くすりのしおり

Internal
Revised: 12/2012

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 previously experienced any allergic reactions (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 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 (0.125mg 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 miss a dose, take a dose as soon as you remember. Take the remaining dose for that day at an equal interval. 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 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

The most commonly reported adverse reactions include feeling of sickness (upset stomach or nausea), somnolence (clouding of consciousness and almost sleeping state), headache and 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. 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, agitation, confusion]
  • 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, moisture and light.
  • 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.