くすりのしおり

Internal
Published: 6/2015

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 :
MEXILETINE HYDROCHLORIDE Tablets 50mg "KCC"
 Active ingredient:
Mexiletine hydrochloride
 Dosage form:
white tablet, diameter: 7.2 mm, thickness: 3.4 mm
 Print on wrapping:
メキシレチン塩酸塩錠50mg「KCC」, 50mg, NOM305, Mexiletine Hydrochloride 50

Effects of this medicine

This medicine relieves abnormal excitation of the heart, and regulates disturbed pulse. It also shows analgesic action on stimulation, and relieves limb pain and numbness caused by diabetes mellitus.
It is usually used for the treatment of tachyarrhythmia (ventricular tachyarrhythmia), and for the improvement of subjective symptoms (spontaneous pain and numbness sensation) associated with diabetic neuropathy.

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 conduction disturbances or heart failure.
  • 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 tachyarrhythmia (ventricular tachyarrhythmia): In general, for adults, the initial dose is started at 2 tablets (100 mg of the active ingredient) at a time, 3 times a day, after meals. If the effect is insufficient, the dosage is increased up to 3 tablets (150 mg) at a time, 3 times a day, after meals. The dosage may be adjusted according to the age or symptoms.
    For the improvement of subjective symptoms (spontaneous pain and numbness sensation) associated with diabetic neuropathy: In general, for adults, take 2 tablets (100 mg of the active ingredient) at a time, 3 times a day, after meals.
    In any case, strictly follow the instructions.
  • 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 blank feeling/dizziness/numbness. Avoid operating dangerous machinery such as driving a car.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include gastrointestinal symptoms such as nausea or vomiting, muscle pain/joint pain, erythema, itch, generalized rash, fever, hives and erythema multiforme (exudativum). 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.
  • fever, mucosal redness/erosion, erythema [toxic epidermal necrolysis, Stevens-Johnson syndrome, erythroderma]
  • fever, rash, swelling of lymph nodes [hypersensitivity syndrome]
  • palpitation, shortness of breath, dizziness [ventricular tachycardia, atrioventricular block]
  • decreased urine output, edema, thirst [renal failure]
  • general malaise, nausea, yellowing of the skin and the conjunctiva [liver dysfunction, jaundice]
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.
  • 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.