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Manufacturer's name : Nippon Boehringer Ingelheim Co., Ltd. |
620000436 |
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Revised: 01/2010 |
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Brand name : |
BI・Sifrol Tablets 0.5mg [Dopaminergic Agents for Parkinson's Disease] |
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Active ingredient: |
Pramipexole hydrochloride hydrate |
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Dosage form: |
white tablet (major axis: 10.6mm, minor axis: 7.6mm, thickness: 2.7-2.9mm) |
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Printings on wrapping: |
(Face) BI・Sifrol 0.5mg, P8
(Back) ビ・シフロール0.5mg, company logo, Boehringer Ingelheim |
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Effects of this medicine
By stimulating dopamine D2 receptors in the brain, this medicine improves symptoms of Parkinson's disease (shaking of hands, muscle stiffness, slow movement and inability to maintain posture).
Usually, this medicine is used to treat Parkinson's disease. |
Before using this medicine, tell your doctor/pharmacist
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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.
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If you are already pregnant or are breastfeeding.
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If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.)
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Dosage regimen (proper use of this medicine)
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Your dosage regimen is:(order of your doctor)
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General dosage regimen: Usually for adults, start with 1/2 tablet (0.25mg of pramipexole hydrochloride hydrate) daily for the first week, and increase to one tablet (0.5mg) daily for the second week. Thereafter increase the daily dose by an increment of one tablet (0.5mg) at weekly intervals by checking your condition and your maintenance dose is determined [standard daily dose: 3-9 tablets (1.5-4.5mg)]. If the daily dose is less than three tablets (1.5mg), divide it into two doses and take each dose after breakfast and dinner. If the daily dose is 3 tablets (1.5mg) or more, divide it into three doses and take each dose after each meal. The dosage may be adjusted according to your age and the severity of symptoms, but the maximum daily dose should not exceed 9 tablets (4.5mg). Follow your doctor's instructions.
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Missed dose: 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.
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Overdose: If you took too much of this medicine (more than ordered), check with your doctor/pharmacist.
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Others: 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.
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Precautions while using this medicine
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Do not engage in driving a car, operating machinery, working at high places or engaging in other hazardous activities. This medicine may cause drowsiness or sudden onset of sleep without warning signs, etc.
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Avoid drinking alcohol since it may increase the effects of this medicine.
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Side effects of this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: dyskinesia (involuntary movements of mouth chewing and tongue thrusting and pulling), somnolence (clouding of consciousness and almost sleeping state), nausea, indigestion, hallucination, etc.In rare cases, symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop taking your medicine and check with your doctor immediately.
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sudden onset of sleep without warning signs[sudden onset of sleep]
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seeing things and hearing sounds that do not exist, baseless and subjective thought, mild disturbance of consciousness[hallucination, delusion, delirium]
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severe excitation, loud voice and irritation[agitation, confusion]
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fever, strong muscle stiffness, clouding of consciousness[syndrome malin]
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom. |
Storage and other information
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Keep out of the reach of children. Store away from heat, moisture and light.
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Discard unused medicine. Ask the pharmacy how to discard.
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For further information, ask your doctor/pharmacist. "Kanjamuke Iyakuhin Guide" and Japanese package insert information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices Agency. |
