OLANZAPINE SANDOZ ODT 20 olanzapine 20mg orally disintegrating tablet blister pack

Main information

  • Trade name:
  • OLANZAPINE SANDOZ ODT 20 olanzapine 20mg orally disintegrating tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • OLANZAPINE SANDOZ ODT 20 olanzapine 20mg orally disintegrating tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 179093
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

179093

OLANZAPINE SANDOZ ODT 20 olanzapine 20mg orally disintegrating tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

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 SANDOZ ODT 20 olanzapine 20mg orally disintegrating tablet blister pack

Product Type

Single Medicine Product

Effective date

9/08/2017

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

18 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 SANDOZ ODT 20 olanzapine 20mg orally disintegrating tablet blister pack

Dosage Form

Tablet, orally disintegrating

Route of Administration

Oral

Visual Identification

Yellow, round flat tablets

Active Ingredients

Olanzapine

20 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 09:24:27 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 09:24:27 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 SANDOZ

OLANZAPINE

SANDOZ

®

ODT

olanzapine orally dispersible tablets

Consumer Medicine Information

What is in this leaflet

This leaflet is designed to provide

you with answers to 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.

All medicines have risks and

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 OLANZAPINE

SANDOZ

®

ODT is

used for

OLANZAPINE SANDOZ® ODT

belongs to a group of medicines

called antipsychotics. It helps to

correct chemical imbalances in the

brain, which may cause mental

illness.

OLANZAPINE SANDOZ

ODT is

used to treat symptoms of

schizophrenia and related psychoses.

OLANZAPINE SANDOZ

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 SANDOZ

ODT 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 in thinking,

feelings and behaviour.

Bipolar I Disorder is a mental illness

with symptoms such as 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 may have prescribed

OLANZAPINE SANDOZ

ODT for

another reason.

Ask your doctor if you have any

questions about why

OLANZAPINE SANDOZ

®

ODT

has been prescribed for you.

This medicine is available only with

a doctor's prescription.

Before taking

OLANZAPINE

SANDOZ

®

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 OLANZAPINE

SANDOZ

®

ODT:

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 may

include a 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 OLANZAPINE

SANDOZ

®

ODT, 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 of the pituitary gland (a

small gland at the base of the

brain)

OLANZAPINE SANDOZ

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 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

heart disease, including irregular

heart rhythm

neuroleptic malignant syndrome,

a reaction to some medicines with

a sudden increase in body

temperature, extremely high

blood pressure and severe

convulsions

tardive dyskinesia, a reaction to

some medicines with

uncontrollable twitching or

jerking movements of the arms

and legs.

if you are pregnant or intend to

become pregnant.

Like most antipsychotic medicines,

OLANZAPINE SANDOZ

ODT is

not recommended for use during

pregnancy. If there is a need to

consider OLANZAPINE SANDOZ

ODT during your pregnancy, your

doctor will discuss with you the

benefits and risks of using it.

Shaking, muscle stiffness and

difficulty in feeding, all of which are

reversible, may occur in newborns, if

a mother uses the medicine in the last

trimester of her pregnancy.

OLANZAPINE SANDOZ

should be used in pregnancy only if

the anticipated benefit outweighs the

risk and the administered dose and

duration of treatment should be as

low and as short as possible.

if you are breast-feeding or

plan to breast-feed.

It is recommended that you do not

breast-feed while taking

OLANZAPINE SANDOZ

ODT.

if you suffer from lactose

intolerance (because

OLANZAPINE SANDOZ

®

ODT contains lactose).

OLANZAPINE SANDOZ

ODT is

not recommended for use in children.

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

OLANZAPINE SANDOZ

ODT 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 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(e.g. tranquillisers)

ciprofloxacin, a medicine used to

treat bacterial infections

medicines that lower blood

pressure

medicines used for Parkinson's

disease

medicines that can change the

heart's electrical activity or make

it more likely to change.

Smoking may affect OLANZAPINE

SANDOZ

ODT or may affect how

it works.

Your doctor or pharmacist has more

information on medicines to be

careful with or avoid while taking

OLANZAPINE SANDOZ

ODT.

Tell your doctor about these things

before you take OLANZAPINE

SANDOZ

®

ODT.

How to take

OLANZAPINE

SANDOZ

®

ODT

Follow all directions given to you

by your doctor or pharmacist

carefully.

These may differ from the

information contained in this leaflet.

How much to take

OLANZAPINE SANDOZ

®

ODT

orally dispersible tablets:

Your doctor will tell you how many

OLANZAPINE SANDOZ

tablets 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 may increase or

decrease your dose in order to find

the appropriate dose for your

condition.

A lower starting dose may be

prescribed for elderly patients over

the age of 65 years.

How to take it

OLANZAPINE SANDOZ

®

ODT:

These orally disintegrating tablets

will dissolve in 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 SANDOZ

®

ODT

should be taken once a day as

advised by your doctor.

OLANZAPINE SANDOZ

Take your prescribed dose at the

same time each day.

OLANZAPINE SANDOZ

ODT can

be taken with or without food.

How long to take it

Do not stop taking OLANZAPINE

SANDOZ

®

ODT just because you

feel better. It is important that you

do NOT stop taking

OLANZAPINE SANDOZ

®

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 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 go to Accident and

Emergency at your nearest

hospital, if you think that you or

anyone else has taken too much

OLANZAPINE SANDOZ

®

ODT.

Do this even if there are no signs of

discomfort or poisoning.

If you have taken too much

OLANZAPINE SANDOZ

ODT,

the most common signs are fast heart

beat, agitation/aggression, difficulty

speaking, uncontrollable movements

and sedation.

While you are taking

OLANZAPINE

SANDOZ

®

ODT

Things you must do

It is important that you remember

to take OLANZAPINE SANDOZ

®

ODT daily and at the dose

prescribed by your doctor.

Tell all doctors, dentists and

pharmacists who are treating you

that you are taking OLANZAPINE

SANDOZ

®

ODT.

While you are taking

OLANZAPINE SANDOZ

®

ODT,

tell your doctor or pharmacist

before you start any new medicine.

If you become pregnant while

taking OLANZAPINE SANDOZ

®

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

OLANZAPINE SANDOZ

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.

Things you must not do

Do not stop taking OLANZAPINE

SANDOZ

®

ODT, or lower the

dosage, even if you are feeling

better, without checking with your

doctor.

Do not give OLANZAPINE

SANDOZ

®

ODT to anyone else,

even if their symptoms seem

similar or they have the same

condition as you. Your doctor has

prescribed OLANZAPINE

SANDOZ® ODT for you and your

condition.

Things to be careful of

OLANZAPINE SANDOZ

may cause drowsiness in some

people.

Be careful driving or operating

machinery until you know how

OLANZAPINE SANDOZ

®

ODT

affects you.

Be careful when drinking alcohol

while taking OLANZAPINE

SANDOZ

®

ODT. The effects of

alcohol could be made worse while

taking OLANZAPINE SANDOZ

®

ODT.

Your doctor may suggest you avoid

alcohol while you are being treated

with OLANZAPINE SANDOZ

ODT.

If OLANZAPINE SANDOZ

®

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 15+

sunscreen.

OLANZAPINE SANDOZ

may cause your skin to be 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 SANDOZ

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 SANDOZ

®

ODT.

Like other medicines,

OLANZAPINE SANDOZ

OLANZAPINE SANDOZ

may cause some unwanted side

effects. These are likely to vary from

patient to patient. Some side effects

may be related to the dose of

OLANZAPINE SANDOZ

ODT.

Accordingly, it is important that you

tell your doctor as soon as possible

about any unwanted effects. Your

doctor may then decide to adjust the

dose of OLANZAPINE SANDOZ

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 or difficulty sitting

still

dizziness, confusions,

forgetfulness

increased appetite, weight gain

constipation, bloating

dry mouth

swelling of your hands, feet and

ankles

nose bleeds

aching joints

Some people may feel dizzy in the

early stages of treatment, especially

when getting up from a lying or

sitting position. This side effect

usually passes after taking

OLANZAPINE SANDOZ

ODT for

a few days.

Elderly patients with dementia-

related psychosis may notice the

following side effects:

unusual manner of walking

falls

pneumonia

involuntary passing of urine

Some patients with Parkinson's

disease may hallucinate (see, feel or

hear things that are not there) or

develop worsening symptoms of

Parkinson's disease.

Patients with bipolar mania taking

OLANZAPINE SANDOZ

ODT in

combination with lithium or

valproate may notice the 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

SANDOZ

ODT.

Tell your doctor if you notice any

of the following side effects:

symptoms of sunburn (such as

redness, itching, swelling or

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 in men or

women

symptoms of high sugar levels in

the blood (including passing large

amounts of urine, excessive thirst,

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)

reaction following abrupt

discontinuation (profuse

sweating, nausea or vomiting)

absence of menstrual periods and

changes in the regularity of

menstrual periods

involuntary passing of urine or

difficulty in initiating urination

unusual hair loss or thinning.

Tell your doctor if your monthly

periods are absent for six months

or more.

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 as skin rash,

itching, shortness of breath or

swelling of the fact, lips or tongue

frequent infections such as fever,

severe chills, sore throat or mouth

ulcers

bleeding or 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 of the skin

and/or eyes

inflammation of the pancreas

severe upper stomach pain often

with nausea and vomiting

worm-like movements of the

tongue, or other uncontrolled

movements of the tongue, mouth,

cheeks, or jaw which may

progress to the arms and legs

sudden increase in 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 and dizziness,

which may lead to collapse.

These are very serious side effects.

You may need urgent medical

attention or hospitalisation.

All of these side effects are very rare.

All of these side effects are very rare.

The following additional side effects

may occur in some group of people

taken olanzapine.

Elderly patients with dementia-

related psychosis

may notice the following side effects:

unusual manner of walking

OLANZAPINE SANDOZ

falls

pneumonia

involuntary passing of urine.

Parkinson's disease psychosis

Some patients with Parkinson's

disease may hallucinate (see, feel or

hear things that are not there) or

develop worsening symptoms of

Parkinson's disease.

Patients with bipolar mania taking

OLANZAPINE SANDOZ® ODT in

combination with lithium or

valproate may notice the following

side effects:

tremors

speech disorder.

These are the more common side

effects of OLANZAPINE

SANDOZ® ODT.

Also, some side effects, such as

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 not listed above

may also occur in some patients.

Tell your doctor if you notice

anything else 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

SANDOZ

®

ODT

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

SANDOZ

ODT after the expiry

date on the pack has passed.

Disposal

If your doctor tells you to stop taking

OLANZAPINE SANDOZ

ODT or

you find that the tablets have passed

their expiry date, please return any

left over tablets or wafers to your

pharmacist.

Product Description

What it looks like

OLANZAPINE SANDOZ

orally disintegrating tablets:

5 mg: Yellow, round, biconvex

orally disintegrating tablets -

blister packs of 7 and 28

10 mg: Yellow, round, flat orally

disintegrating tablets - blister

packs of 7 and 28

15 mg: Yellow, round, biconvex

orally disintegrating tablets -

blister packs of 7 and 28

20 mg: Yellow, round, flat orally

disintegrating tablets - blister

packs of 7 and 28

Not all strengths and pack sizes may

be available.

Ingredients

Active ingredient

OLANZAPINE SANDOZ

contains the active ingredient,

Olanzapine:

5 mg - 5 mg Olanzapine per tablet

10 mg - 10 mg Olanzapine per

tablet

15 mg - 15 mg Olanzapine per

tablet

20 mg - 20 mg Olanzapine per

tablet

OLANZAPINE SANDOZ

orally disintegrating tablets:

lactose monohydrate

crospovidone

hyprolose

colloidal anhydrous silica

purified talc

magnesium stearate

mint Flavouring E-0613218

(acacia, cineole, maltodextrin,

mint oil, mint oil dementholised,

peppermint oil, menthone,

isomenthone, menthyl acetate and

menthol)

Supplier

SANDOZ Pty Ltd

ABN 60 075 449 553

54 Waterloo Road,

Macquarie Park, NSW 2113

Australia

Tel: 1800 726 369

Australian Registration

Numbers

OLANZAPINE SANDOZ

®

ODT

(orally disintegrating tablets)

5 mg AUST R 179092

10 mg AUST R 179086

15 mg AUST R 179073

20 mg AUST R 179093

This leaflet was prepared in May

2019.