くすりのしおり

Internal
Published: 12/2017

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 :
ROSUVASTATIN Tablets 5mg "SANWA"
 Active ingredient:
Rosuvastatin calcium
 Dosage form:
light reddish yellow to smoky reddish yellow tablet, diameter: approx. 7.6 mm, thickness: approx. 3.4 mm
 Print on wrapping:
ロスバスタチン錠5mg「三和」, ロスバスタチン, 5mg, ROSUVASTATIN 5mg “SANWA”, ロスバスタチン5mg「三和」, 血液中のコレステロールを下げるお薬です

Effects of this medicine

This medicine selectively and competitively inhibits the activity of HMG-CoA reductase involving in cholesterol synthesis in liver, thereby inhibiting cholesterol synthesis and then reducing cholesterol level in blood.
It is usually used for the treatment of 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 disease or renal disease.
  • 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))
  • In general, for adults, start taking 2.5 mg of rosuvastatin at a time, once a day. If you need to reduce LDL-cholesterol level promptly, your doctor may prescribe 1 tablet (5 mg) at a time, as an initial dose. The dosage may be adjusted according to the age or symptoms. If it does not show enough efficacy after 4 weeks from the start, you may take higher dose and the dosage can be increased up to 4 tablets (20 mg) a day. This preparation contains 5 mg of rosuvastatin in a tablet. 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

  • Strictly follow the instructions on dietary/exercise therapy.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include muscle pain, itch, rash and hives. 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, muscle weakness, lassitude [rhabdomyolysis, myopathy, immune-mediated necrotizing myopathy]
  • general malaise, nausea, yellowing of the skin and the conjunctiva [hepatitis, liver dysfunction, jaundice]
  • nasal bleeding, gum bleeding, subcutaneous bleeding in limbs [thrombocytopenia]
  • angioedema (swelling of eyelid/lip/tongue), rash/itch, consciousness disorder [hypersensitivity]
  • fever, dry cough, respiratory distress [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.