LEVOFLOXACIN TABLETS 500mg «DSEP» [Class 1 Drugs]

The most commonly reported adverse reactions include rash, insomnia, dizziness, headache, nausea, vomiting, diarrhea, abdominal discomfort, loss of appetite and dyspepsia. 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.

• erythema, chill, breathing difficulty, pale face, cold sweat[shock, anaphylaxis]
• fever, erythema, blister, erosion[toxic epidermal necrolysis, oculomucocutaneous syndrome]
• muscle spasmodically contracting[convulsion]
• chest pain, palpitation, chest discomfort[QT prolongation, ventricular tachycardia (including Torsade de pointes)]
• fever, general malaise, decreased urine output, edema of limbs or face[acute renal disorder, interstitial nephritis]
• nausea, vomiting, loss of appetite, malaise, itch, yellowing of the skin or white eyes[fulminant hepatitis, liver dysfunction, jaundice]
• fever, sore throat, general malaise, bleeding tendency (e.g. gum/nose/subcutaneous bleeding)[pancytopenia, agranulocytosis, hemolytic anemia, thrombocytopenia]
• fever, dry cough, breathing difficulty[interstitial pneumonia, eosinophilic pneumonia]
• abdominal pain, frequent diarrhea, nausea[serious colitis with bloody stool such as pseudomembranous colitis]
• muscle pain, weakness, red-brown urine[rhabdomyolysis]
• sweating, palpitation, weakness[hypoglycemia]
• pain in the periphery of tendons, edema, redness[tendon disorders, such as Achilles tendonitis and tendon rupture]
• difficulty in thinking, unable to recognize time or place, incoherent speech and action[psychiatric symptom such as confusion, delirium, depression]
• fever, joint pain, purpura[hypersensitivity vasculitis]
• drooping eyelids, double-vision, muscle fatigue during exercise[exacerbation of myasthenia gravis]
• hoarseness, swallowing difficulty, pain in the chest and back, breathing difficulty[aortic aneurysm, aortic dissection]
• numbness of limbs, muscle weakness, pain[peripheral neuropathy]

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.

• Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
• In general, for adults, take one tablet (500 mg of levofloxacin) at a time, once a day. The dose may be decreased according to the type of infection and symptoms. For pulmonary tuberculosis and other tuberculosis diseases, this medicine is basically co-administered with other anti-tuberculosis medicines.
  Typhoid and paratyphoid: In general, for adults, take one tablet (500 mg of levofloxacin) at a time, once a day for 14 days.
  In any 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.

• If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines or foods.
  If you have: kidney dysfunction, cardiac diseases (arrhythmia, ischemic heart disease, etc.), convulsive disease such as epilepsy or a history of it, or myasthenia gravis.
• 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.)

• Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
• Discard the remainder. Do not store them. If you do not know how to discard, seek advice of your pharmacy or medical institution. Do not give the unused medicines to others.