くすりのしおり

Internal
Revised: 7/2014

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 20mg "TOWA"
 Active ingredient:
Paroxetine hydrochloride hydrate
 Dosage form:
reddish white tablet, diameter 8.1 mm, thickness 3.4 mm
 Print on wrapping:
Tw755, パロキセチン20mg「トーワ」, 20mg

Effects of this medicine

This medicine shows the antidepressant/anxiolytic effect by acting on the neurotransmitter (serotonin) in the brain, and improves gloomy feeling, anxiety, irritation, loss of motivation, loss of appetite, insomnia, acute anxiety, obsession and excessive anxiety/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, comorbid disorder with high impulsivity, or glaucoma.
    If you have suicidal ideation, or a history of suicidal ideation or suicide attempt.
    If you have predisposition to organic brain disorder or schizophrenia.
    If you have a history of epilepsy.
    If you have 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))
  • For depression/depressive state: In general, for adults, take 20 to 40 mg of paroxetine at a time, once a day after dinner. The initial dose is started with 10 to 20 mg at a time. As a rule, the dosage is increased by 10 mg per day at weekly intervals, and may be adjusted up to no more than 40 mg per 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. The initial dose is started with 10 mg at a time. As a rule, the dosage is increased by 10 mg per day at weekly intervals, and may be adjusted up to no more than 30 mg per 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. The initial dose is started with 20 mg at a time. As a rule, the dosage is increased by 10 mg per day at weekly intervals, and may be adjusted up to no more than 50 mg per 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. The initial dose is started with 10 mg at a time. As a rule, the dosage is increased by 10 mg per day at weekly intervals but may be adjusted up to no more than 40 mg per 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. The initial dose is started with 10 to 20 mg at a time. As a rule, the dosage is increased by 10 mg per day at weekly intervals but may be adjusted up to no more than 40 mg per day according to your symptoms.
    This medicine contains 20 mg of paroxetine in 1 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 this medicine after it shows effects.
  • If you miss a dose, take as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue 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 and 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 drowsiness or dizziness. Be aware of driving a car or operating dangerous machinery.
  • Drinking alcohol may enhance medicinal effects. Avoid drinking alcohol while taking this medicine.
  • Be aware of taking hypericum perforatum (Saint John's wort)-contained food, since it may intensify the therapeutic effects.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, drowsiness, dry mouth, dizziness, constipation, headache and loss of appetite. 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, shaking in limbs [serotonin syndrome]
  • muscle stiffness, sweating, acute fever [malignant syndrome]
  • impaired mind, seeing things that do not exist, decreased conciousness [confusion, hallucination, delirium, convulsion]
  • general dullness, decreased consciousness, convulsion [syndrome of inappropriate antidiuretic hormone secretion]
  • general dullness, loss of appetite, yellowing of skin/conjunctiva [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 pharmacist or healthcare facility 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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