|Active Ingredient: Pramipexole dihydrochloride|
|Manufacturer: Boehringer Ingelheim Pharmaceuticals|
MIRAPEX is a prescription medicine used in the treatment of moderate to severe primary restless legs syndrome (RLS).
Important facts about MIRAPEX
Aside from restless legs syndrome, MIRAPEX can also be used in the treatment of Parkinson’s disease. However, having one condition does not mean you have or will develop the other
Patients using MIRAPEX for RLS are likely to use a lower dose of MIRAPEX than patients being treated for Parkinson’s disease
The most frequently observed side effects of MIRAPEX in RLS are nausea, headache, and tiredness. These side effects are generally mild and do not last very long
Until you know how MIRAPEX will affect you, you should be careful when driving a car, operating heavy machinery, or doing similar activities since MIRAPEX can cause excessive daytime sleepiness
Some patients taking MIRAPEX have reported having hallucinations (seeing, hearing, feeling, smelling, or tasting something that does not actually exist)
Usually your doctor will start you out with a low dose of MIRAPEX to be taken 2 to 3 hours before bedtime. Your doctor may adjust your dose of MIRAPEX to better control your RLS symptoms
How MIRAPEX should be taken
Always take MIRAPEX as prescribed by your doctor
MIRAPEX can be taken on an empty stomach or with food
If you miss a dose of MIRAPEX, do not take twice as much at your next dose
Patients who are allergic to pramipexole or any of the inactive ingredients should not take MIRAPEX
MIRAPEX is contraindicated in people who have an allergy to the active or inactive ingredients of MIRAPEX. Your doctor or pharmacist should have a list of the active and inactive ingredients.
Also, before you take MIRAPEX, be sure to tell your doctor:
If you have any problems with low blood pressure, dizziness, or becoming light-headed
If you are pregnant, breastfeeding, or are planning to become pregnant
If you drink alcohol or smoke cigarettes
If you are suffering from a sleeping disorder or kidney disease
Generally, people who take MIRAPEX tolerate it well. The most commonly reported adverse events in RLS clinical trials for MIRAPEX versus placebo were:
Nausea (16% vs 5%)
Headache (16% vs 15%)
Fatigue (9% vs 7%)
Somnolence (6% vs 3%)
When beginning to take MIRAPEX, you should be cautious until you know how the drug will affect you. Some people who take MIRAPEX can become sleepy or fall asleep while doing normal everyday activities like driving a car. It is possible that MIRAPEX treatment can cause someone to feel faint or become dizzy when standing up from a seated or prone position. There are reports of some people having hallucinations (seeing, hearing, feeling, smelling, or tasting something that does not actually exist) while taking MIRAPEX. However, hallucinations are uncommon in people taking MIRAPEX for primary restless legs syndrome and occur more frequently in people over 65 taking MIRAPEX for Parkinson’s disease.
There have been reports of patients taking certain medications to treat Parkinson's disease or RLS, including MIRAPEX, that have reported problems with gambling, compulsive eating, and increased sex drive. It is not possible to reliably estimate how often these behaviors occur to determine which factors may contribute to them. If you or your family members notice that you are developing unusual behaviors, talk to your doctor.
Please note that this is not a complete list of possible side effects. Your doctor or pharmacist can give you further information. Likewise, it is important to talk to your doctor if you experience any of these problems.
The efficacy (effectiveness) of MIRAPEX in the treatment of moderate to severe primary restless legs syndrome was proven in 4 clinical trials. Clinical trials are research studies done to test the safety and efficacy of a particular drug before that drug is approved for use. Individual results may vary.
In those trials:
MIRAPEX showed a significant improvement in the severity of their symptoms compared to patients given a placebo (pill with no active ingredients)
MIRAPEX showed symptom improvements sustained up to 9 months
Dosing and Administration
Before starting MIRAPEX, tell your doctor if:
You take other medicines (prescription or over-the-counter)
You drink alcohol. Drinking may increase your chances of becoming drowsy while taking MIRAPEX
You are pregnant, breastfeeding, or plan to become pregnant
You suffer from a sleep disorder other than restless legs syndrome (RLS)
You suffer from kidney disease
You are allergic to the active ingredient pramipexole, or to any of the inactive ingredients in MIRAPEX (ask your doctor or pharmacist for a list)
When taking MIRAPEX tell your doctor if:
You become unexpectedly sleepy
You feel dizzy, nauseated, sweaty or faint – especially when you stand up after sitting or lying down
Some key points about taking MIRAPEX:
Take MIRAPEX as your doctor directs. It is often recommended that MIRAPEX be taken once a day, 2 or 3 hours before bedtime
Take MIRAPEX every day – even if you do not feel RLS symptoms every day
MIRAPEX may be taken with or without food
If you miss a dose, DO NOT double your next dose. Take only your usual dose, as you doctor directs
Make it easy to remember. Find ways to make taking MIRAPEX part of your evening routine
We sell Pexola™ which is identical to Mirapex™ and is produced by the same drug manufacturer Boehringer Ingelheim Pharmaceuticals. The medicine is marketed under the name Pexola in some European countries and under the name Mirapex in the US. Pexola and Mirapex are the same and are not generics.
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Information presented is not medically approved, may be inaccurate and is unreliable. It can not and must not serve as any basis of decision making regarding any health concern or issue.