Download Drug Information Sheet("Kusuri-no-Shiori") Internal Revised: 01

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Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 01/2016
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:PERGOLIN Gran. 0.025%
Active ingredient:Pergolide mesilate
Dosage form:pale yellow granule
Print on wrapping:(0.2g packet)ペルゴリン顆粒 0.025%,0.2g,(メシル酸ペルゴリド
0.025%顆粒),(1.0g packet)ペルゴリン顆粒 0.025%,1.0g,(メシル酸ペ
ルゴリド 0.025%顆粒)
Effects of this medicine
This medicine stimulates receptors for dopamine, neurtransmitter in the brain, to improve symptoms of Parkinson's
disease such as numbness of limbs, muscle stiffness, bradykinesia and gait disorder.
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 been diagnosed to have cardiac valve disease by echocardiography or a history of it.
・If you are 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, this medicine is combined with levodopa preparation. Take 0.2 g (50 μg of the active
ingredient) at a time immediately after dinner for 2 days. Then, the dose will be increased by 0.2 g (50 μg) a day
every 2 to 3 days, becoming 0.6 g (150 μg) a day at the end of the first week of administration. In the second
week, the dose will be started with 1.2 g (300 μg) a day and increased by 0.6g (150 μg) a day every 2 to 3 days.
At the end of the second week, the dose will be 2.4 g (600 μg) a day. If the daily dose is 0.4 g (100 μg), take it
immediately after breakfast and dinner. If the daily dose is 0.6 g (150 μg) or over, take it immediately after each
meals. In the third week, the dose will be started with 3 g (750 μg) a day, increased under efficacy and safety, and
a maintenance dose will be decided [standard daily dose 3 to 5 g (750 to 1,250 μg)]. The speed of increasing the
dosage is adjusted according to associated sypmtoms and age. Strictly follow the instructions.
・If you miss a dose, take a dose as soon as you remember. However, if it is almost time for the next dose, skip the
missed dose and follow 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 sleep without warning or somnolence (close to sleep). Avoid operating in
potentially hazardous activities such as driving a car and working at heights.
・Uncontrollable urges to gamble or pathologycal increase of sexual desire are reported. Consult with your doctor or
pharmacist if you have such sypmtoms.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include rash, erythema, dyskinesia (continuous involuntary
movement of mouth), dizziness/light headedness, headache/dull headache, anemia and edema. 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.
・high fever, consciousness disorder, muscle stiffness [malignant syndrome]
・fever, cough, respiratory distress [interstitial pneumonia]
・chest pain, fever, respiratory distress [pleurisy, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis,
pericardial exudate]
・palpitation, shortness of breath, leg edema [valvular heart disease]
・back pain, leg edema, decreased urine output [retroperitoneal fibrosis]
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
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・Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
・Discard the remainder. Do not store them. Ask the pharmacist or medical facility how to discard unneeded
medicines.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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