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APO-Pramipexole

Contains the active ingredient pramipexole (as pramipexole hydrochloride monohydrate)
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about APO-Pramipexole. It does not contain all the information that is known about APO-Pramipexole. It 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 using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What this medicine is used for

The name of your medicine is APO-Pramipexole Tablets. It contains the active ingredient pramipexole (as pramipexole hydrochloride monohydrate).
It is used to treat Parkinson's disease.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.

How it works

It belongs to a group of medicines known as "dopamine agonists".
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. Pramipexole works by having a similar effect to dopamine in the brain.
There is no evidence that this medicine is addictive.

Use in children

The use of pramipexole is not recommended in children below 18 years of age.

Before you take this medicine

When you must not take it

Do not take this medicine if:
You are hypersensitive to, or have had an allergic reaction to, pramipexole or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.
If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
The expiry date (EXP) printed on the pack has passed.
The packaging is torn, shows signs of tampering or it does not look quite right.

Before you start to take it

Before you start taking this medicine, tell your doctor if:

1. You have allergies to:

any other medicines
any other substances, such as foods, preservatives or dyes.

2. You have or have had any medical conditions, especially the following:

kidney problems
mental illnesses
heart problems
blood pressure problems
eye problems.

3. You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.

4. You are currently breastfeeding or you plan to breast-feed. Do not take this medicine whilst breastfeeding. In animal studies, pramipexole was shown to pass into breast milk, and can stop the production of milk.

5. You are planning to have surgery or an anaesthetic.

6. You are currently receiving or are planning to receive dental treatment.

7. You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Some medicines may interact with pramipexole. These include:
any medicines for the treatment of Restless Legs Syndrome
levodopa, or other medicines used to treat Parkinson's disease (e.g. amantadine, selegiline)
medicines used in the treatment of high blood pressure or heart problems (e.g. digoxin, diltiazem, procainamide, quinidine, triamterene, verapamil)
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
trimethoprim - an antibiotic
medicines used to produce calmness or help you sleep e.g. sleeping tablets, sedatives or tranquillisers, and pain relievers.
If you are taking any of these you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with pramipexole.

How to take this medicine

Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.

How much to take

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
Parkinson's disease:
The recommended initial dose for adults is one pramipexole 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 is 4.5 mg.
Make sure that you only take the tablet strength that your doctor has prescribed.
Do not stop taking your medicine or change your dosage without first checking with your doctor.

How to take it

The tablets should be swallowed whole with a glass of water.

When to take it

Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.
It does not matter if you take it before, with or after food.

How long to take it for

Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.

If you forget to take it

If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. 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 missed doses.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively, go to the Accident and Emergency department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much pramipexole, you may experience nausea, vomiting, abnormal uncontrolled movements, hallucinations, agitation and dizziness or lightheadedness.

While you are taking this medicine

Things you must do

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 that you are taking this medicine if:
you are about to be started on any new medicine
you become pregnant or are planning to become pregnant
you are planning to breast-feed
you are about to have any blood tests
you are going to have surgery or an anaesthetic or are going into hospital.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

Things you must not do

Do not:
Give this medicine to anyone else, even if their symptoms seem similar to yours.
Take your medicine to treat any other condition unless your doctor tells you to.
Stop taking your medicine, or change the dosage, without first checking with your doctor.
It is important to not suddenly stop taking your tablets, unless advised to do so by your doctor as your condition may worsen.
If your doctor asks you to stop taking pramipexole the dose will normally need to be reduced gradually over several days.

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine affects you.
Pramipexole may cause drowsiness, hallucinations and episodes of sudden onset of sleep, in some people.
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. Contact your doctor for advice.

Possible side effects

Tell your doctor as soon as possible if you do not feel well while you are taking pramipexole or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor if you notice any of the following:
nausea,
constipation
drowsiness
hallucinations
confusion
dizziness
swelling of hands, ankles or feet (peripheral oedema).
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.
Sudden onset of sleep episodes (while engaged in daily activities) have been reported with/without prior warning signs, such as excessive drowsiness.
In patients taking other medicines to treat Parkinson's disease abnormal, uncontrolled movements can also occur.
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects and you may need medical attention:
If you or your family notice an increase in compulsive behaviour, seek immediate medical advice. Your doctor may consider reducing or ceasing your treatment.
Compulsive behaviour such as gambling, hypersexuality, shopping, eating, medication use and repetitive purposeless activities have been reported in patients taking medicines for the treatment of Parkinson's disease, especially at high doses.
Other side effects not listed above may occur in some patients.

Allergic reactions

If you think you are having an allergic reaction to pramipexole, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
cough, shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue, throat or other parts of the body
rash, itching or hives on the skin
fainting
hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, 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 this medicine 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 it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What APO-Pramipexole tablets look like

0.125 mg tablet:
White coloured, circular, flat, bevelled edged uncoated tablet, debossed 'CL' on one side of the tablet and '2' on other side.
Blister pack of 30.
0.25 mg tablet:
White coloured, oval shaped, uncoated tablet, debossed 'CL' and '3' on one side of the tablet
with a breakline in between and a breakline on the other side.
Blister pack of 100.
1 mg tablet:
White coloured, flat, circular, bevelled edged uncoated tablet, debossed 'CL' and '5' on one
side with a breakline in between and a breakline on the other side.
Blister pack of 100.

Ingredients

Each tablet contains 0.125 mg, 0.25 mg, 0.5 mg or 1 mg of pramipexole as the active ingredient.
It also contains the following inactive ingredients:
mannitol
pregelatinised maize starch
colloidal anhydrous silica
povidone
magnesium stearate
 
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

APO-Pramipexole 0.125 mg tablets (blister): AUST R 229626.
APO-Pramipexole 0.25 mg tablets (blister): AUST R 229627.
APO-Pramipexole 1 mg tablets (blister): AUST R 229628.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
 
APO and APOTEX are registered trade marks of Apotex Inc.
 
This leaflet was last updated in December 2014.