Benagol 16 tablets with vitamin C orange flavour

Benagol with Vitamin C is a throat antiseptic formulated to relieve sore throat and protect the oropharyngeal mucosa. Thanks to the combination of 2,4-dichlorobenzyl alcohol and amylmetacresol , it has an antibacterial and disinfectant action, helping to combat the microorganisms responsible for irritation.

Enriched with Vitamin C , these tablets contribute to the normal functioning of the immune system, offering a double benefit against flu symptoms. The orange flavor makes them pleasant to take, while the orosoluble formulation guarantees a gradual release for prolonged relief. The pack of 16 tablets is ideal for a practical and effective treatment.

ACTIVE INGREDIENTS

Active ingredients contained in Benagol 16 tablets with vitamin C orange flavour - What is the active ingredient of Benagol 16 tablets with vitamin C orange flavour?

BENAGOL Ginger and Spice 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), spice flavoring and ginger flavoring (containing cinnamal, citral, citronellol, eugenol, farnesol, geraniol, isoeugenol and linalool). BENAGOL Honey and Lemon Flavor Lozenges Active ingredients: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg. Excipients with known effects: liquid glucose (containing sulphites and wheat starch), liquid sucrose, mint essence and lemon essence (containing citral, d-limonene, geraniol and linalool), honey (invert sugar). BENAGOL Lemon flavoured lozenges Sugar Free 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 flavoured lozenges Sugar Free Active ingredients: 2,4-dichlorobenzyl 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 flavoured 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 flavour and eucalyptus essence (containing propylene glycol, benzyl alcohol, cinnamyl alcohol, citral, citronellol, d-limonene, eugenol and linalool). BENAGOL Menthol-Eucalyptus flavour lozenges Active ingredients: 2,4-dichlorobenzyl alcohol 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). BENAGOL Orange flavour lozenges with Vitamin C 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 effect: liquid sucrose, liquid glucose (containing sulphites and wheat starch), orange flavour (containing citral, citronellol, d-limonene, geraniol, linalool), propylene glycol. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Benagol 16 tablets with vitamin C orange flavor - What does Benagol 16 tablets with vitamin C orange flavor contain?

BENAGOL Ginger and Spice Flavor Lozenges : One lozenge contains: liquid sucrose, liquid glucose (containing sulphites and wheat starch), tartaric acid, anthocyanins (E163) (containing sodium), plum flavoring, cream flavoring, spice flavoring and ginger flavoring (containing cinnamal, citral, citronellol, eugenol, farnesol, geraniol, isoeugenol and linalool), medium chain saturated triglycerides. BENAGOL Honey and Lemon Flavor Lozenges : One lozenge 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 lozenge 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 flavour lozenges with Vitamin C : One lozenge contains: liquid sucrose, liquid glucose (containing sulphites and wheat starch), tartaric acid, orange flavouring (containing citral, citronellol, d-limonene, geraniol and linalool), levomenthol, propylene glycol. BENAGOL Lemon Flavored Sugar Free Lozenges : One lozenge contains: lemon flavoring (containing benzyl alcohol, citral, citronellol, dilimonene, geraniol and linalool), sodium saccharin, tartaric acid, liquid maltitol, isomalt. BENAGOL Strawberry Flavored Sugar Free Lozenges : One lozenge contains: strawberry flavoring (containing propylene glycol and benzyl alcohol), anthocyanins (E163) (containing sodium), sodium saccharin, tartaric acid, liquid maltitol, isomalt. BENAGOL Cold Mint Flavor Lozenges : One lozenge contains: xylitol, levomenthol, mint flavor 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).

DIRECTIONS

Therapeutic indications Benagol 16 tablets with vitamin C orange flavor - Why is Benagol 16 tablets with vitamin C orange flavor used? What is it for?

Oral antiseptic.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Benagol 16 tablets with vitamin C orange flavor - When should Benagol 16 tablets with vitamin C orange flavor not be used?

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-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.

DOSAGE

Quantity and method of taking Benagol 16 tablets with vitamin C orange flavor - How to take Benagol 16 tablets with vitamin C orange flavor?

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 maximum daily dose of 8 tablets. For all other flavours 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.

CONSERVATION

Storage Benagol 16 tablets with vitamin C orange flavour - How to store Benagol 16 tablets with vitamin C orange flavour?

Do not store above 25°C.

WARNINGS

Warnings Benagol 16 tablets with vitamin C orange flavour - About Benagol 16 tablets with vitamin C orange flavour it is important to know that:

Be careful with preschool children as if the tablets are swallowed whole they may cause choking. If sensitization or irritation occurs, administration should be stopped and appropriate treatment should be instituted. BENAGOL Menthol-Eucalyptus flavour contains terpene derivatives which, in excessive doses, may cause neurological disorders such as convulsions in infants 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 terpene derivatives, such as camphor, cineole, niaouli, wild thyme, terpineol, terpin, citral, menthol and essential oils of pine needles, eucalyptus and turpentine (due to their lipophilic properties the speed of metabolism and disposal is unknown) in the tissues and brain, in particular neuropsychological disorders. A higher dose than recommended should not be used to avoid a higher risk of adverse reactions to the medicinal product 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 of the excipients BENAGOL Ginger and Spice flavour Lozenges, BENAGOL Honey and Lemon flavour Lozenges , BENAGOL Menthol-Eucalyptol flavour Lozenges, BENAGOL Orange flavour Lozenges with Vitamin C, BENAGOL Cold Mint flavour Lozenges 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-Eucalyptus 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 serious 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 is coeliac. One lozenge of BENAGOL Ginger and Spice flavour lozenges contains no more than 22.04 micrograms of gluten. One lozenge of BENAGOL Honey and Lemon flavour lozenges contains no more than 19.52 micrograms of gluten. One tablet of BENAGOL Menthol-Eucalyptus flavour 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 Pastilles Cold Mint flavour contains no more than 22.04 micrograms of gluten. If the patient is allergic to wheat (other than coeliac 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 Pastilles Ginger and Spice flavour contains 1.38 g of sucrose per tablet. BENAGOL Pastilles Honey and Lemon flavour contains 1.44 g of sucrose per tablet. 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, BENAGOL Lemon flavoured lozenges Sugar Free, BENAGOL Strawberry flavoured lozenges Sugar Free These medicines contain less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”. BENAGOL Lemon flavoured lozenges Sugar Free and BENAGOL Strawberry flavoured lozenges Sugar Free 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 caloric value of maltitol and isomalt is 2.3 kcal/g. BENAGOL Ginger and Spice flavour lozenges This medicine contains a flavouring containing cinnamal, citral, citronellol, eugenol, farnesol, geraniol, isoeugenol and linalool. Cinnamal, citral, citronellol, eugenol, farnesol, geraniol, isoeugenol and linalool 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 flavour lozenges This medicine contains a flavouring containing citral, d-limonene, geraniol and linalool. Citral, d-limonene, geraniol and linalool may cause allergic reactions. This medicinal product contains honey (invert sugar). Patients with rare hereditary problems of fructose intolerance or glucose-galactose malabsorption should not take this medicine. BENAGOL Menthol-Eucalyptol flavour lozenges This medicinal product contains a flavouring containing d-limonene. D-limonene may cause allergic reactions. BENAGOL Orange flavour lozenges with Vitamin C This medicinal product contains a flavouring containing citral, citronellol, d-limonene, geraniol and linalool. Citral, citronellol, d-limonene, geraniol and linalool may cause allergic reactions. This medicinal product contains 3 mg of propylene glycol per lozenge. BENAGOL Lemon Flavour Lozenges Sugar Free This medicine contains a flavouring containing benzyl alcohol, citral, citronellol, d-limonene, geraniol and linalool. Benzyl alcohol, citral, citronellol, d-limonene, geraniol and linalool may cause allergic reactions. BENAGOL Strawberry Flavour Lozenges Sugar Free This medicine contains a flavouring containing benzyl alcohol. Benzyl alcohol may cause allergic reactions. This medicine contains 7.30 mg of propylene glycol in each lozenge. BENAGOL Cold Mint Flavour Lozenges This medicine contains a flavouring containing 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.

INTERACTIONS

Interactions Benagol 16 tablets with vitamin C orange flavour - Which medicines or foods can modify the effect of Benagol 16 tablets with vitamin C orange flavour?

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

Like all medicines, Benagol 16 tablets with vitamin C orange flavour can cause side effects - What are the side effects of Benagol 16 tablets with vitamin C orange flavour?

BENAGOL Menthol - Eucalyptus flavour: 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 <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 decreasing order of seriousness.

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.

OVERDOSE

Overdose Benagol 16 tablets with vitamin C orange flavor - What are the risks of Benagol 16 tablets with vitamin C orange flavor in case of overdose?

Any overdose could only cause gastrointestinal disorders, for which appropriate symptomatic treatments must be adopted. BENAGOL Menthol-Eucalyptol flavor: in case of accidental oral intake or incorrect administration in newborns and children, the risk of neurological disorders may occur. If necessary, administer appropriate symptomatic treatment in specialized care centers.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Benagol 16 tablets with vitamin C, orange flavour.

In pregnant women and during breastfeeding, the product should be administered only if really necessary. Pregnancy There are no, or limited, data 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. 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-Eucalyptus flavour is not recommended in women of childbearing age who do not use contraceptive measures.

DRIVING AND USE OF MACHINERY

Take Benagol 16 lozenges with vitamin C orange flavour before driving or using machinery - Does Benagol 16 lozenges with vitamin C orange flavour affect driving or using machinery?

No effects on the ability to drive or use machines have been reported.