Fluditec

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

Composition:

Active substance: carbocisteine;

1 sachet (10 ml of oral solution) contains carbocisteine 750 mg;

Excipients: sodium saccharin; sodium methylparahydroxybenzoate (E 219); hydroxyethylcellulose; caramel-vanilla flavoring; sorbitol solution (70%), non-crystallizing; liquid maltitol; sodium hydroxide; purified water.

Pharmaceutical form.

Oral solution.

Main physicochemical properties: clear, viscous, light brown liquid with a caramel odor.

Pharmacotherapeutic group.

Agents used for cough and colds. Mucolytic agents. Carbocisteine. ATC code R05CB03.

Pharmacological Properties.

Pharmacodynamics.

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

The mucoregulatory effect of carbocisteine is associated with activation of sialyltransferase—an enzyme of goblet cells in the bronchial mucosa. Carbocisteine normalizes the quantitative ratio of acidic and neutral sialomucins in bronchial secretions, restores their viscosity and elasticity, enhances ciliary epithelium activity, 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 (nonspecific protection). It exerts an anti-inflammatory effect through kinin-inhibiting activity of sialomucins, leading to reduced edema and broncho-obstruction.

Pharmacokinetics.

After oral administration, carbocisteine 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. Carbocisteine 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 impaired expectoration, particularly in acute bronchopulmonary diseases such as acute bronchitis, and 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 Warnings and Precautions for Use").

Peptic ulcer of the stomach or duodenum in the acute phase.

Interaction with other medicinal products and other forms of interaction.

During treatment with Fluityc, antitussive agents and drugs that suppress bronchial secretion should not be used. The drug 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-suppressing agents and/or substances that reduce secretion (such as atropine group drugs).

This medicinal product contains a small amount of ethanol (alcohol) present in the caramel-vanilla flavouring – less than 100 mg per sachet.

Precautions for use

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

The product should be used with caution in elderly patients, 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 97.5 mg of sodium per dose, equivalent to 4.9% of the maximum daily intake of 2 g for adults recommended by WHO. This should be taken into account when administering the product to patients on a strict low-sodium diet.

This medicinal product contains sodium methyl parahydroxybenzoate (E 219), which may cause allergic reactions (possibly delayed in time).

This medicinal product does not contain sugar (sucrose) and therefore may be taken by patients on a hypoglycaemic or low-calorie diet.

This medicinal product contains liquid maltitol and 910 mg of sorbitol per 1 dose. Use of this product is not recommended in patients with fructose intolerance (a rare hereditary condition).

Use during pregnancy or breastfeeding.

In animal studies, no teratogenic effects were observed.

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 affect reaction speed when driving or operating machinery.

No effect.

Dosage and Administration.

FOR ADULTS AND CHILDREN AGED 15 YEARS AND OLDER.

This medicinal product can be used by patients following a hypoglycemic or low-calorie diet.

Dosage

1 sachet of 10 ml contains 750 mg of carbocysteine.

The recommended dose is 750 mg three times daily, i.e. 1 sachet three times daily.

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

Administration method

For oral use.

Children.

Fluditec, oral solution in sachets, is administered to children aged 15 years and older.

Overdose.

Symptoms: stomach pain, nausea, diarrhea.

Treatment: symptomatic therapy.

Side effects

• Possible allergic skin reactions such as itching, erythematous rash, urticaria, and angioneurotic edema.
• There have been several cases of fixed drug eruption associated with the use of this medicinal product.
• Gastrointestinal disturbances (stomach pain, nausea, vomiting, diarrhea) may occur (see section "Method of administration").
• Gastrointestinal bleeding (see section "Method of administration").
• Isolated cases of bullous dermatitis, such as Stevens-Johnson syndrome and erythema multiforme, have been reported.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after the medicinal product has received marketing authorization. This enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the national pharmacovigilance reporting system.

Shelf life: 18 months.

Storage conditions:

Store at a temperature not exceeding 25 °C. Keep out of reach and sight of children.

Packaging:

10 ml of oral solution in 1 sachet, 15 sachets in a cardboard box.

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

Manufacturer:

Innothera Chouzy, France / Innothera Chouzy, France.

Manufacturer's address:

Rue Rene Chantereau, Chouzy-sur-Cisse, Valloire-sur-Cisse, 41150, France / Rue Rene Chantereau, Chouzy-sur-Cisse, Valloire-sur-Cisse, 41150, France.

Marketing Authorization Holder:

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

Address of Marketing Authorization Holder:

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