Benagol cold mint - 24 throat lozenges

Product Description

Benagol cold mint flavor is an oral antiseptic.

Indications

Oral antiseptic.

Composition

Active ingredients

Active ingredients: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg.

Excipients with known effect: liquid sucrose, liquid glucose (containing sulphites and wheat starch), mint and eucalyptus essence flavouring (containing propylene glycol, benzyl alcohol, cinnamyl alcohol, citral, citronellol, d-limonene, eugenol and linalool).

Excipients

One lozenge contains: xylitol, levomenthol, mint and eucalyptus essence flavouring (containing propylene glycol, benzyl alcohol, cinnamyl alcohol, citral, citronellol, d-limonene, eugenol and linalool), liquid sucrose, liquid glucose (containing sulphites and wheat starch).

Directions for use and Dosage

Posology

The lowest effective dose should be used for the longest duration. short as needed to relieve symptoms.

• Adults and children over 6 years of age: One lozenge every 2 or 3 hours.
• Children over 6 years of age: Consult your doctor for an appropriate dosage.
• Maximum doses:
  • Do not exceed the daily maximum of 8 lozenges.
• BENAGOL cold mint flavour: Administer to adults and children over 12 years of age.
• Elderly population: No data available.

Method of administration

Oromucosal administration. The lozenge should be dissolved slowly in the mouth.

Warnings

Important warnings:

• Pay attention to preschool children, as swallowing whole lozenges can cause choking.
• If sensitization or irritation occurs, discontinue administration and initiate appropriate treatment.
• BENAGOL Menthol-Eucalyptol flavor contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in newborns and children.
• Treatment with BENAGOL Menthol-Eucalyptol flavor should not be prolonged for more than 1 month. of 3 days due to the risks associated with the accumulation of terpene derivatives (such as camphor, cineole, niaouli, wild thyme, terpineol, terpin, citral, menthol and essential oils of pine needles, eucalyptus and turpentine) in tissues and the brain, particularly neuropsychological disorders. Due to their lipophilic properties, the rate of metabolism and disposal is not known.
• A dose higher than the recommended one should not be used to avoid a greater risk of adverse reactions to the medicinal product and disorders associated with overdose (see section 4.9 of the package leaflet).
• BENAGOL Menthol-Eucalyptol flavour is flammable, it should not be brought close to flames.

Important information about some of the excipients:

• Liquid glucose: BENAGOL Ginger and Spice flavoured lozenges, BENAGOL Honey and Lemon flavoured lozenges, BENAGOL Menthol-Eucalyptol flavoured lozenges, BENAGOL Orange flavoured lozenges with Vitamin C, BENAGOL Cold Mint flavoured lozenges contain liquid glucose.

  • Patients with rare hereditary problems of malabsorption of glucose-galactose should not take this medicine.
  • To be taken into account in people with diabetes mellitus:
    • BENAGOL Ginger and Spice flavoured Lozenges contain 1.10 g of glucose per lozenge.
    • BENAGOL Honey and Lemon flavoured Lozenges contain 0.98 g of glucose per lozenge.
    • BENAGOL Menthol-Eucalyptol flavoured Lozenges contain 1.01 g of glucose per lozenge.
    • BENAGOL Orange flavoured Lozenges with Vitamin C contain 0.97 g of glucose per lozenge.
    • BENAGOL Cold Mint flavoured Lozenges contain 1.10 g of glucose per lozenge.
  • Liquid glucose contains sulphites, which can rarely cause serious hypersensitivity reactions and bronchospasm.
  • Liquid glucose contains wheat starch. These medicines contain only a very small amount of gluten (from wheat starch) and are considered "gluten-free". They are very unlikely to cause problems if the patient is coeliac.
    • One BENAGOL Ginger and Spice flavoured lozenge contains no more than 22.04 micrograms of gluten.
    • One BENAGOL Honey and Lemon flavoured lozenge contains no more than 19.52 micrograms of gluten.
    • One BENAGOL Menthol-Eucalyptol flavoured lozenge contains no more than 20.26 micrograms of gluten.
    • One BENAGOL Orange flavoured Lozenges with Vitamin C contains no more than 19.38 micrograms of gluten.
    • One BENAGOL Cold Mint flavoured lozenge contains no more than 22.04 micrograms of gluten. of 22.04 micrograms of gluten.
  • If the patient is allergic to wheat (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 in people with 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 Honey and Lemon flavoured lozenges contain 1.44 g of sucrose per lozenge.
    • BENAGOL Menthol-Eucalyptol contains 1.50 g of sucrose per lozenge.
    • BENAGOL Orange-flavored Lozenges with Vitamin C contain 1.44 g of sucrose per lozenge.
    • BENAGOL Cold Mint-flavored Lozenges contain 1.38 g of sucrose per lozenge.

• Sodium: BENAGOL Ginger and Spice-flavored Lozenges, BENAGOL Menthol-Eucalyptol-flavored Lozenges, BENAGOL Orange-flavored Lozenges with Vitamin C, BENAGOL Lemon-flavored Lozenges Sugar-Free, BENAGOL Strawberry-flavored Lozenges Sugar-Free contain less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

• Liquid maltitol and isomalt: BENAGOL Lemon Flavored Sugar-Free Lozenges and BENAGOL Strawberry Flavored Sugar-Free Lozenges 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 caloric value of maltitol and isomalt is 2.3 kcal/g.

• Flavors:

  • BENAGOL Ginger and Spice Flavored Lozenges: contain a flavoring containing cinnamal, citral, citronellol, eugenol, farnesol, geraniol, isoeugenol, and linalool. These substances may cause allergic reactions. This medicine contains excipients that may induce a sensation of heat in the mouth and throat when sucking the lozenge.
  • BENAGOL Honey and Lemon Flavored Lozenges: contains a flavoring containing citral, d-limonene, geraniol, and linalool. These substances may cause allergic reactions. This medicine contains honey (invert sugar). Patients with rare hereditary problems of fructose intolerance or glucose-galactose malabsorption should not take this medicine.
  • BENAGOL Menthol-Eucalyptol Flavored Lozenges: contains a flavoring containing d-limonene, which may cause allergic reactions.
  • BENAGOL Orange Flavored Lozenges with Vitamin C: contains a flavoring containing citral, citronellol, d-limonene, geraniol, and linalool. These substances may cause allergic reactions. This medicine contains 3 mg of propylene glycol per lozenge.
  • BENAGOL Lemon Flavored Sugar-Free Lozenges: contains a flavoring containing benzyl alcohol, citral, citronellol, d-limonene, geraniol, and linalool. These substances may cause allergic reactions.
  • BENAGOL Strawberry Flavored Sugar-Free Lozenges: contains a flavoring containing benzyl alcohol, which may cause allergic reactions. This medicine contains 7.30 mg of propylene glycol in each lozenge.
  • BENAGOL Cold Mint Flavored Lozenges: contains a flavoring containing benzyl alcohol, cinnamyl alcohol, citral, citronellol, d-limonene, eugenol, and linalool. These substances may cause allergic reactions. This medicine contains 1.89 mg of propylene glycol in each lozenge.

Undesirable effects

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 of the package leaflet.
• Do not administer to children under 6 years of age.
• BENAGOL menthol-eucalyptol 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.

Pregnancy and breastfeeding

In pregnant and breastfeeding women, the product should be administered only if strictly necessary.

• Pregnancy: There are no or limited data on the use of the active ingredients of BENAGOL in pregnant women. BENAGOL Menthol-Eucalyptol flavour is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures.
• Breastfeeding: It is not known whether the active ingredients 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-Eucalyptol flavour is not recommended in women of childbearing potential who are not using contraceptive measures.

Format

24 Tablets