Fluditek

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FLUDITEC (FLUDITEC)

Composition:

Active substance: carbocisteine;

1 ml of 2% syrup contains 20 mg of carbocisteine;

Excipients: glycerol, methyl p-hydroxybenzoate (E 218), sucrose, orange-yellow S dye (E 110), banana flavor, sodium hydroxide, purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: clear orange-colored liquid.

Pharmacotherapeutic group.

Agents used for cough and common cold. Mucolytic agents. Carbocisteine. ATC code R05C B03.

Pharmacological properties.

Pharmacodynamics.

Carbocysteine affects the gel phase of respiratory tract mucus: by cleaving disulfide bridges of glycoproteins, it causes liquefaction of excessively viscous bronchial secretions, thus facilitating expectoration.

The mucoregulatory effect of carbocysteine is associated with activation of sialyltransferase – an enzyme of goblet cells in the bronchial mucosa. Carbocysteine normalizes the quantitative ratio of acidic and neutral sialomucins in bronchial secretion, restoring its viscosity and elasticity. It activates ciliary epithelium function and improves mucociliary clearance. It promotes regeneration of the respiratory tract mucosa, normalizes its structure, reduces goblet cell hyperplasia, and consequently decreases mucus production. It restores secretion of immunologically active IgA (specific protection) and increases the number of sulfhydryl groups in mucus components (non-specific protection). It exhibits anti-inflammatory effects due to kinin-inhibiting activity of sialomucins, resulting in reduced edema and bronchoobstruction.

Pharmacokinetics.

After oral administration, carbocysteine is rapidly absorbed. Peak plasma concentration of the active substance is reached within 2 hours. Bioavailability is low – less than 10% of the administered dose – due to extensive metabolism in the gastrointestinal tract and first-pass liver effect. Carbocysteine and its metabolites are primarily excreted via the kidneys. Elimination half-life is approximately 2 hours.

Clinical characteristics.

Indications.

Treatment of symptoms related to impaired bronchial secretion and mucus clearance, particularly in acute bronchopulmonary diseases such as acute bronchitis; during exacerbations of chronic respiratory tract diseases in children aged 2 years and older.

Contraindications.

• Hypersensitivity to the active substance or to any of the excipients (see section "Special precautions").
• Children under 2 years of age (see section "Special precautions").
• Peptic ulcer of the stomach and duodenum during the period of exacerbation.

Interaction with other medicinal products and other forms of interaction.

During treatment with Fluadetec, antitussive agents and drugs that suppress bronchial secretion should not be used. This medicinal product enhances the effectiveness of glucocorticoid therapy (mutually) and antibacterial therapy. Use with caution in patients taking medications that may cause gastrointestinal bleeding.

Special precautions for use

Special warnings

Productive cough is a fundamental protective mechanism of the bronchopulmonary system and therefore should not be suppressed. It is irrational to combine medicinal products that modify bronchial secretion with cough suppressants and/or substances that reduce secretion (such as atropine-like drugs).

The use of mucolytic agents may lead to impaired bronchial patency in children under 2 years of age due to limited ability to clear bronchial secretions, related to age-specific anatomical and physiological characteristics. Mucolytic agents should not be used in children under 2 years of age (see sections "Contraindications" and "Special precautions for use").

Treatment should be re-evaluated if there is no therapeutic effect or if symptoms worsen.

If productive cough with purulent sputum, high fever, or chronic bronchial or lung disease is present, the clinical situation should be re-assessed.

The medicinal product contains sucrose. Its use is not recommended in patients with rare hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

Precautions for use

In case of gastrointestinal disorders (stomach pain, nausea, vomiting, diarrhea), the dose should be reduced.

The product should be used with caution in patients with a history of peptic ulcer of the stomach or duodenum or in those who are concurrently taking medicinal products that may cause gastrointestinal bleeding. If gastrointestinal bleeding occurs, treatment should be discontinued.

This medicinal product contains 3.5 g of sucrose in 5 ml of syrup. This should be taken into account for patients with diabetes mellitus.

This medicinal product contains less than 1 mmol of sodium (23 mg) in 5 ml of syrup, i.e. it is essentially sodium-free.

This medicinal product contains methyl 4-hydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed).

This medicinal product contains the colouring agent sunset yellow FCF (E 110), which may cause allergic reactions.

Use during pregnancy or breastfeeding

Teratogenic effects were not observed in animal studies. The absence of teratogenic effects in animals indicates that congenital malformations are not expected in humans.

There are insufficient data on the clinical use of carbocisteine in pregnant women. Therefore, carbocisteine is not recommended during pregnancy.

There are no data on the passage of carbocisteine into breast milk. Thus, breastfeeding during carbocisteine use is not recommended.

Ability to influence reaction speed when driving or operating machinery

No effect.

Method of administration and dosage.

FOR CHILDREN AGED 2 YEARS AND OLDER.

Dosage

The dosing cup filled to the 5 ml mark contains 100 mg of carbocisteine.

Children aged 2 to 5 years: 200 mg per day in 2 divided doses, i.e. one dosing cup filled to the 5 ml mark, twice daily.

Children aged 5 to 15 years: 300 mg per day in 3 divided doses, i.e. one dosing cup filled to the 5 ml mark, three times daily.

The duration of treatment should not exceed 8–10 days without consulting a physician.

Method of administration

For oral use.

Children.

The medication is intended for children aged 2 years and older.

Treatment of children should be carried out under medical supervision.

Overdose.

Symptoms: stomach pain, nausea, diarrhea.

Treatment: symptomatic therapy.

Side effects.

• Risk of developing impaired bronchial patency in children under 2 years of age (see sections "Contraindications" and "Special precautions").
• Allergic skin reactions such as itching, erythematous rash, urticaria, and angioneurotic edema may occur.
• Several cases of fixed drug eruption have been reported.
• Gastrointestinal disturbances (stomach pain, nausea, vomiting, diarrhea) are possible (see section "Special precautions").
• Gastrointestinal bleeding (see section "Special precautions").
• Isolated cases of bullous dermatitis, such as Stevens-Johnson syndrome and erythema multiforme, have been reported.

Shelf life. 2 years. Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging.

A bottle containing 125 ml of syrup with a measuring cup in a cardboard package.

Supply category. Over-the-counter.

Manufacturer.

Innothera Chouzy, France / Innothera Chouzy, France.

Manufacturer's address.

Rue René Chantereau, Chouzy-sur-Cisse, Valloire-sur-Cisse, 41150, France / Rue René Chantereau, Chouzy-sur-Cisse, Valloire-sur-Cisse, 41150, France

Marketing authorization holder.

Laboratoire Innotech International, France / Laboratoire Innotech International, France.

Address of the marketing authorization holder.

22 avenue Aristide Briand, 94 110 Arcueil, France / 22 avenue Aristide Briand, 94 110 Arcueil, France.