くすりのしおり

Internal
Revised: 3/2019

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 :
GRACEVIT FINE GRANULES 10%
 Active ingredient:
Sitafloxacin hydrate
 Dosage form:
pale yellow to yellow fine granule
 Print on wrapping:

Effects of this medicine

This medicine is a new quinolone antibacterial oral agent which inhibits DNA replication of bacteria at the time of infection, and shows bactericidal action.
It is usually used to treat a wide range of infections such as respiratory infections, urinary tracts infections, gynecologic infections, otolaryngologic infections, and dental infections.

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 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, take 0.5 g (50 mg of sitafloxacin) at a time, twice a day, or 1.0 g (100 mg) at a time, once a day. If the effect is insufficient, the dosage may be increased to 1.0 g (100 mg) at a time, twice a day. Strictly follow the instructions.
  • If you miss a dose, take a dose as soon as possible. However, 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

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include diarrhea, loose stool, headache, and rash. 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.
  • pale face, cold sweat, dizziness, breathing difficulty, eruption, angioedema  [shock, anaphylaxis]
  • fever, loss of appetite, erythema [oculomucocutaneous syndrome]
  • general malaise, decrease of urine output, swelling [acute renal disorder]
  • loss of appetite, general malaise, yellowing in the skin or conjunctiva [liver dysfunction]
  • nose/gums bleeding, increased menstrual bleeding, bleeding under skin seen in limbs [thrombocytopenia]
  • nausea, vomiting, stomachache, frequent diarrhea [pseudomembranous colitis]
  • sweating, palpitation, lassitude [hypoglycaemia]
  • impaired mind, unable to recognize time / place, seeing thing or hearing sound that does not really exist [psychiatric symptom such as confusion, delirium, hallucination]
  • hoarseness, swallowing difficulty, pain in the chest and back, bloody phlegm, breathing difficulty  [aortic aneurysm, aortic dissection]
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 light, 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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