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 5mg "NP"
 Active ingredient:
Paroxetine hydrochloride hydrate
 Dosage form:
yellowish white tablet, diameter: 6.6 mm, thickness: 3.5 mm
 Print on wrapping:
(Face)パロキセチン5mg「NP」, パロキセチン, 5, (Back)PAROXETINE5mg「NP」, パロキセチン, 5, NP-257

Effects of this medicine

This medicine relieves depressive mood and feeling by inhibiting serotonin reuptake in the brain.
It is usually used to treat depression, depressive state, panic disorder, obsessive-compulsive disorder, social phobia and posttraumatic 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 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 4 to 8 tablets (20 to 40 mg of paroxetine) at a time, once a day after dinner. Initially take 2 to 4 tablets (10 to 20 mg) at a time, the dosage will be increased by 2 tablets (10 mg) a day, at one week intervals in principle. The dosage may be adjusted according to symptoms of the patient. DO NOT exceed the daily maximum dosage, 8 tablets (40 mg).
    Panic disorder: In general, for adults, take 6 tablets (30 mg of paroxetine) at a time, once a day after dinner. Initially take 2 tablets (10 mg) at a time, the dosage will be increased by 2 tablets (10 mg) a day, at one week intervals in principle. The dosage may be adjusted according to symptoms of the patient. DO NOT exceed the daily maximum dosage, 6 tablets (30 mg).
    Obsessive-compulsive disorder: In general, for adults, take 8 tablets (40 mg of paroxetine) at a time, once a day after dinner. Initially take 4 tablets (20 mg) at a time, the dosage will be increased by 2 tablets (10 mg) a day, at one week intervals in principle. The dosage may be adjusted according to the symptoms. DO NOT exceed the daily maximum dosage, 10 tablets (50 mg).
    Social phobia: In general, for adults, take 4 tablets (20 mg of paroxetine) at a time, once a day after dinner. Initially take 2 tablets (10 mg) at a time, the dosage will be increased by 2 tablets (10 mg) a day, at one week intervals in principle. The dosage may be adjusted according to the symptoms. DO NOT exceed the daily maximum dosage, 8 tablets (40 mg).
    Posttraumatic stress disorder: In general, for adults, take 4 tablets (20 mg of paroxetine) at a time, once a day after dinner. Initially take 2 to 4 tablets (10 to 20 mg) at a time, the dosage will be increased by 2 tablets (10 mg) a day, at one week intervals in principle. The dosage may be adjusted according to the symptoms. DO NOT exceed the daily maximum dosage, 8 tablets (40 mg).
    Strictly follow the instructions in any case.
  • 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. Avoid stopping or reducing paroxetine too quickly for it may cause intolerable symptoms including headache, nausea, dizziness, anxiety and sleep disorder.

Precautions while taking this medicine

  • This medicine may cause sleepiness, dizziness, etc. Be aware of operating in potentially hazardous activities such as driving a car.
  • Intake of alcohol may enhance the effect of this medicine. Refrain from drinking alcohol while taking this medicine.
  • Note that foods containing Saint John's wort may enhance the effect of this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include sleepiness, nausea, dizziness, headache, constipation, rash, itch, hives, angioedema, erythema and solar sensitiveness. 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, agitate, sweat [serotonin syndrome]
  • acute fever, tremoring limbs, muscular stiffness [malignant syndrome]
  • convulsion, consciousness disturbance, impaired mind [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 [liver disorder]
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 unneeded medicine.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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