くすりのしおり

Internal
Published: 12/2018

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 :
MIRTAZAPINE Tablets 15 mg "KYOSOMIRAI"
 Active ingredient:
Mirtazapine
 Dosage form:
yellow tablet, major axis: approx. 10.1 mm, minor axis: approx. 6.1 mm, thickness: approx. 3.5 mm
 Print on wrapping:
(Face)ミルタザピン錠15 mg「共創未来」, ミルタザピン, 15 mg
(Back)MIRTAZAPINE 15 mg「KYOSOMIRAI」, ミルタザピン「共創未来」, 15 mg

Effects of this medicine

This medicine eases mental mood and improves symptoms such as anxiety, irritation and insomnia by enhancing neurotransmission of noradrenaline and serotonin in the brain.
It is usually used to treat depression and depressive state.

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 medicine.
    If you have: liver dysfunction, renal dysfunction, suicidal ideation, manic depression, organic brain disorder, comorbid disorder with high impulsivity, cardiac disease (myocardial infarction, angina, conduction disorder, etc.), hypotension, glaucoma, elevated intraocular pressure or dysuria.
    If you have a history of suicidal ideation or suicide attempt.
    If you are predisposed to schizophrenia.
    If you have convulsive diseases such as epilepsy or have a history of these diseases.
  • 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, take 1 tablet (15 mg of the active ingredient) at a time, once a day, as the initial dose, then take 1 to 2 tablets (15 to 30 mg) before bedtime. The dose may be adjusted according to your age and symptoms, but it does not exceed 3 tablets (45 mg) a day. The dose will be increased by 1 tablet (15 mg) as a daily dose at intervals of 1 week or more. Strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as possible. 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

  • This medicine may cause sleepiness or dizziness. Avoid operating dangerous machinery, such as driving a car.
  • Alcohol may intensify the sedative effects of this medicine. Avoid drinking alcohol as much as possible.
  • Please note that foods containing St. John's wort (a kind of herb) may interact with this medicine to cause serotonin syndrome (anxiety, excitement, etc.).

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include somnolence, dry mouth, malaise, constipation, body weight increase and dizziness. 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.
  • anxiety, excitation, sweat [serotonin syndrome]
  • sore throat, headache, high fever [agranulocytosis, neutropenia]
  • muscle spasmodically contracting [convulsion]
  • general malaise, loss of appetite, yellowness in skin or in conjunctiva [liver dysfunction, jaundice]
  • convulsion, consciousness disorder, general malaise [syndrome of inappropriate antidiuretic hormone secretion]
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 your pharmacy or medical institution on how to discard the remainder.
  • [To family members] Patients may develop change in behavior such as suicidal ideation / aggression or deterioration of underlying diseases. Family members should be in close contact with the doctor.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.