Download Drug Information Sheet("Kusuri-no-Shiori") Internal Revised: 09

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 09/2016
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:CLOZARIL Tablets 25mg
Active ingredient:Clozapine
Dosage form:yellow tablet, φ: 6.3 mm, thickness: 2.35 mm
Print on wrapping:クロザリル 25mg, CLOZARIL 25mg, CLOZARIL 25
Effects of this medicine
This medicine acts on dopaminergic receptor in the brain, and regulates the balance of the central nervous system. It
consequently relieves symptoms such as nervousness or irritation, and stabilizes the mood to improve state of losing
energy or apathy.
It is usually used to treat schizophrenia which is resistant to previous treatment.
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 are not compliant with the requirement of Clozaril Patient Monitoring Service (CPMS*).
If you are a patient with a history of discontinuation of the medicine according to the CPMS-defined hematological
discontinuation criteria, agranulocytosis or neutropenia.
If you are a patient with bone marrow disorder, convulsive disease, epilepsy, acute intoxication of alcohol or drugs,
cardiac/renal/hepatic disorder, paralytic ileus, diabetes mellitus or its history.
If you are undergoing radiation therapy.
*CPMS: a protocol that aims early detection of side effects such as agranulocytosis of the medicine by regular blood
tests.
・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,on the first day, take a half tablet (12.5 mg of the active ingredient) at a time, once a day. On
the second day, take 1 tablet (25 mg) at a time, once a day. On the third day and thereafter, increase daily dose by
1 tablet (25 mg), in principle, to reach 8 tablets (200 mg) a day over 3 weeks. If your daily dose exceeds 2 tablets
(50 mg), take it in 2-3 divided doses. As maintenance dose, take 8 to 16 tablets (200-400 mg) a day in 2-3 divided
doses. The dosage can be adjusted according to the symptoms, however, at least 4 days should be kept apart
between dose increases at increment not exceeding 4 tablets (100 mg) per day. The daily dose should not exceed
24 tablets (600 mg). Strictly follow the instructions.
・If you miss a dose, take a dose as soon as possible when you remembered that you missed a dose. 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
・Be careful in regard to your diet, since the medicine may cause weight gain.
・The medicine may cause drowsiness or decreased attentiveness/mental concentration/reflex movement. Avoid
operating dangerous machinery such as driving a car.
・Note that alcohol may intensify the action of the medicine, and cause marked sedation or drowsiness.
・Note that smoking may weaken the action of the medicine, and that the action may be intensified by discontinuation
of smoking while taking the medicine.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include somnolence (drowsiness), nausea/vomiting, salivary
hypersecretion, constipation, tachycardia, tremor (trembling of limbs), and weight gain, 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.
・fever, sore throat [agranulocytosis, leukopenia, neutropenia]
・lassitude, palpitation, breathing difficulty [myocarditis, cardiomyopathy, pericarditis, pericardial effusions]
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・dry mouth, excess intake of fluid, decreased consciousness [hyperglycemia, diabetic ketoacidosis, diabetic coma]
・muscle stiffness, difficulty in swallowing, fever [neuroleptic malignant syndrome]
・convulsion, decreased consciousness, muscle stiffness [epileptic seizure, convulsion, myoclonic seizure]
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 the reach of children. Store away from direct sunlight, heat and moisture.
・Discard the remainder. Do not store them. Ask the pharmacy how to discard.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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