NEOBOROCILLIN * 16PAST S / Z
Therapeutic indications
Antiseptic of the oropharyngeal cavity.
Dosage and method of use
Slowly dissolve one tablet in your mouth every 2-3 hours, up to a maximum of 8 tablets per day. Do not exceed the recommended dose.
Contraindications
Hypersensitivity to the active substances or to any of the excipients. The tablets are contraindicated in children under two years of age, with a predisposition to laryngospasm and convulsions. Due to the presence of aspartame, the product is contraindicated in case of phenylketonuria.
Side effects
Very rarely reported: hypersensitivity reactions, spinning sensation, respiratory failure, glottal edema, vomiting, malaise, sweating, arm edema, perioral edema, eyelid edema, face edema, urticaria, haemolytic anemia, jaundice . Sodium benzoate is mildly irritating to the skin and mucous membranes. Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Special warnings
Sugar-free Neo Borocillin tablets, due to the presence of menthol, are contraindicated in children under two years of age with a predisposition to laryngospasm and convulsions. They must be used with caution, and under direct medical supervision, even in older children. The product does not contain sucrose, therefore it can be taken by those who must avoid the administration of this sugar. Aspartame: This medicine contains 3 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It can be harmful to you if you have phenylketonuria, a rare genetic disease that causes phenylalanine to build up because the body cannot dispose of it properly. Neither non-clinical nor clinical studies are available on the use of aspartame in children below 12 weeks of age. Sodium: This medicinal product contains 3.2 mg of sodium as the active ingredient per tablet and 25.5 mg of sodium per daily dose equivalent to 1.3% of the WHO recommended maximum daily intake which corresponds to 2 g of sodium for one adult. The use, especially if prolonged, of products for topical oral use can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and consult the doctor in order to establish any suitable therapy. After a short period of treatment without noticeable results, consult your doctor. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Pregnancy and breastfeeding
There are no adequate data from the use of 2,4 dichlorobenzyl alcohol and sodium benzoate in pregnant women. In pregnant and lactating women, the product should be administered in case of real need and under direct medical supervision.
Expiration and retention
Store at a temperature not exceeding 30 ° C.
Interactions with other drugs
Avoid the simultaneous use of other antiseptics.
Overdose
No cases of overdose have been reported. In the event of an overdose, appropriate symptomatic treatments should be adopted.
Active principles
One tablet contains: Active ingredients - 2,4 DICHLOROBENZIL ALCOOL 1,2 mg; - SODIUM BENZOATE 20 mg (equivalent to 17 mg of benzoic acid). Excipients with known effects: - aspartame 10 mg. For the full list of excipients, see 6.1.
Excipients
Magnesium stearate, hydrated colloidal silica, levomenthol, mint essence, eucalyptol, citral, peppermint, aspartame , granular mannitol (containing mannitol and polyvinylpyrrolidone), mannitol.