くすりのしおり

Internal
Published: 9/2015

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 :
Plaquenil Tablets 200mg
 Active ingredient:
Hydroxychloroquine sulfate
 Dosage form:
white tablet, major axis: 12.9 mm, minor axis: 6.2 mm
 Print on wrapping:
プラケニル200 mg

Effects of this medicine

This medicine suppresses changes in pH mainly due to accumulation of hydroxychloroquine in lysosomes and various lysosomal functions associated with the changes, thereby improving cutaneous symptoms in patients with systemic lupus erythematosus or cutaneous lupus erythematosus with localized cutaneous symptoms alone, as well as systemic symptoms such as malaise or musculoskeletal symptoms in patients with systemic lupus erythematosus.
It is usually used to treat cutaneous and systemic lupus erythematosus.

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 or have a history of retinopathy (excluding SLE retinopathy) or maculopathy.
    If you are under 6 years old.
  • 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))
  • In general, take 200 or 400 mg as hydroxychloroquine sulfate, once a day after meal. However, the daily dosage is based on ideal body weight (IBW) described below.
    IBW (kg) for female patients = (height (cm)-100) × 0.85
    IBW (kg) for male patients = (height (cm)-100) × 0.9
    If your IBW is 31 kg or over but under 46 kg, take 1 tablet (200 mg), once a day.
    If your IBW is 46 kg or over but under 62 kg, take 1 tablet (200 mg), once a day and 2 tablets (400 mg), once a day alternately.
    If your IBW is 62 kg or over, take 2 tablets (400 mg), once a day.
    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 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 immediately.
  • Do not stop taking this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • Take an eye examination on a regular basis, since this medicine may cause eye disorder.
  • Hypoglycemic symptoms such as dizziness or consciousness disorder may occur. If they occur, consult with your doctor.
  • Pay attention when operating dangerous machinery, such as driving a car, or working at heights.
  • Pay attention when operating dangerous machinery, such as driving a car, or working at heights, since this medicine may cause visual abnormalities such as disorder of visual adjustment or blurring of eyes, or hypoglycemic symptoms.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include diarrhea, headache, toxic skin eruption and cellulitis (chill, high fever). 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.
  • blurring of eyes, impaired color vision, tunnel vision [retinopathy, maculopathy, macular degeneration]
  • blister, rash, skin ulcer [toxic epidermal necrolysis, mucocutaneous ocular syndrome, erythema multiforme, erythroderma (exfoliative dermatitis), drug-induced hypersensitivity syndrome, acute generalized exanthematous pustulosis]
  • fever, chill, infection [bone marrow suppression (thrombocytopenia, agranulocytosis, leukopenia, aplastic anemia)]
  • muscular weakness, malaise [myopathy, neuromyopathy]
  • lassitude, a severe sense of hunger, sweating [hypoglycemia]
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 them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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