BENAGOL * 16PAST HONEY LEMON

BENAGOL * 16PAST HONEY LEMON

Therapeutic indications

Antiseptic of the oral cavity.

Dosage and method of use

Dosage: The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.Adults and children over 6 years of age:One tablet every 2 or 3 hours. In children over 6 years of age, consult your doctor for an appropriate dosage. Do not exceed the recommended doses and in particular, for BENAGOL with Vitamin C Orange flavor and BENAGOL Cold Mint flavor, do not exceed the daily maximum of 8 tablets. For all other flavors of BENAGOL, do not exceed the maximum daily dose of 12 tablets.Administer BENAGOL flavor Cold Mint and BENAGOL flavor Ginger and Spices to adults and children over 12 years of age.. The duration of treatment with BENAGOL Menthol-Eucalyptol flavor should not exceed 3 days. BENAGOL Sugar-Free Lemon flavor and BENAGOL Sugar-Free Strawberry flavor are suitable for those patients who need to control their sugar and calorie intake.Elderly population:No data are available.Method of administration: Oromucosal administration. The tablet is dissolved slowly in the mouth.

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Do not give to children under the age of 6. BENAGOL Menthol-Eucalyptol taste is contraindicated in children with a history of epilepsy or febrile convulsions. Do not give BENAGOL Cold Mint flavor and BENAGOL Ginger and Spice flavor to children under the age of 12.

Side effects

BENAGOL taste Menthol - Eucalyptol: due to the presence of menthol and in case of non-observance of the recommended doses, there may be a risk of convulsions in children and infants. Adverse reactions associated with the use of 2,4 dichlorobenzyl alcohol, amylmetacresol, levomentol and ascorbic acid are listed below, divided by frequency and organ class. Frequencies are defined as: Very common (≥1 / 10); Common (≥1 / 100 e

. 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 www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

Beware of preschool children as if the tablets are swallowed whole they can cause choking. In case of sensitization or irritation phenomena it is necessary to interrupt the administration and institute suitable treatment. BENAGOL taste Menthol-Eucalyptol contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children. Treatment with BENAGOL Menthol-Eucalyptol flavor should not be prolonged for more than 3 days due to the risks associated with the accumulation of terpene derivatives, such asexample camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine(due to their lipophilic properties the rate of metabolism and disposal is not known) in tissues and in the brain, in particular neuropsychological disorders. A higher dose than recommended should not be used to avoid an increased risk of adverse drug reactions and disorders associated with overdose (see section 4.9). BENAGOL taste Menthol-Eucalyptol is flammable, it must not be approached to flames.Important information about some of the ingredients: BENAGOL Ginger and Spice flavored tablets, BENAGOL Honey and Lemon flavored tablets, BENAGOL Cold Mint flavored tablets, BENAGOL Menthol-Eucalyptus flavored tablets and BENAGOL Orange flavored Vitamin C tablets contain glucose. Patients with rare hereditary problems of glucose-galactose malabsorption should not take this medicine. BENAGOL Ginger and Spice flavored tablets, BENAGOL Honey and Lemon flavored tablets, BENAGOL Cold Mint tablets, BENAGOL Menthol-Eucalyptus flavored tablets and BENAGOL Orange flavored Vitamin C tablets contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. BENAGOL Sugar-Free Lemon-flavored Tablets and BENAGOL Sugar-Free Strawberry-flavored Tablets contain maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. BENAGOL Ginger and Spice flavor tablets contains excipients capable of inducing a sensation of heat in the mouth and throat when sucking the tablet.

Pregnancy and breastfeeding

In pregnant and lactating women, the product should be administered only in case of real need.Pregnancy: There are no, or limited numbers, of data on the use of the active substances of BENAGOL in pregnant women. BENAGOL taste Menthol-Eucalyptol is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures.Feeding time: It is not known whether the active substances or their metabolites are excreted in human milk. A risk to newborns and infants cannot be excluded. Ascorbic acid or its metabolites are excreted in breast milk.FertilityNo data on the effect on fertility are available. BENAGOL taste Menthol-Eucalyptol is not recommended in women of childbearing potential who are not using contraceptive measures.

Expiration and retention

Do not store above 25 ° C.

Interactions with other drugs

There are no known interactions with other drugs. BENAGOL taste Menthol-Eucalyptol should not be used concomitantly with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation).

Overdose

Any overdose could only cause gastrointestinal disturbances, for which appropriate symptomatic treatments must be adopted. BENAGOL menthol-eucalyptol taste: in case of accidental oral intake or incorrect administration in infants and children there may be a risk of neurological disorders. If necessary, administer appropriate symptomatic treatment in specialized treatment centers.

Active principles

BENAGOL Ginger and Spice flavor tablets: Active ingredients: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg. Excipients with known effects: sucrose and glucose BENAGOL Honey and Lemon flavored tablets: Active ingredients: 2,4-dichlorobenzyl alcohol 1,2 mg; amylmetacresol 0.6 mg. Excipients with known effects: glucose and sucrose BENAGOL Sugar-free Lemon flavor tablets: Active ingredients: 2,4-dichlorobenzyl alcohol 1,2 mg; amylmetacresol 0.6 mg. Excipients with known effects: maltitol BENAGOL Sugar-free Strawberry flavor tablets: Active ingredients: 2,4-dichlorobenzyl alcohol 1,2 mg; amylmetacresol 0.6 mg. Excipients with known effects: maltitol BENAGOL Cold Mint flavor tablets: Active ingredients: 2,4-dichlorobenzyl alcohol 1,2 mg; amylmetacresol 0.6 mg. Excipients with known effects: sucrose and glucose BENAGOL Menthol-Eucalyptol flavor tablets: Active ingredients: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg; menthol 8.0 mg. Excipients with known effects: sucrose and glucose BENAGOL Tablets with Vitamin C Orange flavor: Active ingredients: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg; sodium ascorbate 74.9 mg; ascorbic acid 33.5 mg. Excipients with known effects: sucrose and glucose. For the full list of excipients, see section 6.1.

Excipients

BENAGOL Ginger and Spice flavored tablets: One tablet contains:sucrose,liquid glucose, tartaric acid, anthocyanins (E163), plum flavor, cream flavor, spice flavor, ginger flavor, medium chain triglycerides.BENAGOL Honey and Lemon flavored tablets: One tablet contains: mint essence, lemon essence, tartaric acid, honey,liquid glucose,sucrose.BENAGOL Menthol-Eucalyptol flavor tablets: One tablet contains: indigo carmine (E 132), eucalyptol essence, tartaric acid,liquid sucrose,liquid glucose.BENAGOL Tablets with Vitamin C Orange flavor: One tablet contains:sucrose,liquid glucose, tartaric acid, orange flavor, menthol, propylene glycol.BENAGOL Sugar-free Lemon flavor tablets: One tablet contains: lemon flavor, sodium saccharinate, tartaric acid,maltitol syrup, isomaltose.BENAGOL Strawberry flavored tablets without sugar: One tablet contains: strawberry flavor, anthocyanins (E163), sodium saccharinate, tartaric acid,maltitol syrup, isomaltose.BENAGOL Cold Mint tablets: One tablet contains: xylitol, menthol, mint flavor, eucalyptus oil,liquid sucrose,liquid glucose.