くすりのしおり

Internal
Published: 3/2019

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 "FFP"
 Active ingredient:
Paroxetine hydrochloride hydrate
 Dosage form:
white tablet, diameter: 6.6 mm, thickness: 3.8 mm
 Print on wrapping:
(Face)パロキセチン 10 mg「FFP」, 10 mg「FFP」, パロキセチン
(Back)Paroxetine 10 mg「FFP」, パロキセチン, 10 mg

Effects of this medicine

This medicine relieves depressed mood, anxiety and tension by inhibiting the reuptake of serotonin in the brain and smoothing neurotransmission.
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, glaucoma, suicidal ideation, a history of suicidal ideation or suicide attempt, predisposition to organic brain disorder or schizophrenia, a history of epilepsy, 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 2 to 4 tablets (20 to 40 mg of paroxetine) at a time, once a day after dinner. Start with 1 to 2 tablets (10 to 20 mg) at a time. As a rule, the dosage will be increased by 1 tablet (10 mg) as a daily dose every week but may be adjusted within the range that does not exceed 4 tablets (40 mg) a day according to your symptoms.
    For panic disorder: In general, for adults, take 3 tablets (30 mg of paroxetine) at a time, once a day after dinner. Start with 1 tablet (10 mg) at a time. As a rule, the dosage will be increased by 1 tablet (10 mg) as a daily dose every week but may be adjusted within the range that does not exceed 3 tablets (30 mg) a day according to your symptoms.
    For obsessive-compulsive disorder: In general, for adults, take 4 tablets (40 mg of paroxetine) at a time, once a day after dinner. Start with 2 tablets (20 mg) at a time. As a rule, the dosage will be increased by 1 tablet (10 mg) as a daily dose every week but may be adjusted within the range that does not exceed 5 tablets (50 mg) a day according to your symptoms.
    For social-anxiety disorder: In general, for adults, take 2 tablets (20 mg of paroxetine) at a time, once a day after dinner. Start with 1 tablet (10 mg) at a time. As a rule, the dosage will be increased by 1 tablet (10 mg) as a daily dose every week but may be adjusted within the range that does not exceed 4 tablets (40 mg) a day according to your symptoms.
    For post-traumatic stress disorder: In general, for adults, take 2 tablets (20 mg of paroxetine) at a time, once a day after dinner. Start with 1 to 2 tablets (10 to 20 mg) at a time. As a rule, the dosage will be increased by 1 tablet (10 mg) as a daily dose every week but may be adjusted within the range that does not exceed 4 tablets (40 mg) a day according to your symptoms.
    In any case, strictly follow the instructions.
  • 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 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 or dizziness. Be aware of working at heights or operating dangerous machinery such as driving a car.
  • Avoid alcohol since it may intensify the therapeutic effects of this medicine.
  • Be aware of taking hypericum perforatum (Saint John's wort)-contained food, since it may intensify the therapeutic effects of this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, dizziness, headache and constipation. 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, sweat [serotonin syndrome]
  • sudden fever, muscle stiffness, fast pulse [malignant syndrome]
  • mild consciousness disorder, hallucination, convulsion [confusion, hallucination, delirium, convulsion]
  • general malaise, frequent urination, thirst [syndrome of inappropriate antidiuretic hormone secretion]
  • general malaise, loss of appetite, yellowness in skin or in conjunctiva [severe 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 your pharmacy or medical institution on how to discard the remainder.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.