くすりのしおり

Internal
Revised: 1/2011

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 :
AMIODARONE HYDROCHLORIDE Tablets 100mg "SAWAI"
 Active ingredient:
Amiodarone hydrochloride
 Dosage form:
white to faint yellow tablet, diameter: 8.0 mm, thickness: 3.4 mm
 Print on wrapping:
アミオダロン塩酸塩, 100 mg「サワイ」, SW-AND, 不整脈治療剤, Amiodarone Hydrochloride 100 mg

Effects of this medicine

This medicine suppresses abnormal cardiac excitation and controls irregular pulse.
It is usually used to treat recurrent arrhythmia.

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 sick sinus syndrome or atrioventricular block.
  • 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 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))
  • Introduction period: In general, for adults, take 4 tablets (400 mg of the active ingredient) a day in 1 to 2 divided doses for 1 to 2 weeks.
    Maintenance period: In general, for adults, take 2 tablets (200 mg of the active ingredient) a day in 1 to 2 divided doses.
    In any case, the dosage may be adjusted according to the disease, age or symptoms. 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. 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

  • Refrain from taking any food containing St. John's wort (a kind of herb) with the medicine, as medicinal effects will be affected.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, pulmonary dysfunction, abnormal thyroid function, corneal pigmentation and vision disorder (reduced visual acuity, sensitive to light, foggy vision). 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.
  • cough, respiratory distress, fever [interstitial pneumonia, pulmonary fibrosis, alveolitis]
  • palpitation, shortness of breath, dizziness [severe aggravation of pre-existing arrhythmia, Torsades de pointes, heart failure, slow pulse, cardiac arrest, complete atrioventricular block, decreased blood pressure]
  • general malaise, loss of appetite, yellow discoloration of the skin and the white of eyes [fulminant hepatitis, cirrhosis, liver disorder]
  • weight loss, bulging eyes, edema of the whole face [hyperthyroidism, thyroiditis, hypothyroidism]
  • convulsion, consciousness disorder, headache [syndrome of inappropriate antidiuretic hormone secretion]
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 light, heat and moisture.
  • Discard the remainder. Do not store them. Ask your pharmacy on how to discard the remainder.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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