ARIPIPRAZOLE GH aripiprazole 10 mg tablet blister pack

Main information

  • Trade name:
  • ARIPIPRAZOLE GH aripiprazole 10 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ARIPIPRAZOLE GH aripiprazole 10 mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 176808
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

176808

ARIPIPRAZOLE GH aripiprazole 10 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

18/11/2011

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. ARIPIPRAZOLE GH aripiprazole 10 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

2/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Aripiprazole GH is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.

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

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

30 (3 Blisters each containing 10 tablets)

(S4) Prescription Only Medicine

Components

1. ARIPIPRAZOLE GH aripiprazole 10 mg tablet blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White, oval-shaped, biconvex bevelled edgeduncoated tablets, plain on

both sides

Active Ingredients

aripiprazole

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 12:25:55 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

Aripiprazole GH

CMI v4.0

Page 1 of 4

CONSUMER MEDICINE INFORMATION

ARIPIPRAZOLE GH

aripiprazole

What is in this leaflet?

This leaflet answers some common

questions about Aripiprazole GH. It

does not contain all the available

information. Some of the information

contained in this leaflet may not apply

to you.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and benefits.

Your doctor has weighed the risks of

you taking Aripiprazole GH against

the benefits it is expected to have for

you.

If you have concerns about taking

this medicine, ask your doctor or

pharmacist.

Keep this leaflet with the medicine as

you may need to read it again.

What is Aripiprazole GH?

Aripiprazole (Ari-pip-rah-zol) belongs

to a group of medicines called

antipsychotic agents.

Aripiprazole GH is used to treat

symptoms of Schizophrenia.

Schizophrenia is a mental illness with

disturbances in thinking, feelings and

behaviour.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

There is no evidence that

Aripiprazole GH is addictive.

This medicine is available only with a

doctor’s prescription.

Aripiprazole GH is not recommended

for use in children under the age of

18, as safety and efficacy has not

been established in this age group.

Before Taking Aripiprazole GH

When you must not take it

Do not take Aripiprazole GH if you

have an allergy to:

aripiprazole;

any ingredients listed at the

end of this leaflet.

Symptoms of an allergic reaction

include:

rash, itching, or hives on the

skin;

shortness of breath, wheezing

or difficulty breathing;

swelling of the face, lips,

tongue, throat or other parts of

the body.

Do not take Aripiprazole GH after the

expiry date printed on the pack as it

may not work as well.

Do not take Aripiprazole GH if the

packaging is torn or show signs of

tampering. If this is the case, return it

to your pharmacist.

If you are not sure whether you

should start taking this medicine, talk

to your doctor or pharmacist.

Before you start to take it

Tell your doctor or pharmacist if

you have allergies to:

any other medicines;

any other substances such as

foods, preservatives or dyes.

Tell your doctor or pharmacist if

you are pregnant or intend to

become pregnant.

Aripiprazole GH is not recommended

for use during pregnancy.

If you need to take Aripiprazole GH

during your pregnancy, your doctor

will discuss with you the benefits and

risks to taking it. Babies exposed to

antipsychotics (including to

aripiprazole) during the third trimester

of pregnancy are at risk of

experiencing shaking, muscle

stiffness, difficulty in feeding and/or

withdrawal symptoms. These

symptoms may resolve

spontaneously or require additional

medical treatment.

Tell your doctor or pharmacist if

you are breast-feeding or plan to

breast-feed.

It is recommended that you do not

breast-feed while taking Aripiprazole

GH as it may pass into breast milk

and therefore there is a possibility

that the breast-fed baby may be

affected.

Tell your doctor or pharmacist if

you have, or have had any medical

conditions, especially the

following:

a reaction to some medicines

with a sudden increase in

body temperature, sweating,

fast heartbeat, muscle

stiffness and fluctuating blood

pressure, which may lead to

coma. This reaction is called

neuroleptic malignant

syndrome.

a reaction to some medicines

with abnormal movements of

the tongue, or other

uncontrolled movements of the

mouth, tongue, cheeks or jaw

which may progress to the

arms and legs. This reaction

is called tardive dyskinesia.

low blood pressure.

problems with your heart or

blood vessels.

epilepsy, seizures or fits.

problems with your

oesophagus (food pipe) such

as difficulty in swallowing.

Aripiprazole GH

CMI v4.0

Page 2 of 4

high blood sugar or diabetes

mellitus.

Alzheimer's disease or

dementia.

alcohol or drug abuse or

dependence or a history of

one of these.

venous thromboembolism or

are at risk of venous

thromboembolism

lactose intolerance

Tell your doctor if you have past

experience of excessive gambling.

Tell your doctor if you drink

alcohol.

Your doctor may advise you to avoid

alcohol as it can magnify the side-

effects of this medicine.

If you have not told your doctor or

pharmacist about any of the above,

tell them before you start taking

Aripiprazole GH.

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 Aripiprazole GH

may interfere with each other. These

include:

medicines used to treat

braindisorders such as,

anxiety, depression, mood

swings, epilepsy or seizures,

Parkinson's disease or

insomnia;

medicines used to treat high blood

pressure;

medicines used to treat fungal

infections;

medicines used to treat heart

rhythm disturbances;

medicines used to treat bacterial

or viral infections;

a medicine called cyclosporin

(Neoral

; Sandimmun

a medicine called cimetidine

(Tagamet

; Magicul

These medicines may be affected by

Aripiprazole GH, or may affect how

well it works. Your doctor may need

to adjust your dose of Aripiprazole

GH or of the other medicine.

Eating grapefruit or drinking

grapefruit juice may affect how

Aripiprazole GH works.

Your doctor or pharmacist may have

more information on medicines to be

careful with or avoid while taking

Aripiprazole GH.

How to take

Aripiprazole GH

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the information

contained in this leaflet.

Your doctor or pharmacist will tell you

how much you will need to take each

day. This will depend on your

condition and whether you are taking

any other medicines.

The label put on the carton by the

pharmacist will tell you how much you

should take.

If you do not understand the

instructions on the carton, ask

your doctor or pharmacist for help.

How to take it

Aripiprazole GH tablets should be

swallowed whole and washed down

with a glass of water.

Take Aripiprazole GH at about the

same time each day.

Unless your doctor gives you other

directions, you should take

Aripiprazole GH only once a day.

Taking the medicine at the same time

each day will have the best effect. It

will also help you remember when to

take it.

It does not matter whether you take

Aripiprazole GH with or without food.

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, and 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.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints.

How long to take it

Continue taking Aripiprazole GH

for as long as your doctor tells

you.

Aripiprazole GH helps to control your

condition but does not cure it.

Therefore you must take Aripiprazole

GH every day.

Improvement in symptoms may take

several days to some weeks to occur.

Even if you feel better do not stop

taking Aripiprazole GH unless your

doctor tells you to.

If you take too much (overdose)

Immediately telephone your doctor

or pharmacist or the Poisons

Information Centre (telephone 13

1126), or go to the Accident and

Emergency Centre at your nearest

hospital, if you or anyone else may

have taken too much Aripiprazole

GH.

Do this even if there are no signs

of discomfort or poisoning.

You may need urgent medical

attention.

While you are taking

Aripiprazole GH

Things you must do

Tell any doctors, dentists or

pharmacists who are treating you

that you are taking Aripiprazole

GH.

If you are about to be started on

any new medicine, tell your doctor,

dentist and pharmacist that you

are taking Aripiprazole GH.

If you plan to have any kind of

surgery that needs a general

anaesthetic, tell your doctor or

dentist that you are taking

Aripiprazole GH.

Aripiprazole GH

CMI v4.0

Page 3 of 4

If you become pregnant while

taking Aripiprazole GH, tell your

doctor immediately.

Be sure to keep all of your doctor's

appointments so that your

progress can be checked.

Things you must not do

Do not give Aripiprazole GH to

anyone else, even if their

symptoms seem similar or they

have the same condition as you.

Do not take Aripiprazole GH to treat

any other complaints unless your

doctor or pharmacist tells you to.

Do not stop taking Aripiprazole GH

or lower the dosage, even if you

are feeling better, without checking

with your doctor.

If you stop taking Aripiprazole GH

suddenly your condition may worsen.

Do not take more of this medicine

and do not take it more often than

your doctor has ordered.

Things to be careful of

Make sure that you know how you

react to Aripiprazole GH before

you drive a car, operate machinery

or do anything else that could be

dangerous if you are dizzy or light

headed or not alert.

Aripiprazole GH may cause some

people to become drowsy or less

alert than they are normally or cause

light-headedness, dizziness or

tiredness. If this occurs do not

undertake the activity.

If Aripiprazole GH makes you feel

light-headed, dizzy or faint, be

careful when getting up from a

sitting or lying position.

Getting up slowly may help.

Be careful when drinking alcohol

while taking Aripiprazole GH.

Your doctor may suggest you avoid

alcohol while you are being treated

with Aripiprazole GH.

Make sure you keep cool in hot

weather and keep warm in cool

weather.

Aripiprazole GH may affect the way

your body reacts to temperature

changes. It may prevent sweating,

even during heat waves. You may

feel dizzy or faint if you are too hot.

To stay cool in hot weather, try to do

the following:

wear light clothing;

spend time in air-conditioned

environments (or keep windows

open and use electric fans);

drink plenty of water;

take cool baths or showers and

avoid hot baths and saunas;

try to restrict exercise or heavy

work to cool parts of the day.

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Aripiprazole GH.

Like other medicines Aripiprazole GH

may cause some unwanted side

effects. These are likely to vary from

patient to patient.

Aripiprazole GH is generally well-

tolerated and the side effects are

often hard to distinguish from disease

symptoms. It is important that you

tell your doctor as soon as possible

about any unwanted effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following side effects and

they worry you:

headache;

indigestion;

nausea;

vomiting;

insomnia;

constipation;

light-headedness;

drowsiness;

agitation;

anxiety;

inability to sit or stand still; restless

movement of the arms and legs

such as tapping, marching in

places, rocking, crossing and

uncrossing the legs.

These are the more common side

effects of Aripiprazole GH.

Tell your doctor if you notice the

following side effects:

feeling dizzy especially when

getting up from a lying or sitting

position

altered or increased sexual

interest

These side effects are uncommon.

high blood sugar (excessive thirst,

hunger and weakness) or the

onset or worsening of diabetes

This side effect is rare.

weight gain;

weight loss;

loss of appetite;

excessive sweating;

drowsiness.

high blood pressure

chest pain

frequent infections such as fever,

severe chills, sore throat or mouth

ulcers

bleeding or bruising more easily

than normal

speech disorder

urinary incontinence

difficult swallowing

hiccups

These side effects are very rare.

Tell your doctor if you have

obsessive (recurring) thoughts or

behaviours or trouble controlling

impulsive urges or while taking

Aripiprazole GH.

Obsessive compulsive behaviours

(feeling the need to check things

repeatedly or having certain thoughts

repeatedly), gambling urges, sexual

urges, compulsive spending, binge or

compulsive eating and other urges

have occurred in some patients.

Tell your doctor immediately or go

to Accident and Emergency at your

nearest hospital if you notice any

of the following:

seizure, fits or convulsions.

fainting.

abnormal 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

heartbeat, muscle stiffness, high

blood pressure and convulsions.

rash.

allergic reaction (rash, itching or

hives on the skin; shortness of

breath, wheezing or difficulty

Aripiprazole GH

CMI v4.0

Page 4 of 4

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body).

muscle pain, muscle weakness or

muscle stiffness.

inflammation of the pancreas,

severe upper stomach pain often

with nausea and vomiting.

disorder of body temperature

regulation resulting in low body

temperature or high body

temperature.

painful irreversible erection.

difficulty in passing urine.

yellowing of the skin and/or eyes,

also called jaundice with or without

nausea, vomiting, loss of appetite,

feeling generally unwell, fever,

itching and dark coloured urine.

serious lung infection with fever,

chills, shortness of breath, cough,

chest pain and blood streaked

phlegm.

thoughts or talk about death or

suicide; thoughts or talk about self-

harm or doing harm to others; any

recent attempts at self-harm; an

increase in aggressive behaviour,

irritability or agitation.

If you or someone you know is

showing these signs contact your

doctor or a mental health advisor

right away or go to the nearest

hospital for treatment.

These are very serious side

effects.

You may need urgent medical

attention or hospitalisation.

All of these side effects are very rare.

Other side effects not listed above

may occur in some patients.

Also, while taking Aripiprazole GH,

some elderly patients with dementia

have suffered serious side effects

such as a "mini" stroke, stroke,

pneumonia or heart problems. These

serious side effects can be life

threatening.

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 or only

some of them.

After using Aripiprazole GH

Storage

Store Aripiprazole GH in a cool

place where the temperature stays

below 30

o

C.

Do not store it or any other

medicine in the bathroom. Do not

leave it in the car or on window

sills.

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.

Do not keep outdated medicine or

medicine no longer needed.

Disposal

If your doctor tells you to stop

taking Aripiprazole GH or the

medicine has passed its expiry

date, ask your pharmacist what to

do with any leftover medicine.

Be sure that any discarded

medicine is out of the reach of

children.

Product Description

What it looks like

Aripiprazole GH, 5 mg tablets are

white, round, uncoated, biconvex with

a bevelled edge, plain on both sides.

Aripiprazole GH, 10 mg tablets are

white, oval-shaped, uncoated,

biconvex with a bevelled edge, plain

on both sides.

Aripiprazole GH, 15 mg tablets are

white, round, uncoated, biconvex with

a bevelled edge, plain on both sides.

Aripiprazole GH, 20 mg tablets are

white, round, uncoated, biconvex,

plain on both sides.

Aripiprazole GH, 30 mg tablets are

white, round, uncoated, biconvex with

a bevelled edge plain on both sides.

Aripiprazole GH tablets are available

aluminium blisters in a

carton. Each carton contains

30 tablets.

Ingredients

Active ingredients: Aripiprazole

Other ingredients: lactose,

microcrystalline cellulose, maize

starch, hydroxypropylcellulose,

purified water and magnesium

stearate.

Sponsor

Generic Health Pty Ltd

Level 1, 1102 Toorak Road

CAMBERWELL VIC 3124

Australian Registration Number

Aripiprazole GH 5 mg tablets –

AUST R 176806.

Aripiprazole GH 10 mg tablets -

AUST R 176808.

Aripiprazole GH 15 mg tablets -

AUST R 176810.

Aripiprazole GH 20 mg tablets -

AUST R 176813.

Aripiprazole GH 30 mg tablets -

AUST R 176815.

Not all pack sizes may be marketed.

This leaflet was prepared in June

2017.