くすりのしおり

Internal
Revised: 10/2016

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 No.4 "SAWAI"
 Active ingredient:
Amlodipine besilate
Atorvastatin calcium hydrate
 Dosage form:
white tablet, major axis: 8.6 mm, minor axis: 4.9 mm, thickness: 3.0mm
 Print on wrapping:
アマルエット4番「サワイ」, アムロジピン5mg・アトルバスタチン10mg, Amaluet 4Ban「SAWAI」

Effects of this medicine

This medicine is a combination tablet combining a calcium antagonist and a HMG-CoA reductase inhibitor. It blocks the calcium channel to suppress inflow of calcium into cells. It consequently decreases blood pressure by expanding blood vessels and improves/prevents chest pain by expanding blood vessels that carry oxygen and nutrition to the heart. It also lowers cholesterol in the blood by inhibiting cholesterol synthesis in the liver.
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 liver or renal disorder.
  • 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))
  • For 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 the symptoms. If the effect is insufficient, the dosage may be increased up to 10 mg of amlodipine at a time, once a day.
    For angina: In general, for adults, take 5 mg of amlodipine at a time, once a day. The dosage may be adjusted according to the symptoms.
    For hypercholesterolemia: In general, for adults, take 10 mg of atorvastatin at a time, once a day. The dosage may be adjusted according to the age and symptoms. If the symptoms are severe, the dosage may be increased up to 20 mg of atorvastatin a day.
    For familial hypercholesterolemia: In general, for adults, take 10 mg of atorvastatin at a time, once a day. The dosage may be adjusted according to the age and symptoms. If the symptoms are severe, the dosage may be increased up to 40 mg of atorvastatin a day.
    This medicine contains 5 mg of amlodipine and 10 mg of atorvastatin 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. 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 due to decreased blood pressure. Pay close attention when working at heights or operating dangerous machinery, such as driving a car.
  • Strictly follow the instructions on dietary/exercise therapy.
  • Avoid taking grapefruit juice with this medicine, since it may intensify the therapeutic effects of this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include itch, photosensitivity, rash, erythema multiforme, hives, vasculitis, angioedema, liver dysfunction, gingival hypertrophy, headache, dizziness/light headedness and palpitation. 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, yellow discolation of the skin and the white of eyes [fulminant hepatitis, liver dysfunction, jaundice, hepatitis]
  • fever, bleeding tendency, general malaise [agranulocytosis, leukopenia, thrombocytopenia, pancytopenia]
  • bradycardia, dizziness [atrioventricular block]
  • muscle pain, lassitude, reddish brown urine [rhabdomyolysis, myopathy, immune-mediated necrotizing myopathy]
  • swelling of the eyelids/lips/tongue, dizziness, hives [hypersensitivity]
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 and the medical institution 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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