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 5mg "DK"
 Active ingredient:
Paroxetine hydrochloride hydrate
 Dosage form:
white tablet, with a split line, diameter: 6.6 mm, thickness: 3.8 mm
 Print on wrapping:
パロキセチン錠5mg「DK」, パロキセチン, 5, 5mg, HS5, PAROXETINE 5mg "DK", パロキセチン5mg「DK」

Effects of this medicine

This medicine shows the antidepressive/anxiolytic effect by acting on the neurotransmitter (serotonin) in the brain, and improves feeling of gloom, anxiety, irritation, loss of motivation, loss of appetite, insomnia, acute anxiety, obsession, etc.
It is usually used for 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 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 4 to 8 tablets (20 to 40 mg of paroxetine) at a time, once a day, after dinner. The initial dose is started with 2 to 4 tablets (10 to 20 mg) at a time. As a rule, the dosage is increased by 2 tablets (10 mg) daily at weekly intervals, and may be adjusted up to 8 tablets (40 mg) daily according to your symptoms.
    For panic disorder: In general, for adults, take 6 tablets (30 mg of paroxetine) at a time, once a day, after dinner. The initial dose is started with 2 tablets (10 mg) at a time. As a rule, the dosage is increased by 2 tablets (10 mg) daily at weekly intervals, and may be adjusted up to 6 tablets (30 mg) daily according to your symptoms.
    For obsessive-compulsive disorder: In general, for adults, take 8 tablets (40 mg of paroxetine) at a time, once a day, after dinner. The initial dose is started with 4 tablets (20 mg) at a time. As a rule, the dosage is increased by 2 tablets (10 mg) daily at weekly intervals, and may be adjusted up to 10 tablets (50 mg) daily according to your symptoms.
    For social-anxiety disorder: In general, for adults, take 4 tablets (20 mg of paroxetine) at a time, once a day, after dinner. The initial dose is started with 2 tablets (10 mg) at a time. As a rule, the dosage is increased by 2 tablets (10 mg) daily at weekly intervals, and may be adjusted up to 8 tablets (40 mg) daily according to your symptoms.
    For post-traumatic stress disorder: In general, for adults, take 4 tablets (20 mg of paroxetine) at a time, once a day, after dinner. The initial dose is started with 2 to 4 tablets (10 to 20 mg) at a time. As a rule, the dosage is increased by 2 tablets (10 mg) daily at weekly intervals, and may be adjusted up to 8 tablets (40 mg) daily according to your symptoms.
    Strictly follow the instructions in any case.
  • If you miss a dose, take a dose as soon as possible. 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.

Precautions while taking this medicine

  • This medicine may cause drowsiness/dizziness. Pay close attention when you perform dangerous operations such as driving a car or operating machinery.
  • Alcohol may intensify the therapeutic effect of this medicine. Avoid drinking alcohol while taking this medicine.
  • Foods containing St. John's wort may intensify the therapeutic effect of this medicine. Pay close attention when you take foods containing St. John's wort.

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, hands/feet tremor [serotonin syndrome]
  • muscle rigidity, sweating, acute fever [neuroleptic malignant syndrome]
  • impaired mind, seeing things that do not exist, decreased consciousness [confusion, hallucination, delirium, convulsion]
  • general malaise, decreased consciousness, convulsion [syndrome of inappropriate antidiuretic hormone secretion]
  • general malaise, nausea, yellowness in skin or 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.
  • Do not store the remainder and consult your pharmacy or medical institution how to discard it.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.