OLANZACCORD TABLETS 10 mg olanzapine 10 mg film-coated tablet blister pack

Main information

  • Trade name:
  • OLANZACCORD TABLETS 10 mg olanzapine 10 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • OLANZACCORD TABLETS 10 mg olanzapine 10 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 177123
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

177123

OLANZACCORD TABLETS 10 mg olanzapine 10 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street,Melbourne, VIC, 3000

Australia

ARTG Start Date

23/03/2012

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. OLANZACCORD TABLETS 10 mg olanzapine 10 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

28/11/2013

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Olanzapine tablets are indicated for the treatment of schizophrenia and related psychoses. ,Olanzapine tablets 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 tablets are also 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

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

7 Tablets in blister pack

(S4) Prescription Only Medicine

28 Tablets in blister pack

(S4) Prescription Only Medicine

Components

1. OLANZACCORD TABLETS 10 mg olanzapine 10 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off white round, biconvex, film-coated tablets debossed with "O3"

on one side and plain 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 11:42:47 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

OLANZACCORD TABLETS

CONSUMER MEDICINE INFORMATION

Version: 2.0

-2013- Page: 1 of 6

Olanzaccord Tablets

Olanzapine 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

with your doctor.

More

recent

information

about

this medicine may be available.

Make

sure

speak

your

pharmacist

doctor

obtain

the most up to date information

on this medicine.

medicines

have

risks

benefits.

Your

doctor

more

information about this medicine

than is contained in this leaflet.

Also,

your

doctor

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

this

medicine.

You may need to read it again.

What Olanzaccord

Tablets are used for

Olanzaccord Tablets belongs to a

group

medicines

called

antipsychotics. It helps to correct

chemical imbalances in the brain,

which may cause mental illness.

Olanzaccord Tablets are used to

treat symptoms of schizophrenia

related

psychoses.

Schizophrenia is a mental illness

with

disturbances

thinking,

feelings and behaviour.

Olanzaccord Tablets alone, or in

combination

with

lithium

valproate, is used for the short-

term

treatment

acute

manic

episodes associated with Bipolar

I Disorder. Olanzaccord Tablets

are also a mood stabiliser that

prevents further occurrences of

disabling

high

(depressed)

extremes

mood

associated

with

Bipolar

Disorder.

Bipolar I Disorder is a mental

illness with symptoms such as

feeling “high”, having excessive

amounts

energy,

needing

much

less

sleep

than

usual,

talking very quickly with racing

ideas

sometimes

severe

irritability.

Your

doctor

have

prescribed Olanzaccord Tablets

for another reason.

Ask your doctor if you have

any

questions

about

why

Olanzaccord Tablets has been

prescribed for you.

This medicine is available only

with a doctor’s prescription.

Olanzaccord

Tablets

recommended for use in children

under

years

there is not enough information

on its effects in this age group.

Before taking

Olanzaccord Tablets

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 Olanzaccord

Tablets:

if you have had an allergic

reaction

to

Olanzaccord

Tablets 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 or wafers 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

Olanzaccord

Tablets,

talk

to

your doctor or pharmacist.

Before you start to take it

Tell your doctor if you have had

allergic

reaction

medicine which you have taken

previously to treat your current

condition.

OLANZACCORD TABLETS

CONSUMER MEDICINE INFORMATION

Version: 2.0

-2013- Page: 2 of 6

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 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 of breast cancer

paralytic

ileus,

condition

where the small bowel does

not work properly

epilepsy (seizures or fits)

glaucoma,

condition

which

there

usually

build up of fluid in the eye

heart

disease,

including

irregular heart rhythm

neuroleptic

malignant

syndrome,

reaction

some

medicines

with

sudden

increase

body

temperature, extremely high

blood

pressure

severe

convulsions

tardive

dyskinesia,

reaction to some medicines

with

uncontrollable

twitching

jerking

movements of the arms and

legs.

Tell

your

doctor

pregnant

intend

become

pregnant.

Like

most

antipsychotic

medicines,

Olanzaccord

Tablets

recommended

during pregnancy. If there is a

need

consider

Olanzaccord

Tablets during your pregnancy,

your doctor will discuss with you

the benefits and risks of using it.

Tell

your

doctor

breast-feeding or plan to breast-

feed.

It is recommended that you do

breast-feed

while

taking

Olanzaccord Tablets.

Tell your doctor if you suffer

from lactose intolerance

(because Olanzaccord Tablets

contain lactose).

Tell your doctor if you will be in

a hot environment or do a lot of

vigorous exercise.

Olanzaccord Tablets may make

you sweat less, causing your

body to overheat.

Tell your doctor if you smoke.

Smoking may affect

Olanzaccord Tablets 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 Olanzaccord Tablets or may

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 can change the

heart’s electrical activity or

make it more likely to change.

Your doctor or pharmacist has

more information on medicines

to be careful with or avoid while

taking Olanzaccord Tablets.

Tell your doctor about these

things

before

you

take

Olanzaccord Tablets.

How to take

Olanzaccord Tablets

Follow all directions given to

you

by

your

doctor

or

pharmacist carefully.

These

differ

from

information

contained

this

leaflet.

How much to take

Your doctor will tell you how

many Olanzaccord Tablets you

should

take.

dose

your

doctor

will

prescribe

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

Olanzaccord Tablets should be

swallowed whole with a glass of

water.

When to take it

OLANZACCORD TABLETS

CONSUMER MEDICINE INFORMATION

Version: 2.0

-2013- Page: 3 of 6

Olanzaccord Tablets

should be

taken once a day as advised by

your doctor.

Take your prescribed dose at the

same time each day.

Olanzaccord Tablets can be taken

with or without food.

How long do I take it

Do not stop taking

Olanzaccord Tablets just

because you feel better. It is

important that you do NOT

stop taking Olanzaccord

Tablets 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

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 Olanzaccord Tablets

Do

this even if there are no signs of

discomfort or poisoning.

If you have taken too much

Olanzaccord Tablets, the most

common signs are fast heart beat,

agitation/aggression, difficulty

speaking, uncontrollable

movements and sedation.

While you are taking

Olanzaccord Tablets

Things you must do

It is important that you

remember to take

Olanzaccord Tablets daily and

at the dose prescribed by your

doctor.

Tell all doctors, dentists and

pharmacists who are treating

you

that

you

are

taking

Olanzaccord Tablets.

While you are taking

Olanzaccord Tablets,

tell your

doctor or pharmacist before

you start any new medicine.

If you become pregnant while

taking Olanzaccord Tablets,

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 Olanzaccord Tablets.

Patients with diabetes or who

have

higher

chance

developing

diabetes

should

have

their

blood

sugar

checked often.

over

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

worsening

your

mental

illness.

Things you must not do

Do

not

stop

taking

Olanzaccord Tablets, or lower

the

dosage,

even

if

you

are

feeling

better,

without

checking with your doctor.

Do

not

give

Olanzaccord

Tablets to anyone else, even if

their symptoms seem similar

or

they

have

the

same

condition as you.

Your

doctor

prescribed

Olanzaccord Tablets for you and

your condition.

Things to be careful of

Be

careful

driving

or

operating machinery until you

know

how

Olanzaccord

Tablets affects you.

Olanzaccord Tablets may cause

drowsiness in some people.

Be

careful

when

drinking

alcohol

while

taking

Olanzaccord Tablets.

The effects of alcohol could be

made

worse

while

taking

Olanzaccord Tablets.

Your doctor may

suggest you

avoid

alcohol

while

being treated with Olanzaccord

Tablets.

If Olanzaccord Tablets 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.

OLANZACCORD TABLETS

CONSUMER MEDICINE INFORMATION

Version: 2.0

-2013- Page: 4 of 6

Olanzaccord Tablets may cause

your

skin

much

more

sensitive

sunlight

than

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.

Olanzaccord Tablets may affect

your

body

reacts

temperature changes

Side effects

All medicines may have some

unwanted side effects.

Sometimes they are serious, but

most of the time they are not.

Your doctor has weighed the

risks of using this medicine

against the benefits they expect it

will have for you.

Like

other

medicines,

Olanzaccord Tablets

may cause

some

unwanted

side

effects.

These

likely

vary

from

patient

patient.

Some

side

effects may be related to the dose

of Olanzaccord Tablets.

Accordingly, it is important that

you tell your doctor as soon as

possible

about

unwanted

effects.

Your

doctor

then

decide

adjust

dose

Olanzaccord

Tablets

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 of your hands, feet

and ankles

dizziness

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 Olanzaccord Tablets for a

few days.

Tell your doctor if you notice

any of the above side effects

and they worry you.

These are the more common

side effects of Olanzaccord

Tablets.

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

prolonged and/or painful

erection

unusual secretion of breast

milk

breast enlargement

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)

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.

These

side

effects

uncommon

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 a skin rash.

Itching, shortness of breath or

swelling of the face, lips or

tongue.

frequent

infections

such

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

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

body

temperature, sweating, fast heart

beat,

muscle

stiffness,

high

blood pressure and convulsions

sharp chest pain, coughing of

blood,

sudden

shortness

breath

pain/tenderness

calf

muscle area

muscle pain, muscle weakness

and brown urine

heart

palpitations

dizziness,

which

lead

collapse.

These are very serious side

effects. You may need urgent

medical attention or

hospitalisation.

All of these side effects are very

rare.

OLANZACCORD TABLETS

CONSUMER MEDICINE INFORMATION

Version: 2.0

-2013- Page: 5 of 6

The following additional side

effects may occur in some groups

of people taking Olanzaccord

Tablets:

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 are not there)

or develop worsening symptoms

of Parkinson's disease.

Olanzaccord Tablets in

combination with lithium or

valproate

Patients with bipolar mania

taking Olanzaccord Tablets 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 as

changes

liver

function,

cholesterol

triglycerides

occur. These can only be found

when your doctor does tests from

time

time

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.

After taking

Olanzaccord Tablets

Storage

Keep

your

tablets

in

the

blister/bottle

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

Olanzaccord

Tablets or any other medicine

in the bathroom or near a

sink.

Do not leave your tablets in

the car on hot days or on

window sills.

Heat and dampness can destroy

some medicines.

All medicines should be kept

where young children cannot

reach them.

A locked cupboard at least one

half

metres

above

ground is a good place to store

medicines.

There

will

expiry

date

(month,

year)

your

Olanzaccord Tablets container.

The

medicine

should

not

be

taken after this date

because it

have

lost

some

strength.

Disposal

If your doctor tells you to stop

taking

Olanzaccord

Tablets

you find

that

tablets have

passed their expiry date,

please

return any left over tablets to

your pharmacist.

Product Description

What Olanzaccord Tablets

looks like

Olanzaccord

tablets

film-

coated tablets and are available

in the following strengths:

2.5 mg tablet:

White to off

white,

round,

biconvex,

film-

coated

tablets,

debossed

with

“O” on one side and plain on the

other side.

5

mg

tablet:

White

white,

round,

biconvex,

film-

coated

tablets,

debossed

with

“O1” on one side and plain on

the other side.

7.5 mg tablet:

White to off

white,

round,

biconvex,

film-

coated

tablets,

debossed

with

“O2” on one side and plain on

the other side.

10 mg tablet:

White to off

white,

round,

biconvex,

film-

coated

tablets

debossed

with

“O3” on one side and plain on

the other side.

15

mg

tablet:

Light

blue,

elliptical, biconvex, film-coated

tablets, debossed with “O4” on

one side and plain on the other

side.

The pack sizes for each strength

* Olanzaccord Tablets 2.5 mg

- blister packs of 28 tablets.

* Olanzaccord Tablets 5 mg -

blister packs of 7 & 28 tablets.

* Olanzaccord Tablets 7.5 mg

-

blister packs of 28 tablets

* Olanzaccord Tablets 10 mg -

blister packs of 7 & 28 tablets.

OLANZACCORD TABLETS

CONSUMER MEDICINE INFORMATION

Version: 2.0

-2013- Page: 6 of 6

* Olanzaccord Tablets 15 mg -

blister packs of 28 tablets per

carton and bottles containing 100

tablets per bottle

Olanzaccord Tablets are packed

in Alu/Alu blister pack & HDPE

Bottle pack (15 mg).

Ingredients

Each

Olanzaccord

Tablets

contains olanzapine as the active

ingredient

plus,

Lactose,

Microcrystalline cellulose,

Crospovidone,

Hydroxypropylcellulose,

Magnesium stearate,

Hypromellose

Film-coating contains OPADRY

complete

film

coating

system

13B58802 WHITE (ARTG No.

12811) [2.5 mg, 5 mg, 7.5 mg, &

10 mg], OPADRY complete film

coating system 13B80968 Blue

(ARTG No. 106174) [15 mg].

Olanzaccord

Tablets

contain gluten.

Name

and

Address

of

the

Sponsor

Accord Healthcare Pty Ltd.

15 Melliodora Crescent,

Greensborough, VIC 3088

Australia

Australian Registration

Numbers

Olanzaccord Tablets 2.5 mg:

AUST R 177122 (Blister Pack)

Olanzaccord Tablets 5 mg:

AUST R 177127 (Blister Pack)

Olanzaccord Tablets 7.5 mg:

AUST R 177120 (Blister Pack)

Olanzaccord Tablets 10 mg:

AUST R 177123 (Blister Pack)

Olanzaccord Tablets 15 mg:

AUST R 177124 (Blister Pack)

AUST R 178016 (Bottle Pack)

Date of first inclusion in the

ARTG

March 2012

This leaflet was revised in

October 2013.