くすりのしおり

Internal
Revised: 4/2019

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 OD Tablets 5mg "KYOSOMIRAI"
 Active ingredient:
Rosuvastatin calcium
 Dosage form:
white tablet, diameter:7.0mm, thickness:3.9 mm
 Print on wrapping:
(Face)ロスバスタチン OD 錠 5 mg「共創未来」, ロスバスタチン, 2.5, OD 5 mg
(Back)ROSUVASTATIN OD 5 mg「KYOSOMIRAI」, 5 mg, OD, ロスバスタチン「共創未来」, 高コレステロール血症の薬

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 to treat 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 your age and 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.
  • This medicine will be dissolved with saliva when you place it on the tongue, however, it won't be absorbed from the oral mucosa. Swallow the tablet with saliva or water.
  • If you miss a dose, take it as soon as you remember. If it is close to your 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

  • Follow your instructed dietary and/or exercise therapy properly.

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.
  • pain in muscle, muscle weakness, lassitude [rhabdomyolysis, myopathy, immune-mediated necrotizing myopathy]
  • red-brown urine [rhabdomyolysis]
  • loss of appetite, general dullness, yellowing of the skin/white of eyes [hepatitis, liver dysfunction, jaundice]
  • nose bleeding, bleeding from gum, subcutaneous bleeding in limbs [thrombocytopenia]
  • angioedema (swollen face/lips/eyelids), rash, itch, faint consciousness [hypersensitivity]
  • fever, dry cough, respiratory distress [interstitial pneumonitis]
  • hypoesthesia, numbness, muscle weakness [peripheral neuropathy]
  • fever, rash, blister [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 children. Store it at room temperature (1 to 30 ℃) away from light 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.