くすりのしおり

Internal
Revised: 4/2017

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 :
Fluvoxamine maleate Tablets 50mg"TAKATA"
 Active ingredient:
Fluvoxamine maleate
 Dosage form:
yellow tablet, diameter: approx. 6.1mm,thickness: approx.3.1mm
 Print on wrapping:
(face)フルボキサミン50mg「タカタ」,TTS-157,フルボキサミン,50mg
(Back)FLUVOXAMINE50mg「TAKATA」,フルボキサミンマレイン酸塩50mg「タカタ」,50mg

Effects of this medicine

This medicine improves symptoms such as depressed feelings, obsessions, excessive anxiety and tension in public by inhibiting reuptake of serotonin, one of the neurotransmitters in the brain.
It is usually used to treat depression/depressive states, obsessive-compulsive disorder, and social anxiety disorder.

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 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 50 mg as active ingredient per day as an initial dose, which may be increased to up to 150 mg per day, taken in two divided doses. The dose may be adjusted depending on age or symptoms.
    This medicine contains 50 mg of the active ingredient per tablet. Strictly follow the instructions.
  • Take this medicine with sufficient water without chewing. When chewed, it tastes bitter and may cause tongue numbness.
  • If you miss a dose, take a dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose. 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 the medicine unless your doctor instructs you to do so. Stopping and reducing the medicine abruptly can cause headache, nausea, dizziness, anxiety, insomnia or decreased attention.

Precautions while taking this medicine

  • This medicine may cause disturbed consciousness such as sleepiness, decreased level of consciousness or loss of consciousness. Do not operate dangerous machinery with potential risk such as driving a car.
  • Refrain from drinking alcohol as it may enhance the effects of the medicine.
  • Pay attention that any foods containing Hypericum perforatum (St. Johns wort) concomitantly with the medicine, as it may lead to enhanced the action of medicine and may cause adverse reactions.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include sleepiness, nausea, dry mouth, constipation, dizziness, light headedness, dizziness on standing up and malaise. If any of these symptoms occurs, 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.
  • seizure, mild disturbed consciousness, to see things that are not really there [convulsion, delirium, confusion, hallucination, delusion]
  • fainting, loss of consciousness [disturbed consciousness]
  • pale face, cold sweat, respiratory distress [shock, anaphylaxis]
  • confusion, fever, sweating [serotonin syndrome]
  • acute fever, muscle stiffness, difficulty swallowing [malignant syndrome]
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.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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