Oilatum Emollient                                       

Esclebin Norfloxacin

Active ingredient: Norfloxacin

400mg

Film coated tablets in packaging of 14 units and 20 units

Antiseptic and anti-infective of urinary tract

Treatment of infection of upper and lower urinary tract, including cystitis, pyelitis,cystopyelitis and pyelonephritis caused by bacteria susceptible to Norfloxacin.

Treatment of acute bacteria gastroenteritis caused by susceptible germs.

Persons with a history of hypersensitivity associated with the use of the drug or any member of the quinolone group of antimicrobial agents like pipemidic acid.

Children: The safety and efficacy of oral Norfloxacin in pediatrics patients have not been established, therefore must not be used in children before puberty.

CNS: As other member of quinolone group, should be used with caution in patients with known history of convulsions.

Renal impairment: In patient with creatinin clearance rate of 30 ml/min or less, recommended dosage is one tablet daily to keep blood levels equivalent to dosage of patients with normal renal function. If impairment is advanced, the convenience of treatment should be evaluated.

Pregnancy: The safety and efficacy of oral Norfloxacin in pregnant women have not been established, therefore convenience of treatment should be evaluated.

Nursing Mothers: Norfloxacin is excreted in human milk appearing in umbilical cord and amniotic fluid.

Effect over driving ability: None described

Pediatric use: Not to administer in children before puberty.

Urinary Tract Infections: Recommended daily dose for adults is 400mg (1 tablet) twice a day, from 7 to 10 days, although symptoms have disappeared. In Women suffering from uncomplicated acute cystitis, the therapeutic regimen lasts 3 days. Infectious Acute Gastroenteritis: 1 tablet should be taken every 12 hours for 5-7 days.

Instruction for a correct administration of drug: Tablets should be taken with a glass of water.

No experience with overdosage have been reported; symptoms, signs and treatment are unknown. In the event of acute overdosage, the stomach should be emptied by inducing vomit or by gastric lavage and the patient carefully observed and given symptomatic and supportive treatment. Adequate hydration must be maintained, since a high dosage of Norfloxacin can cause crystalluria.

In case of overdosage or accidental intake, call the local toxicological information center.

Adverse reactions reported have been light and not frequent (incidence rate 4.4%). Adverse reactions more frequently reported were gastrointestinal, including light gastric disorders, anorexia and nausea. Also reported were headache, dizziness and skin reactions. Less frequent effecy were abnormal laboratory values, leukopenia, eosinophilia, elevation of SGOT and SGPT, alkaline phosphatase, bilirubin, BUN and creatinin.

No special storage conditions.

This product must not be used beyond the expiry date specified on the packaging.