Instructions for Fluditec syrup 2% bottle 125 ml
Composition
active ingredient: carbocisteine;
1 ml of 2% syrup contains 20 mg of carbocysteine;
excipients: glycerin, methyl parahydroxybenzoate (E 218), sucrose, orange-yellow dye S (E 110), banana flavoring, sodium hydroxide, purified water.
Dosage form
Syrup.
Main physicochemical properties: clear orange liquid.
Pharmacotherapeutic group
Drugs used for coughs and colds. Mucolytics. Carbocysteine. ATX code R05C B03.
Pharmacological properties
Pharmacodynamics
Carbocysteine affects the gel phase of respiratory tract mucus: by breaking disulfide bridges of glycoproteins, it causes liquefaction of excessively viscous bronchial secretion, which promotes sputum excretion.
The mucoregulatory effect of carbocysteine is associated with the activation of sialic transferase, an enzyme of the goblet cells of the bronchial mucosa. Carbocysteine normalizes the quantitative ratio of acidic and neutral sialomucins of the bronchial secretion, restores its viscosity and elasticity. Activates the activity of the ciliated epithelium and improves mucociliary clearance. Promotes the regeneration of the respiratory tract mucosa, normalizes its structure, reduces goblet cell hyperplasia and, as a result, reduces mucus production. Restores the secretion of immunologically active IgA (specific protection) and the number of sulfhydryl groups of mucus components (nonspecific protection). It exhibits an anti-inflammatory effect due to the kinin-inhibiting activity of sialomucins, which leads to a decrease in edema and bronchial obstruction.
Pharmacokinetics
When taken orally, carbocysteine is rapidly absorbed. The peak concentration of the active substance in the blood plasma is reached after 2 hours. Bioavailability is low - less than 10% of the administered dose - due to intensive metabolism in the gastrointestinal tract and the effect of first passage through the liver. Carbocysteine and its metabolites are excreted mainly by the kidneys. The half-life is about 2 hours.
Indication
Treatment of symptoms of disorders of bronchial secretion and sputum discharge, especially in acute bronchopulmonary diseases, such as acute bronchitis; in exacerbations of chronic diseases of the respiratory system in children aged 2 years and older.
Contraindication
Hypersensitivity to the active substance or to any of the excipients (see section "Special warnings and precautions for use").
Children under 2 years of age (see section "Special instructions for use").
Peptic ulcer of the stomach and duodenum during the exacerbation period.
Interaction with other medicinal products and other types of interactions
During treatment with Fluditec, antitussives and agents that suppress bronchial secretion should not be used. This drug enhances the effectiveness of glucocorticoid (mutually) and antibacterial therapy. Use with caution in patients taking medications that may cause gastrointestinal bleeding.
Application features
Special precautions
Productive cough is a fundamental defense mechanism of the bronchopulmonary system and as such should not be suppressed. It is irrational to combine drugs that modify bronchial secretion with cough suppressants and/or substances that reduce secretion (atropine group).
The use of mucolytic agents may lead to impaired bronchial patency in children under 2 years of age due to the limited ability to clear the respiratory tract of bronchial secretions due to age-related anatomical and physiological characteristics. Any mucolytic agents should not be used in children under 2 years of age (see sections "Contraindications" and "Peculiarities of use").
Treatment should be reviewed if there is no effect or if symptoms worsen.
In the presence of a productive cough with purulent sputum, high fever, or chronic bronchial or pulmonary disease, the clinical situation should be reviewed.
This medicinal product contains sucrose. Its use is not recommended in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Precautions for use
In case of gastrointestinal disorders (stomach pain, nausea, vomiting, diarrhea), the dose should be reduced.
The drug should be used with caution in patients with a history of gastric or duodenal ulcer or those who are taking additional medications that may cause gastrointestinal bleeding. If gastrointestinal bleeding occurs, treatment should be discontinued.
This medicinal product contains 3.5 g of sucrose per 5 ml of syrup. This should be taken into account in patients with diabetes.
This medicine contains less than 1 mmol sodium (23 mg) per 5 ml of syrup, i.e. essentially sodium-free.
This medicine contains methyl parahydroxybenzoate (E 218) which may cause allergic reactions (possibly delayed).
This medicine contains the colouring agent sunset yellow S (E 110), which may cause allergic reactions.
Use during pregnancy or breastfeeding
No teratogenic effects were observed in animal studies. The absence of teratogenic effects in animals means that no malformations are expected in humans.
There are insufficient data on the clinical use of carbocysteine in pregnant women. Therefore, carbocysteine is not recommended for use during pregnancy.
There is no data on the penetration of carbocysteine into breast milk. Therefore, breastfeeding is not recommended during the use of carbocysteine.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
FOR CHILDREN AGE 2 AND UP.
Dosage
A dosing cup filled to the 5 ml mark contains 100 mg of carbocysteine.
Children aged 2 to 5 years: 200 mg per day in 2 doses, i.e. 1 measuring cup filled to the 5 ml mark, 2 times a day.
Children aged 5 to 15 years: 300 mg per day in 3 doses, i.e. 1 measuring cup filled to the 5 ml mark, 3 times a day.
The duration of treatment should not exceed 8–10 days without consulting a doctor.
Method of application
For internal use.
Children
The drug is used in children aged 2 years and older.
Treatment of children should be carried out under the supervision of a physician.
Overdose
Symptoms: stomach pain, nausea, diarrhea.
Treatment: symptomatic therapy.
Side effects
Risk of bronchial obstruction in children under 2 years of age (see sections "Contraindications" and "Peculiarities of use").
Allergic skin reactions such as itching, erythematous rash, urticaria and angioedema are possible.
Several cases of fixed rash have been reported.
Digestive disorders (stomach pain, nausea, vomiting, diarrhea) are possible (see section "Special instructions").
Gastrointestinal bleeding (see section "Special warnings and precautions for use").
Isolated cases of bullous dermatitis, such as Stevens-Johnson syndrome and erythema multiforme, have been reported.
Expiration date
2 years. Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Packaging
A bottle containing 125 ml of syrup with a dosing cup in a cardboard box.
Vacation category
Without a prescription.
Producer
Innothera Chouzy, France.
Address
22 avenue Aristide Briand, 94 110 Arcueil, France/22 avenue Aristide Briand, 94 110 Arcueil, France.
Applicant
Innotech International Laboratory, France/Laboratoire Innotech International, France.
