Bronchodual Sedative And Fluidifying 8mg/ml + 55.3mg/ml Oral Solution 120 ml

Therapeutic indications

Traditional herbal medicine used to facilitate the expectoration of phlegm in case of cough associated with colds and for the symptomatic treatment of the oral or pharyngeal mucosa and associated dry cough. The use of this traditional herbal medicinal product for the aforementioned therapeutic indications is based exclusively on the experience of many years of use.

Dosage

Posology Adults and adolescents (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. The maximum daily dose is 6 doses per day (90 ml) Pediatric population Children aged 6 to 12 years 7.5 ml every 3 to 4 hours (4 times a day). If necessary, the doses can be increased up to 6 times a day. The maximum daily dose is 6 doses per day (45 ml) Children aged between 3 and 6 years 7.5 ml every 3 - 4 hours 4 times a day. The 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 as there are insufficient safety and efficacy data available. Duration of treatment The maximum duration of treatment is 5 days. Method of administration The measuring cup attached to the package has a graduated scale from 2.5 ml to 20 ml. The oral solution can be taken directly from the dispenser; if necessary, it can be diluted in water or hot tea.

Overdose

No cases of overdose have been reported.

Contraindications

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

Side effects

The following side effects have been reported, the frequency of which is not known. Immune system disorders Hypersensitivity reactions, anaphylactic shock, Quincke's edema Gastrointestinal disorders Gastrointestinal disorders Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

As no data are available, use during pregnancy and lactation is not recommended. There are no data on the influence on fertility.

Special warnings

Use with caution in case of respiratory tract disease with dyspnoea, fever or purulent sputum. Important information about some of the ingredients of Bronchodual Sedative and Fluidifier This medicinal product contains methyl-para4-hydroxybenzoate and propyl-para4-hydroxybenzoate used as preservatives which can induce hypersensitivity reactions, even delayed ones.

Expiry and Retention

Do not store above 25 ° C. Keep the bottle tightly closed in the original package in order to protect the medicine from light.

Active principles

15 ml (= 16.7 g) of oral solution contain: Active ingredients: –117 mg of extract (as dry extract) of Thymus vulgaris L. or Thymus zygis L. (Thyme leaf and flower) (7-13: 1 ) corresponding to 820–1522 mg of Thymi herba. Extraction solvent: water. Essential oil content in the extract equal to 2.5-3.3 mg (1.5-2.0%). –830 mg of extract (as liquid extract) of Althaea officinalis L. (Altea root) (1: 12–14) corresponding to 59–69 mg of Althaeae radix . Extraction solvent: water. Excipients : Methyl – para 4 – hydroxybenzoate 12.53 mg, Propyl – para 4 – hydroxybenzoate 6.68 mg For a full list of excipients, see section 6.1.

Excipients

Xylitol, methyl-para4-hydroxybenzoate, propyl-para4-hydroxybenzoate, raspberry juice concentrate, raspberry flavor, xanthan gum, citric acid monohydrate (E 330), maltodextrin, gum arabic, purified water.