Fluidite® (Fluditec®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCarbocysteineCarbocysteine
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    • Dosage form: & nbspsyrup for children
    Composition:

    Composition per 100 ml:

    active substance: carbocysteine ​​2.0 g;

    Excipients: glycerol 5.0 g, methyl parahydroxybenzoate 0.15 g, sucrose 70.0 g, dye sunset yellow (E 110) 0.001 g, sodium hydroxide to pH 6.2, banana flavor 0.2 g, water purified to 100 ml .

    Description:

    Transparent orange liquid with the smell of a banana.

    Pharmacotherapeutic group:mucolytic agent
    ATX: & nbsp

    R.05.C.B.03   Carbocysteine

    Pharmacodynamics:Mucolytic and expectorant action is due to the activation of sialic transferase enzyme goblet cells of the bronchial mucosa. Normalizes the quantitative ratio of acidic and neutral sialomucines of bronchial secretion, restores the viscosity and elasticity of mucus, facilitates its departure.Promotes regeneration of the mucous membrane, normalizes its structure, reduces the production of mucus, activates the activity of the ciliary epithelium, improves mucociliary clearance. Restores the secretion of immunologically active IgA (specific protection) and the amount of sulfhydryl groups of mucus components (nonspecific protection).
    Pharmacokinetics:The maximum concentration in serum and respiratory tract mucosa is achieved after 2-3 h after ingestion and is stored in the mucosa for 8 hours. The deduced mainly by the kidneys partially in an unmodified form, partly in the form of metabolites.
    Indications:Acute and chronic bronchopulmonary disease (tracheitis, bronchitis, tracheobronchitis, bronchial asthma, bronchiectasis) and inflammatory diseases of the nasal cavity, the nasopharynx, the paranasal sinuses and the middle ear (rhinitis, adenoids, sinusitis, otitis media) are accompanied by formation viscous secretions (sputum, mucus); preparation for bronchoscopy and / or bronchography.
    Contraindications:

    - Hypersensitivity to carbocysteine ​​or other components of the drug;

    - peptic ulcer of the stomach and duodenum in the stage of exacerbation;

    - chronic glomerulonephritis (in the phase of exacerbation), cystitis;

    - children under 2 years.

    Carefully:Care should be taken when taking the drug with chronic glomerulonephritis (in the anamnesis), peptic ulcer of the stomach and duodenum (in the anamnesis).
    Dosing and Administration:

    For oral administration.

    Before using the drug should consult a doctor.

    5 ml of syrup (1 teaspoon) contains 100 mg of carbocysteine.

    Children aged 2 to 5 years: 5 ml 2 times a day. Dosage should not exceed 200 mg / day.

    Children over 5 years: 5 ml 3 times a day. Dosage should not exceed 300 mg / day.

    Treatment should not last more than 8-10 days without consulting a doctor.

    Side effects:

    Nausea, vomiting, diarrhea, epigastric pain, flatulence, gastrointestinal bleeding, dizziness, weakness, malaise, in rare cases - allergic reactions (itching, urticaria, exanthema, angioedema).

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    Symptoms: gastralgia, nausea, diarrhea.

    Treatment: symptomatic.

    Interaction:When combined with glucocorticosteroids, a synergistic effect is observed. Increases the effectiveness of antibacterial therapy for inflammatory diseases of the upper and lower respiratory tract. Strengthens the bronchodilator effect of theophylline. Carbocisteine ​​activity is weakened by antitussive and atropine-like agents.
    Special instructions:

    Patients with diabetes should take into account that the content of sucrose per 5 ml (one teaspoon of syrup) 3.5 g.

    Form release / dosage:

    Syrup for children, 20 mg / ml.

    Packaging:For 125 ml of syrup in a clear glass bottle, closed with a plastic screw cap with a plastic gasket and with an opening control.
    One bottle with a measuring cup of polypropylene and instructions for use in a cardboard bundle.
    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.
    Shelf life:

    2 years.

    He apply at the expiration date indicated on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N014782 / 02-2003
    Date of registration:11.01.2009
    The owner of the registration certificate:Laboratory Innotech InternationalLaboratory Innotech International France
    Manufacturer: & nbsp
    Representation: & nbspLaboratory Innotech International Laboratory Innotech International France
    Information update date: & nbsp25.11.2011
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