くすりのしおり

Internal
Revised: 4/2016

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 :
REFLEX TABLETS 15mg
 Active ingredient:
Mirtazapine
 Dosage form:
yellow tablet, major axis: 10 mm, minor axis: 6 mm, thickness: 3.5 mm
 Print on wrapping:
(Face) リフレックス15mg,meiji,M28 (Back) REFLEX 15mg,リフレックス15mg

Effects of this medicine

This medicine eases mental mood and improves symptoms such as anxiety, jitteriness and insomnia by enhancing neurotransmission of noradrenaline and serotonin in the brain.
It is usually used in the treatment of 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) at a time, once a day, before going to bed. The dosage may be adjusted in the dose range within 3 tablets (45 mg) daily according to the age or symptoms, however, if the dosage needs to be increased, the daily dose will be increased by 1 tablet (15 mg) at an interval of more than a week. Strictly follow the instructions.
  • If you miss a dose and notice that within a day, take the missed dose as soon as possible. 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 sleepiness/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.).
  • Patients may develop change in behavior such as suicidal ideation and aggression or deterioration of underlying diseases. Family members should be in close contact with the doctor closely.

Possible adverse reactions to this medicine

The most commonly reported reactions include somnolence, dry mouth, malaise, constipation, body weight increase, dizziness and headache. 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, feeling irritated, fever  [serotonin syndrome]
  • fever, sore throat, muscle pain  [agranulocytosis, neutropenia]
  • convulsion  [convulsion]
  • general malaise, loss of appetite, yellowing of the skin and the white of eyes  [liver dysfunction, jaundice]
  • convulsion, consciousness disorder, headache  [syndrome of inappropriate antidiuretic hormone secretion]
  • fever, general malaise, erythema with dropsical swelling in the center (red rash) [muco-cutaneo-ocular syndrome, erythema multiform]
  • chest pain, chest discomfort, palpitation [prolonged QT, ventricular tachycardia]
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 reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Seek advice of your pharmacy or medical institution about proper disposal of the unused medicines.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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