OLANZACOR

Main information

  • Trade name:
  • OLANZACOR olanzapine 2.5mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • OLANZACOR olanzapine 2.5mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207850
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207850

OLANZACOR olanzapine 2.5mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Pharmacor Pty Ltd

Postal Address

Suite 501,7 Oaks Ave,Dee Why, NSW, 2099

Australia

ARTG Start Date

12/12/2014

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. OLANZACOR olanzapine 2.5mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

9/03/2016

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

Al/Al

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Moisture

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

28's blister pack (2 x 14 or 4x7's tablets)

(S4) Prescription Only Medicine

Components

1. OLANZACOR olanzapine 2.5mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off white colored, film coated, round shaped, biconvex tablets,

imprinted '2.5' with black ink on one side and plain on the other side.

Active Ingredients

Olanzapine

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 27.11.2017 at 11:55:51 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

Olanzacor

OLANZACOR

olanzapine

Consumer Medicine Information

What is in this leaflet

This

leaflet

designed

provide

you with answers to some common

questions about this medicine. It does

contain

available

information

does

take

place of talking with your doctor.

The information in this leaflet was

last updated on the date shown on the

final page. More recent information

about this medicine may be available.

Make

sure

speak

your

pharmacist

doctor

obtain

most up to date information on this

medicine.

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 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 Olanzacor is

used for

Olanzacor

belongs

group

medicines

called

antipsychotics.

helps to correct chemical imbalances

in the brain, which may cause mental

illness.

Olanzacor is used to treat symptoms

schizophrenia

related

psychoses. Schizophrenia is a mental

illness with disturbances in thinking,

feelings and behaviour.

Olanzacor alone, or in combination

with lithium or valproate, is used for

short-term

treatment

acute

manic

episodes

associated

with

Bipolar I Disorder. Olanzacor is also

mood

stabiliser

that

prevents

further occurrences of the disabling

high and low (depressed) extremes

of 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 may have prescribed

Olanzacor for another reason.

Ask your doctor if you have any

questions about why Olanzacor

has been prescribed for you.

This medicine is available only with

a doctor's prescription.

Olanzacor is not recommended for

use in children under the age of 18

years

there

enough

information on its effects in this age

group.

Before taking

Olanzacor

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 Olanzacor:

if

you

have

had

an

allergic

reaction

to

any

type

of

Olanzacor

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

Olanzacor,

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:

Olanzacor

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

heart disease, including irregular

heart rhythm

neuroleptic malignant syndrome,

a reaction to some medicines with

sudden

increase

body

temperature, extremely high

blood pressure and 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,

Olanzacor is not recommended for use

during pregnancy. If there is a need to

consider

Olanzacor

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 Olanzacor.

Tell your doctor if you suffer from

lactose

intolerance

(because

Olanzacor tablets contain lactose).

Tell your doctor if you will be in a

hot

environment

or

do

a

lot

of

vigorous exercise.

Olanzacor

make

sweat

less, causing your body to overheat.

Tell your doctor if you smoke.

Smoking may affect Olanzacor 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

Olanzacor

affect

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 for 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

Olanzacor.

Tell your doctor about these things

before you take Olanzacor.

How to take Olanzacor

Follow all directions given to you

by

your

doctor

or

pharmacist

carefully.

These

differ

from

information

contained

this

leaflet.

How much to take

Olanzacor tablets:

Your doctor will tell you how many

Olanzacor 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

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

Olanzacor

tablets

should

swallowed whole with a glass of

water.

When to take it

Olanzacor

tablets

should

be

taken once a day as advised by

your doctor.

Take your prescribed dose at the

same time each day.

Olanzacor

tablets

taken

with or without food.

How long do I take it

Do

not

stop

taking

Olanzacor

just because you feel better. It is

important that you do NOT stop

taking

Olanzacor

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.

Olanzacor

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

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 Olanzacor. Do this even if

there are no signs of discomfort or

poisoning.

have

taken

much

Olanzacor, the most common signs

fast

heart

beat,

agitation/

aggression,

difficulty

speaking,

uncontrollable

movements

sedation.

While you are taking

Olanzacor

Things you must do

It is important that you remember

to take Olanzacor daily and at the

dose prescribed by your doctor.

Tell

all

doctors,

dentists

and

pharmacists who are treating you

that you are taking Olanzacor.

While you are taking Olanzacor,

tell

your

doctor

or

pharmacist

before

you

start

any

new

medicine.

If

you

become

pregnant

while

taking Olanzacor, 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

Olanzacor.

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.

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 Olanzacor, or

lower the dosage, even if you are

feeling

better,

without

checking

with your doctor.

Do not give Olanzacor to anyone

else, even if their symptoms seem

similar

or

they

have

the

same

condition as you.

Your

doctor

prescribed

Olanzacor

your

condition.

Things to be careful of

Be

careful

driving

or

operating

machinery

until

you

know

how

Olanzacor affects you.

Olanzacor may cause drowsiness in

some people.

Be careful when drinking alcohol

while taking Olanzacor.

The effects of alcohol could be made

worse while taking Olanzacor.

Your doctor may suggest you avoid

alcohol while you are being treated

with Olanzacor.

If Olanzacor 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.

Olanzacor 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.

Olanzacor may 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

the benefits they

expect it will have for you.

Like

other

medicines,

Olanzacor

cause

some

unwanted

side

effects. These are likely to vary from

patient to patient. Some side effects

related

dose

Olanzacor.

Accordingly,

important that you tell your doctor

soon

possible

about

unwanted effects. Your doctor may

then

decide

adjust

dose

Olanzacor 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

increased appetite, weight gain

constipation, bloating

dry mouth

swelling of your hands, feet and

ankles

aching joints

nose bleeds

dizziness, confusion, forgetfulness

Olanzacor

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

Olanzacor 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 Olanzacor.

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

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 of menstrual periods and

changes

regularity

menstrual periods

• involuntary passing of urine or

difficulty in initiating urination

• unusual hair loss or thinning.

These

side

effects

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

breath

swelling

face,

lips

tongue.

frequent infections such as fever,

severe

chills,

sore

throat

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.

All of these side effects are very

rare.

The following additional side

effects may occur in some groups of

people taking Olanzacor:

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.

Olanzacor in combination

with lithium or valproate

Patients

with

bipolar

mania

taking

Olanzacor in 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.

Olanzacor

After taking Olanzacor

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.

Do

not

store

Olanzacor

in

the

bathroom or near a sink.

Do not leave your tablets 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.

There will be an expiry date (month,

year) on your Olanzacor container.

The medicine should not be taken

after this date because it may have

lost some of its strength.

Disposal

your

doctor

tells

stop

taking Olanzacor or you find that the

tablets have passed their expiry date,

please return any left over tablets to

your pharmacist.

Product Description

What it looks like

Olanzacor tablets 2.5 mg: White to

off white colored, film coated,

round shaped, biconvex

tablets,

imprinted “2.5” with black ink on

one side and plain on the other side.

Olanzacor tablets 5 mg: White to

off white colored, film coated,

round shaped, biconvex

tablets,

imprinted “5” with black ink on one

side and plain on the other side

Olanzacor tablets 7.5 mg: White to

white

colored,

film

coated,

round

shaped,

biconvex

tablets,

imprinted “7.5” with black ink on

side

plain

other

side.

Olanzacor tablets 10 mg: White to

off white colored, film

coated,

round

shaped,

biconvex

tablets, imprinted “10” with black

ink on one side and plain on the

other side.

Olanzacor tablets come in blister

packs in the following pack sizes:

Olanzacor 2.5 mg tablets– 28

tablets;

Olanzacor

tablets–

tablets and 28 tablets;

Olanzacor 7.5 mg tablets– 28

tablets;

Olanzacor 10 mg tablets– 7

tablets and 28 tablets;

Ingredients

Olanzacor

tablets:

Active

Ingredient:

tablet

olanzapine per tablet

5 mg tablet - 5 mg

olanzapine per tablet

tablet

olanzapine per tablet

tablet

olanzapine per tablet

Inactive Ingredient:

lactose, hydroxypropylcellulose,

mannitol, magnesium stearate,

pectin, glycerol triacetate, titanium

dioxide, talc-purified, isopropyl

alcohol and Opacode S-1-17823

black (ARTG # 12108).

Supplier

PHARMACOR PTY LIMITED

Suite 401, 7 Oaks Avenue

Dee Why NSW 2099

Australia

Australian Registration

Numbers

Olanzacor tablets:

2.5 mg tablet - AUST R 207850

5 mg tablet - AUST R 207858

7.5 mg tablet - AUST R 207851

10 mg tablet - AUST R 207847

This leaflet was prepared in December

2014.