mg Olanzapine

per tablet

5mg – 5mg Olanzapine per

tablet

7.5mg – 7.5mg Olanzapine

per tablet

10mg

10mg

Olanzapine

per tablet

15mg

15mg

Olanzapine

per tablet

20mg

20mg

Olanzapine

per tablet

Inactive Ingredients

Olanzapine

AN

film

coated

tablets:

Lactose

Microcrystalline cellulose

Crospovidone

Hydroxypropylcellulose

Purified talc

Magnesium stearate

Opadry AMB complete film

coating system OY-B-28920

Opadry

aqueous

moisture

barrier

coating

system 80W26503 Grey (15

mg only)

Opadry

aqueous

moisture

barrier

coating

system 80W24003 Pink (20

mg only)

Olanzapine AN ODT

Lactose

Crospovidone

Hydroxypropylcellulose

Colloidal anhydrous silica

Purified talc

Magnesium stearate

Mint flavouring E_0613218

Name

and

Address

of

the

Sponsor

Amneal

Pharma

Australia

12 River St

South Yarra,

VIC – 3141

Australia

Date of Preparation

June 2014