PRAMIPEXOLE

Main information

  • Trade name:
  • PRAMIPEXOLE GH pramipexole dihydrochloride 1.5 mg tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PRAMIPEXOLE GH pramipexole dihydrochloride 1.5 mg tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214454
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214454

PRAMIPEXOLE GH pramipexole dihydrochloride 1.5 mg tablets 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

23/09/2014

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. PRAMIPEXOLE GH pramipexole dihydrochloride 1.5 mg tablets blister pack

Product Type

Single Medicine Product

Effective date

20/02/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Pramipexole tablets are indicated for:,-the treatment of signs and symptoms of idiopathic Parkinson's disease. It may be used as monotherapy or in

combination with levodopa.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

3 Years

Store below 25

degrees Celsius

Child resistant closure

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

10, 30, 100

(S4) Prescription Only Medicine

Components

1. PRAMIPEXOLE GH Pramipexole hydrochloride 1.5 mg tablets blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White, circular, flat, beveled edged, uncoated tablets debossed with 'CL'

and '6' debossed on one side with breakline in between and a breakline on

the other side.

Active Ingredients

pramipexole dihydrochloride monohydrate

1.5 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 26.11.2017 at 09:45:16 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

Pramipexole GH CMI v2

Page 1 of 5

CONSUMER MEDICINE INFORMATION

PRAMIPEXOLE GH

pramipexole dihydrochloride monohydrate

What is in this leaflet

This leaflet answers some

common questions about

PRAMIPEXOLE GH. It does

not contain all the information

and does not take the

place

of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has

weighed the risk of you taking

PRAMIPEXOLE GH against

the benefits they expect it will

have for you.

Talk to your doctor or

pharmacist if you have any

concerns about taking this

medicine.

Keep this leaflet with the

medicine.

You may need to read it

again.

What PRAMIPEXOLE GH

is used for

PRAMIPEXOLE GH is used

in the treatment of

Parkinson's disease.

Parkinson's disease is a

disease of the brain that

affects body movement.

The symptoms of Parkinson's

disease are caused by a lack

of dopamine, a naturally

occurring chemical produced

by certain brain cells.

Dopamine relays messages

in the part of the brain that

controls movement. When

too little dopamine is

produced, this results in

Parkinson's disease.

PRAMIPEXOLE GH works by

having a similar effect as

dopamine in the brain.

PRAMIPEXOLE GH contains

the active ingredient

Pramipexole hydrochloride.

Pramipexole hydrochloride

belongs to a group of

medicines known as

"dopamine agonists".

Ask your doctor if you have

any questions about why

PRAMIPEXOLE GH has

been prescribed for you.

Your doctor may have

prescribed PRAMIPEXOLE

GH for another reason.

Before you take

PRAMIPEXOLE GH

When not to take it

Only use PRAMIPEXOLE

GH if it has been

prescribed for you by a

doctor.

Never give it to someone

else even if their symptoms

seem to be the same as

yours.

Do not take PRAMIPEXOLE

GH if you are allergic to

pramipexole or any of the

other ingredients listed at

the end of this leaflet.

If you are not sure if you

have these allergies, you

should raise those

concerns with your doctor.

Signs of an allergic reaction

may include itching of skin,

shortness of breath and

swelling of the tongue or

face.

You should not use

PRAMIPEXOLE GH after

the EXPIRY DATE on the

carton or blister strips, or if

the packaging is torn or

damaged.

Before you start to take it

It is essential that your

doctor knows your medical

history before prescribing

PRAMIPEXOLE GH.

Before taking this medicine,

you must tell your doctor if

you have, or have had, any of

the following conditions:

kidney problems

mental illnesses

heart problems

blood pressure problems

eye problems

trouble controlling your

muscles (dyskinesia).

If you are not sure if you

have, or have had, any of

these conditions, you should

raise those concerns with

your doctor.

Before using

PRAMIPEXOLE GH, it is

important to tell your

doctor if you are taking any

other medicines, obtained

with or without a doctor's

prescription.

In particular, you should tell

your doctor if you are taking:

Pramipexole GH CMI v2

Page 2 of 5

any medicines for the

treatment of Restless

Legs Syndrome

levodopa,

levodopa/carbidopa

combination, or other

medicines used to treat

Parkinson's disease (e.g.

amantadine)

medicines used in the

treatment of high blood

pressure or heart

problems (e.g. digoxin,

diltiazem, procainamide,

quinidine, triamterene,

verapamil,

hydrochlorothiazide)

certain medicines used in

the treatment of mental

illness/psychosis

(antipsychotics or

neuroleptics)

metoclopramide -

commonly used to help

control nausea and

vomiting

cimetidine or ranitidine -

used to treat stomach

ulcer or reflux

quinine - used to treat

malaria

some antibiotics (eg

trimethoprim,

cephalosporins,

penicillins)

indomethacin, a medicine

used to treat arthritis

chlorpropamide, a

medicine used to treat

diabetes

medicines used to

produce calmness or help

you sleep e.g. sleeping

tablets, sedatives or

tranquillisers, and pain

relievers

other medicines that can

cause drowsiness or

sleepiness (eg

antihistamine or some

cough and cold

preparations)

These medicines may be

affected by PRAMIPEXOLE

GH or may affect how well it

works. You may need

different amounts of the

medicine, or you may need to

take different medicines. Your

doctor or pharmacist will

advise you.

Ask for your doctor's

advice if you are pregnant,

or likely to become

pregnant during your

course of medication.

Special care is recommended

during pregnancy. The

benefits of PRAMIPEXOLE

GH must be assessed

against the possible effects

on your unborn child.

PRAMIPEXOLE GH is not

recommended during

breastfeeding.

Ask for your doctor's

advice if you are

breastfeeding, or likely to

breastfeed during your

course of medication.

In animal studies,

PRAMIPEXOLE GH was

shown to pass into breast

milk, and can stop the

production of milk.

Use in Children

The use of PRAMIPEXOLE

GH is not recommended in

children below 18 years of

age.

How to take

PRAMIPEXOLE GH

It is important to take your

PRAMIPEXOLE GH tablets

as directed by your doctor.

A number of tablet strengths

are available (see Product

Description). Make sure that

you only take the tablet

strength that your doctor has

prescribed.

Your doctor may reduce your

daily dose if you have

another medical condition

such as a kidney problem, or

if you are currently taking

other medicines.

How much to take

The recommended initial

dose for adults is one

PRAMIPEXOLE GH 0.125

mg tablet three times per day.

Your daily dose will be

increased every week by your

doctor until a suitable daily

dose is reached. The

maximum recommended

daily dose for

PRAMIPEXOLE GH is 4.5

mg pramipexole

hydrochloride.

Ask your doctor for more

information if you have

been advised to take a

different dose to that

referred to above.

How to take it

The tablets should be

swallowed whole with a glass

of water. PRAMIPEXOLE GH

can be taken with or without

food.

If you take too much

Immediately telephone your

doctor, pharmacist or

Poisons Information Centre

(telephone 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 PRAMIPEXOLE GH.

Do this even if there are no

signs of discomfort or

poisoning.

You may need urgent

medical attention.

Pramipexole GH CMI v2

Page 3 of 5

Signs of overdose may

include nausea, vomiting,

abnormal uncontrolled

movements, hallucinations,

agitation and dizziness or

light-headedness.

While you are taking

PRAMIPEXOLE GH

Things you must do

Tell all doctors and

pharmacists who are

treating you that you are

taking PRAMIPEXOLE GH.

Do not stop taking

PRAMIPEXOLE GH or

change the dose without

checking with your doctor.

It is important not to suddenly

stop taking your

PRAMIPEXOLE GH tablets,

unless advised to do so by

your doctor, since your

condition may worsen.

If your doctor asks you to

stop taking PRAMIPEXOLE

GH, the dose will normally

need to be reduced gradually

over several days.

Tell your doctor as soon as

possible if there is any

worsening of your

condition.

Seek immediate medical

advice if you or your family

notices an increase in

compulsive behaviour.

If you forget to take it

If it is almost time for your

next dose, skip the dose you

missed and take the next

dose when you are meant to.

Otherwise, take it as soon as

you remember, then go back

to taking it as you would

normally.

Do not try to make up for

missed doses by taking more

than one dose at a time.

If you are not sure what to

do, check with your doctor

or pharmacist.

Things to be careful of

Do not drive a car, operate

machinery, or do anything

else that could be

dangerous (after taking

PRAMIPEXOLE GH) until

you know how the

medicine affects you.

It may cause drowsiness,

hallucinations and

episodes of sudden onset

of sleep, in some people.

Make sure you know how

you react to it before you

engage in any activities

where impaired alertness

may put yourself or others

at risk of serious injury.

If you experience excessive

drowsiness or an episode of

sudden onset of sleep (while

performing daily activities), do

not drive or perform any

potentially dangerous

activities, and contact your

doctor.

Be careful when drinking

alcohol while taking

PRAMIPEXOLE GH.

Combining it and alcohol

can make you more drowsy

or sleepy.

Be careful getting up from

a sitting or lying position.

You may feel dizzy or

lightheaded while taking

PRAMIPEXOLE

GH, especially during the first

few weeks of treatment. If

you wish to stand up, you

should do so slowly.

Patients with Parkinson's

Disease

may have an

increased risk of developing

melanoma.

You should monitor your skin

and see your doctor in case

of any concerns.

Side Effects

You should be aware that all

prescription medicines carry

some risks and that all

possible risks may not be

known at this stage despite

thorough testing.

Your doctor has weighed the

risks of your taking

PRAMIPEXOLE GH against

the expected benefits.

Ask for the advice of your

doctor or pharmacist if you

have any concerns about

the effects of taking

PRAMIPEXOLE GH.

The most common side

effects of PRAMIPEXOLE

GH include nausea,

constipation, drowsiness,

hallucinations, confusion,

dizziness and swelling of

hands, ankles or feet

(peripheral oedema). In

patients also taking other

medicines to treat

Parkinson's disease,

abnormal uncontrolled

movements can occur.

These side effects tend to

appear at

the start of

treatment and lessen or

disappear with time.

Sudden onset of sleep

episodes (while engaged in

daily activities) have been

reported with/without prior

warning signs, such as

excessive drowsiness.

Pramipexole GH CMI v2

Page 4 of 5

Other reported side effects

include hypersensitivity,

diarrhoea, dry mouth, fatigue,

visual disturbance including

blurred vision and reduced

visual acuity, vomiting,

headache, lightheadedness

or low blood pressure

(hypotension), trouble

sleeping (insomnia),

amnesia, restlessness,

dream

abnormalities,

delusion, paranoia,

weight

gain, weight decrease.

Compulsive behaviour such

as gambling, hypersexuality,

shopping, eating, medication

use and repetitive

purposeless activities have

been reported in patients

taking dopamine agonists for

the treatment of Parkinson's

disease, especially at high

doses.

If you or your family notice

an increase in compulsive

behaviour, seek immediate

medical advice. Your

doctor may consider

reducing or ceasing your

treatment.

Tell your doctor as soon as

possible if you experience

any side effects during or

after taking PRAMIPEXOLE

GH, so that these effects

may be properly treated.

Other side effects not yet

known or listed above, may

also occur in some patients.

You should tell your doctor or

pharmacist if you notice

anything unusual, during or

after taking PRAMIPEXOLE

How to store

PRAMIPEXOLE GH

Storage

PRAMIPEXOLE GH should

be kept in a cool dry and

dark place where the

temperature stays below

25°C. Keep tablets in the

packet

until used, to

protect from light.

Do not store your

PRAMIPEXOLE GH in direct

sunlight or heat.

For example, do not leave

your PRAMIPEXOLE GH in

the car on hot days.

Keep your medicine where

children cannot reach it.

Disposal

Return any unused medicine

to your pharmacist so that it

can be disposed of safely.

Product description

What PRAMIPEXOLE GH

tablets look like

PRAMIPEXOLE GH tablets

are round and white for each

strength.

PRAMIPEXOLE GH 0.125

mg tablets are debossed with

‘CL’ on one side of the tablet

and ‘2’ on the other side.

PRAMIPEXOLE GH 0.25 mg

tablets are with ‘CL’ and ‘3’

debossed on one side of the

tablet with breakline

separating ‘CL’ and ‘3’ and

having a breakline on the

other side.

PRAMIPEXOLE GH 0.5* mg

tablets are with ‘CL’ and ‘4’

debossed on one side of the

tablet with breakline

separating ‘CL’ and ‘4’ and

having a breakline on the

other side.

PRAMIPEXOLE GH 1 mg

tablets are with ‘CL’ and ‘5’

debossed on one side of the

tablet with breakline

separating ‘CL’ and ‘5’ and

having a breakline on the

other side.

PRAMIPEXOLE GH 1.5* mg

tablets are with ‘CL’ and ‘6’

debossed on one side of the

tablet with breakline

separating ‘CL’ and ‘6’ and

having a breakline on the

other side.

Presented in Al/Al blister

packs of 10’s, 30’s and 100’s

tablets.

*Not all strengths or pack

sizes may be available.

Ingredients

Each PRAMIPEXOLE GH

tablet contains the following

amount of active ingredient:

0.125 mg tablet contains

0.125 mg of pramipexole

hydrochloride.

0.25 mg tablet contains

0.25 mg of pramipexole

hydrochloride.

0.5 mg tablet contains 0.5

mg of pramipexole

hydrochloride.

1 mg tablet contains 1 mg

of pramipexole

hydrochloride.

1.5 mg tablet contains 1.5

mg of pramipexole

hydrochloride.

The other ingredients found

in all strengths are:

mannitol,

pregelatinized maize

starch

povidone,

colloidal anhydrous silica

magnesium stearate

Sponsor

Generic Health Pty Ltd

Pramipexole GH CMI v2

Page 5 of 5

Level 1, 1102 Toorak Road

Camberwell, VIC, 3124

Australian Registration

Numbers

PRAMIPEXOLE GH 0.125

- AUST R 214463

PRAMIPEXOLE GH 0.25 mg

- AUST R 214456

PRAMIPEXOLE GH 0.5 mg -

AUST R 214438

PRAMIPEXOLE GH 1 mg -

AUST R 214453

PRAMIPEXOLE GH 1.5 mg -

AUST R 214454

This leaflet was prepared in

November 2017.

30-10-2018

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12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

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