PRYZEX olanzapine 7.5mg tablet blister pack

Main information

  • Trade name:
  • PRYZEX olanzapine 7.5mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PRYZEX olanzapine 7.5mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 178987
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

178987

PRYZEX olanzapine 7.5mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

11/08/2011

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. PRYZEX olanzapine 7.5mg tablet blister pack

Product Type

Single Medicine Product

Effective date

13/02/2013

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

3 Years

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. PRYZEX olanzapine 7.5mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, round, biconvex film coated tablets

Active Ingredients

Olanzapine

7.5 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 09:51:21 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 09:51:21 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

PRYZEX and PRYZEX ODT tablets – Consumer Medicine Information

PRYZEX and ODT CMI

Page 1

PRYZEX and PRYZEX 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

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 PRYZEX is used

for

PRYZEX

used

treat

symptoms of schizophrenia and

related

psychoses.

PRYZEX

alone,

combination

with

lithium or valproate, is used for

the short-term treatment of acute

manic episodes associated with

Bipolar I Disorder.

PRYZEX

also

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.

PRYZEX belongs to a group of

medicines called antipsychotics.

helps

correct

chemical

imbalances in the brain, which

may cause mental illness. Your

doctor

have

prescribed

PRYZEX for another reason.

Ask your doctor if you have any

questions

about

PRYZEX

has been prescribed for you.

This medicine is available only

with a doctor's prescription.

PRYZEX

recommended

for use in children under the age

years

there

enough information on its effects

in this age group.

Before taking

PRYZEX

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 PRYZEX:

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

PRYZEX, 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 (a small gland at

the base of the brain)

disease of the blood with

reduced

number

white or red blood cells

disease

blood

vessels

brain,

including stroke

prostate problems

kidney or liver disease

high

blood

sugar,

diabetes

family

history of diabetes

breast cancer or a family

history of breast cancer

paralytic

ileus,

condition

where

bowel

does

work

properly

epilepsy, seizures or fits

glaucoma, a condition in

which there is usually a

build up of fluid in the

heart disease, including

PRYZEX and PRYZEX ODT tablets – Consumer Medicine Information

PRYZEX and ODT CMI

Page 2

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,

reaction

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,

PRYZEX

recommended for use during

pregnancy. If there is a need

to consider PRYZEX during

your pregnancy, your doctor

will

discuss

with

benefits and risks of using it.

Shaking,

muscle

stiffness

and difficulty in feeding, all

of which are reversible, may

occur

newborns,

mother uses the medicine in

last

trimester

pregnancy. PRYZEX should

be used in pregnancy only if

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 PRYZEX.

If you suffer from lactose

intolerance

(because

PRYZEX

tablets

contain

lactose).

PRYZEX

recommended

for use in children.

Tell your doctor if you will be

in a hot environment or do a

lot of vigorous exercise.

PRYZEX may make you sweat

less,

causing

your

body

overheat.

Tell your doctor if you smoke.

Smoking may affect PRYZEX 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 a

pharmacy,

supermarket

or

health food shop.

Some

medicines

affected

PRYZEX

affect

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

Parkinson’s disease

medicines that can change

the heart’s electrical activity

make

more

likely

change

Your doctor or pharmacist has

more information on medicines

carefully

with

avoid

while taking PRYZEX.

Tell your doctor about these

things

before

you

take

PRYZEX.

How to take PRYZEX

Follow all directions given to

you

by

your

doctor

or

pharmacist carefully.

These

differ

from

information

contained

this

leaflet.

How much to take

PRYZEX film coated or orally

dispersible tablets:

Your

doctor

will

tell

many

PRYZEX

tablets

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

PRYZEX:

These film coated tablets should

be swallowed whole with a glass

of water.

PRYZEX 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

PRYZEX 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.

PRYZEX tablets can be taken

with or without food.

How long to take it

Do

not

stop

taking

PRYZEX

just because you feel better. It

is important that you do NOT

stop

taking

PRYZEX

unless

your doctor tells you.

If you forget to take it

PRYZEX and PRYZEX ODT tablets – Consumer Medicine Information

PRYZEX and ODT CMI

Page 3

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

(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 PRYZEX.

Do this even if there are no signs

of discomfort or poisoning.

have

taken

much

PRYZEX,

most

common

signs

fast

heartbeat,

agitation/aggression,

difficulty

speaking,

uncontrollable

movements and sedation.

While you are taking

PRYZEX

Things you must do

It

is

important

that

you

remember

to

take

PRYZEX

daily

and

at

the

dose

prescribed by your doctor.

Tell all doctors, dentists and

pharmacists who are treating

you

that

you

are

taking

PRYZEX.

While you are taking PRYZEX,

tell your doctor or pharmacist

before

you

start

any

new

medicine.

If you become pregnant while

taking

PRYZEX,

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

PRYZEX.

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

worsening

your

mental

illness.

Things you must not do

Do not stop taking PRYZEX, or

lower the dosage, even if you

are

feeling

better,

without

checking with your doctor.

Do

not

give

PRYZEX

to

anyone

else,

even

if

their

symptoms

seem

similar

or

they have the same condition

as

you.

Your

doctor

prescribed PRYZEX for you and

your condition.

Things to be careful of

PRYZEX may cause drowsiness

in some people. Be careful

driving or operating

machinery until you know how

PRYZEX affects you.

Be careful drinking alcohol

while taking PRYZEX.

The effects of alcohol could be

made worse while taking

PRYZEX.

Your doctor may suggest you

avoid alcohol while you are

being treated with PRYZEX.

If

PRYZEX

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 30+

sunscreen.

PRYZEX

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.

PRYZEX

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 PRYZEX.

Like other medicines, PRYZEX

may cause some unwanted side

effects. These are likely to vary

from

patient

patient.

Some

side effects may be related to

dose

PRYZEX.

Accordingly, it is important that

you tell your doctor as soon as

possible

about

unwanted

effects.

Your

doctor

then

decide

adjust

dose

PRYZEX you are taking.

Tell your doctor if you notice

any

of

the

following

side

effects and they worry you:

drowsiness

unusual

tiredness

weakness

fever

restlessness

difficulty

sitting still

increased

appetite,

weight

gain

constipation, bloating

PRYZEX and PRYZEX ODT tablets – Consumer Medicine Information

PRYZEX and ODT CMI

Page 4

dry mouth

swelling of your hands, feet

and ankles

aching joints

nose bleeds

dizziness,

confusion,

forgetfulness.

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 PRYZEX 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 PRYZEX.

Tell your doctor if you notice

any of the above side effects

and they worry you. These are

the more common side effects of

PRYZEX.

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 or allergic reaction

slow heart beat

changes

sexual

functioning

drive

men or women

prolonged

and/or

painful

erection

unusual secretion of breast

milk

breast enlargement in men

and women

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 of 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

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:

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 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

severe upper stomach pain

often

with

nausea

vomiting (inflammation of the

pancreas)

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

heartbeat, 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.

following

additional

side

effects

occur

some

groups

people

taking

PRYZEX:

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

hallucinate

(see,

feel

hear

things

that

there)

develop worsening symptoms of

Parkinson's disease.

Patients

with

bipolar

mania

taking PRYZEX in combination

with lithium or valproate may

notice the following additional

side effects:

tremors

speech disorder

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.

PRYZEX and PRYZEX ODT tablets – Consumer Medicine Information

PRYZEX and ODT CMI

Page 5

After taking PRYZEX

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 PRYZEX after the

expiry

date

pack

passed.

Disposal

If your doctor tells you to stop

taking PRYZEX or you find that

tablets

have

passed

their

expiry

date,

please

return

leftover tablets or wafers to your

pharmacist.

Product description

PRYZEX

PRYZEX film coated tablets are

presented in PA/Al/PVC/Al

blister packs.

2.5 mg (AUST R 178975): white,

round,

biconvex

film

coated

tablets

5 mg (AUST R 178991): white,

round,

biconvex

film

coated

tablets

7.5mg (AUST R 178987): white,

round,

biconvex

film

coated

tablets

10mg (AUST R 178996): white,

round,

biconvex

film

coated

tablets

15mg* (AUST R 178979): light

blue,

oblong,

biconvex

film

coated tablets tablets

20mg* (AUST R 178995): pink,

oblong,

biconvex

film

coated

tablets

PRYZEX ODT

PRYZEX Orally Disintegrating

Tablets are presented in

PA/Al/PVC/Al blister packs.

5 mg (AUST R 179079): yellow,

round,

biconvex

orally

disintegrating tablets

10

mg

(AUST

R

179076):

yellow,

round,

flat

orally

disintegrating tablets

15

mg

(AUST

R

179082):

yellow,

round,

biconvex

orally

disintegrating tablets

20

mg

(AUST

R

179071):

yellow,

round,

flat

orally

disintegrating tablets

Presentations

currently

available

Ingredients

Active Ingredient:

PRYZEX

PRYZEX

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

PRYZEX film coated tablets:

Lactose monohydrate

Microcrystalline cellulose

Crospovidone

Hyprolose

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)

PRYZEX ODT

Lactose monohydrate

Crospovidone

Hyprolose

Colloidal anhydrous silica

Purified talc

Magnesium stearate

Mint flavouring E_0613218

Name

and

Address

of

the

Sponsor

Arrow Pharma Pty Ltd

15-17 Chapel Street

Cremorne VIC 3121

Date of Preparation

May 2019