Mirapex ER (Pramipexole)

Usual adult dose:

Parkinson's Disease:

Take MIRAPEX in equal doses, three times daily as prescribed by your doctor. Dosages should be increased gradually from a starting dose of 0.125 mg three times daily and should not be increased more frequently than every 5 to 7 days. It is important that your doctor increases your dosage of MIRAPEX gradually to avoid side effects and to achieve the best therapeutic effect. Your dose will probably change each week until your doctor and you decide what the best dose is for you. Make sure that you only use the tablet strength that your doctor has prescribed. The maximal recommended dose of MIRAPEX is 4.5 mg per day. Lower doses are recommended for patients with kidney disease.

Your doctor may decide to lower your dose of levodopa to prevent excessive side effects and to make sure that you are getting the best results from both drugs. Pay close attention to your doctor's instructions and never change the dose of either drug yourself.

You should not change the dose or discontinue treatment with MIRAPEX without the recommendation of your doctor.

You may take MIRAPEX without food or with food if you find that you feel sick to your stomach while taking the tablets.

Restless Legs Syndrome:

The recommended starting dose of MIRAPEX is 0.125 mg taken once daily (2-3 hours before bedtime) as prescribed by your doctor. If it is required, your doctor may change the dose every 4-7 days to achieve the best therapeutic effect. Tablets should be swallowed with water, and can be taken either with or without food. The maximal recommended dose of MIRAPEX is 0.50 mg per day.

Do not stop taking MIRAPEX suddenly, as this may result in worsened RLS symptoms. Talk to your doctor about slowly stopping the medication if necessary.

Overdose:

If you accidentally take too many tablets, you should get medical help immediately; either by calling your doctor, the regional Poison Control centre or by going to the nearest hospital (do not drive yourself). Always take the labelled medicine container with you whether or not there are any MIRAPEX tablets left.

Missed dose:

If you forget to take a dose, take it as soon as you remember, then carry on as before. However, if it is almost time for your next dose, skip the dose you missed and take the next dose when you are supposed to. Do not take more than one dose at a time.

MIRAPEX has been prescribed for you. Do not give these tablets to anyone else, even if you think they have the same condition as you.

You should be aware that prescription medicines carry some risks and that all possible risks may not be known at this stage. Discuss with your doctor the risks of taking MIRAPEX against the expected benefits.

If you do experience any unusual or unwanted effects while you are taking MIRAPEX, be sure to tell your doctor. It is important that he/she knows of any unwanted effects to determine the best dose of MIRAPEX for you.

• MIRAPEX may cause unwanted effects such as nausea, constipation, sleepiness, dizziness, dream abnormalities, amnesia (memory loss), fatigue, muscle weakness, restlessness, weight decrease, including decreased appetite, weight increased, hiccups, accidental injury, confusion, pneumonia, abnormal behaviour (reflecting symptoms of impulse control disorders and compulsions), overeating, headache, hyperkinesia (unusually overactive), fainting, visual impairment, including double vision, vision blurred and visual acuity reduced, shortness of breath, vomiting, heart failure, and peripheral oedema (swelling of hands, ankles or feet).
• MIRAPEX does not usually affect people's normal activities. However, some people may feel dizzy or sleepy while takingMIRAPEX, especially during the first few weeks of treatment.
• If you are taking MIRAPEX for RLS you may notice an increase in your symptoms in the early morning or the afternoon/early evening hours. If this happens, please, let your doctor know.

You are warned of a sudden onset of sleep condition which may occur without warning, while taking MIRAPEX. You should not drive, operate machinery or engage in activities that require alertness, as you may put yourself and others at risk of serious injury or death. This sudden onset of sleep condition has also been reported in patients taking other anti-Parkinson drugs of the same class.

Studies of people with Parkinson's disease show that they may be at an increased risk of developing melanoma (a form of skin cancer) when compared to people without Parkinson's disease. It is not known if this problem is associated with Parkinson's disease or the drugs used to treat Parkinson's disease. MIRAPEX is one of the drugs used to treat Parkinson's disease; therefore, patients treated with MIRAPEX should have periodic skin examinations.

Patients and caregivers should be aware of the fact that abnormal behavior such as pathological gambling, increased sexual desire, excessive sexual activity, compulsive shopping or binge eating have been reported. Those changes have also been reported in patients taking other anti-Parkinson drugs of the same class.

BEFORE you use MIRAPEX talk to your doctor or pharmacist:

• if you have any health problems, especially kidney problems or blood pressure problems;
• if you have any unusual conditions related to your eyes or eyesight;
• if you have previously taken MIRAPEX and became unwell;
• if you have any allergies or reactions to foods or drugs;
• if you are pregnant or intend to become pregnant;
• if you are breast feeding;
• if you are taking any other medications, including any drugs you can buy without a prescription;
• if you drive a vehicle or perform hazardous tasks during your work.

Other medications may be affected by MIRAPEX or may affect how MIRAPEX works. Do not take any other medication, including over-the-counter medications or herbal products unless your doctor tells you to. Tell any other doctor, dentist or pharmacist that you talk to that you are taking MIRAPEX.

Avoid alcohol or other sedatives while taking MIRAPEX.