Description
BENAGOL TABLETS
PHARMACOTHERAPEUTIC CATEGORY:
Antiseptic.
DIRECTIONS:
Oral antiseptic.
ACTIVE INGREDIENTS:
Benagol Ginger and Spice Flavored Lozenges.
Active ingredients: 2,4-dichlorob enzyl alcohol 1.2 mg; amylmetacresol 0.6 mg.
Excipients with known effects: liquid sucrose, liquid glucose (containing sulphites and wheat starch), spice flavouring and ginger flavouring (containing cinnamal, citral, citronellol, eugenol, farnesol, geraniol, isoeugenol and linalool).
Benagol Honey and Lemon Flavored Lozenges.
Active ingredients: 2,4-diclo robenzil alcohol 1.2 mg; amylmetacresol 0.6 mg.
Excipients with known effects: liquid glucose (containing sulphites and wheat starch), liquid saccharose, mint essence and lemon essence (containing citral, dilimonene, geraniol and linalool), honey (invert sugar).
Benagol Lemon Flavored Sugar Free Lozenges.
Active ingredients: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg.
Excipients with known effects: liquid maltitol, isomalt, lemon flavouring (containing benzyl alcohol, citral, citronellol, d-limonene, geraniol and linalool).
Benagol Strawberry Flavor Sugar Free Lozenges.
Active ingredients: 2,4-dichlorob enzyl alcohol 1.2 mg; amylmetacresol 0.6 mg.
Excipients with known effects: liquid maltitol, isomalt, strawberry flavouring (containing propylene glycol and benzyl alcohol).
Benagol Cold Mint Flavor Lozenges.
Active ingredients: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg.
Excipients with known effects: liquid sucrose, liquid glucose (containing sulphites and wheat starch), mint flavouring and eucalyptus essence (containing propylene glycol, benzyl alcohol, cinnamyl alcohol, citral, citronellol, d-limonene, eugenol and linalool).
Benagol Pastilles Menthol-Eucalyptus flavour.
Active ingredients: 2,4-dichlorobenzyl alcool 1.2 mg; amylmetacresol 0.6 mg; menthol 8.0 mg.
Excipients with known effects: liquid sucrose, liquid glucose (containing sulphites and wheat starch) and eucalyptus essence (containing d-limonene).
Benag ol Orange flavor Vitamin C tablets.
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: liquid sucrose, liquid glucose (containing sulphites and wheat starch), orange flavouring (containing citral, citronellol, d-limonene, geraniol, linalool), propylene glycol.
For the full list of excipients, see section 6.1.
EXCIPIENTS:
Benagol Ginger and Spice Flavored Lozenges.
One tablet contains: liquid sucrose, liquid glucose (containing sulphites and wheat starch), tartaric acid, oenocyanin (E163) (containing sodium), plum flavouring, cream flavouring, spice flavouring and ginger flavouring (containing cinnamal, citral, citronellol, eugenol, farnesol, geraniol, isoeugenol and linalol), medium chain saturated triglycerides.
Benagol Honey and Lemon Flavored Lozenges.
One tablet contains: mint essence and lemon essence (containing citral, d-limonene, geraniol and linalool), tartaric acid, honey (invert sugar), liquid glucose (containing sulphites and wheat starch), liquid sucrose.
Benagol Menthol-Eucalyptus flavour lozenges.
One tablet contains: indigo carmine (E 132) (containing sodium), eucalyptus essence (containing d-limonene), tartaric acid, liquid sucrose, liquid glucose (containing sulphites and wheat starch).
Benagol Orange Flavored Vitamin C Tablets.
One lozenge contains: liquid sucrose, liquid glucose (containing sulphites and wheat starch), tartaric acid, orange flavour (containing citral, citronellol, d-limonene, geraniol and linalool), levomenthol, propylene glycol.
Benagol Lemon Flavor Sugar Free Lozenges.
One tablet contains: lemon flavour (containing benzyl alcohol, citrate, citronellol, d-limonene, geraniol and linalool), sodium saccharin, tartaric acid, liquid maltitol, isomalt.
Benagol Strawberry Flavor Sugar Free Lozenges.
One tablet contains: strawberry flavour (containing propylene glycol and benzyl alcohol), anthocyanins (E163) (containing sodium), sodium saccharin, tartaric acid, liquid maltitol, isomalt.
Benagol Cold Mint Flavor Lozenges.
One tablet contains: xylitol, levomenthol, mint flavour and eucalyptus essence (containing propylene glycol, benzyl alcohol, cinnamyl alcohol, citral, citronellol, d-limonene, eugenol and linalool), liquid sucrose, liquid glucose (containing sulphites and wheat starch).
DOSAGE:
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 flavour and Benagol Cold Mint flavour, 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 Cold Mint flavour and Benagol Ginger and Spice flavour to adults and children over 12 years of age.
The duration of treatment with Benagol Menthol-Eucalyptus flavour should not exceed 3 days.
Benagol Lemon flavour Sugar Free and Benagol Strawberry flavour Sugar Free are suitable for those patients who need to control their sugar and calorie intake.
Elderly population: no data available.
Method of administration: oromucosal administration.
The tablet should be dissolved slowly in the mouth.
WARNINGS:
Be careful with preschool children as tablets swallowed whole may cause choking.
If sensitization or irritation phenomena appear, administration must be discontinued and appropriate treatment instituted.
Benagol gusta Menthol-Eucalyptus contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in newborns and children.
Treatment with Benagol Menthol-Eucalyptus flavour should not be prolonged for more than 3 days due to the risks associated with the accumulation of terpenic derivatives, such as camphor, cineole, neole, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine (due to their lipophilic properties, the speed of metabolism and disposal is not known) in the tissues and in the brain, in particular neuropsychological disorders.
A dose higher than the recommended one should not be used to avoid an increased risk of adverse reactions to the medicinal product and disorders associated with overdose (see section 4.9).
Benagol Menthol-Eucalyptus flavour is flammable, it must not be brought close to flames.
Important information about some of the excipients.
Benagol Pastilles Ginger and Spice flavour, Benagol Pastilles Honey and Lemon flavour, Benagol Pastilles Menthol-Eucalyptol flavour, Benagol Pastilles with Vitamin C Orange flavour, Benagol Pastilles Cold Mint flavour contain liquid glucose: patients with rare hereditary problems of glucose-galactose malabsorption should not take this medicine.
To be taken into consideration in people with diabetes mellitus: Benagol Ginger and Spice flavour lozenges contain 1.10 g of glucose per lozenge; Benagol Honey and Lemon flavour lozenges contain 0.98 g of glucose per lozenge; Benagol Menthol-Eucalyptol flavour lozenges contain 1.01 g of glucose per lozenge; Benagol Orange flavour lozenges with Vitamin C contain 0.97 g of glucose per lozenge; Benagol Cold Mint flavour lozenges contain 1.10 g of glucose per lozenge; liquid glucose contains sulphites.
These medicines can rarely cause severe hypersensitivity reactions and bronchospasm; liquid glucose contains wheat starch.
These medicines contain only a very small amount of gluten (from wheat starch).
These medicines are considered "gluten-free" and are very unlikely to cause problems if the patient has celiac disease.
One Benagol Pastiglie Ginger and Spice flavour tablet contains no more than 22.04 micrograms of gluten.
One tablet of Benagol Pastiglie gus to Honey and Lemon contains no more than 19.52 micrograms of gluten.
One Benagol Menthol-Eucalyptus flavour tablet contains no more than 20.26 micrograms of gluten.
One tablet of Benagol Pastilles with Vitamin C, Orange flavour, contains no more than 19.38 micrograms of gluten.
One tablet of Benagol Pastiglie Mint Cold flavour contains no more than 22.04 micrograms of gluten.
If the patient is allergic to wheat (a condition other than celiac disease) he/she should not take these medicines.
Liquid sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
To be taken into consideration by people suffering from diabetes mellitus: Benagol Ginger and Spice flavoured lozenges contain 1.38 g of sucrose per lozenge; Benagol Honey and Lemon flavoured lozenges contain 1.44 g of sucrose per lozenge; Benagol Menthol-Eucalyptol flavoured lozenges contain 1.50 g of sucrose per lozenge; Benagol Orange flavoured lozenges with Vitamin C contain 1.44 g of sucrose per lozenge; Benagol Cold Mint flavoured lozenges contain 1.38 g of sucrose per lozenge.
Benagol Ginger and Spice flavoured lozenges, Benagol Menthol-Eucalyptol flavoured lozenges, Benagol Orange flavoured lozenges with Vitamin C, Benagol Lemon flavoured lozenges Sugar Free, Benagol Strawberry flavoured lozenges Sugar Free: these medicines contain less than 1 mmol (23 mg) sodium per dose, that is to say essentially "sodium-free".
Benagol Lemon Flavor Sugar-Free Lozenges and Benagol Strawberry Flavor Sugar-Free Lozenges: these medicines contain liquid maltitol and isomalt.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
They may have a mild laxative effect.
The calorific value of maltitol and isomalt is 2.3 kcal/g.
Benagol Pastilles taste Ginger and Spices: this medicine contains a flavouring which in turn contains cinnamal, citral, citronellol, eugenol, farnesol, geranium, isoeugenol and linalool.
Cinnamal, citral, citronellol, eugenol, farnesol, geraniol, isoeugenol and linalool may cause allergic reactions.
This medicine contains excipients which may induce a sensation of heat in the mouth and throat when sucking the lozenge.
Benagol Honey and Lemon Flavored Pastilles: this medicine contains a flavoring which in turn contains citral, d-limonene, geraniol and linalool.
Citral, d-limonene, geraniol and linalool may cause allergic reactions.
This medicine contains honey (sugar or invert).
Patients with rare hereditary problems of fructose intolerance or glucose-galactose malabsorption should not take this medicine.
Benagol Menthol-Eucaliptol flavour pastilles: this medicine contains a flavouring which in turn contains dlimonene.
D-limonene may cause allergic reactions.
Benagol Pastiglies with Vitamin C Orange Flavour: this medicine contains a flavouring which in turn contains citral, citronellol, d-limonene, geraniol and inhalol.
Citral, citronellol, d-limonene, geraniol and linalool may cause allergic reactions.
This medicine contains 3 mg propylene glycol per lozenge.
Benagol Lemon Flavored Sugar Free Lozenges: this medicine contains a flavoring which in turn contains benzyl alcohol, citral, citronellol, d-limonene, geraniol and linalool.
Benzyl alcohol, citral, citronellol, d-limonene, geraniol and linalol may cause allergic reactions.
Benagol Strawberry Flavored Sugar Free Lozenges: this medicine contains a flavoring which in turn contains benzyl alcohol.
Benzyl alcohol may cause allergic reactions.
This medicine contains 7.30 mg propylene glycol in each lozenge.
Benagol Cold Mint Flavor Pastilles: this medicine contains a flavoring which in turn contains benzyl alcohol, cinnamyl alcohol, citral, citronellol, d-limonene, eugenol and linalool.
Benzyl alcohol, cinnamyl alcohol, citral, citronellol, d-limonene, eugenol and linalool may cause allergic reactions.
This medicine contains 1.89 mg propylene glycol in each lozenge.
CONSERVATION:
Do not store above 25 degrees C.
CONTRAINDICATIONS/SIDE EFFECTS:
Hypersensitivity to the active substances or to any of the excipients listed in paragraph 6.1.
Do not administer to children under 6 years of age.
Benagol Menthol-Eucalyptus flavour is contraindicated in children with a history of epilepsy or febrile convulsions.
Do not administer Benagol Cold Mint flavour and Benagol Ginger and Spice flavour to children under 12 years of age.
INTERACTIONS:
No interactions with other drugs are known.
Benagol Menthol-Eucalyptus flavour must 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).
SIDE EFFECTS:
Benagol Menthol flavor.
Eucalyptol: due to the presence of menthol and in case of non-compliance with 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, levomenthol and ascorbic acid are listed below, divided by frequency and organ class.
Frequencies are defined as: very common (>=1/10); common (>=1/100 and <1/10); uncommon (>=1/1000 and <1/100); rare (>=1/10000 and <1/1000); very rare (<1/10000); not known (frequency cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Immune system disorders.
Rare: hypersensitivity.
Gastrointestinal disorders.
Rare: glossitis; not known: abdominal pain, nausea, gastrointestinal discomfort.
Pathologies of the skin and subcutaneous tissue.
Not known: skin rash.
Reporting of suspected 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 https://www.aifa.gov .it/content/segnalazioni-reazioni-avverse.
PREGNANCY AND BREASTFEEDING:
In pregnant and breastfeeding women, the product should be administered only if strictly necessary.
Pregnancy: There are no or limited amount of data from the use of the active ingredients of Benagol in pregnant women.
Benagol flavour Menthol-Eucalyptus is not recommended during pregnancy and in women of childbearing age who do not use contraceptive measures.
Breastfeeding: It is not known whether the active substances or their metabolites are excreted in breast milk.
A risk to newborns and infants cannot be excluded.
Ascorbic acid or its metabolites are excreted in breast 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.
