くすりのしおり

Internal
Published: 11/2019

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 :
Trintellix Tablets 10mg
 Active ingredient:
Vortioxetine hydrobromide
 Dosage form:
faint yellow tablet, diameter: approx. 7.6 mm, thickness: approx. 3.3 mm
 Print on wrapping:
(Face)トリンテリックス錠10mg 114, (Back)10mg トリンテリックス

Effects of this medicine

This medicine inhibits the reuptake of serotonin and modulates serotonin receptors, thereby makes intracerebral neurotransmission smooth and improves symptoms such as depressed mood.
It is usually used for the treatment of depression and depressive states.

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: a history of suicidal thought or suicide attempt, predisposition of bipolar disorder, organic brain disorder or schizophrenia, a highly impulsive comorbid disorder, convulsive disorders such as epilepsy or its history, bleeding tendency or predisposition, glaucoma or ocular hypertension.
  • 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 (10 mg of vortioxetine) at a time, once a day. The dosage may be adjusted according to the symptoms, but should not exceed 2 tablets (20 mg) a day. If the dosage needs to be increased, it will be increased with an interval of at least 1 week. Strictly follow the instructions.
  • If you miss a dose, take a 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. Sudden discontinuation of this medicine may cause symptoms such as anxiety, restlessness, excitement, dizziness, paraesthesias, headache and nausea.

Precautions while taking this medicine

  • This medicine may cause sleepiness, dizziness, etc. Pay close attention when operating dangerous machinery, such as driving a car. If you become aware of these symptoms, avoid operating dangerous machinery, such as driving a car.
  • Refrain from drinking alcohol or taking any food containing St. John's wort (a kind of herb) with the medicine, because the effect of the medicine may be affected.
  • The following symptoms may appear: anxiety, feeling irritated, easily excited, sudden panic attack, insomnia, change in mental or physical condition due to slight irritation, aggression, impulsive behavior, restlessness, etc. This medicine may cause deterioration of underlying diseases, suicidal thought, suicide attempt and harming others, although these causal relationships are unknown. If any of these signs occur, consult with your doctor.
  • At the beginning of a course of treatment or at the time of dose changes, if exacerbation of symptoms occurs, consult with your doctor.
  • If you notice any change in symptoms of the disease, inform your family members.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, sleepiness 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, excitement, sweating, fever, shivering of hands [serotonin syndrome]
  • convulsive muscle contraction, decreased consciousness [convulsion]
  • convulsion, consciousness disorder, general malaise, frequent urination, thirst [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 reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Consult with your pharmacy or medical institution how to discard them.
  • [To family members] Family members of the patient should receive a sufficient explanation from the doctor about possible behavioral changes of the patient and observe the patient's condition. If family members notice any change in patient's condition, contact the doctor.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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