Fluditek

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

Composition:

Active substance: carbocisteine;

1 ml of 5% syrup contains 50 mg of carbocisteine;

Excipients: glycerol, methyl p-hydroxybenzoate (E 218), sucrose, orange-yellow S dye (E 110), patent blue V dye (E 131), caramel flavor, sodium hydroxide, purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: clear pale green liquid with a brownish tint and a caramel odor.

Pharmacotherapeutic group.

Medicinal products used for cough and colds. Mucolytics. Carbocisteine. ATC code R05CB03.

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, thereby 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 secretions, restoring their viscosity and elasticity. It activates the function of ciliated epithelium and improves mucociliary clearance. It promotes regeneration of the respiratory tract mucosa, normalizes its structure, reduces hyperplasia of goblet cells, 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 exerts an anti-inflammatory effect due to the kinin-inhibiting activity of sialomucins, leading to reduction of 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 the first-pass effect in the liver. Carbocysteine and its metabolites are primarily excreted by the kidneys. The 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 diseases in adults and children aged 15 years and older.

Contraindications.

• Hypersensitivity to the active substance or to any of the excipients (see section "Special precautions for use").
• Peptic ulcer of the stomach and duodenum in the acute phase.

Interaction with other medicinal products and other forms of interaction.

During treatment with Fluityek, antitussive agents and drugs that suppress bronchial secretion should not be used. This medicinal product enhances the efficacy 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-suppressant agents and/or substances that reduce secretion (anticholinergic group, e.g. atropine-like drugs).

Precautions for use

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

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

This medicinal product contains sucrose. Its use is not recommended in patients with rare hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency. This medicinal product contains 5.25 g of sucrose in 15 ml of syrup. This should be taken into account in patients with diabetes mellitus.

This medicinal product contains 100 mg of sodium in 15 ml of syrup, which is equivalent to 5% of the maximum daily intake of 2 g for adults recommended by the WHO.

This medicinal product contains methylparahydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed).

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

Use during pregnancy or breastfeeding

In animal studies, no teratogenic effects were observed.

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. Therefore, breastfeeding during carbocisteine use is not recommended.

Ability to influence reaction speed when driving or operating machinery

No influence.

Method of Administration and Dosage.

FOR ADULTS AND CHILDREN AGED 15 YEARS AND ABOVE.

Dosage

The dosing cup filled up to the 15 ml mark contains 750 mg of carbocysteine.

Take 1 dose (15 ml) 3 times daily, preferably between meals.

The duration of treatment should be short and must not exceed 5 days.

Method of Administration

For oral use.

Children.

The medication may be administered to children aged 15 years and above.

Treatment of children should be conducted under medical supervision.

Overdose.

Symptoms: stomach pain, nausea, diarrhea.

Treatment: symptomatic therapy.

Adverse reactions.

• Possible allergic skin reactions such as itching, erythematous rash, urticaria, and angioneurotic edema.
• Several cases of fixed drug eruption have been reported.
• Possible gastrointestinal disturbances (stomach pain, nausea, vomiting, diarrhea) (see section "Instructions for use").
• Gastrointestinal bleeding (see section "Instructions for use").
• 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.

Bottle containing 125 ml of syrup with a measuring cup in a cardboard box.

Availability category. Over-the-counter (without prescription).

Manufacturer.

Innothera Chouzy, France / Innothera Chouzy, France.

Manufacturer's address and place of business.

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, 94110 Arcueil, France / 22 avenue Aristide Briand, 94110 Arcueil, France.