FLUISEDAL WITHOUT PROMETHAZINE Syrup bottle 250ml

Meglumine benzoate

Quantity corresponding to anhydrous product........................................................................................................ 2,600 g

Polysorbate 20......................................................................................................................................................... 0,300 g

For 100 ml of syrup.

1 teaspoon contains 3,6 g of sucrose.

1 tablespoon contains 10,8 g of sucrose.

Adjunctive treatment of bronchial secretion disorders.

In adults and children from 12 years : 2 to 4 tablespoons per day.

In children aged 6 to 12 years : 4 to 8 teaspoons per day.

In children aged 30 months to 6 years : 3 to 4 teaspoons per day.

In children aged 24 to 30 months : 1 to 3 teaspoons per day.

• History of hypersensitivity to any of the constituents.

• Infants (less than 2 years) (see section Warnings and precautions).

This medicine is GENERALLY NOT RECOMMENDED during pregnancy (see section Fertility, pregnancy and breastfeeding).

Warnings

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.

Mucolytics may induce bronchial overload in infants. Indeed, their capacity to drain bronchial mucus is limited, due to the physiological characteristics of their respiratory tree. They should therefore not be used in infants (see sections Contraindications and 4.8).

The treatment should be re-evaluated in case of persistence or worsening of the symptoms or of the condition.

This medicine contains sucrose. Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency.

Precautions for use

Caution is recommended in subjects with gastroduodenal ulcers.

In case of diabetes or a low-carbohydrate diet, take into account the intake of 3,6 g of sucrose per teaspoon and 10,8 g per tablespoon.

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

Pregnancy

There is no reliable data on teratogenicity in animals.

There are currently not enough data to assess a possible malformative or foetotoxic effect of meglumine benzoate when administered during pregnancy.

Consequently, the use of this medicine is not recommended during pregnancy.

Breast-feeding

As a precaution, it is preferable not to use this medicine during breast-feeding.

Fertility

There are no clinical or non-clinical data on the effects of the use of meglumine benzoate or polysorbate 20 on fertility.

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

Risk of bronchial over-accumulation of secretions, particularly in infants and in certain patients unable to expectorate effectively (see sections Contraindications and 4.4).

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/.

Overdose risks worsening bronchial over-accumulation of secretions (see section Adverse effects).

MUCOLYTIC (R: respiratory system).

Polysorbate 20: a published study did not demonstrate embryo-foetal developmental toxicity in rats after administration of high oral doses.

3 years.

Store below 25°C and protected from light.

No special requirements.