QUETIAPINE GH quetiapine (as fumarate) 300 mg tablet blister pack

Main information

  • Trade name:
  • QUETIAPINE GH quetiapine (as fumarate) 300 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • QUETIAPINE GH quetiapine (as fumarate) 300 mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 179896
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

179896

QUETIAPINE GH quetiapine (as fumarate) 300 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Generic Health Pty Ltd

Postal Address

Level 1 / 1102 Toorak Road,CAMBERWELL, VIC, 3124

Australia

ARTG Start Date

4/11/2011

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. QUETIAPINE GH quetiapine (as fumarate) 300 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

26/09/2012

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,=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

3 Years

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

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

Components

1. QUETIAPINE GH quetiapine (as fumarate) 300 mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Quetiapine 300 mg (as fumarate) tablets: Oval, white film-coated tablet,

embossed with Q on one side and 300 on the other side.

Active Ingredients

Quetiapine fumarate

345.39 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 08:40:09 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

Quetiapine GH CMI v4 Sep2017

Page 1 of 6

CONSUMER MEDICINE INFORMATION

QUETIAPINE GH

quetiapine fumarate

What is in this leaflet

This leaflet answers some of

the common questions

people ask about

QUETIAPINE GH. It does not

contain all the available

information.

It does not take the place of

talking to your doctor or

pharmacist.

All medicines have risks and

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 Quetiapine GH is

used for

QUETIAPINE GH helps to

correct chemical imbalances

in the brain. It is used to treat

conditions such as:

Schizophrenia, an illness

with disturbances in

thinking, feelings and

behaviour

Bipolar disorder, an

illness in which there are

sustained mood swings

either up (mania) or down

(depression). During

mania, patients

experience episodes of

overactivity, elation or

irritability. During

depression, patients may

feel depressed or guilty,

lack energy, lose their

appetite and have trouble

sleeping.

QUETIAPINE GH belongs to

a group of medicines called

antipsychotics.

Ask your doctor if you have

any questions about why it

has been prescribed for

you.

Your doctor may prescribe

this medicine for another

reason.

It is not addictive.

This medicine is available

only with a doctor's

prescription.

Before you take

Quetiapine GH

When not to take it

Do not take QUETIAPINE

GH 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 may include

shortness of breath,

wheezing or 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 QUETIAPINE

GH to children or

adolescents unless

recommended by your

doctor.

The effects of QUETIAPINE

GH 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.

If it has expired or is

damaged, return it to your

pharmacist for disposal.

If you are not sure whether

you should start taking

QUETIAPINE GH, talk to

your doctor or pharmacist.

Before you start to take it

Tell your doctor if you have

any allergies to:

any other medicines

any other substances,

such as foods, dyes or

preservatives

Quetiapine GH CMI v4 Sep2017

Page 2 of 6

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

low blood pressure,

stroke, problems with

your circulation or any

condition that affects

blood flow to the brain,

problems with the way

your heart beats or a

history of heart attack

liver problems

diabetes (or a family

history of diabetes).

Patients with diabetes or

who have a higher

chance of diabetes

should have their blood

sugar checked before and

during treatment with

QUETIAPINE GH.

epilepsy (seizures or fits)

dementia or related

behavioural disorders

(especially in 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 and other mental

illnesses can increase the

risk of suicide. It is important

to discuss all the risks of

treating depression and

mental illness as well as the

risks of not treating it.

You should discuss all

treatment choices with your

doctor, not just the use of

antidepressants.

Patients (and caregivers of

patients) need to monitor for

any worsening of their

condition and/or the

emergence of thoughts of

suicide or suicidal behaviour

or thoughts of harming

themselves and to seek

medical advice immediately if

these symptoms present.

Do not take QUETIAPINE

GH 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 QUETIAPINE GH

while you are pregnant.

However, if you need to take

it 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 is not known

whether it passes into breast

milk.

Before your doctor starts you

on QUETIAPINE GH your

doctor may want to take

some tests (eg blood tests,

blood pressure, weight or

height measurements).

These tests may help to

prevent side effects.

Tell your doctor if you are

lactose intolerant.

QUETIAPINE GH 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 and

QUETIAPINE GH may

interfere with each other.

These include:

medicines used to treat

anxiety, depression,

mood swings, attention

deficit hyperactivity

disorder (ADHD) or other

mood disorders

lorazepam - a medicine

used to help you sleep

phenytoin or

carbamazepine -

medicines for epilepsy

medicines for high blood

pressure (including

diuretics or fluid tablets)

for heart conditions

some antibiotics such as

rifampicin and

erythromycin

medicines used for fungal

infections such as

ketoconazole

medicines for Human

Immunodeficiency Virus

(HIV)

thioridazine - an

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 QUETIAPINE

GH, 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 and pharmacist

have more information on

medicines to be careful with

or avoid while taking

QUETIAPINE GH.

If you have not told your

doctor about any of these

things, tell them before you

take any QUETIAPINE GH.

Quetiapine GH CMI v4 Sep2017

Page 3 of 6

How to take Quetiapine

Follow all directions given

to you by your doctor or

pharmacist carefully.

They may differ from the

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

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.

QUETIAPINE GH is 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 on

various factors including your

age, condition being treated,

other medical conditions (eg

liver problems), other

medicines you are taking and

how you may react to

QUETIAPINE GH. Your

doctor will monitor your

condition and may change

your dose depending on how

you respond to it. Your doctor

will use the lowest dose for

the least amount of time to

keep you well.

When to take it

QUETIAPINE GH is taken

once or twice a day

depending on your condition.

Your doctor will tell you how

you should take it.

How to take it

Swallow your QUETIAPINE

GH tablets whole with a full

glass of water.

You can take them with or

without food.

How long to take it for

Continue taking the tablets

for as long as your doctor

tells you.

QUETIAPINE GH helps

control your condition, but

does not cure it.

Therefore you must take it

every day.

Do not stop taking it unless

your doctor tells you to -

even if you feel better.

If you take too much

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 QUETIAPINE GH. Do

this even if there are no

signs of discomfort or

poisoning.

You may need urgent

medical attention.

If you take too many

QUETIAPINE GH tablets you

may feel drowsy, sleepy,

dizzy or have fast heart

beats.

While you are taking

Quetiapine GH

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, the symptoms

of depression may include

thoughts of suicide or self-

harm. These symptoms may

continue or get worse during

the early stages of treatment

until the effect of the

medicine becomes apparent.

All 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.

It may affect the results of

some tests.

Quetiapine GH CMI v4 Sep2017

Page 4 of 6

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

or height measurements)

from time to time. These tests

may help to prevent side

effects.

If you forget to take it

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.

If you have trouble

remembering when to take

your medicine, ask your

pharmacist for some hints.

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 may worsen or

your chance of getting an

unwanted side effect may

increase. To prevent this,

your doctor may gradually

reduce the amount of

QUETIAPINE GH 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 QUETIAPINE GH

affects you.

It can make some people

dizzy or sleepy. Make sure

you know how you react to it

before you do anything that

could be dangerous if you are

dizzy or sleepy. Children

should be 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 get used to the

change in position and blood

pressure. If this problem

continues or gets worse, talk

to your doctor.

Be careful when drinking

alcohol while you are

taking it.

Combining QUETIAPINE GH

and alcohol can make you

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.

QUETIAPINE GH may affect

the way your body reacts to

temperature changes.

Avoid drinking large

quantities of grapefruit

juice.

This medicine may be

affected by grapefruit juice.

Talk to your doctor or

pharmacist if you have any

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.

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 may be related to the

dose of QUETIAPINE GH or

may be more likely to occur

during long term treatment.

Therefore, it is important that

you tell your doctor as soon

as possible if you notice

anything that is making you

feel unwell, even if you think

the problems are not

Quetiapine GH CMI v4 Sep2017

Page 5 of 6

connected with this medicine.

Your doctor may 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

indigestion, upset

stomach, constipation,

vomiting (mainly in elderly

or children)

swelling of your hands,

feet or ankles

blurred vision

abnormal dreams,

nightmares

irritability

Shortness of breath,

difficulty in breathing

and/or tightness in the

chest

Fast or 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 and 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 as fever,

chills, sore throat or

mouth ulcers

bleeding or bruising more

easily than normal

very marked drowsiness

reduced consciousness

abnormal muscle

movements, including

difficulty starting muscle

movements, shaking,

restlessness or muscle

stiffness without pain.

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

a sudden increase in

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

and vomiting (particularly

in patients with other risk

factors such as

gallstones, alcohol

consumption and/or

increased levels of certain

fats within the blood)

These are very serious side

effects.

You may need urgent

medical attention or

hospitalisation.

Occasionally, QUETIAPINE

GH may be associated with

changes in your liver function

or blood (eg blood fat levels

such as cholesterol or

triglycerides, blood sugar

levels, blood pressure, throid

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.

You may not experience any

of them.

How to store Quetiapine

Storage

Keep your QUETIAPINE GH

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.

Quetiapine GH CMI v4 Sep2017

Page 6 of 6

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 and dampness can

destroy some medicines.

Keep it where young

children cannot reach it.

A locked cupboard at least

one-and a-half metres 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.

Product description

What Quetiapine GH

tablets look like

QUETIAPINE GH tablets are

film-coated. All tablets except

300 mg are embossed with

"Q" and are plain on the other

side. QUETIAPINE GH 300

mg tablets are embossed

with "Q" on one side and

"300" on the other.

Tablet shape and colouring is

as follows:

25 mg: round light orange

100 mg: round yellow

150 mg: oval, pale yellow

200 mg: oval white

300 mg: oval white.

The available pack sizes are:

25 mg: 10, 30, 60, 90,

100 tablets

100 mg: 10, 30, 60, 90,

100 tablets

150 mg: 10, 30, 50, 60

tablets

200 mg: 10, 30, 50, 60

tablets

300 mg: 10, 30, 50, 60

tablets

Ingredients

Each tablet contains

quetiapine fumarate as the

active ingredient equivalent to

quetiapine 25 mg, 100 mg,

150mg, 200 mg or 300 mg.

Other ingredients include:

Povidone

Calcium hydrogen

phosphate

Cellulose microcrystalline

Sodium starch glycollate

Type A

Lactose

Magnesium stearate

Opadry II Pink 33G34594

(25mg tablets only)

Opadry II Yellow

33G32578 (100mg tablets

only)

Opadry II Yellow

33G32605 (150 mg

tablets only)

Opadry II White

33G28435 (200mg and

300mg tablets only)

QUETIAPINE GH tablets do

not contain gluten or sucrose.

Sponsor

Generic Health Pty Ltd

Level 1, 1102 Toorak Road

Camberwell VIC 3124

Australian Registration

Number

QUETIAPINE GH 25 mg:

179902

QUETIAPINE GH 100 mg:

179895

QUETIAPINE GH 150 mg:

179903

QUETIAPINE GH 200 mg:

179897

QUETIAPINE GH 300 mg:

179896

This leaflet was prepared in

September 2017.