PASSEDYL Sirop enfant nourrisson Fl/125ml

Sulfoguaiacol................................................................................................................................................ 1,174 g

Sodium benzoate...................................................................................................................................2,268 g

For 100 mL of syrup.

Excipients with known effect: sodium methyl parahydroxybenzoate (E219) (6,3 mg per 5 mL dose), sucrose (3,1 g per 5 mL dose), ethanol (150 mg per 5 mL dose), propylene glycol (E1520).

Adjunctive treatment of bronchial secretion disorders.

Oral use.

Infant and child under 5 years: 1 oral syringe filled up to the 5 mL graduation mark, 2 to 3 times a day.

Child over 5 years: 1 oral syringe filled up to the 5 mL graduation mark, 3 to 5 times a day.

History of hypersensitivity to any of the constituents (in particular to sodium benzoate, sodium methyl parahydroxybenzoate (E219).

Special warnings

In case of greasy, purulent expectoration, in case of fever or in case of chronic bronchial and lung disease, re-examine the clinical situation.

Productive coughs, which are a fundamental element of bronchopulmonary defence, should be preserved.

The combination of bronchial mucomodifiers with antitussives and/or secretion-drying substances (antimuscarinics) is irrational.

The indication does not justify prolonged treatment.

Precautions for use

Caution is recommended in subjects with gastroduodenal ulcer.

This medicine contains sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions (possibly delayed).

This medicine contains 3,1 g of sucrose per 5 mL of syrup. This should be taken into account for patients with diabetes mellitus.

Patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases) must not take this medicine.

This medicine contains 150 mg of alcohol (ethanol) per 5 mL of syrup. The amount in 5 mL of this medicine is equivalent to 4 mL of beer or 2 mL of wine.

A dose of 5 taken of 5 mL of this medicine administered to a child over 5 years weighing 20 kg would result in an exposure to 37,5 mg/kg of ethanol likely to cause an increase in blood alcohol of about 2 mg/100 mL. For comparison, for an adult drinking a glass of wine or 500 mL of beer, the blood alcohol level should be about 50 mg/100 mL.

Co-administration of medicines containing, for example, propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects, particularly in young children with low or immature metabolic capacity.

The data available to date do not suggest the existence of clinically significant interactions.

Use with caution in pregnant or breastfeeding women, due to a lack of usable clinical data.

No effect on the ability to drive vehicles or use machines has been observed.

Possibility of digestive disorders (nausea, vomiting).

Hypersensitivity reactions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions 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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

Pharmacotherapeutic class: expectorants, ATC code: R: respiratory system.

3 years.

Store below 25°C.

To open the bottle,  Press firmly on the sides of the cap while turning it.

The vial must be closed again after each use.

The dose to be administered for one intake is obtained by pulling the plunger up to the 5 mL graduation. The dose is read at the flange of the syringe.

The use of the syringe for oral administration is strictly reserved for administering PASSEDYL CHILDREN AND INFANTS syrup.

The oral syringe must be rinsed after each use. Do not let it soak in the bottle.