くすりのしおり

Internal
Published: 12/2016

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 :
PRAMIPEXOLE HYDROCHLORIDE LA Tablets 0.375mgMI"DSEP"
 Active ingredient:
Pramipexole hydrochloride hydrate
 Dosage form:
white tablet, diameter: 9.1mm, thickness: 4.4mm
 Print on wrapping:
(Face)プラミペキソール塩酸塩錠0.375mg「DSEP」, 第一三共エスファ, プラミペキソールLA, 0.375mgMI, 1日1回服用, プラミペキソールLA (back) PRAMIPEXOLE HYDROCHLORIDELA0.375mgMI「DSEP」, プラミペキソール塩酸塩, LA錠, 0.375mgMI「DSEP」, 1日1回服用, 吸湿に注意

Effects of this medicine

This medicine stimulates the dopamine D2 receptor of the brain and improves symptoms (shaking of hands, muscle stiffness, slow movement and inability to maintain posture) of Parkinson's disease.
It is usually used to treat Parkinson's disease.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
    If you have problems in kidney requiring dialysis.
  • If you are pregnant, possibly pregnant or 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))
  • In general, for adults, start with 1 tablet (0.375 mg of active ingredient)...increase to 2 tablets (0.75 mg) daily for the second week. Thereafter increase the daily dose by an increment of 2 tablets (0.75 mg)...maintenance dose is determined [standard daily dose: 4 to 12 tablets (1.5 to 4.5mg)]. The dosage may be adjusted according to your age and symptoms, but the maximum daily dose should not exceed 12 tablets (4.5 mg). Strictly follow the instructions.
  • If you take this medicine as broken or crushed tablet, the adverse reactions may occur. Shallow the tablet without chewing.
  • If you miss a dose, take a dose as soon as you remember. You should never take two doses at one time.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop taking this medicine unless your doctor instructs you to do so. Especially, if you suddenly reduce the dose or stop taking this medicine, it may cause adverse reactions.

Precautions while taking this medicine

  • Do not engage in hazardous activities such as driving a car, operating machinery or working at high places, since this medicine may cause drowsiness or sudden onset of sleep without warning signs.
  • Avoid drinking alcohol since it may increase the effects of this medicine.

Possible adverse reactions to 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 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 or hearing something that is not really there, baseless and subjective thought, having trouble thinking clearly [hallucination, delusion, delirium, confusion, agitation]
  • convulsion, disturbance of consciousness [syndrome of inappropriate secretion of antidiuretic hormone (SIADH)]
  • fever, strong muscle stiffness, clouding of consciousness [syndrome malin]
  • 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.

Storage conditions and other information

  • Keep out of the reach of children. Store away from heat and moisture.
  • Discard unused medicine. Ask the pharmacy or medical institutions how to discard.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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