STADA OLANZAPINE ODT 5 olanzapine 5 mg orodispersible tablet blister pack

Main information

  • Trade name:
  • STADA OLANZAPINE ODT 5 olanzapine 5 mg orodispersible tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • STADA OLANZAPINE ODT 5 olanzapine 5 mg orodispersible tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 177794
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

177794

STADA OLANZAPINE ODT 5 olanzapine 5 mg orodispersible tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Torrent Australasia Pty Ltd

Postal Address

Coleman & Greig L9/10 George St,PARRAMATTA, NSW, 2150

Australia

ARTG Start Date

18/01/2012

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. STADA OLANZAPINE ODT 5 olanzapine 5 mg orodispersible tablet blister pack

Product Type

Single Medicine Product

Effective date

22/10/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of schizophrenia and related psychoses. Short-term treatment, alone or in combination with lithium or valproate, of acute manic episodes

assoicated with bipolar I disorder.

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

Protect from Moisture

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

28 tablets in blisters

(S4) Prescription Only Medicine

Components

1. STADA OLANZAPINE ODT 5 olanzapine 5 mg orodispersible tablet blister pack

Dosage Form

Tablet, orally disintegrating

Route of Administration

Oral

Visual Identification

Yellow coloured, round, flat, bevel edged uncoated orodispersible tablet

with break line on one side and plain on other side

Active Ingredients

Olanzapine

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 29.11.2017 at 11:01:45 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

131118 Stada Olanzapine ODT CMI v 2

Page 1 of 6

CONSUMER MEDICINE INFORMATION

Stada Olanzapine ODT

Olanzapine orally disintegrating tablets

What is in this leaflet

This leaflet is designed to provide

you with answers to 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.

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 you

speak to your pharmacist or

doctor to obtain the most up to

date information on this medicine.

The updated leaflet may contain

important information about Stada

Olanzapine ODT and its use that

you should be aware of.

All medicines have risks and

benefits.

Your doctor has 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 Stada Olanzapine

ODT is used for

Stada Olanzapine ODT belongs

to a group of medicines called

antipsychotics. It helps to correct

chemical imbalances in the brain,

which may cause mental illness.

Stada Olanzapine ODT is used to

treat symptoms of schizophrenia

and related psychoses.

Schizophrenia is a mental illness

with disturbances in thinking,

feelings and behaviour.

Stada Olanzapine ODT alone, or

in combination with lithium or

valproate, is used for the short-

term treatment of acute manic

episodes associated with Bipolar I

Disorder. Stada Olanzapine ODT

is also a 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 as

feeling “high”, having excessive

amounts of energy, needing

much less sleep than usual,

talking very quickly with racing

ideas and sometimes severe

irritability.

Your doctor may have prescribed

Stada Olanzapine ODT for

another reason.

Ask your doctor if you have

any questions about why Stada

Olanzapine ODT has been

prescribed for you.

This medicine is available only

with a doctor’s prescription.

Stada Olanzapine ODT is not

recommended for use in children

under the age of 18 years as

there is not enough information

on its effects in this age group.

Before taking Stada

Olanzapine ODT

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 Stada Olanzapine

ODT:

if you have had an allergic

reaction to Stada Olanzapine

ODT or to any of the

ingredients listed at the end

of this leaflet (see ‘Product

Description’).

Signs of an allergic reaction

may include a 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.

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 Stada

Olanzapine ODT, 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:

131118 Stada Olanzapine ODT CMI v 2

Page 2 of 6

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 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 a

sudden increase in body

temperature, extremely high

blood pressure and severe

convulsions;

tardive dyskinesia, a

reaction to some medicines

with uncontrollable twitching

or jerking movements of the

arms and legs.

Tell your doctor if you are

pregnant or intend to become

pregnant.

Like most antipsychotic

medicines, Stada Olanzapine

ODT is not recommended for use

during pregnancy. If there is a

need to consider Stada

Olanzapine ODT 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

Stada Olanzapine ODT.

Tell your doctor if you suffer

from lactose intolerance

(because Stada Olanzapine

ODT tablets contain lactose).

Tell your doctor if you suffer

from phenylketonuria (because

Stada Olanzapine ODT wafers

contain aspartame).

Tell your doctor if you will be in

a hot environment or do a lot of

vigorous exercise.

Stada Olanzapine ODT may

make you sweat less, causing

your body to overheat.

Tell your doctor if you smoke.

Smoking may affect Stada

Olanzapine ODT 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 Stada Olanzapine ODT or may

affect how it 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 Stada Olanzapine ODT.

Tell your doctor about these

things before you take Stada

Olanzapine ODT.

How to take Stada

Olanzapine ODT

Follow all directions given to

you by your doctor or

pharmacist carefully.

These may differ from the

information contained in this

leaflet

How much to take

Your doctor will tell you how

many Stada Olanzapine ODT

orally disintegrating 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 may increase or

decrease your dose in order to

find the appropriate dose for your

condition.

A lower starting dose may be

prescribed for elderly patients

over the age of 65 years.

How to take it

Stada Olanzapine ODT tablets:

Do not handle the tablets with

wet hands as the tablet may

break up.

Stada Olanzapine ODT orally

disintegrating tablets break easily,

so you should handle them

carefully.

To take a tablet directly into

your mouth:

1. Hold the blister strip at the

edges and separate one

131118 Stada Olanzapine ODT CMI v 2

Page 3 of 6

blister cell from the rest of

the strip by gently tearing

along the perforations

around it.

2. Carefully peel off the

coloured backing.

3. Gently push the tablet out.

4. Put the tablet in your mouth.

It will dissolve directly in

your mouth, so that it can be

easily swallowed.

To take a tablet in a drink:

You can also place the tablet in a

full glass or cup 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.

Do not place the tablet in cola

drinks.

When to take it

Stada Olanzapine ODT should

be taken once a day as advised

by your doctor.

Take your prescribed dose at the

same time each day.

Stada Olanzapine ODT can be

taken with or without food.

How long do I take it

Do not stop taking Stada

Olanzapine ODT just because

you feel better. It is important

that you do NOT stop taking

Stada Olanzapine ODT 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 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 Stada Olanzapine ODT.

Do this even if there are no

signs of discomfort or

poisoning.

If you have taken too much Stada

Olanzapine ODT, the most

common signs are fast heart beat,

agitation/aggression, difficulty

speaking, uncontrollable

movements and sedation.

While you are taking

Stada Olanzapine ODT

Things you must do

It is important that you

remember to take Stada

Olanzapine ODT daily and at

the dose prescribed by your

doctor.

Tell all doctors, dentists and

pharmacists who are treating

you that you are taking Stada

Olanzapine ODT.

While you are taking Stada

Olanzapine ODT, tell your

doctor or pharmacist before

you start any new medicine.

If you become pregnant while

taking Stada Olanzapine ODT,

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 Stada Olanzapine ODT.

Patients with diabetes or who

have a higher chance of

developing diabetes should

have their blood sugar

checked often.

If you are over 65, your doctor

may 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 Stada

Olanzapine ODT, or lower the

dosage, even if you are feeling

better, without checking with

your doctor.

Do not give Stada Olanzapine

ODT to anyone else, even if

their symptoms seem similar or

they have the same condition

as you.

Your doctor has prescribed Stada

Olanzapine ODT for you and your

condition.

Things to be careful of

131118 Stada Olanzapine ODT CMI v 2

Page 4 of 6

Be careful driving or operating

machinery until you know how

Stada Olanzapine ODT affects

you.

Stada Olanzapine ODT may

cause drowsiness in some people.

Be careful when drinking

alcohol while taking Stada

Olanzapine ODT.

The effects of alcohol could be

made worse while taking Stada

Olanzapine ODT.

Your doctor may suggest you

avoid alcohol while you are being

treated with Stada Olanzapine

ODT.

If Stada Olanzapine ODT 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.

Stada Olanzapine ODT 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.

Stada Olanzapine ODT may

affect the way your body reacts to

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, Stada

Olanzapine ODT may cause

some unwanted side effects.

These are likely to vary from

patient to patient. Some side

effects may be related to the dose

of Stada Olanzapine ODT.

Accordingly, it is important that

you tell your doctor as soon as

possible about any unwanted

effects. Your doctor may then

decide to adjust the dose of

Stada Olanzapine ODT you are

taking.

Tell your doctor if you notice

any of the following side

effects and they worry you:

Drowsiness.

Restlessness or difficulty sitting

still.

Fevers.

Dizziness, confusion,

forgetfulness.

Increased appetite, weigh gain.

Constipation, bloating.

Dry mouth.

Swelling of your hands, feet

and ankles.

Aching joints.

Nose bleeds.

Unusual tiredness or weakness.

Some people may feel dizzy in

the early stages of treatment,

especially when getting up from a

lying or sitting position. This side

effect usually passes after taking

Stada Olanzapine ODT 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 Stada Olanzapine ODT.

Tell your doctor as soon as

possible 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.

Changes in sexual functioning

or sex drive in men or women.

Prolonged and/or painful

erection.

Unusual secretion of breast

milk.

Breast enlargement in men or

women.

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 are 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 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 or bruising more

easily than normal.

Seizures, fits or convulsions.

Yellowing of the skin and/or

eyes.

Nausea, vomiting, loss of

appetite, generally feeling

unwell, fever, itching, yellowing

of the skin and/or eyes.

Severe upper stomach pain

often with nausea and vomiting

(inflammation of the pancreas).

131118 Stada Olanzapine ODT CMI v 2

Page 5 of 6

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 in body

temperature, sweating, fast

heart beat, muscle stiffness,

high blood pressure and

convulsions.

Sharp chest pain, coughing of

blood, or sudden shortness of

breath.

Pain/tenderness in the 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. You may 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 Stada

Olanzapine ODT:

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.

Stada Olanzapine ODT in

combination with lithium or

valproate

Patients with bipolar mania taking

Stada Olanzapine ODT 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 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 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 Stada

Olanzapine ODT

Storage

Keep the orally disintegrating

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.

Stada Olanzapine ODT tablets

should be kept out of direct

light.

Do not store Stada Olanzapine

ODT 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

and a half metres above the

ground is a good place to store

medicines.

There will be an expiry date

(month, year) on your container.

The medicine should not be taken

after this date because it may

have lost some of its strength.

Disposal

If your doctor tells you to stop

taking Stada Olanzapine ODT 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

Stada Olanzapine ODT 5,

5 mg tablets are yellow

coloured, round shaped,

flat orally disintegrating

tablets.

Stada Olanzapine ODT 10,

10 mg tablets are yellow

coloured, round shaped, flat

orally disintegrating tablets.

Ingredients

Active Ingredient:

Stada Olanzapine ODT 5 - 5

mg olanzapine per tablet

Stada Olanzapine ODT 10 - 10

mg olanzapine per tablet.

131118 Stada Olanzapine ODT CMI v 2

Page 6 of 6

Inactive ingredients – mannitol,

aspartame, crospovidone,

cellulose microcrystalline,

magnesium stearate.

Supplier

Stada Olanzapine ODT is

distributed in Australia by:

Generic Health Pty Ltd

Level 1, 1102 Toorak Road

Camberwell VIC 3124

Australian Registration

Numbers

Stada Olanzapine ODT 5 - AUST

R 177794

Stada Olanzapine ODT 10 -

AUST R 177795

This leaflet was prepared in

November 2013.