Drug Information Sheet("Kusuri-no-Shiori")
Internal
Published: 01/2010
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is
important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response,
patients should understand their medication and cooperate with the treatment.
Brand name:BI・Sifrol Tablets 0.125mg [Medication for Restless Legs
Syndrome]
Active ingredient:Pramipexole hydrochloride hydrate
Dosage form:white tablet (length: 6.0mm, thickness: 2.3-2.5mm)
Print on wrapping:(Face) BI・Sifrol 0.125mg, P6
(Back) ビ・シフロール 0.125mg, company logo, Boehringer Ingelheim
Effects of this medicine
By stimulating dopamine D2 receptors in the brain, this medicine improves symptoms of idiopathic restless legs
syndrome (a condition in which your legs, or sometimes your arms, feel extremely uncomfortable while you're sitting
or lying down, and feel an irresistible urge to move or jerk the legs).
Usually, this medicine is used to treat idiopathic restless legs syndrome.
Before using this medicine, be sure to tell your doctor and pharmacist
・If you have ever had any unusual or allergic reaction (itch, rash etc.) to any medicines.
If you have heart disease, kidney disease or a history of such problems.
If you have hypotension.
・If you are already pregnant or are breastfeeding.
・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal
effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
・Your dosing schedule prescribed by your doctor is<<
to be written by a healthcare professional>>
・General dosage regimen: Usually for adults, start with 1 tablet (0.125mg of pramipexole hydrochloride hydrate) two
to three hours before bedtime. Increase the daily dose by an increment of 1 tablet (0.125mg) at weekly intervals by
checking your condition and your maintenance dose is determined. The maximum daily dose should not exceed 6
tablets (0.75mg).
・If you are ordered to use this medicine on regular schedule and you missed a dose, apply as soon as possible. Take
the remaining dose for that day at an equal interval. DO NOT take a double dose to make up for the missed dose.
・If you took too much of this medicine (more than ordered), check with your doctor/pharmacist.
・Do not stop your medication without the instructions of your doctor. Especially, if you suddenly reduce the dose or
stop the medication, side effects may occur.
Precautions while taking this medicine
・Do not engage in driving a car, operating machinery, working at high places or other hazardous activities. This
medicine may cause drowsiness or sudden onset of sleep without warning signs, etc.
・Avoid drinking alcohol since it may increase the effects of this medicine.
Possible adverse reactions to this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: feeling of
sickness (upset stomach or nausea), somnolence (clouding of consciousness and almost sleeping state), headache,
stomach discomfort. Also onset of the symptom of restless legs syndrome at night more than two hours earlier than
usual, a progressive worsening of symptoms, or expanding the symptoms to other limbs, etc.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated
in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor
immediately.
・sudden onset of sleep without warning signs [sudden onset of sleep]
・seeing things and hearing sounds that do not exist, baseless and subjective thought, mild disturbance of
consciousness [hallucination, delusion, delirium]
・severe excitation, loud voice and irritation [agitation, confusion]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your
doctor or pharmacist if you notice any symptoms of concern other than those listed above.
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Storage conditions and other information
・Keep out of the reach of children. Store away from heat, moisture and light.
・Discard unused medicine. Ask the pharmacy how to discard.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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