Benactiv Throat Honey Lemon 16 Lozenges

Benactiv Gola Miele Limone is an over-the-counter analgesic medicine based on flurbiprofen indicated to relieve sore throat and associated cough, providing long-lasting relief for up to 6 hours.

Benactiv Gola Miele Limone combines flurbiprofen, an active ingredient that is analgesic and anti-inflammatory, with the emollient action of a tablet. It penetrates from the surface to the deepest layers of the throat tissue and combats irritative-inflammatory conditions of the oropharyngeal cavity, also associated with pain, such as gingivitis, pharyngitis and stomatitis.

Benactiv Gola Miele Limone does not contain gluten and can also be taken by celiac subjects.

ACTIVE INGREDIENTS

Active ingredients contained in Benagol Honey and Lemon 36 Sore Throat Lozenges - What is the active ingredient in Benagol Honey and Lemon 36 Sore Throat Lozenges?

Benagol Ginger and Spice 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), spice flavouring and ginger flavouring (containing cinnamal, citral, citronellol, eugenol, farnesol, geraniol, isoeugenol and linalool). Benagol Honey and Lemon flavoured 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 Flavor Sugar Free Lozenges. Active ingredients: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg. Excipients with known effects: liquid maltitol, isomalt, lemon flavoring (containing benzyl alcohol, citral, citronellol, d-limonene, geraniol and linalool). Benagol Strawberry Flavor Sugar Free Lozenges. Active ingredients: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg. Excipients with known effects: liquid maltitol, isomalt, strawberry flavoring (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 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 Honey and Lemon 36 Sore Throat Lozenges - What does Benagol Honey and Lemon 36 Sore Throat Lozenges contain?

Benagol Ginger and Spice Flavor Lozenges. One lozenge contains: liquid sucrose, liquid glucose (containing sulphites and wheat starch), tartaric acid, enocyanin (E163) (containing sodium), plum flavor, cream flavor, spice flavor and ginger flavor (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-Eucalyptol Flavor 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 flavoured lozenges with Vitamin C. One tablet 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 flavoured lozenges without sugar. One tablet contains: lemon flavouring (containing benzyl alcohol, citral, citronellol, d-limonene, geraniol and linalool), sodium saccharin, tartaric acid, liquid maltitol, isomalt. Benagol Strawberry flavoured lozenges without sugar. One lozenge contains: strawberry flavour (containing propylene glycol and benzyl alcohol), anthocyanins (E163) (containing sodium), sodium saccharin, tartaric acid, liquid maltitol, isomalt. Benagol Cold Mint flavour lozenges. One lozenge 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).

DIRECTIONS

Therapeutic indications Benagol Honey and Lemon 36 Sore Throat Pastilles - Why is Benagol Honey and Lemon 36 Sore Throat Pastilles used? What is it for?

Oral antiseptic.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Benagol Honey and Lemon 36 Sore Throat Lozenges - When should Benagol Honey and Lemon 36 Sore Throat Lozenges 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-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.

DOSAGE

Quantity and method of taking Benagol Honey and Lemon 36 Sore Throat Lozenges - How to take Benagol Honey and Lemon 36 Sore Throat Lozenges?

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 lozenge 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 lozenges. For all other Benagol flavours, do not exceed the maximum daily dose of 12 lozenges. 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 are available. Method of administration: oromucosal administration. The tablet should be dissolved slowly in the mouth.

CONSERVATION

Storage Benagol Honey and Lemon 36 Sore Throat Lozenges - How do you store Benagol Honey and Lemon 36 Sore Throat Lozenges?

Do not store above 25 degrees C.

WARNINGS

Warnings Benagol Honey and Lemon 36 Sore Throat Lozenges - About Benagol Honey and Lemon 36 Sore Throat Lozenges 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-Eucalyptus 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-Eucalyptus 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 Pastilles Menthol-Eucalyptus flavour contains 1.01 g of glucose per lozenge; Benagol Pastilles with Vitamin C Orange flavour contains 0.97 g of glucose per lozenge; Benagol Pastilles Cold Mint flavour contains 1.10 g of glucose per lozenge; the liquid glucose contains sulphites. These medicines can rarely cause serious hypersensitivity reactions and bronchospasm; the 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 Pastilles Ginger and Spice flavour contains no more than 22.04 micrograms of gluten. One lozenge of Benagol Pastilles Honey and Lemon flavour contains no more than 19.52 micrograms of gluten. One Benagol Menthol-Eucalyptus flavour lozenge contains no more than 20.26 micrograms of gluten. One Benagol Pastiglie with Vitamin C Orange flavour lozenge contains no more than 19.38 micrograms of gluten. One Benagol Pastiglie Cold Mint flavour lozenge 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 Pastiglie Ginger and Spice flavour contains 1.38 g of sucrose per lozenge; Benagol Pastiglie Honey and Lemon flavour contains 1.44 g of sucrose per lozenge; Benagol Menthol-Eucalyptus flavour lozenges contain 1.50 g of sucrose per lozenge; Benagol Orange flavour lozenges with Vitamin C contain 1.44 g of sucrose per lozenge; Benagol Cold Mint flavour lozenges contain 1.38 g of sucrose per lozenge. Benagol Ginger and Spice flavour lozenges, Benagol Menthol-Eucalyptus flavour lozenges, Benagol Orange flavour lozenges with Vitamin C, Benagol Lemon flavour lozenges Sugar Free, Benagol Strawberry flavour lozenges Sugar Free: these medicines contain less than 1 mmol sodium (23 mg) per dose, that is to say essentially "sodium-free". Benagol Lemon flavour lozenges Sugar Free and Benagol Strawberry flavour 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 Pastilles Ginger and Spice flavour: 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 can induce a sensation of heat in the mouth and throat when sucking the lozenge. Benagol Pastilles Honey and Lemon flavour: 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 Pastilles Menthol-Eucalyptol flavour: this medicinal product contains a flavouring containing d-limonene. D-limonene may cause allergic reactions. Benagol Pastilles with Vitamin C Orange flavour: 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 Flavor Sugar Free Lozenges: This medicine contains a flavoring 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 Flavor Sugar Free Lozenges: This medicine contains a flavoring containing benzyl alcohol. Benzyl alcohol may cause allergic reactions. This medicine contains 7.30 mg of propylene glycol in each lozenge. Benagol Cold Mint Flavor Lozenges: This medicine contains a flavoring 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 Honey and Lemon 36 Sore Throat Pastilles - Which medicines or foods can modify the effect of Benagol Honey and Lemon 36 Sore Throat Pastilles?'

No interactions with other drugs are known. Benagol Menthol-Eucalyptus flavour should not be used in conjunction with other products (medicines or cosmetics) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation).

SIDE EFFECTS

Like all medicines, Benagol Honey and Lemon 36 Pastiglie Mal di Gola can cause side effects - What are the side effects of Benagol Honey and Lemon 36 Pastiglie Mal di Gola?

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 <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. Immune system disorders. Rare: hypersensitivity. Gastrointestinal disorders. Rare: glossitis; not known: abdominal pain, nausea, gastrointestinal discomfort. Skin and subcutaneous tissue disorders. Not known: 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

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 Honey and Lemon 36 Sore Throat Pastilles.

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 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.