くすりのしおり

Internal
Published: 12/2012

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 :
AMANTADINE HYDROCHLORIDE Tablets 100mg "SAWAI" [for influenza A infection]
 Active ingredient:
Amantadine hydrochloride
 Dosage form:
white tablets, diameter: 8.2 mm, thickness: 4.2 mm
 Print on wrapping:
アマンタジン塩酸塩100mg「サワイ」, SW-386, Amantadine Hydrochloride 100mg

Effects of this medicine

This medicine inhibits the process of influenza A virus entering the cells and prevents proliferation of the virus in the cells.
It is usually used to treat influenza A virus infection.
It can also be used to prevent influenza A virus infection, but is used only when influenza vaccines are unavailable, in patients who cannot be vaccinated because of a certain disease, or until the vaccine becomes effective after injection.

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 epilepsy and a history of it, or have a convulsive predisposition or renal disorder requiring dialysis.
  • If you are pregnant, breastfeeding or possibly pregnant.
  • 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, for adults, take 100 mg in 1 dose or in 2 divided doses a day. The dosage may be adjusted according to the age or symptoms, but the maximum daily dose is 100 mg for the elderly and patients with renal disorder. This medicine contains 100 mg of the active ingredient in a tablet. 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.
  • Do not stop taking this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • Regarding children/minors, pay attention to the following points to prevent rare accidents such as fall due to abnormal behavior:
    - After treatment using this medicine is started, abnormal behavior may occur.
    - In cases where children/minors are treated at home, their guardians should be careful not to leave them alone for at least 2 days after starting this medicine.
    - Also pay attention that there have been reports that similar symptoms are caused by influenza encephalopathy.
  • This medicine may cause dizziness, light headedness or dizziness on standing up. Avoid performing dangerous operations such as driving a car, operating machinery or working at heights.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include sleep disorder, drowsiness, anxiety, elevated mood, agitation, ataxia, excitement, dizziness, headache/dull headache, hypersensitivity, concentration disorder, involuntary movement [tremor (shivering of limbs) and dyskinesia], accommodation disorder of the eye (foggy vision), constipation, diarrhea, loss of appetite, nausea/vomiting, dry mouth, dizziness on standing up (orthostatic hypotension), decreased blood pressure, rash, lassitude, malaise, sweating and livedo reticularis. 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.
  • high fever, consciousness disorder, muscle stiffness [malignant syndrome]
  • fever, redness and swelling of skin/mucosa with rash or blisters, conjunctival hyperemia [mucocutaneous ocular syndrome, toxic epidermal necrolysis]
  • foreign-body sensation in the eye, sensitivity to light, reduced visual acuity [diffuse superficial keratitis, corneal epithelial edema accompanied by reduced visual acuity]
  • general edema, breathing difficulty, easier to breath when sitting up than when lying down [heart failure]
  • decreased consciousness, hallucination/delusion, convulsion [consciousness disorder, psychological symptoms, convulsion, myoclonus]
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.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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