20PAST

BRONCHODILATOR COUGH AND THROAT

active ingredients

A soft pastel contains: 51.1 mg of extract (as dry extract) of Thymus vulgaris L. or Thymus zygis L. herb (Timo leaf and flower) (7-13:1), corresponding to 357.7-664.3 mg of Timo. Extraction solvent: water. The extract contains 1.1-1.5 mg of essential oil of thyme; 4.5 mg of extract (as dry extract) of Althaeae workshoplis L. radix, (Altea root) (7-9:1), corresponding to 31.5-40.5 mg of Altea. Extraction solvent: water. Excipients with known effects: maltitol (E 965) 615 mg, sorbitol (E 420) 210 mg, propylene glycol (E1520) 6.42 mg, benzyl alcohol (E1519) 0.005 mg For the complete list of excipients, see paragraph 6.1.

Excellent

Excipients of plant preparation: Arabian rubber (E 414) Excipient maltodextrin of the medicinal product: Arabian rubber (E 414) Liquid Sorbitol 70% non-clearizing (E 420); Liquid malt (E 965); Anidro citric acid (E 330); Sodium saccharin (E 954); Aroma of aronia (containing propylene glycol (E1520)); Fruit aroma (containing glycol propylene (E1520) and benzilic alcohol (E1519)) Clear liquid paraffin; Purified water

Therapeutic indications

Traditional medicinal of vegetable origin used to facilitate the appearance of the catarrh in case of cough associated with colds and for the symptomatic treatment of oral mucosa irritation or pharyngeal and associated dry cough. The use of this traditional medicinal product of vegetable origin for the therapeutic indications indicated, is based exclusively on the experience of multiannual use.

Contraindications

Hypersensitivity to active ingredients, to other components of the Lamiaceae family or to any of the excipients listed in the paragraph 6.1.

Population

Population Adults and teenagers over the age of 12: 1-2 soft tablets every 4 hours (from 4 to 6 times a day). The maximum daily dose is 12 soft tablets. Children aged between 6 and 12 years: 1 soft pad every 3 - 4 hours (from 4 to 6 times a day). The maximum daily dose is 6 soft tablets. Children under the age of 6: The safety and effectiveness of BRONCHODUAL TOSSE AND GOLA in children under the age of 6 have not yet been established. Method of administration: Oramucosal use (let melt in the mouth) Duration of treatment: The maximum duration of treatment is 5 days.

Conservation

Do not store at temperature above 30°C.

Warnings

Patients who suffer from dispnea, fever or purulent constituency must be treated properly. Absorption of medicinal products administered in conjunction can be delayed. For precautionary purposes, the medicinal product should not be taken from 1⁄2 to 1 hour before or after taking other medicines. Important information about some excipients This medicine contains 615 mg of maltilol (E965) and 210 mg of sorbitol (E420) in each pill. Patients with hereditary intolerance to fructose should not be given this medicine if not strictly necessary. The additive effect of co-administration of medicinal products containing fructose (or sorbitol) and the intake of fructose (or sorbitol) with the diet must be considered. The content of sorbitol in oral medicinal products may affect the bioavailability of other oral medicinal products administered in conjunction with this. A pastel corresponds approximately to 0.1 bread units. To be considered in patients with diabetes mellitus. The drug contains 6.42 mg of glycol propylene in each pill. This drug contains 0.005 mg of benzilic alcohol in each pill. Benzylic alcohol may cause reactions allergiche.Questo this medicine contains less than 1 mmol (23 mg) of sodium per pastilla, i.e. eessentially 'without sodium'.

Interactions

No interaction studies have been carried out.

Effects

Hypersensitivity reactions and gastrointestinal disorders were observed with thyme-based medicines. Frequency is not known (frequency cannot be defined on the basis of available data). 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/content/come-segnalare-una-sospetta-reazione-avversa

Overdosing

No overdose cases have been reported.

No fertility studies have been carried out. Safety during pregnancy and nursing with breast milk has not been established. The administration of BRONCHODUAL TOSSE AND GOLA during pregnancy and nursing with breast milk must be taken into account only if the expected benefit for the mother exceeds the risk for the fetus or child.

Source: Farmadati