くすりのしおり

Internal
Published: 12/2015

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 :
AMALUET Combination Tablets 1Ban "Nichiiko"
 Active ingredient:
Amlodipine besilate
Atorvastatin calcium hydrate
 Dosage form:
white tablet, diameter: 6.1 mm, thickness: 2.6 mm
 Print on wrapping:
アマルエット配合錠1番「日医工」,アマルエット,日医工,1番,n195,配合錠,AMALUET 1Ban,2.5mg,アムロジピン,5mg,アトルバスタチン

Effects of this medicine

This medicine decrease the influx of calcium into the cells to relax the coronary and peripheral vessels, lower blood pressure and prevent an angina attack. Also, it inhibits hepatic cholesterol synthesis to lower the blood cholesterol.
It is usually used to treat hypertension or angina complicated by hypercholesterolemia or familial hypercholesterolemia.

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 decreased liver function.
  • If you are pregnant, possibly 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))
  • Hypertension: In general, for adults, take 2.5 to 5 mg of amlodipine at a time once a day. The dosage may be adjusted according to symptoms of patient. If the effect is insufficient, the dosage may be increased up to 10 mg at a time, once a day.
    Angina: In general, for adults, take 5 mg of amlodipine at a time once a day. The dosage may be adjusted according to symptoms of patient.
    Hypercholesterolemia: In general, for adults, take 10 mg of atorvastatin at a time once a day. The dosage may be adjusted according to age and symptoms of patient. If the symptoms are severe, the dosage may be increased up to 20 mg.
    Familial hypercholesterolemia: In general, for adults, take 10 mg of atorvastatin at a time once a day. The dosage may be adjusted according to age and symptoms of patient. If the symptoms are severe, the dosage may be increased up to 40 mg.
    This preparation contains 2.5 mg of amlodipine and 5 mg of atorvastain in a tablet. Strictly follow the instructions in any case.
  • If you miss a dose, take a dose as soon as you remember. 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

  • This medicine may cause dizziness/lightheadedness due to its hypotensive action. Be aware of operating in potentially hazardous activities such as driving a car and working at heights.
  • Strictly follow the instructions on dietary/exercise therapy.
  • Do not take grapefruit juice and the medicine together as the components of it may intensify the effect of this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include headache, dizziness/lightheadedness, palpitation, itch, photosensitivity, rash, erythema multiforme, hives, vasculitis, angioedema and gingival overgrowth. 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.
  • general malaise, loss of appetite, yellowing of the skin and the whites of the eyes [fulminant hepatic failure, hepatitis, liver dysfunction, jaundice]
  • chilliness, headache dull, gum bleeding [agranulocytosis, leukopenia, pancytopenia, thrombocytopenia]
  • angioneurotic edema, anaphylactoid reaction (flare with general itch), hives [hypersensitivity]
  • bradycardia, faint, dizziness [atrioventricular block]
  • muscle pain, lassitude, reddish brown urine [rhabdomyolysis, myopathy]
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 the pharmacist or medical facility how to discard unneeded medicine.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.