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The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
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Brand name :
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Mirapex-LA Tablets 0.375mg
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Active ingredient:
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Pramipexole hydrochloride hydrate
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Dosage form:
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White Tablet (9.0mm in diameter, 4.1mm in thickness, 0.25g in weight)
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Print on wrapping:
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(Face） Mirapex-LA 0.375mg, P1, (back) ミラペックスLA 0.375mg,社マーク, 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.
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Before using this medicine, be sure to tell your doctor and pharmacist
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If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have problems in kidney requiring dialysis.
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If you are pregnant, possibly pregnant or breastfeeding.
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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.)
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Dosing schedule (How to take this medicine)
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Your dosing schedule prescribed by your doctor is << to be written by a healthcare professional>>
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In general, for adults, start with 1 tablet (0.375mg of pramipexole hydrochloride hydrate) after the meal once daily for the first week, and increase to 2 tablets (0.75mg) daily for the second week. Thereafter increase the daily dose by an increment of 2 tablets (0.75mg) at weekly intervals by checking your condition and your maintenance dose is determined [standard daily dose: 4-12 tablets (1.5-4.5mg)]. The dosage may be adjusted according to your age and the severity of symptoms, but the maximum daily dose should not exceed 12 tablets (4.5mg). Strictly follow the instructions.
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This medicine is to be swallowed whole, not chewed since the side effects are possibly developed to be taken by breaking or crunching of the tablets.
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If you miss a dose, take a dose as soon as you remember. You should never take two doses at one time.
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If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
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Do not stop taking this medicine unless your doctor instructs you to do so. It may cause side effects when you rapidly decrease the dosage amount or when you stop taking the medicine.
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Precautions while taking 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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Possible adverse effects of this medicine
The most commonly reported adverse reactions include somnolence (clouding of consciousness and almost sleeping state), nausea, dizziness, constipation and dry mouth. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse effects indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
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sudden onset of sleep without warning signs [sudden onset of sleep]
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seeing or hearing something that is not really there, baseless and subjective thought, having trouble thinking clearly[hallucination, delusion, delirium, confusion, agitation]
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convulsion, disturbance of consciousness[syndrome of inappropriate secretion of antidiuretic hormone (SIADH)]
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fever, strong muscle stiffness, clouding of consciousness[syndrome malin]
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lassitude, muscle pain, brown urine[rhabdomyolysis]
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
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Keep out of the reach of children. Store away from heat and moisture.
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Discard unused medicine. Ask the pharmacy or medical institutions how to discard.
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