Patient Medication Information: uses, side effects, how to take - Nu-Pramipexole
ABOUT THIS MEDICATION
What the medication is used for:
NU-PRAMIPEXOLE is used to treat early and late stage Parkinson’s disease. NU-PRAMIPEXOLE provides relief of signs and symptoms of Parkinson’s Disease. Sign and symptoms of the disease include: shaking (tremor), slowness in performing activities of daily living (bradykinesia), muscle stiffness (rigidity) and mood changes (depression). In late stage Parkinson’s disease, NU-PRAMIPEXOLE will be used in combination with levodopa.
What it does:
NU-PRAMIPEXOLE belongs to a group of medicines known as “dopamine agonists”. NU-PRAMIPEXOLE improves some of the chemical imbalance in the part of the brain affected by Parkinson’s Disease.
When it should not be used:
If you are allergic to NU-PRAMIPEXOLE, or any of the nonmedicinal ingredients of the product (see list below).
NU-PRAMIPEXOLE is not recommended for children under 18 years of age.
What the medicinal ingredient is:
Pramipexole dihydrochloride monohydrate
What the important nonmedicinal ingredients are:
Magnesium stearate, microcrystalline cellulose and starch (corn).
What dosage forms it comes in:
Tablets, 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg
WARNINGS AND PRECAUTIONS
You are warned of a sudden onset of sleep condition which may occur without warning, while taking NU-PRAMIPEXOLE. You should not 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.
NU-PRAMIPEXOLE is one of the drugs used to treat Parkinson’s disease; therefore, patients treated with NU-PRAMIPEXOLE should have periodic skin examinations.
Patients and caregivers should be aware of the fact that behavioural changes such as pathological
gambling, increased sexual desire or binge eating, can occur. Those changes have also been reported in patients taking other anti-Parkinson drugs of the same class.
BEFORE you use NU-PRAMIPEXOLE 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 NU-PRAMIPEXOLE 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.
INTERACTIONS WITH THIS MEDICATION
Other medications may be affected by NU-PRAMIPEXOLE or may affect how NU-PRAMIPEXOLE 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 NU-PRAMIPEXOLE.
Avoid alcohol or other sedatives while taking NU-PRAMIPEXOLE.
PROPER USE OF THIS MEDICATION
Usual dose
Parkinson’s Disease:
Take NU-PRAMIPEXOLE in equal doses, three times daily as prescribed by your doctor. It is important that your doctor increases your dosage of NU-PRAMIPEXOLE 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.
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 NU-PRAMIPEXOLE without the recommendation of your doctor.
You may take NU-PRAMIPEXOLE with food if you find that you feel sick to your stomach while taking the tablets.
Overdose:
If you accidentally take too many tablets, you should get medical help immediately; either by calling your doctor 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 NU-PRAMIPEXOLE 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 (lose when you are supposed to. Do not take more than one dose at a time.
NU-PRAMIPEXOLE has been prescribed for you. Do not give these tablets to anyone else, even if you think they have the same condition as you.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
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 NU-PRAMIPEXOLE against the expected benefits.
NU-PRAMIPEXOLE may cause some changes in
behaviour, such as compulsive gambling or change in sexual desire. Such changes in behaviour have also been
reported in patients taking other anti-Parkinson drugs. Discuss with your doctor immediately, if you experience any behavioural changes.
- NU-PRAMIPEXOLE may cause hallucinations or unwanted fidgety movements (dyskinesia). Tell your doctor right away if you have any of these symptoms.
- NU-PRAMIPEXOLE can lower blood pressure in some patients when they are sitting or standing. This means that if you sit or stand up after lying down, you may feel dizzy, lightheaded, sick, faint, or you may sweat. These effects happen most often at the start of treatment. Be sure to tell your doctor if you feel like this.
- NU-PRAMIPEXOLE may also cause other unwanted effects such as nausea. If you do experience any unusual or unwanted effects while you are taking NU-PRAMIPEXOLE, be sure to tell your doctor. It is important that he/she knows of any unwanted effects to determine the best dose of NU-PRAMIPEXOLE for you.
You may feel dizzy or sleepy while taking NU-
PRAMIPEXOLE, especially during the first few weeks of treatment.
Most frequent adverse events, listed in decreasing order of frequency observed in:
- Early Parkinson’s Disease: nausea, dizziness, sleepiness, difficulty falling asleep (insomnia), muscle weakness (asthenia), and constipation.
Advanced Parkinson’s Disease: low blood pressure
(postural), impaired voluntary movements (dyskinesia, difficulty falling asleep (insomnia), dizziness, hallucinations, accidental injury, dream abnormalities, constipation and confusion.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
This is not a complete list of side effects. For an unexpected effects while taking NU-PRAMIPEXOLE, contact your doctor or pharmacist immediately, so that these effects may be properly addressed.
HOW TO STORE IT
- NU-PRAMIPEXOLE should be stored at room temperature 15 - 30°C (59-86°F).
- The expiry date of this medicine is printed on the label. Do not use the medicine after this date.
- Keep this drug out of the reach of children. REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701C
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect ™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Nu-Pharm Inc. at:
1-800-267-1438
Date of Preparation: October 7, 2009