Patient Medication Information: uses, side effects, how to take - Auro-Pramipexole (Auro Pharma, 0.125 mg)
ABOUT THIS MEDICATION
What the medication is used for:
AURO-PRAMIPEXOLE is used to treat early and late stage Parkinson’s disease. AURO-PRAMIPEXOLE provides relief of signs and symptoms of Parkinson’s disease. Signs 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, AURO-PRAMIPEXOLE will be used in combination with levodopa.
What it does:
AURO-PRAMIPEXOLE belongs to a group of medicines known as “dopamine agonists”. AURO-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 AURO-PRAMIPEXOLE, or any of the nonmedicinal ingredients of the product (see list below).
AURO-PRAMIPEXOLE is not recommended for children under 18 years of age.
What the medicinal ingredient is:
pramipexole dihydrochloride
What the non-medicinal ingredients are:
Mannitol (Pearlitol 50C), Corn Starch (Extra White Maize Starch), Povidone (Kollidone-30), Povidone (Kollidone 90 F), Colloidal Silicon dioxide (Aerosil 200) and Magnesium Stearate (Ligamed MF-2-V).
What dosage forms it comes in:
AURO-PRAMIPEXOLE (Pramipexole dihydrochloride monohydrate) is supplied in blister pack of 90 tablets and bottles of 90’s, 100’s and 1000’s tablets for 0.125 mg, 0.25 mg, 0.5 mg, 1.0 mg, and 1.5 mg tablets.
WARNINGS AND PRECAUTIONS
| You are warned of a sudden onset of sleep condition which may occur without warning, while taking AURO-PRAMIPEXOLE. 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. AURO-PRAMIPEXOLE is one of the drugs used to treat Parkinson’s disease; therefore, patients treated with AURO-PRAMIPEXOLE should have periodic skin examinations.
Patients and caregivers should be aware of the fact that abnormal behaviour 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 AURO-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 AURO-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;
if you drive a vehicle or perform hazardous tasks during your work.
INTERACTIONS WITH THIS MEDICATION
Other medications may be affected by AURO-PRAMIPEXOLE or may affect how AURO-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 AURO-PRAMIPEXOLE.
Avoid alcohol or other sedatives while taking AURO-PRAMIPEXOLE.
PROPER USE OF THIS MEDICATION
Usual Adult dose:
Parkinson’s disease
Take AURO-PRAMIPEXOLE 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 AURO-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. The maximal recommended dose of AURO-PRAMIPEXOLE 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 AURO-PRAMIPEXOLE without the recommendation of your doctor.
You may take AURO-PRAMIPEXOLE without food or 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, 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 AURO-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 dose when you are supposed to. Do not take more than one dose at a time.
AURO-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 AURO-PRAMIPEXOLE against the expected benefits.
If you do experience any unusual or unwanted effects while you are taking AURO-PRAMIPEXOLE, be sure to tell your doctor. It is important that he/she knows of any unwanted effects to determine the best dose of AURO-PRAMIPEXOLE for you.
- AURO-PRAMIPEXOLE 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) .
- AURO-PRAMIPEXOLE does not usually affect people’s normal activities. However, some people may feel dizzy or sleepy while taking AURO-PRAMIPEXOLE, especially during the first few weeks of treatment.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmac ist | ||
| Only if severe | In all cases | |||
| Common | Dyskinesia (Difficulty performing voluntary movements) | ✓ | ||
| Hallucinations (see, hear, smell, taste or feel some-thing that is not there) | ✓ | |||
| Insomnia (Difficulty falling asleep) | ✓ | |||
| Low blood pressure with dizziness when rising to a sitting or standing position. You may feel sick, light-headed, faint or you may sweat. | ✓ | |||
| Uncommon | Behavioral changes such as compulsive gambling, compulsive shopping, changes in sexual desire or sexual activity, increased eating | ✓ | ||
| Delusion (a false belief, despite incontrovertible evidence, that something is false) | ✓ | |||
| Paranoia (unrealistic and excessive anxiety and worry) | ✓ | |||
| Sudden onset of sleep | ✓ | |||
| Hypersensitivity (allergic reaction) with symptoms such as: red, itchy swellings on the skin, | ✓ | |||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmac ist |
|---|
| Only if severe | In all cases |
|---|---|
| swelling of the face, lips, mouth, tongue or throat, difficulty swallowing or breathing, rash or intense itching. | |
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 any unexpected effects while taking AURO-PRAMIPEXOLE, contact your doctor or pharmacist immediately, so that these effects may be properly addressed.
HOW TO STORE IT
Store at room temperature (15°C to 30°C).
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:
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
This document plus the full Product Monograph, prepared for health professionals can be found at: http:// www.auropharma.ca
or by contacting the sponsor, Auro Pharma Inc., at:
1-855-648-6681
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Preparation: April 23, 2014