BRONCHODUAL SEDATIVE FLU 120ML

BRONCHODILATOR AND SEDATIVE

active ingredients

15 ml (= 15,45 g) of oral solution contain: Active ingredients: -117 mg of extract (as dry extract) of Thymus vulgaris L Thymus zygis L. (foil and flower of thyme) (7-13:1) corresponding to 820-1522 mg Thymi herba. Extraction solvent: water. Essential oil content in the extract of 2,5-3.3 mg (1.5-2.0%). -830 mg of extract (as liquid extract) of Althaea officinalis L. (Altea code) (1:12-14) corresponding to 59-69 mg Althaeae radix. Extraction solvent: water. Excipients with known effect: Each single dose (15 ml) contains: 11.59 mg of methyl-parahydroxybenzoate (E218), 6.18 mg of propyl-parahydroxybenzoate (E216), 131 mg of total sugars from raspberry juice concentrate (containing sucrose, glucose and fructose) and 38.9 mg of propylene glycol (E1520) contained in raspberry aroma. For the full list of excipients, see paragraph 6.1.

Excellent

Xilitol (E967), methyl-4-hydroxybenzoate (E218), propil-4-hydroxybenzoate (E216), raspberry juice concentrate (containing sucrose, glucose and fructose), raspberry aroma (synthetic and natural aroma, propylene glycol (E1520)), xantana gum, monohydrol (E422), sodium saclone

Therapeutic indications

Traditional vegetable medicine used for fat cough associated with cold and 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 mentioned above is based exclusively on the experience of multiannual use.

Contraindications

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

Population

Population Adults and teenagers (12-18 years) 15 ml every 4 hours (4 times a day). If necessary the doses can be increased up to 6 times a day. Maximum daily dose is 6 doses per day (90 ml) Pediatric population Children aged between 6 and 12 7.5 ml every 3 - 4 hours (4 times a day). If necessary the doses can be increased up to 6 times a day. Maximum daily dose is 6 doses per day (45 ml) Children between 3 and 6 years old 7.5 ml every 3 - 4 hours per 4 times a day. Maximum daily dose is 4 doses per day (30 ml) Children under 3 years The use of Bronchodual Sedative and Fluidifier is not recommended in children under 3 years of age since there is no sufficient safety and effectiveness data available. Duration of treatment The maximum duration of treatment is 5 days. Method of administration The dispenser glass attached to the packaging has a graduated scale of 2.5 ml to 20 ml. The oral solution can be taken directly by the doser; in case of need, it can be diluted in water or hot tea.

Conservation

Do not store at temperature above 25°C. Keep the bottle closed in the original packaging to protect the medicine from light.

Warnings

Use with caution in case of respiratory tract with dispnea, fever or purulent esperato. Important information about some Bronchodual Sedative and Fluidifier excipients This medicine contains: § methyl-para-hydroxybenzoate and propyl-para-hydroxybenzoate used as preservatives that can cause allergic reactions (also delayed); 131 mg of total sugars (specific sucrose, glucose and fructose, contained in raspberry juice concentrate). Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption or sucrasis-isomaltase failure should not take this medicine. § 66 mg of fructose in every 15 ml. The additive effect of products administered in conjunction with products containing fructose (or sorbitol) and the intake of fructose (or sorbitol) in the diet must be considered. § 38.9 mg of propylene glycol in every 15 ml § This medicine contains less than 1 mmol of sodium (23 mg) per dose of 15 ml, i.e. essentially "without sodium".

Interactions

No interaction studies have been carried out.

Effects

The following side effects were found, the frequency of which is not known. Immune system disorders Reactions of hypersensitivity, anaphylactic shock, Quincke edema Gastrointestinal diseases Gastrointestinal disorders 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.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

No overdose cases have been reported.

Since there are no data available, we do not recommend the use during pregnancy and nursing. There is no fertility influence data.

Source: Farmadati