BENAGOL 16PAST EUCALIP MENT

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-Eucalyptus taste should not be prolonged for more than 3 days for the risks associated with the accumulation of terpenic derivatives, such as example canphora, cineol, niaouli, wild thyme, terpineol, terpineol, citral, menthol and essential oils of pine needles, eucalyptus and trementina (due to their lipophilic properties it is not known the speed of metabolism and disposal) in tissues and brains, especially neuropsychological disorders. A dose higher than the recommended dose should not be used to avoid greater risk of adverse reactions to the medicinal product and overdosage disorders (see paragraph 4.9). BENAGOL menthol-Eucalyptus taste is flammable, it should not be approached to flames. Important information about some excipients: BENAGOL Ginger and Spices taste, BENAGOL Pastiglie gusto Miele e Limone, BENAGOL Pastiglie gusto Menta Fredda, BENAGOL Pastiglie gusto Mentolo-Eucaliptolo e BENAGOL Pastels with Vitamin C flavor Orange contain glucose. Patients suffering from rare hereditary problems of glucose-galactose disease should not take this medicine. BENAGOL Ginger and Spices taste, BENAGOL Pastiglie gusto Miele e Limone, BENAGOL Pastiglie gusto Menta Fredda, BENAGOL Pastiglie gusto Mentolo-Eucaliptolo e BENAGOL Pastels with Vitamin C flavor Orange contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. BENAGOL Pastiglie taste Lemon Without Sugar 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-Eucalyptol taste should not be used in conjunction with other products (medicinal or cosmetic) containing terpenic derivatives, regardless of the way of administration (oral, rectal, cutaneous, nasal or inhalation).

Effects

BENAGOL menthol - Eucalyptus: due to the presence of menthol and in case of non-compliance with recommended doses, a risk of seizures in children and infants may arise. Adverse reactions associated with the use of 2.4 dichlorobenzil alcohol, amilmetacresolo, levomentol 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 diseases Rare Glossiti Notable Abdominal pain, nausea, gastrointestinal disease Pathologies of skin and subcutaneous tissue Notable Skin rash Reporting of suspicious adverse reactions . The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Any overdose could only cause gastrointestinal disorders, for which appropriate symptomatic treatments should be adopted. BENAGOL menthol-Eucalyptus taste: In case of accidental oral intake or incorrect administration in infants and children, the risk of neurological disorders may arise. If necessary, administer appropriate symptomatic treatment in specialized care centers.

In pregnant women and during breastfeeding, the product should only be administered in case of actual need. Pregnancy: There are, or are available in limited number, data relating to the use of active ingredients of BENAGOL in pregnant women. BENAGOL menthol-Eucalyptus taste is not recommended during pregnancy and in women in fertile age who do not use contraceptive measures. Food: It is not known whether the active ingredients or their metabolites are excreted in breast milk. The risk for infants and infants cannot be excluded. Ascorbic acid or metabolites are excreted in breast milk. Fertility No fertility effect data is available. BENAGOL menthol-Eucalyptus taste is not recommended in women of fertile age who do not use contraceptive measures.

Source: Farmadati