Active ingredients: Benzyl alcohol
NEO BOROCILLIN "1.2 mg + 20 mg tablets"
Neo Borocillin package inserts are available for pack sizes:- NEO BOROCILLIN "1.2 mg + 20 mg tablets"
- NEO BOROCILLIN "1.2 mg + 20 mg sugar-free tablets"
- NEO BOROCILLIN "1.2 mg + 70 mg tablets with vitamin C"
- NEO BOROCILLINA "1.2 mg + 70 mg tablets with sugar-free vitamin C"
- NEO BOROCILLIN "28.8 mg / 120 ml mouthwash"
- NEO BOROCILLIN 0,6% spray for oral mucosa 1 bottle of 10 ml
Why is Neo Borocillin used? What is it for?
WHAT IS IT
Neo Borocillin tablets is a preparation for the oropharyngeal cavity based on 2,4 dichlorobenzyl alcohol and sodium benzoate.
Neo Borocillina is a product for the symptomatic treatment of inflammatory affections of the mouth and pharyngeal cavity. Its main component is 2,4 dichlorobenzyl alcohol, an antibacterial drug with an antiseptic action against numerous pathogenic germs of the oral cavity.
The product has a rapid bactericidal action and a prolonged effect.
The product contains sodium benzoate (benzoic acid salt) which is known for its antiseptic action and modifies the secretions of the respiratory tract; salt, in particular, has an alkalizing, mucolytic, saline type action.
WHY IT IS USED
Neo Borocillin is indicated as an antiseptic of the oropharyngeal cavity (mouth and throat).
Contraindications When Neo Borocillin should not be used
Individual hypersensitivity to the components, or other strictly correlated substances from a chemical point of view.
The tablets are contraindicated in children under two years of age, with a predisposition to laryngospasm and convulsions.
Precautions for use What you need to know before taking Neo Borocillin
Due to the presence of menthol, the product is contraindicated in children under the age of two years with a predisposition to laryngospasm and convulsions. It must be used with caution, and under direct medical supervision, even in older children.
In addition, one tablet contains an amount of sodium equal to 3.22 mg. Subjects who follow a low sodium diet should keep in mind that at the maximum recommended daily dose of 8 tablets a quantity of sodium equal to 25.76 mg is reached, corresponding to about 0.5 g of table salt.
The product contains sucrose, which must be taken into account in case of diabetes or low-calorie diets.
In case of ascertained intolerance to sugars, contact your doctor before taking the medicine.
Interactions Which drugs or foods can modify the effect of Neo Borocillin
If you are using other medicines, ask your doctor or pharmacist for advice.
Avoid the simultaneous use of other antiseptics.
Warnings It is important to know that:
It is important to know that:
The use, especially if prolonged, of products for topical 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 treatment period not exceeding 7 days, with no appreciable results, consult your doctor.
WHAT TO DO DURING PREGNANCY AND BREASTFEEDING
Ask your doctor or pharmacist for advice before taking any medicine.
There are no adequate data from the use of 2,4 dichlorobenzyl alcohol and sodium benzoate in pregnant women.
During pregnancy and breastfeeding, Neo Borocillin should be administered in case of real need and under the direct supervision of the doctor.
Dose, Method and Time of Administration How to use Neo Borocillin: Posology
Slowly dissolve one tablet in your mouth every 2/3 hours up to a maximum of 8 tablets per day.
To keep the mucosa under the action of the drug for as long as possible, the tablets should be dissolved slowly in the mouth.
WARNING: DO NOT EXCEED THE DOSES WITHOUT THE ADVICE OF THE DOCTOR. USE ONLY FOR SHORT PERIODS OF TREATMENT.
Overdose What to do if you have taken an overdose of Neo Borocillin
In case of accidental intake of excessive doses of Neo Borocillin, notify your doctor immediately or go to the nearest hospital.
IF YOU ARE IN ANY DOUBT ABOUT USING NEO BOROCILLIN, CONTACT YOUR DOCTOR OR PHARMACIST.
Side Effects What are the side effects of Neo Borocillin
Like all medicines, NEO BOROCILLIN can cause side effects, although not everybody gets them.
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.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist. Request and fill in the undesirable effects report form available at the pharmacy.
Expiry and Retention
Expiry: see the expiry date indicated on the package. The expiry date refers to the product in intact packaging, correctly stored.
Store at a temperature not exceeding 30 ° C.
Warning: do not use the medicine after the expiry date indicated on the package.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
Deadline "> Other information
COMPOSITION
One tablet contains:
- Active ingredients: 2,4-dichlorobenzyl alcohol 1.2 mg; sodium benzoate 20 mg (equivalent to 17 mg benzoic acid)
- Excipients: magnesium stearate, precipitated silica, menthol, mint essence, eucalyptol, citral, sucrose.
HOW IT LOOKS
Neo Borocillina is in tablet format (to be dissolved in the mouth). The box contains 20 tablets in blister packs.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
NEO BOROCILLIN 1,2 MG + 20 MG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
A tablet contains:
Active principles
• 2,4 DICHLOROBENZIL ALCOOL .......... 1,2 mg
• SODIUM BENZOATE ............................... 20 mg
(equivalent to 17 mg of benzoic acid)
Excipients
• menthol ....................................... 4.5 mg
• sucrose ............ ................................. 906.384 mg
For the full list of excipients, see 6.1
03.0 PHARMACEUTICAL FORM -
Tablet.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Antiseptic of the oropharyngeal cavity.
04.2 Posology and method of administration -
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.
04.3 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.
04.4 Special warnings and appropriate precautions for use -
Due to the presence of menthol, Neo Borocillin tablets 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.
This medicine contains 0.9 g of sucrose per dose: to be taken into consideration in people with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.
The use, especially if prolonged, of products for oral topical 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.
04.5 Interactions with other medicinal products and other forms of interaction -
Avoid the simultaneous use of other antiseptics.
04.6 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.
04.7 Effects on ability to drive and use machines -
No studies on the ability to drive and use machines have been performed.
04.8 Undesirable 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.
04.9 Overdose -
No cases of overdose have been reported.
In the event of an overdose, appropriate symptomatic treatments should be adopted.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group:
Antiseptics of the oropharyngeal cavity - ATC code: R02AA03.
NEO BOROCILLINA is a useful means for the symptomatic treatment of inflammatory affections of the mouth and pharyngeal cavity. Its main active component is 2,4 dichlorobenzyl alcohol, an antibacterial drug with antiseptic action against numerous pathogenic germs of the oral cavity.
The product also contains sodium benzoate salt of benzoic acid which is known for its mildly antiseptic action and modifies respiratory tract secretions; salt, in particular, also has an alkalizing, mucolytic, saline-type action.
05.2 "Pharmacokinetic properties -
The germicidal action of benzoic acid occurs at a concentration of 0.4%, the bacteriostatic action at 0.3 - 0.5%.
Sodium benzoate is used as an expectorant (200 - 500 mg, one or more times a day).
05.3 Preclinical safety data -
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive and neonatal developmental toxicity.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Magnesium stearate, precipitated silica, menthol, mint essence, eucalyptol, citral, sucrose.
06.2 Incompatibility "-
No incompatibilities of the product have been reported.
06.3 Period of validity "-
3 years.
06.4 Special precautions for storage -
Store at a temperature not exceeding 30 ° C.
06.5 Nature of the immediate packaging and contents of the package -
Blister consisting of white PVC / PE / PVDC heat-sealed to aluminum foil.
The contents of the package are 16, 18, 20 tablets. Not all pack sizes may be marketed.
06.6 Instructions for use and handling -
No special instructions.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
ALFA WASSERMANN S.p.A.
Registered office - Via E. Fermi, n. 1 - Alanno (PE)
Administrative headquarters - Via Ragazzi del "99 n. 5 - Bologna
08.0 MARKETING AUTHORIZATION NUMBER -
"1,2 mg + 20 mg tablets" 16 tablets in blister PVC-PE-PVDC / AL - A.I.C. n. 022632121
"1.2 mg + 20 mg tablets" 18 tablets in blister PVC-PE-PVDC / AL - A.I.C. n. 022632133
"1,2 mg + 20 mg tablets" 20 tablets in blister PVC-PE-PVDC / AL - A.I.C. n. 022632044
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
Date of first authorization: 15 November 1972
Date of most recent renewal: 1 June 2010
10.0 DATE OF REVISION OF THE TEXT -
September 28, 2016
