GRACEVIT TABLETS 50mg

Generic name: Sitafloxacin Hydrate

Manufactured by: Daiichi Sankyo

Description

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.

Ingredients and dosage form

white to slightly yellowish white tablet (diameter: 7.7 mm, thickness: 4.1 mm)

Dosing schedule/Directions

Your dosing schedule must prescribed by your doctor or healthcare professional.

In general, for adults, take 1 tablet (50 mg of sitafloxacin) at a time, twice a day, or 2 tablets (100 mg) at a time, once a day. If the effect is insufficient, the dosage may be increased to 2 tablets (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.

Warnings

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.)

Precautions while taking this medicine

- no records

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include diarrhea, loose stool, abdominal pain, 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, erythema/blister/erosion, congested bulbar conjunctiva [toxic epidermal necrolysis, 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, jaundice]

fever, sore throat, general malaise, bleeding tendency (e.g. gum/nose/subcutaneous bleeding) [pancytopenia, agranulocytosis, hemolytic anemia, 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]

pain in the periphery of tendons, edema, redness [achilles tendonitis, tendinopathy such as tendon rupture]

fitful muscular contraction [convulsion]

palpitation, chest pain, discomfort in chest [QT prolongation, ventricular tachycardia (including Torsades de pointes)]

fever, dry cough, breathing difficulty, headache, general malaise [interstitial pneumonia]

muscle pain, lassitude, red-brown urine [rhabdomyolysis]

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.

Storing Conditions

Keep out of the reach of children. Store away from direct sunlight, heat and moisture.

Discard the remainder, do not store.

Product specifications, appearance and package content are subject to change without prior notice.

Description of the medical drugs is not intended for prescribing treatment without the involvement of a physician.