くすりのしおり

Internal
Revised: 8/2014

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 "DSEP"
 Active ingredient:
Paroxetine hydrochloride hydrate
 Dosage form:
pale reddish white tablet, diameter 6.5 mm, thick 3.6 mm
 Print on wrapping:
(front) パロキセチン10mg「DSEP」, 第一三共エスファ, パロキセチン, 10mg, (back) PAROXETINE 10mg「DSEP」, 10, パロキセチン10mg「DSEP」

Effects of this medicine

This medicine acts on the neurotransmitters (serotonin) in the brain and shows antidepressant and anxiolytic actions. It consequently improves symptoms such as depressive mood, anxiety, irritability, loss of motivation, loss of appetite, insomnia, acute anxious and obsessive idea.
It is usually used in the treatment of 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, a history of suicidal ideation or suicide attempt, predisposition to organic brain disorder or schizophrenia, comorbid disorder with high impulsivity, a history of epilepsy, glaucoma, a tendency to bleed or predisposition to bleeding.
  • 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))
  • Depression/depressive state: In general, for adults, take 20 to 40 mg of paroxetine at a time, once daily after dinner. Initially take 10 to 20 mg of paroxetine at a time, the dose will be increased 10 mg/day at one week intervals. It should be adjusted according to symptoms in the dose range of 40 mg of paroxetine daily.
    Panic disorder: In general, for adults, take 30 mg of paroxetine at a time, once daily after dinner. Initially take 10 mg of paroxetine at a time, the dose will be increased 10 mg/day at one week intervals. It should be adjusted according to symptoms in the dose range of 30 mg of paroxetine daily.
    Obsessive-compulsive disorder: In general, for adults, take 40 mg of paroxetine at a time, once daily after dinner. Initially take 20 mg of paroxetine at a time, the dose will be increased 10 mg/day at one week intervals. It should be adjusted according to symptoms in the dose range of 50 mg of paroxetine daily.
    Social-anxiety disorder: In general, for adults, take 20 mg of paroxetine at a time, once a day after dinner. Initially take 10 mg at a time, the dose will be increased 10 mg/day at one week intervals. It should be adjusted according to symptoms in the dose range of 40 mg daily.
    Post-traumatic stress disorder: In general, for adults, take 20 mg of paroxetine at a time, once a day after dinner. Initially take 10 to 20 mg at a time, the dose will be increased 10 mg/day at one week intervals. It should be adjusted according to symptoms in the dose range of 40 mg daily.
    This preparation contains 10 mg of paroxetine in a tablet. Strictly follow the instructions in any case.
  • It usually takes about 2 weeks for this medicine to show its therapeutic effects. You should continue to take after it shows effects.
  • If you miss a dose, take a dose as soon as you remember. 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. Never discontinue suddenly or reduce dose of taking this medicine, since it may cause intolerable symptoms including dizziness, nausea or sweating.

Precautions while taking this medicine

  • This medicine may cause sleepiness and dizziness. Take care in driving a car or operating dangerous machinery.
  • Alcohol may intensify the therapeutic effects of this medicine. Avoid drinking alcohol while taking this medicine.
  • Take care in taking food that contains hypericum perforatum (St. John's wort) since it may intensify the therapeutic effects of this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, constipation, loss of appetite, dry mouth, sleepiness, 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, excitation, tremor in limbs [serotonin syndrome]
  • muscle stiffness, sweating, sudden onset of fever [malignant syndrome]
  • thinking disturbance, seeing things that is not existing, decreased consciousness [confusion, hallucination, delirium, convulsion]
  • general malaise, decreased consciousness, convulsion [syndrome of inappropriate secretion of antidiuretic hormone]
  • general malaise, loss of appetite, yellowing in skin and white of eyes [hepatic 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 pharmacist or medical facility how to discard them.
  • [To family members] Pay attention to daily living of a patient. He/she may show unusual behaviors and symptoms such as suicidal wishes, aggressive behavior, getting excitable or feeling change caused by slight stimulation. If you notice them, they may be the possibility of adverse effects of the medicine, so consult with your doctor or pharmacist immediately.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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