Treatment of bronchial secretion disorders, particularly in acute bronchial disease: acute bronchitis and acute episodes of chronic obstructive pulmonary disease.

One 5 mL measuring spoon contains 100 mg of carbocisteine. Children aged 2 to 5 years: 200 mg per day, divided into 2 doses, i.e. one 5 mL measuring spoon twice a day. Children aged over 5 years: 300 mg per day, divided into 3 doses, i.e. one 5 mL measuring spoon three times a day. Duration of treatment Treatment duration should be short and not exceed 8 to 10 days.

Special warnings

In patients with thick and purulent sputum, fever or chronic bronchial and pulmonary disease, the clinical situation should be reassessed. Productive cough, which is a fundamental bronchopulmonary defense mechanism, should not be suppressed. Combining drugs that affect bronchial secretions with cough suppressants and/or substances that dry up secretions (atropine-like agents) is irrational. Mucolytic agents may induce severe bronchial congestion in infants. Infant bronchial mucus drainage capacities are limited due to the physiological characteristics of their bronchial tree. Mucolytics should therefore not be used in infants (see sections 4.3 and 4.8). Treatment should be re-evaluated if the symptoms or disease persist or worsen.

Precautions for use

Caution is recommended in the elderly, in those with a history of gastroduodenal ulcers, or those taking concomitant medications known to cause gastrointestinal bleeding. If gastrointestinal bleeding occurs, patients should discontinue medication.

Excipients with known effect:

This medicine contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. This medicine contains 3.5 g of sucrose per measuring spoon. This should be taken into account in patients following a low-sugar diet or with diabetes mellitus. This medicine contains sodium. This medicine contains 13 mg sodium in each 5 mL measuring spoon of syrup. This should be taken into account in patients following a strict low-sodium diet. This medicine contains methyl parahydroxybenzoate (E 218); it may provoke allergic reactions (possibly with a delayed onset).
This medicine contains 31 mg of ethanol per 5 mL measuring spoon, which is equivalent to 6.2 mg/mL (0.62% w/v). The amount of ethanol in 5 mL of this medicine is equivalent to less than 1 mL of beer or less than 1 mL of wine.
The small amount of alcohol in this medicinal product is not likely to lead to a significant effect.

Notapplicable.

Pregnancy

Animal studies do not indicate any teratogenic effect. There are no available data on carbocisteine use in pregnant women. The use of carbocisteine in pregnant women is therefore not recommended.

Breast-feeding

There are no available data on the presence of carbocisteine in human milk. The use of carbocisteine in breast-feeding women is therefore not recommended.

Notapplicable.

• Risk of severe bronchial congestion in infants (see sections 4.3 and 4.4).
• Epigastric discomfort.
• Gastrointestinal disorders (gastric pain, nausea, vomiting, and diarrhea). If these occur, the dose should be reduced.
• Gastrointestinal bleeding. Treatment should be discontinued.
• Allergic skin eruption and anaphylactic reactions such as pruritus, erythematous rash, urticaria and angioedema.
• Fixed rash of drug origin.
• Some cases of fixed drug eruption have been reported.
• Isolated cases of dermatitis bullous, 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:
• Saudi Arabia:

The National Pharmacovigilance and Drug Safety Centre (NPC)
• SFDA Call Center : 19999
• E-mail: npc.drug@sfda.gov.sa
• Website: https://ade.sfda.gov.sa/
• Opella-Pharmacovigilance email: pv-opellaksa@sanofi.com

Not applicable.

Pharmacotherapeutic group: MUCOLYTICS, ATC code: R05CB03. (R: respiratory system). Carbocisteine has a mucolytic effect on bronchial secretions. It acts on the gel phase of mucus production, most likely by breaking down the disulfide bonds in the glycoproteins, thus promoting expectoration.

Absorption

Orally administered carbocisteine is rapidly absorbed; peak plasma concentrations are reached in two hours.

Biotransformation

Bioavailability is low (less than 10% of the administered dose), probably as a result of intraluminal metabolism and a marked liver first-pass effect.

Elimination

Elimination half-life is approximately 2 hours. Carbocisteine and its metabolites are eliminated primarily in the urine.

Notapplicable.

Sucrose, methyl parahydroxybenzoate (E 218), raspberry flavouring (contains ethanol) (raspberry and vanilla tincture, raspberry and lemon alcohol extracts), cherry flavouring (contains ethanol) (cherry tincture, marasca cherry, raspberry and lemon alcohol extracts), sodium hydroxide, purified water.

Notapplicable.

Do not store above 25°C.

• 125 mL in a bottle (brown glass) with a child-proof security cap (polypropylene) and a 5-mL measuring spoon (polystyrene).
• 200 mL in a bottle (brown glass) with a child-proof security cap (polypropylene) and a 5-mL measuring spoon (polystyrene).

1. To open the bottle, turn the child-proof security cap while pressing it down, as indicated in the following drawing:

2. This medicine is administered using a measuring spoon for oral administration provided in the carton together with the bottle. The use of this measuring spoon is strictly reserved to oral administration of Rhinathiol expectorant carbocisteine 2% enfants, syrup. The total volume of the measuring spoon filled to the brim corresponds to a volume of 5 mL, or a 100 mg dose of carbocisteine.

3. After each use, close the syrup bottle, rinse well the measuring spoon for oral administration with water and dry it, then immediately return the measuring spoon for oral administration in its carton to a place inaccessible for children. Never keep the measuring spoon for oral administration separately from other elements of the medicine package (bottle, carton, package leaflet). Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Once the treatment is completed, the medicinal product should be returned to a pharmacist (open cartons including the measuring spoon and the bottle) for correct and proper disposal of this medicine.