くすりのしおり

Internal
Revised: 6/2021

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 100mg
 Active ingredient:
Clozapine
 Dosage form:
yellow tablet, diameter: 10.0 mm, thickness: 3.85 mm
 Print on wrapping:
クロザリル100mg, CLOZARIL 100mg, CLOZARIL 100

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 have: a history of discontinuation of the medicine according to the CPMS-defined hematological discontinuation criteria, agranulocytosis or neutropenia.
    If you have: 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 adverse reactions 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 12.5 mg of the active ingredient at a time, once a day. On the second day, take 25 mg at a time, once a day. On the third day and thereafter, increase daily dose by 25 mg, in principle, to reach 200 mg a day over 3 weeks. If your daily dose exceeds 50 mg, take it in 2 to 3 divided doses. As maintenance dose, take 200 to 400 mg a day in 2 to 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 100 mg per day. The daily dose should not exceed 6 tablets (600 mg). This preparation contains 100 mg of the active ingredient in a tablet. 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 took 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, dizziness, tremor (trembling of limbs), and weight gain. 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]
  • fatigue, palpitation, breathing difficulty [myocarditis, cardiomyopathy, pericarditis, pericardial effusions]
  • breathing difficulty, fever, chest pain [pleurisy]
  • dry mouth, excessive drinking, decreased consciousness [hyperglycemia, diabetic ketoacidosis, diabetic coma]
  • muscle stiffness, difficulty in swallowing, fever [neuroleptic malignant syndrome]
  • shortness of breath, chest pain, pain of limbs, edema [pulmonary embolism, deep vein thrombosis]
  • constipation [intestinal obstruction, paralytic ileus, intestinal ulcer, intestinal perforation]
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. Ask the pharmacy or medical institution how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.