BENAGOL 16PAST LEMON S/Z

BENAGOL PILLS

active ingredients

BENAGOL Ginger and Spices taste: Active ingredients: 2,4-diclorobenzil alcohol 1.2 mg; amilmetacreonly 0.6 mg. Excipients with known effects: sucrose and glucose BENAGOL Honey and Lemon Taste Pastels: Active ingredients: 2,4-diclorobenzil alcohol 1.2 mg; amilmetacreonly 0.6 mg. Excipients with known effects: glucose and sucrose BENAGOL Taste Pastiglie Limone Senza Zucchero: Active ingredients: 2,4-diclorobenzil alcohol 1.2 mg; amilmetacreonly 0.6 mg. Excipients with known effects: maltitol BENAGOL Taste strawberry without sugar: Active ingredients: 2,4-diclorobenzil alcohol 1.2 mg; amilmetacreonly 0.6 mg. Excipients with known effects: maltitol BENAGOL Pastiglie gusto Menta Fredda: Active ingredients: 2,4-diclorobenzil alcohol 1.2 mg; amilmetacreonly 0.6 mg. Excipients with known effects: sucrose and glucose BENAGOL Pastiglie gusto Mentolo-Eucaliptolo: Active ingredients: 2,4-diclorobenzil alcohol 1.2 mg; amilmetacreonly 0.6 mg; menthol 8,0 mg. Excipients with known effects: sucrose and glucose BENAGOL Pastiglie with Vitamin C flavor Orange: Active ingredients: 2,4-diclorobenzil alcohol 1.2 mg; amilmetacreonly 0.6 mg; sodium ascorbate 74,9 mg; ascorbic acid 33,5 mg. For the full list of excipients, see paragraph 6.1.

Excellent

BENAGOL Ginger and Spizie taste pads: A pastel contains: sucrose, , liquid glucose, tartaric acid, antocianine (E163), plum aroma, cream aroma, spices aroma, ginger aroma, medium chain triglycerides. BENAGOL Honey and Lemon Taste Pastillas: A pastilla contains: mint essence, lemon essence, tartaric acid, honey, liquid glucose, , sucrose.BENAGOL Pastiglie gusto Mentolo-Eucaliptolo: A pastel contains: carmine indigo (E 132), eucalyptus essence, tartaric acid, liquid sucrose, , liquid glucose. . BENAGOL Pastiglie with Vitamin C flavor Orange: A pastel contains: sucrose, , liquid glucose, tartaric acid, orange aroma, menthol, propylene glycol. BENAGOL Taste Pastillas Lemon Without Sugar: A pastel contains: lemon aroma, sodium saccharin, tartaric acid, maltitol syrup, isomaltosio. BENAGOL Strawberry Without Sugar: A pastel contains: strawberry aroma, anthocyanin (E163), sodium saccharin, tartaric acid, maltitol syrup, isomaltosio. BENAGOL Pastillas taste Cold Menta: A pastel contains: xylitol, menthol, mint aroma, eucalyptus oil, liquid sucrose, , liquid glucose.

Therapeutic indications

Oral cable antiseptic.

Contraindications

Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. Do not administer children under the age of 6. BENAGOL menthol-Eucalyptol taste is contraindicated in children with a history of epilepsy or fever seizures. Do not administer BENAGOL taste Cold mint and BENAGOL taste Ginger and Spices at children under the age of 12.

Population

Population: The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. Adults and children over 6 years of age: A pill 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 flavor Orange and BENAGOL taste Cold mint, do not exceed the maximum daily of 8 tablets. For all other tastes of BENAGOL, do not exceed the maximum daily dose of 12 tablets. To administer BENAGOL taste Cold mint and BENAGOL taste Ginger and Spices for adults and children over 12 years old. The duration of treatment with BENAGOL taste Menthol-Eucalyptus should not exceed 3 days. BENAGOL taste Lemon Without Sugar and BENAGOL strawberry Without Sugar are suitable for those patients who need to control the intake of sugar and calories. Old population: Data is not available. Method of administration: Horomucosal administration. The batter is slowly dissolved in the mouth.

Conservation

Do not store at temperature above 25°C.

Warnings

Pay attention to preschool children as if the tablets are swallowed whole can cause suffocation. In the event of the appearance of sensitization or irritative phenomena, it is necessary to stop the administration and establish suitable treatment. BENAGOL menthol-Eucalyptol taste contains terpenic derivatives which, in excessive doses, can cause neurological disorders as convulsions in infants and children. Treatment with BENAGOL menthol-Eucalyptol flavour should not be prolonged for more than 3 days due to the risks associated with the accumulation of terpene derivatives, such as example camphor, cineole, niaouli, wild thyme, terpineol, terpin, citral, menthol and essential oils of pine needle, eucalyptus and turpentine (due to their lipophilic properties, the rate of metabolism and disposal is unknown) in tissues and the brain, in particular neuropsychological disorders.A dose higher 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 menthol-Eucalyptol flavour is flammable, it should not be brought close to flames. Important information about some excipients: BENAGOL Ginger and Spices taste, BENAGOL Honey and Lemon Flavored Lozenges, BENAGOL Cold Mint Flavored Lozenges, BENAGOL Menthol-Eucalyptol flavoured lozenges and BENAGOL Orange flavour Vitamin C tablets contain glucose.Patients with rare hereditary problems of glucose-galactose malabsorption should not take this medicine. BENAGOL Ginger and Spices taste, BENAGOL Honey and Lemon Flavored Lozenges, BENAGOL Cold Mint Flavored Lozenges, BENAGOL Menthol-Eucalyptol flavoured lozenges and BENAGOL Orange flavour 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 Lemon Flavored Sugar Free Lozenges and BENAGOL Taste strawberry without sugar contain maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. BENAGOL Ginger and Spizie taste pads contain excipients that can induce a feeling of warmth in the mouth and throat during the suction of the pastel.

Interactions

There are no known interactions with other drugs. BENAGOL menthol-Eucalyptus flavour should not be used in conjunction with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation).

Effects

BENAGOL flavour Menthol - Eucalyptol: due to the presence of menthol and in case of non-compliance with the recommended doses, a risk of convulsions may occur in children and infants.Adverse reactions associated with the use of 2,4 dichlorobenzyl alcohol, amylmetacresol, levomenthol and ascorbic acid are listed below, divided by frequency and organ class.The frequencies are defined as: Very common (≥1/10);Common (≥1/100 and Classification for systems and organs Frequency Adverse reactions Immune system pathologies Rare Hypersensitivity Gastrointestinal disorders Rare Glossitis Notable Abdominal pain, nausea, gastrointestinal discomfort Pathologies of skin and subcutaneous tissue Notable Rash Reporting of suspicious adverse reactions . Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Any overdose may only cause gastrointestinal disturbances, for which appropriate symptomatic treatments should be adopted. BENAGOL menthol-Eucalyptol flavor: 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 care centers.

In pregnant and breastfeeding women, the product should be administered only if strictly necessary. Pregnancy: There are no, or limited, data available on the use of the active ingredients of BENAGOL in pregnant women. BENAGOL menthol-Eucalyptus flavour is not recommended during pregnancy and in women of childbearing age who do not use contraceptive measures. Food: 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 human milk. Fertility No data are available on the effect on fertility. BENAGOL menthol-Eucalyptus flavour is not recommended in women of childbearing age who do not use contraceptive measures.

Source: Farmadati