- Brand name
- APO-Pramipexole Tablets
- Active ingredient
- Pramipexole dihydrochloride monohydrate
- APO-Pramipexole 1 mg Tablets
Consumer medicine information (CMI) leaflet
Please read this leaflet carefully before you start using APO-Pramipexole Tablets.Download CMI (PDF) Download large text CMI (PDF)
What is in this leaflet
Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about pramipexole. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.
Ask your doctor or pharmacist:
- if there is anything you do not understand in this leaflet,
- if you are worried about taking your medicine, or
- to obtain the most up-to-date information.
You can also download the most up to date leaflet from www.apotex.com.au.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
Pharmaceutical companies cannot give you medical advice or an individual diagnosis.
Keep this leaflet with your medicine. You may want 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:
- You have allergies to:
- any other medicines
- any other substances, such as foods, preservatives or dyes.
- You have or have had any medical conditions, especially the following:
- kidney problems
- mental illnesses
- heart problems
- blood pressure problems
- eye problems.
- 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.
- 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.
- You are planning to have surgery or an anaesthetic.
- You are currently receiving or are planning to receive dental treatment.
- 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.
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
- 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:
- swelling of hands, ankles or feet (peripheral oedema).
- dry mouth
- visual disturbance including blurred vision and reduced visual acuity
- lightheadedness or low blood pressure (hypotension)
- trouble sleeping (insomnia)
- dream abnormalities
- 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.
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
- hay fever-like symptoms.
Storage and disposal
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.
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.
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.
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:
- pregelatinised maize starch
- colloidal anhydrous silica
- 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.
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.