AURO-QUETIAPINE 100

Main information

  • Trade name:
  • AURO-QUETIAPINE 100
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AURO-QUETIAPINE 100
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 172846
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

172846

AURO-QUETIAPINE 100 quetiapine (as fumarate) 100mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Aurobindo Pharma Australia Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088

Australia

ARTG Start Date

18/10/2011

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. AURO-QUETIAPINE 100

Product Type

Single Medicine Product

Effective date

8/02/2013

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Bipolar disorder,Adults,? Maintenance treatment of bipolar I disorder, as monotherapy or in combination with lithium or sodium valproate, for the

prevention of relapse/recurrence of manic, depressive or mixed episodes,? Treatment of depressive episodes associated with bipolar disorder (See

Dosage and administration),? Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium

valproate,Children/adolescents aged 10 to 17 years,? Monotherapy treatment of acute mania associated with bipolar I disorder,Schizophrenia (adults

and adolescents aged 13 to 17 years),? Treatment of schizophrenia

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

2 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Yellow, round, biconvex, film-coated tablets imprinted with 'E 53' on one

side and plain on the other side

Active Ingredients

Quetiapine fumarate

115.122 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 05:04:18 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

AURO-QUETIAPINE

CONSUMER MEDICINE INFORMATION

Ver 1.2

Page 1 of 5

AURO-QUETIAPINE 25, 100, 150, 200 & 300

Quetiapine (as fumarate)

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common questions people ask about

AURO-QUETIAPINE.

does

contain all the available information.

It does not take the place of talking

to your doctor or pharmacist.

medicines

have

risks

benefits.

Your

doctor

will

have

weighed the risks of you taking it

against the benefits they expect it

will have for you.

If you have any concerns about

taking

this

medicine,

ask

your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What

AURO-QUETIAPINE

is used for

AURO-QUETIAPINE

helps

correct chemical imbalances in the

brain. It is used to treat conditions

such as:

Schizophrenia,

illness

with

disturbances in thinking, feelings

and behaviour

Bipolar

disorder,

illness

which

there

sustained

mood

swings either up (mania) or down

(depression).

During

mania,

patients

experience

episodes

overactivity, elation or irritability.

During

depression,

patients

feel

depressed

guilty,

lack

energy,

lose

their

appetite

have trouble sleeping.

AURO-QUETIAPINE belongs to a

group

medicines

called

antipsychotics.

Ask your doctor if you have any

questions about why it has been

prescribed for you.

Your

doctor

prescribe

this

medicine for another reason.

It is not addictive.

This medicine is available only with

a doctor's prescription.

Before you take

AURO-QUETIAPINE

When

you

must

not

take

AURO-QUETIAPINE

Do not take AURO-QUETIAPINE

if you have an allergy to

quetiapine, the active ingredient in

the medicine

any of the other ingredients listed

at the end of this leaflet.

Some of the symptoms of an allergic

reaction

include

shortness

breath,

wheezing

difficulty

breathing; swelling of the face, lips,

tongue or other parts of the body;

rash, itching or hives on the skin or

you may feel faint.

Do not give AURO-QUETIAPINE

to children or adolescents unless

recommended by your doctor.

The effects of AURO-QUETIAPINE

have only been studied in children

aged between 10 and 17 years with

mania and in children aged between

13 and 17 years with schizophrenia.

There is not enough information on

its effects in children to recommend

its use in other age groups or for

other conditions.

Do

not

use

it

after

the

use

by

(expiry) date printed on the pack.

Do not use it if the packaging is

torn or shows signs of tampering.

expired

damaged,

return

your

pharmacist

disposal.

sure

whether

should

start

taking

AURO-

QUETIAPINE, talk to your doctor or

pharmacist.

Before

you

start

to

take

AURO-QUETIAPINE

Tell your doctor if you have any

allergies to:

any other medicines

any other substances, such a foods,

dyes or preservatives

Tell your doctor if you have or

have had any medical conditions,

especially the following:

heart or blood vessel problems or

a family history of heart or blood

vessel

problems

including

blood

pressure,

stroke,

problems

with

your

circulation

condition that affects blood flow

brain,

problems

with

way your heart beats or a history

of heart attack

liver problems

diabetes

family

history

diabetes). Patients with diabetes or

have

higher

chance

diabetes should have their blood

sugar checked before and during

treatment

with

AURO-

QUETIAPINE.

Epilepsy (seizures or fits)

dementia

related

behavioural

disorders

(especially

elderly

patients)

low white blood cell count

Tell your doctor or mental health

professional

if

you

have

any

mental/mood changes or suicidal

thoughts.

Depression

other

mental

illnesses

increase

risk

suicide. It is important to discuss all

the risks of treating depression and

mental illness as well as the risks of

not treating it.

should

discuss

treatment

choices with your doctor, not just the

use of antidepressants.

AURO-QUETIAPINE

CONSUMER MEDICINE INFORMATION

Ver 1.2

Page 2 of 5

Patients (and caregivers of patients)

need to monitor for any worsening of

their condition and/or the emergence

thoughts

suicide

suicidal

behaviour

thoughts

harming

themselves

seek

medical

advice

immediately

these

symptoms present.

Do not take AURO-QUETIAPINE

if

you

are

pregnant

or

breastfeeding

unless

your

doctor

says so. Ask your doctor about the

risks and benefits involved.

It is not known if it is safe for you to

take

while

pregnant.

However,

need

take

during your pregnancy, the doctor

will discuss the risks and benefits of

taking it with you.

It is recommended that you do not

breastfeed while taking it, as it may

pass into breast milk.

Before

your

doctor

starts

AURO-QUETIAPINE

your

doctor

want

take

some

tests

blood tests, blood pressure, weight

or height measurements). These tests

may help to prevent side effects.

Tell your doctor if you are lactose

intolerant.

AURO-QUETIAPINE

tablets

contain lactose.

Taking other medicines

Tell your doctor or pharmacist 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

AURO-

QUETIAPINE

interfere

with

each other. These include:

medicines

used

treat

anxiety,

depression,

mood

swings,

attention

deficit

hyperactivity

disorder (ADHD) or other mood

disorders

lorazepam - a medicine used to

help you sleep

phenytoin

carbamazepine

medicines for epilepsy

medicines for high blood pressure

(including

diuretics

fluid

tablets) or heart conditions

some

antibiotics

such

rifampicin and erythromycin

medicines

used

fungal

infections such as ketoconazole

medicines

Human

Immunodeficiency Virus (HIV)

thioridazine

antipsychotic

medicine

medicines used to treat Parkinson's

disease

stimulants such as amphetamines

glucocorticoids - medicines used

to treat inflammation

These medicines may be affected by

AURO-QUETIAPINE, or may affect

how well it works. You may need

different amounts of your medicine,

or you may need to take different

medicines. Your doctor will advise

you.

Your

doctor

pharmacist

have

more information on medicines to be

careful with or avoid while taking

AURO-QUETIAPINE.

If you have not told your doctor

about any of these things, tell them

before

you

take

any

AURO-

QUETIAPINE.

How to take

AURO-QUETIAPINE

Follow all directions given to you

by

your

doctor

or

pharmacist

carefully.

They

differ

from

information contained in this leaflet.

If

you

do

not

understand

the

instructions on the pack, ask your

doctor or pharmacist for help.

How much to take

AURO-QUETIAPINE

Your doctor will tell you how many

tablets you will need to take each

day and how long you need to take

it. This depends on your condition

and whether or not you are taking

any other medicines.

AURO-QUETIAPINE

usually

started as a low dose that will be

gradually increased by your doctor.

Your doctor will recommend a dose

especially for you. This will depend

various

factors

including

your

age, condition being treated, other

medical

conditions

liver

problems), other medicines you are

taking and how you may react to

AURO-QUETIAPINE. Your doctor

will monitor your condition and may

change your dose depending on how

you respond to it. Your doctor will

lowest

dose

least

amount of time to keep you well.

When to take

AURO-QUETIAPINE

AURO-QUETIAPINE is taken once

or twice a day depending on your

condition. Your doctor will tell you

how you should take it.

Swallow

your

AURO-

QUETIAPINE tablets whole with

a full glass of water.

You can take them with or without

food.

How

long

to

take

AURO-

QUETIAPINE

Continue taking the tablets for as

long as your doctor tells you.

AURO-QUETIAPINE helps control

your condition, but does not cure it.

Therefore

must

take

every

day.

Do not stop taking it unless your

doctor tells you to - even if you feel

better.

If you forget to take

AURO-QUETIAPINE

If it is almost time for your next

dose

(within

6

hours),

skip

the

dose

you

missed

and

take

your

next dose when you are meant to.

Otherwise, take it as soon as you

remember, and then go back to

taking your medicine as you would

normally.

Do not take a double dose to make

up for the dose you have missed.

If you are not sure what to do, ask

your doctor or pharmacist.

AURO-QUETIAPINE

CONSUMER MEDICINE INFORMATION

Ver 1.2

Page 3 of 5

If you have trouble remembering

when to take your medicine, ask

your pharmacist for some hints.

If

you

take

too

much

(overdose)

Immediately

telephone

your

doctor or the Poisons Information

Centre (13 11 26) for advice or go

to

Accident

and

Emergency

at

your nearest hospital if you think

that you or anyone else may have

taken

too

much

AURO-

QUETIAPINE.

Do

this

even

if

there are no signs of discomfort or

poisoning.

need

urgent

medical

attention.

take

many

AURO-

QUETIAPINE tablets you may feel

drowsy, sleepy, dizzy or have fast

heart beats.

While you are taking

AURO-QUETIAPINE

Things you must do

Tell

any

other

doctors,

dentists,

and pharmacists who are treating

you that you are taking it.

If you are about to be started on

any

new

medicines,

tell

your

doctor, dentist or pharmacist that

you are taking it.

Tell your doctor or mental health

professional immediately, or go to

the nearest hospital, if you have

any

of

the

following

suicidal

thoughts

or

other

mental/mood

changes:

thoughts or talk of death or suicide

thoughts or talk of self-harm or

harm to others

any recent attempts of self-harm

increase in aggressive behaviour,

irritability or agitation

worsening of depression

Occasionally,

symptoms

depression may include thoughts of

suicide

self-harm.

These

symptoms

continue

worse

during

early

stages

treatment

until

effect

medicine

becomes

apparent.

mentions of suicide or violence must

be taken seriously.

If

you

become

pregnant

while

taking

it,

tell

your

doctor

immediately.

If you plan to have surgery that

needs

a

general

anaesthetic,

tell

your doctor or dentist that you are

taking it.

If you need to have any medical

tests

(including

urine

drug

screening) while you are taking it,

tell your doctor.

affect

results

some

tests.

Be sure to keep all of your doctor's

appointments

so

that

your

progress can be checked.

Your

doctor

will

check

your

progress and may want to take some

tests (eg blood tests, blood pressure,

weight

height

measurements)

from time to time. These tests may

help to prevent side effects.

Things you must not do

Do not stop taking it, or change

the dosage, even if you are feeling

better, without checking with your

doctor.

If you stop taking it suddenly, your

condition

worsen

your

chance of getting an unwanted side

effect may increase. To prevent this,

your

doctor

gradually

reduce

the amount of AURO-QUETIAPINE

you take each day before stopping

completely.

Do not give it to anyone else, even

if their symptoms seem similar or

they have the same condition as

you.

Do not take it to treat any other

complaints unless your doctor tells

you to.

Do

not

take

any

medicines

that

cause

drowsiness

while

you

are

taking it, unless recommended by

your doctor.

Things to be careful of

Be

careful

driving

or

operating

machinery

until

you

know

how

AURO-QUETIAPINE affects you.

It can make some people dizzy or

sleepy. Make sure you know how

react

before

anything that could be dangerous if

dizzy

sleepy.

Children

should

careful

when

riding

bicycles or climbing trees.

If it makes you feel light-headed,

dizzy

or

faint,

be

careful

when

getting up from a sitting or lying

position.

Standing up slowly, especially when

you get up from bed or chairs, will

help

your

body

used

change

position

blood

pressure. If this problem continues or

gets worse, talk to your doctor.

Be careful when drinking alcohol

while you are taking it.

Combining

AURO-QUETIAPINE

alcohol

make

more

sleepy or dizzy. Your doctor may

suggest you avoid alcohol while you

are being treated with it.

Avoid

getting

over-heated

or

dehydrated - do not over-exercise,

in hot weather stay inside in a cool

place, stay out of the sun, do not

wear too much or heavy clothing,

drink plenty of water. Keep warm

in cool weather.

AURO-QUETIAPINE

affect

your

body

reacts

temperature changes.

Avoid drinking large quantities of

grapefruit juice.

This medicine may be affected by

grapefruit juice. Talk to your doctor

pharmacist

have

concerns.

Talk to your doctor or pharmacist

about

these

things

if

you

think

they may bother you.

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking it.

AURO-QUETIAPINE

CONSUMER MEDICINE INFORMATION

Ver 1.2

Page 4 of 5

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects. Some side effects

related

dose

AURO-QUETIAPINE

more

likely

occur

during

long

term

treatment.

Therefore,

important that you tell your doctor as

soon

possible

notice

anything

that

making

feel

unwell,

even

think

problems are not connected with this

medicine.

Your

doctor

then

decide to adjust your dose or use a

different medicine.

Ask your doctor or pharmacist to

answer

any

questions

you

may

have.

Tell your doctor if you notice any

of the following and they worry

you:

feeling sleepy

weight gain, increased appetite

feeling weak

dry mouth

runny or stuffy nose (particularly

in children)

indigestion,

upset

stomach,

constipation, vomiting (mainly in

elderly or children)

swelling

your

hands,

feet

ankles

blurred vision

abnormal dreams, nightmares

irritability

shortness of breath, difficulty in

breathing and/or tightness in the

chest

fast

irregular

heartbeats

(palpitations)

These side effects are usually mild.

Some of these side effects may go

away after a while.

Tell

your

doctor

as

soon

as

possible

if

you

notice

the

following:

falling, feeling dizzy or faint on

standing up

difficulty in speaking

difficulty swallowing

rapid heart beat

symptoms of high sugar levels in

the blood (including passing large

amounts of urine, excessive thirst,

increase in appetite with a loss of

weight,

feeling

tired,

drowsy,

weak,

depressed,

irritable

generally unwell)

breast

enlargement,

unusual

secretion of breast milk

These are serious side effects. You

may need medical attention.

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

long lasting and painful erection

fainting (particularly in children)

signs of frequent infections such

fever,

chills,

sore

throat

mouth ulcers

bleeding or bruising more easily

than normal

very marked drowsiness

reduced consciousness

abnormal

muscle

movements,

including

difficulty

starting

muscle

movements,

shaking,

restlessness

muscle

stiffness

without pain.

worm-like

movements

tongue

other

uncontrolled

movements of the tongue, mouth,

cheeks or jaw which may progress

to the arms and legs

sudden

increase

body

temperature, with sweating, or a

fast heart beat

fits (seizures)

severe

allergic

reaction

(may

include severe difficulty breathing,

shock, swelling of the face, lips,

tongue or other parts of the body,

skin rash, hayfever, or you may

feel faint)

severe upper stomach pain, often

with

nausea

vomiting

(particularly in patients with other

risk

factors

such

gallstones,

alcohol

consumption

and/or

increased

levels

certain

fats

within the blood)

These are very serious side effects.

need

urgent

medical

attention or hospitalisation.

Occasionally, AURO-QUETIAPINE

may be associated with changes in

your

liver

function

blood

blood fat levels such as cholesterol

or triglycerides, blood sugar levels,

blood

pressure,

thyroid

hormone

levels, white blood cells). These can

only be found when your doctor does

tests from time to time to check your

progress.

Other side effects not listed above

may occur in some patients. Tell

your doctor or pharmacist if you

notice anything that is making you

feel unwell.

Do not be alarmed by this list of

possible side effects.

experience

them.

After taking

AURO-QUETIAPINE

Storage

Keep your AURO-QUETIAPINE

tablets in the blister pack until it is

time to take them.

If you take the tablets out of the

blister pack they will not keep well.

Keep it in a cool dry place where

the temperature stays below 25°C.

Do

not

store

it

or

any

other

medicine in the bathroom or near

a sink. Do not leave it in the car or

on a window sill.

Heat

dampness

destroy

some medicines.

Keep

it

where

young

children

cannot reach it.

A locked cupboard at least one-and-a

half meters above the ground is a

good place to store medicines.

Disposal

If

your

doctor

tells

you

to

stop

taking it or the tablets have passed

their

expiry

date,

ask

your

pharmacist what to do with any

that are left over.

AURO-QUETIAPINE

CONSUMER MEDICINE INFORMATION

Ver 1.2

Page 5 of 5

Product Description

What it looks like

AURO-QUETIAPINE

presented in pack size of 20 & 60

tablets in blister and 100 tablets in

bottle.

AURO-QUETIAPINE

presented in pack size of 20, 60 & 90

tablets in blister and 100 tablets in

bottle.

AURO-QUETIAPINE

presented in pack size of 60 & 90

tablets in blister and 100 tablets in

bottle.

AURO-QUETIAPINE

presented in pack size of 20 & 60

tablets in blister and 100 tablets in

bottle.

AURO-QUETIAPINE

presented in pack size of 20 & 60

tablets in blister and 60 tablets in

bottle.

AURO-QUETIAPINE 25

Peach, round, biconvex, film-coated

tablets debossed with ‘E 52’ on one

side and plain on the other side.

AURO-QUETIAPINE 100

Yellow,

round,

biconvex,

film-

coated tablets imprinted with ‘E 53’

on one side and plain on the other

side.

AURO-QUETIAPINE 150

Light yellow, round, biconvex, film-

coated tablets imprinted with ‘E 54’

on one side and plain on the other

side.

AURO-QUETIAPINE 200

White, round, biconvex, film-coated

tablets imprinted with ‘E 55’ on one

side and plain on the other side.

AURO-QUETIAPINE 300

White,

capsule

shaped,

biconvex,

film-coated tablets imprinted with ‘E

56’ on one side and plain on the

other side.

Ingredients

Active Ingredient:

Quetiapine (as fumarate)

Each tablet contains either 25, 100,

150, 200 or 300 mg of Quetiapine as

fumarate.

Other Ingredients:

Calcium hydrogen phosphate

Lactose

Cellulose-microcrystalline (Avicel

PH-101 & PH-102)

Sodium starch glycollate type A

Povidone

Silica-colloidal anhydrous

Talc-purified

Magnesium stearate.

tablet

also

contains

opadry

film

coating

pink

03B84904

(PI-ARTG

106472).

The 100 mg tablet also contains

opadry

film

coating

yellow

03B82923

(PI-ARTG

106480).

The 150 mg tablet also contains

opadry

film

coating

yellow

03B82924

(PI-ARTG

106483).

The 200 mg & 300 mg tablets also

contains

hypromellose,

macrogol

400, titanium dioxide.

100mg,

150mg,

200mg

&

300mg

tablets

also

contains

Opacode

Black

S-1-17823

(PI-

ARTG No. 12108) as imprinting

ink.

Name and Address of the Sponsor

Aurobindo Pharma Australia Pty Ltd

Unit 3, North Rydelink

277-283 Lane Cove Road

Macquarie Park

NSW 2113

Australia

Date of Approval

5 October 2011

Date of Most Recent Amendment

22 January 2013