SIMPRAL pramipexole dihydrochloride monohydrate 0.125 mg tablet blister pack

Main information

  • Trade name:
  • SIMPRAL pramipexole dihydrochloride monohydrate 0.125 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SIMPRAL pramipexole dihydrochloride monohydrate 0.125 mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 173139
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

173139

SIMPRAL pramipexole dihydrochloride monohydrate 0.125 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

9/04/2013

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. SIMPRAL pramipexole dihydrochloride monohydrate 0.125 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

30/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

SIMPRAL is 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

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Store in Original

Container

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

Route of Administration

Oral

Visual Identification

A white to off white, round, flat-faced tablet, debossed with 'PX1' on one

side and 'M' on the other side.

Active Ingredients

pramipexole dihydrochloride monohydrate

.125 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 04:39:42 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

SIMPRAL

pramipexole hydrochloride monohydrate

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about SIMPRAL.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have benefits and

risks. Your doctor has weighed the

risks of you taking SIMPRAL

against the benefits expected for you.

If you have any concerns about

taking this medicine, talk to your

doctor or pharmacist.

Keep this leaflet with your

medicine.

You may need to read it again.

What SIMPRAL is

used for

SIMPRALis used to treat the

symptoms 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.

SIMPRAL works by having a similar

effect as dopamine in the brain.

How SIMPRAL works

SIMPRAL contains the active

ingredient pramipexole

hydrochloride monohydrate.

Pramipexole hydrochloride

monohydrate belongs to a group of

medicines known as "dopamine

agonists", which bind to dopamine

receptors.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

SIMPRAL is not addictive.

This medicine is available only with

a doctor's prescription.

SIMPRAL is not recommended for

use in children under 18 years of age

as its safety and effectiveness in that

age group have not been established.

Before you take

SIMPRAL

When you must not take it

Do not take SIMPRAL if you have

an allergy to:

any medicine containing

pramipexole hydrochloride

monohydrate (active ingredient)

any of the 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

Do not give this medicine to a child

or adolescent under the age of 18

years.

Safety and effectiveness in children

younger than 18 years have not been

established.

Do not take this medicine after the

expiry date printed on the pack or

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 this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

kidney problems

mental illnesses

low blood pressure

trouble controlling your muscles

(dyskinesia).

Tell your doctor if you are

pregnant or likely to become

pregnant during your course of

medication.

Your doctor can discuss with you the

risks and benefits involved.

Tell your doctor if you are

breastfeeding, or likely to

breastfeed during your course of

medication.

SIMPRAL

SIMPRAL is not recommended

during breastfeeding, as it may pass

into breast milk.

If you have not told your doctor

about any of the above, tell him/

her before you start taking

SIMPRAL.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from a

pharmacy, supermarket or health

food shop.

Some medicines and SIMPRAL may

interfere with each other. These

include:

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)

medicines used in the treatment

of mental illness/ psychosis

(antipsychotics or neuroleptics)

metoclopramide, a medicine

commonly used to help control

nausea and vomiting

cimetidine or ranitidine,

medicines used to treat stomach

ulcer or duodenal ulcers

quinine, a medicine used to treat

malaria

some antibiotics (e.g.

trimethoprim, cephalosporins,

penicillins)

indomethacin, a medicine used to

treat arthritis

chlorpropamide, a medicine used

to treat diabetes

other medicines that can cause

drowsiness or sleepiness (e.g.

antihistamine or some cough and

cold preparations).

These medicines may be affected by

SIMPRAL or may affect how well it

works. You may need different

amounts of your medicines, or you

may need to take different medicines.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to take SIMPRAL

Follow all directions given to you

by your doctor and pharmacist

carefully.

They may differ from the

information contained in this leaflet.

Your doctor or pharmacist will tell

you how many tablets you will need

to take each day. This depends on

your condition and whether or not

you are taking any other medicines.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

The usual dose is one tablet a day.

Depending on how you respond to

the treatment, your doctor may

suggest a higher or lower dose.

Follow all directions given to you

by your doctor or pharmacist

carefully.

How to take it

Swallow the tablets whole with a

full glass of water.

When to take it

Take your medicine at about the

same time each day.

Taking it 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 if you take this

medicine before or after food.

How long to take it

Continue taking your medicine for

as long as your doctor tells you to.

This medicine helps to control your

condition, but does not cure it. It is

important to keep taking your

medicine even if you feel well.

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 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.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident and Emergency at

the nearest hospital, if you think

that you or anyone else may have

taken too much SIMPRAL. Do this

even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

Symptoms of an overdose may

include nausea, vomiting, abnormal

uncontrolled movements,

hallucinations, agitation and

dizziness or light-headedness.

While you are taking

SIMPRAL

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking SIMPRAL.

SIMPRAL

Tell any other doctors, dentists and

pharmacists who treat you that

you are taking this medicine.

If you feel that SIMPRAL is not

helping your condition, tell your

doctor or pharmacist.

Tell your doctor if, for any reason,

you have not used SIMPRAL

exactly as prescribed.

Otherwise, your doctor may think

that it was not effective and change

your treatment unnecessarily.

Tell your doctor as soon as possible

if there is any worsening of your

condition.

If you or your family notices an

increase in compulsive behaviour,

seek immediate medical advice.

Tell your doctor if you experience

symptoms such as depression,

apathy, anxiety, fatigue, sweating or

pain after stopping or reducing your

Simpral treatment. If the problems

persist for more than a few weeks,

your doctor may need to adjust your

treatment.

Tell your doctor if you develop an

inability to keep your body and neck

straight and upright. For example,

you may experience abnormal

posture such as forward bending of

the head and neck, forward bending

of the lower back or sidewards

bending of the back

Things you must not do

Do not take SIMPRAL to treat any

other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not stop taking your medicine

or change the dosage without

checking with your doctor.

It is important not to suddenly stop

taking your SIMPRAL tablets, unless

advised to do so by your doctor,

since your condition may worsen.

If your doctor asks you to stop taking

SIMPRAL, the dose will normally

need to be reduced gradually over

several days.

Things to be careful of

Be careful driving or operating

machinery until you know how

SIMPRAL affects you.

This medicine may cause drowsiness,

hallucinations and episodes of

sudden onset of sleep, in some

people.

Make sure you know how you

react to SIMPRAL 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 you are taking this medicine.

Combining SIMPRAL 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 SIMPRAL, 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

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

SIMPRAL.

SIMPRAL helps most people with

Parkinson's disease, but it may have

unwanted side effects in a few

people. 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.

Do not be alarmed by the following

list of side effects.

You may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

feeling sick (nausea)

vomiting

constipation

diarrhoea

dry mouth

drowsiness

tiredness

confusion or hallucinations

(seeing, feeling or hearing things

that are not there)

restlessness

dizziness

headache

light-headedness on standing up,

especially when getting up from a

sitting or lying position

(hypotension)

blurred vision

swelling of hands, ankles or feet

(peripheral oedema)

uncontrolled twitching, jerking or

writhing movements (dyskinesia)

difficulty sleeping or unusual

dreams

weight gain or loss

loss or gain of sexual drive.

forward bending of the head and

neck.

Some of these side effects are more

common at the start of treatment and

lessen or disappear with time.

Tell your doctor immediately if

you or your family notice any of

the following side effects:

loss of memory (amnesia)

fainting

SIMPRAL

signs of allergy such as rash or

hives on the skin; swelling of the

face, lips, tongue or other parts of

the body; wheezing or difficulty

breathing

excessive sleepiness or sudden

onset of sleep during normal daily

activities

compulsive behaviour such as

gambling, hypersexuality,

shopping, eating, medication use

and repetitive purposeless

activities

mental illness causing severe

suspiciousness (paranoia)

shortness of breath or tightness in

the chest (dyspnoea)

shortness of breath, swelling of

the feet or legs due to fluid build-

up (heart failure).

These are serious side effects. You

may need urgent medical attention or

hospitalisation. These side effects are

rare.

Tell your doctor if you notice

anything else that is making you

feel unwell.

Other side effects not listed above

may also occur in some people.

After taking SIMPRAL

Storage

Keep your tablets in the pack until

it is time to take them.

If you take the tablets out of the pack

they may not keep well.

Keep your tablets in a cool dry

place where the temperature stays

below 25C.

Do not store SIMPRAL or any

other medicine in the bathroom or

near a sink. Do not leave it on a

window sill or in the car.

Heat and dampness can destroy some

medicines.

Keep it where 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 this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

What it looks like

SIMPRAL 0.125 mg is a white to

off-white, round, flat-faced tablet,

debossed with "PX1" on one side and

"M" on the other side.

SIMPRAL 0. 25 mg is a white to off-

white, biconvex oval shaped tablet,

debossed with "PX2" on one side and

"M" on one side of breakline on other

side.

SIMPRAL 1 mg is a white to off-

white, round, flat-faced tablet,

debossed with "M" over "PX4" on

one side and breakline on the other

side.

Ingredients

SIMPRAL contains 0.125mg,

0.25mg or 1mg of pramipexole

hydrochloride monohydrate as the

active ingredient.

It also contains the following inactive

ingredients:

mannitol

pregelatinised maize starch

hydroxypropyl cellulose

crospovidone

sodium citrate anhydrous

colloidal anhydrous silica

magnesium stearate

This medicine does not contain

lactose, sucrose, tartrazine or any

other azo dyes.

Supplier

SIMPRAL is supplied in Australia

Alphapharm Pty Limited

(ABN 93 002 359 739)

Level 1, 30 The Bond

30 - 34 Hickson Road

Millers Point NSW 2000

Phone: (02) 9298 3999

www.mylan.com.au

Australian registration numbers:

SIMPRAL 0.125 mg:

AUST R 173139

SIMPRAL 0.25 mg:

AUST R 173138

SIMPRAL 1 mg:

AUST R 173137

This leaflet was prepared on

12 January 2018

SIMPRAL_cmi\Jan18/00

SIMPRAL