Erespal® (Eurespal®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceFenspirideFenspiride
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    • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet, film-coated, contains

    active substance: fenspiride hydrochloride 80 mg;

    Excipients: calcium hydrophosphate 104.5 mg; hypromellose 100 mg; povidone-K-30 12.80 mg; silicon dioxide colloidal anhydrous 0.50 mg; magnesium stearate 2.20 mg;

    sheath: titanium dioxide 0.841 mg; glycerol 0.263 mg; hypromellose 4,370 mg; macrogol 6000 0.263 mg; magnesium stearate 0.263 mg.

    Description:Round, biconvex tablets, covered with a film coat, white.
    Pharmacotherapeutic group:anti-inflammatory anti-bronchoconstrictive agent
    ATX: & nbsp

    R.03.D.X.03   Fenspiride

    Pharmacodynamics:

    The anti-inflammatory and anti-bronchoconstrictive activity of fenspiride is due to a decrease in the production of a number of biologically active substances (cytokines, especially tumor necrosis factor α (TNF-α), arachidonic acid derivatives, free radicals) that play an important role in the development of inflammation and bronchospasm.

    Inhibition of fenspiride metabolism of arachidonic acid potentiates its H1- antihistamine effect, t. histamine stimulates the metabolism of arachidonic acid with the formation of prostaglandins and leukotrienes. Fenspiride blocks α-adrenoceptors, stimulation of which is accompanied by an increase in the secretion of bronchial glands. In this way, fenspiride reduces the effect of a number of factors that contribute to the hypersecretion of proinflammatory factors, the development of inflammation and bronchial obstruction. Fenspiride also has an antispasmodic effect.

    Pharmacokinetics:

    FROMmax after oral administration is achieved after 6 hours. T1/2 -12 hours.

    It is excreted mainly by the kidneys.

    Indications:

    Diseases of the upper and lower respiratory tract:

    - rhinopharyngitis and laryngitis;

    - tracheobronchitis;

    - bronchitis (in the background of chronic respiratory failure or without it);

    - bronchial asthma (as part of complex therapy);

    - respiratory effects (cough, hoarseness, throat swelling) with measles, whooping cough and flu;

    - with infectious diseases of the respiratory tract accompanied by a cough, when the standard antibiotic treatment is shown.

    Otitis and sinusitis of various etiologies.

    Contraindications:

    - Hypersensitivity to the active substance and / or any of the components of the drug;

    - Children under 18 years of age (Erespal® syrup should be used to treat children and adolescents under 18 years of age).

    Pregnancy and lactation:

    Data on the use of Erespal® in pregnant women are absent or limited. Taking the drug during pregnancy is not recommended. Therapy with fenspiride is not a reason for interrupting the pregnancy that has occurred.

    Do not use Erespal® during breastfeeding because of the lack of data on the penetration of fenspiride into breast milk.

    Dosing and Administration:

    Inside.

    Adults: 1 tablet 2-3 times a day.

    The maximum daily dose is 240 mg.

    The duration of treatment is determined by the doctor.

    Side effects:

    The most frequent adverse reactions to the drug Erespal® are observed on the part of the digestive system.

    The frequency of adverse reactions that may occur during therapy is given in the following gradation: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10000, <1/1000); very rarely (<1/10000) and an unset frequency (the frequency can not be calculated from the available data).

    From the cardiovascular system:

    Rarely: moderate tachycardia, the severity of which decreases with a decrease in the dose of the drug.

    Unsettled frequency *: palpitations, decreased blood pressure, possibly associated with tachycardia.

    From the digestive system:

    Often: gastrointestinal disorders, nausea, epigastric pain.

    Unknown frequency *: diarrhea, vomiting.

    From the central nervous system:

    Rarely: drowsiness.

    Unidentified frequency *: dizziness.

    General disorders and symptoms:

    Unidentified frequency *: asthenia, increased fatigue.

    From the skin and subcutaneous fat:

    Rarely: erythema, rash, hives, angioedema, fixed erythema pigmentosa.

    Unidentified frequency *: skin itching, toxic epidermal necrolysis, Stevens-Johnson syndrome.

    * Data of post-registration application.

    Overdose:

    If the drug is overdosed (there have been cases of overdose when taking the drug at a dose of more than 2320 mg), you should immediately seek medical help.

    Symptoms: drowsiness or agitation, nausea, vomiting, sinus tachycardia.

    Treatment: gastric lavage, monitoring of the electrocardiogram (ECG). Maintaining vital body functions.

    Interaction:

    Special studies on the interaction of fenspiride with other drugs are not was conducted.

    Because of the possible increase in sedation with the reception of histamine H blockers1-receptors are not It is recommended to use the preparation Erespala® in combination with drugs that have a sedative effect, or together with alcohol.

    Special instructions:

    For the treatment of children and adolescents under 18 years of age, Erespal® syrup should be used.

    Effect on the ability to drive transp. cf. and fur:

    Studies to study the effect of Erespal® on the ability to drive vehicles and work with mechanisms have not been carried out. Patients should be aware of the possible development of drowsiness when taking Erespal® especially at the beginning of therapy or when combined with taking alcohol, and should be careful when driving vehicles and performing work that requires a high rate of psychomotor reactions.

    Form release / dosage:

    Tablets, film-coated, 80 mg.

    Packaging:

    For 15 tablets per blister (PVC / Al).

    Two blisters with instructions for medical use in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.
    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N012547 / 01
    Date of registration:07.04.2010
    The owner of the registration certificate:Servier LaboratoriesServier Laboratories France
    Manufacturer: & nbsp
    Representation: & nbspServier Laboratories Servier Laboratories France
    Information update date: & nbsp21.09.2015
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