くすりのしおり

Internal
Published: 3/2019

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 Tablets 0.5 mg "FFP" [Medication for Restless Legs Syndrome]
 Active ingredient:
Pramipexole hydrochloride hydrate
 Dosage form:
white tablet, diameter: approx. 7.0 mm, thickness: approx. 3.1 mm
 Print on wrapping:
(Face)プラミペキソール塩酸塩 0.5 mg「FFP」, プラミペキソール, 0.5 mg, 0.5 mg「FFP」
(Back)Pramipexole Hydrochloride 0.5 mg「FFP」, プラミペキソール塩酸塩, 0.5 mg

Effects of this medicine

This medicine exhibits antiparkinsonian action by stimulating dopamine D2 receptors in the brain, and 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).
It is usually used to treat idiopathic restless legs syndrome.

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: renal disorder, heart disease or its history, or hypotension.
  • 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 0.125 mg of the active ingredient two to three hours before bedtime. Thereafter the daily dose is increased by an increment of 0.125 mg at weekly intervals by checking your condition. The dosage may be adjusted according to your symptoms, however, the maximum daily dose should not exceed 0.75 mg. This preparation contains 0.5 mg of the active ingredient in a tablet. Strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. 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.

Precautions while taking this medicine

  • This medicine may cause sudden onset of sleep without warning signs. Do not work at heights or operate dangerous machinery such as driving car.
  • Alcohol may intensify the therapeutic effects of the medicine.Avoid drinking as far as possible.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, somnolence, hradache, gastric distress and dizziness. 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]
  • unfounded subjective assumption, mild consciousness disorder, hallucination [hallucination, delusion, delirium, agitation, confusion]
  • convulsion, consciousness disorder, general malaise [syndrome of inappropriate antidiuretic hormone secretion]
  • sudden fever, muscle stiffness, shivering of limbs [malignant syndrome]
  • muscle pain of limbs, lassitude, reddish 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 light, heat and moisture.
  • Discard the remainder. Do not store them. Ask your pharmacy or medical institution on how to discard the remainder.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.