Download Drug Information Sheet("Kusuri-no-Shiori") Internal Revised: 11

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 11/2016
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:Symmetrel Tablets 100mg
Active ingredient:Amantadine hydrochloride
Dosage form:white tablet, diameter: 8.1 mm, thickness: 3.5 mm
Print on wrapping:100mg, Symmetrel 100mg, CG212
Effects of this medicine
This medicine acts on neurotransmitter such as dopamine or serotonin in the brain, and improves decreased
willingness and spontaneity as sequelae of cerebral infarction. It also relieves the symptoms of Parkinson's syndrome
(tremor of limbs, etc.) by enhancing the activity of dopaminergic neurons in the brain. And it inhibits invading
process of type A influenza virus into human cell, and prevents viral multiplication.
It is usually used for improvement of decreased willingness and spontaneity resulting from sequelae of cerebral
infarction, and to treat Parkinson's syndrome and influenza A infection.
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: epilepsy or a history of it, convulsive predisposition, renal disorder.
If you are on 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))
・For treatment of sequelae of cerebral infarction: In general, for adults, take 100 to 150 mg of the active ingredient
a day in 2 to 3 divided doses. The dosage should be adjusted according to the age or symptoms. The preparation
contains 100mg of the active ingredient in a tablet.
For treatment of Parkinson's syndrome: In general, for adult, initially take 1 tablet (100 mg of the active ingredient)
at a time, once a day. One week later, as a maintenance dose, take 1 tablet (100 mg) at a time, twice a day (200 mg).
The dosage should be adjusted according to the age or symptoms. However, daily dose should not exceed 1 tablet
(100 mg) at a time, 3 times a day (300 mg).
For treatment of influenza A infection: In general, for adults, take 1 tablet (100 mg of the active ingredient) at a
time, once a day. The dosage should be adjusted according to the age or symptoms. However, in elderly or patients
with renal disorder, the daily dose should not exceed 1 tablet (100 mg).
In any case, strictly follow the instructions.
・If you miss a dose, take a dose as soon as possible. However, if it is near the next dose (8 hours or less if your
dosing schedule is once a day, 5 hours or less if your dosing schedule is twice a day), 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. Sudden withdrawal may cause
exacerbations of Parkinson's disease or high fever, etc.
Precautions while taking this medicine
・The medicine may cause dizziness, light-headedness, dizziness on standing up. Do not performe dangerous
operations such as driving a car, operating machinery or working at heights.
It has been reported that psychoneurotic symptoms including abnormal behavior occurred after taking the medicine,
although its relationship to the medicine is unknown. If a child or minor patient is treated at home, the guardians
should be careful not to leave them alone at least for 2 days.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include dizziness, light-headedness, dizziness on standing up,
sleeplessness, hallucination, excitement, headache, constipation, loss of appetite, nausea, dry mouth 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, disturbed consciousness, muscle stiffness [neuroleptic malignant syndrome]
・fever, rash/blister in skin, bloodshot eyes, erosion in lips/mouth [toxic epidermal necrosis, mucocutaneous ocular
1/2
syndrome]
・decreased vision, foreign body sensation in eyes, sensitive to light [diffuse superficial keratitis, corneal edema-like
symptoms]
・body swelling, breathlessness, easy breathing in upright position [heart failure]
・faint consciousness, to see or hear something that is not really there, convulsion [disturbed consciousness,
hallucination, convulsion]
・muscle pain or stiffness, lassitude, red-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 direct sunlight, heat and moisture.
・Discard the remainder. Do not store them.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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