くすりのしおり

Internal
Revised: 5/2013

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 :
FLUVASTATIN Tablets 10mg [SANWA]
 Active ingredient:
Fluvastatin sodium
 Dosage form:
pale yellowish tablet, φ 5.6mm, thickness 2.7mm
 Print on wrapping:
フルバスタチン錠10mg「三和」, FLUVASTATIN 10"SANWA", FLV10

Effects of this medicine

This medicine suppresses hepatic cholesterol synthesis and decreases cholesterol in the blood, by inhibiting HMG-CoA reductase.
It is usually used for the treatment of hypercholesterolemia, 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 are a patient with liver disorder.
  • If you are pregnant, possible 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))
  • In general, for adults, take 2-3 tablets (20-30mg of fluvastatin) at a time, once daily, after dinner. The initial dose is started with 2 tablets (20mg) once daily. The dosage may be adjusted according to the age or symptoms, however, the dose may be increased up to 6 tablets (60mg) a day in severe 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

  • Fundamentals of hypercholesterolemia treatment are dietary and exercise therapies. Taking medicine only is not enough. Try to regulate your daily life as instructed.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include gastric discomfort, rash, heartburn, abdominal pain. 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 in limbs, rigidity, generalized fatigability [rhabdomyolysis, myopathy]
  • generalized fatigability, nausea, yellowness in skin or conjunctiva [liver dysfunction]
  • fever, swelling of eyelid/lip/tongue, breathing difficulty [hypersensitivity symptoms]
  • fever, dry cough, breathing difficulty [interstitial pneumonia]
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.