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 :
ATORVASTATIN Tablets 10mg "SAWAI"
 Active ingredient:
Atorvastatin calcium hydrate
 Dosage form:
white tablet, diameter: 6.1 mm, thickness: 2.9 mm
 Print on wrapping:
アトルバスタチン10 mg「サワイ」, Atorvastatin 10 mg

Effects of this medicine

This medicine lowers cholesterol in the blood by inhibiting cholesterol synthesis in the liver.
It is usually used to treat hypercholesterolemia and 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, breast feeding 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))
  • For hypercholesterolemia: In general, for adults, take 1 tablet (10 mg of atorvastatin) at a time, once a day. The dosage may be adjusted according to the age or symptoms. If the symptoms are severe, the dosage may be increased up to 2 tablets (20 mg) a day.
    For familial hypercholesterolemia: In general, for adults, take 1 tablet (10 mg of atorvastatin) at a time, once a day. The dosage may be adjusted according to the age or symptoms. If the symptoms are severe, the dosage may be increased up to 4 tablets (40 mg) a day.
    In any case, strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as you remember. 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

  • Strictly follow the instructions on dietary/exercise therapy.
  • Avoid taking grapefruit juice with this medicine, since it may intensify medicinal effects.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include itch, rash, skin eruption, anemia, liver disorder, diarrhea, loose stool, nausea, heartburn, constipation, gastric distress, epigastric pain (pain of the epigastrium), abdominal bloating, loss of appetite, indigestion, muscle pain, back pain, neck/shoulder stiffness, stiffness, dizziness, insomnia, numbness of limbs, headache, general malaise and edema (face/limbs). 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.
  • muscle pain, lassitude, reddish brown urine [rhabdomyolysis, myopathy, immune-mediated necrotizing myopathy]
  • general malaise, loss of appetite, yellow discoloration of the skin and the white of eyes [fulminant hepatitis, hepatitis, liver dysfunction, jaundice]
  • swelling of eyelids/lips/tongue, respiratory distress, hives [hypersensitivity]
  • sore throat, general malaise, bleeding tendency  [agranulocytosis, pancytopenia, thrombocytopenia]
  • fever, redness and swelling of the skin/mucosa with rash or blisters, conjunctival hyperemia  [toxic epidermal necrolysis, mucocutaneous ocular syndrome, erythema multiforme]
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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