BRONCHOKOD 5 % S buv adultes édulcorée à la saccharine sod maltitol liq Fl/250ml

Carbocisteine.................................................................................................................................................5,00 g

For 100 mL.

1 dosing cup of 15 mL contains 750 mg of carbocisteine.

Excipients with known effect: liquid maltitol, sodium, ethanol at 96 percent.

This medicine is indicated in adults for recent respiratory disorders with difficulty in expectoration (difficulty in expelling bronchial secretions by spitting).

Dosage

FOR ADULTS ONLY.

• 1 dosing cup of 15 mL = 750 mg of carbocisteine.
• Take 1 dosing cup of 15 mL, 3 times a day, preferably away from meals.

Method of administration

Oral use.

Duration of treatment :

It should be short-term and not exceed 5 days.

• Hypersensitivity to carbocisteine or to any of the excipients listed in the section Composition.
• Children.

Special warnings

Productive coughs, which represent a fundamental element of bronchopulmonary defence, should be respected.

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

Precautions for use

Caution is recommended in elderly subjects, in subjects with gastroduodenal ulcers, or in case of concomitant administration with medicines likely to cause gastrointestinal bleeding. If such bleeding occurs, patients must stop the treatment.

This medicine contains 99,9 mg of sodium per dosing cup of 15 ml. To be taken into account in patients on a strict low-sodium diet.

This medicine contains liquid maltitol (E965). Its use is not recommended in patients with fructose intolerance (rare hereditary disease).

This medicine may cause a moderate laxative effect.

This medicine contains 11,9 % vol of ethanol (alcohol), i.e. up to 1,5 g per dose of 15 mL of oral solution, which is equivalent to 35,6 mL of beer, 14,8 mL of wine per dose.

The use of this medicine is dangerous in alcoholic subjects and must be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with hepatic insufficiency or epileptics.

The amount of alcohol in this medicine may alter the effects of other medicines.

No interaction studies have been performed.

Pregnancy

Animal studies have not shown any teratogenic effect. In the absence of a teratogenic effect in animals, a malformative effect in humans is not expected. Indeed, to date, substances responsible for malformations in humans have been shown to be teratogenic in animals in well-conducted studies in two species.

In clinical practice, no particular malformative or foetotoxic effect has appeared to date.

However, monitoring of pregnancies exposed to carbocisteine is insufficient to rule out any risk. As a precaution, administration of this product should be avoided during pregnancy.

Due to the presence of alcohol, this medicine must not be taken during pregnancy.

Breast-feeding

There is no data concerning the passage of carbocisteine into breast milk.

However, given its low toxicity, the potential risks to the child appear negligible if treated with this medicine.

Due to the presence of alcohol, this medicine must not be taken during breastfeeding.

Due to the presence of alcohol, BRONCHOKOD ADULTES 5 POUR CENT, sweetened oral solution with sodium saccharin and liquid maltitol has a significant influence on the ability to drive vehicles and use machines.

• Gastrointestinal disorders (gastralgia, nausea, vomiting, diarrhoea). In this case, it is advised to reduce the dose.
• Gastrointestinal bleeding. It is recommended to stop the treatment.
• Possibility of allergic skin reactions such as urticaria, angioedema, pruritus, erythematous rash.
• A few cases of fixed pigmented erythema have been reported.
• Isolated cases of bullous dermatoses such as Stevens-Johnson syndrome and erythema multiforme.

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 reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website:www.signalement-sante.gouv.fr.

Pharmacotherapeutic class: MUCOLYTIC - ATC code: R05CB03

(R: respiratory system).

Carbocisteine is a mucomodifier of the mucolytic type. It acts on the gel phase of mucus, probably by breaking the disulfide bridges of glycoproteins, and thus promotes expectoration.

Absorption

Carbocisteine after oral administration is rapidly absorbed; the peak plasma concentration is reached within two hours.

Biotransformation

Bioavailability is low, less than 10 % of the administered dose, probably due to intraluminal metabolism and a significant hepatic first-pass effect.

Elimination

The elimination half-life is approximately 2 hours. Its elimination and that of its metabolites occurs essentially via the kidney.

3 years.

After opening: 15 days.

Store at a temperature not exceeding 25°C.

No special requirements.