くすりのしおり

Internal
Revised: 11/2018

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 :
PAROXETINE Tablets 10mg "KN"
 Active ingredient:
Paroxetine hydrochloride hydrate
 Dosage form:
reddish white round tablet, diameter: approx. 6.6 mm, thickness: approx. 3.5 mm
 Print on wrapping:
(face)パロキセチン10mg「KN」, パロキセチン, 10mg, KN373
(reverse side)PAROXETINE10mg「KN」, パロキセチン, 10mg

Effects of this medicine

This medicine enhances the effects of serotonin that regulates the action of neurotransmission in the brain and shows antidepressant and anxiolytic actions. This medicine improves symptoms including depressive mood, sudden intense anxiety, obsession and tension in front of others.
It is usually used to treat depression/depressive state, panic disorder, obsessive-compulsive disorder, social-anxiety disorder and post-traumatic stress 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 have: manic-depressive illness, suicidal ideation, predisposition to organic
    brain disorder or schizophrenia, highly impulsive complication, glaucoma, bleeding tendency or bleeding diathesis.
    If you have had: suicidal ideation, suicide attempt or epilepsy.
  • 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))
  • For depression/depressive state: In general, for adults, take 20 to 40 mg of paroxetine at a time, once a day after dinner. Start taking 10 to 20 mg at a time. As a rule, the dosage will be increased by 10 mg/day at weekly intervals but may be adjusted up to no more than 40 mg/day according to your symptoms.
    For panic disorder: In general, for adults, take 30 mg of paroxetine at a time, once a day after dinner. Start taking 10 mg at a time. As a rule, the dosage will be increased by 10 mg/day at weekly intervals but may be adjusted up to no more than 30 mg/day according to your symptoms.
    For obsessive-compulsive disorder: In general, for adults, take 40 mg of paroxetine at a time, once a day after dinner. Start taking 20 mg at a time. As a rule, the dosage will be increased by 10 mg/day at weekly intervals but may be adjusted up to no more than 50 mg/day according to your symptoms.
    For social-anxiety disorder: In general, for adults, take 20 mg of paroxetine at a time, once a day after dinner. Start taking 10 mg at a time. As a rule, the dosage will be increased by 10 mg/day at weekly intervals but may be adjusted up to no more than 40 mg/day according to your symptoms.
    For post-traumatic stress disorder: In general, for adults, take 20 mg of paroxetine at a time, once a day after dinner. Start taking 10 to 20 mg at a time. As a rule, the dosage will be increased by 10 mg/day at weekly intervals but may be adjusted up to no more than 40 mg/day according to your symptoms.
    This preparation contains 10 mg of paroxetine in a tablet. Strictly follow the instructions in any case.
  • It usually takes around 2 weeks to show the therapeutic effects of this medicine. You should continue to
    take this medicine even after it shows the effects.
  • If you miss a dose, 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. Abrupt withdrawal or dose reduction may cause intolerant symptoms such as dizziness, nausea and sweating. Never stop taking this medicine without instructions.

Precautions while taking this medicine

  • This medicine may cause sleepiness, dizziness, etc. Pay close attention when operating dangerous machinery, such as driving a car.
  • Avoid drinking alcohol while taking this medicine, since it may intensify medicinal or medical effects.
  • Pay attention when taking any food containing St. John's wort (a kind of herb), since it may intensify medicinal effects.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, sleepiness, dizziness, constipation 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, shivering in hands [serotonin syndrome]
  • acute onset of fever, muscle stiffness, consciousness disorder [neuroleptic malignant syndrome]
  • impaired mind, seeing thing or hearing sound that does not really exist, convulsive muscle contraction  [confusion, hallucination, delirium, convulsion]
  • convulsion, decreased consciousness, headache [syndrome of inappropriate antidiuretic hormone secretion]
  • general malaise, yellowing of the white of eyes, loss of appetite [serious liver dysfunction]
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.

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