Eladon® (Eladon)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceFenspirideFenspiride
Similar drugsTo uncover
  • Sirep
    syrup inwards 
    Pharmaceutical factory "POLFARMA" JSC     Poland
  • Fenspiride
    pills inwards 
    NATIVA, LLC     Russia
  • Fezpalen
    pills inwards 
    ATOLL, LLC     Russia
  • Fezpalen
    syrup inwards 
    ATOLL, LLC     Russia
  • Fespalen Solubles Tablets
    pills inwards 
    ATOLL, LLC     Russia
  • Eladon®
    pills inwards 
    VERTEKS, AO     Russia
  • Eladon®
    syrup inwards 
    VERTEKS, AO     Russia
  • Epistat®
    syrup inwards 
    GEDEON RICHTER, OJSC     Hungary
  • Epistat®
    pills inwards 
    GEDEON RICHTER, OJSC     Hungary
  • Erespal®
    syrup inwards 
    Servier Laboratories     France
  • Erespal®
    pills inwards 
    Servier Laboratories     France
  • Erispirus ®
    pills inwards 
    Sandoz d.     Slovenia
  • Erispirus ®
    syrup inwards 
    Sandoz d.     Slovenia
    • Dosage form: & nbsptablets of prolonged action, film-coated
    Composition:

    1 tablet of prolonged action, film-coated, contains:

    active substance: fenspiride hydrochloride - 80,000 mg;

    Excipients: kollidone SR (polyvinyl acetate 80%, povidone 19%, sodium lauryl sulfate 0.8%, silicon dioxide 0.2%) 120,000 mg, calcium hydrophosphate dihydrate 95.500 mg, silicon colloidal dioxide 1,500 mg, magnesium stearate 3,000 mg;

    film sheath: hypromellose - 4,500 mg, talc - 1,764 mg, giprolase (hydroxypropyl cellulose) 1.746 mg, titanium dioxide 0.990 mg, or a dry film coating mixture containing hypromellose (50%), giprolose (hydroxypropylcellulose) (19.4%), talc (19.6%), titanium dioxide (1%) - 9,000 mg.

    Description:

    Round biconvex tablets covered with a film coat of white or almost white color. On the cross section, the nucleus is white or almost white in color.

    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 H1antihistamine action, 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:

    After oral administration, the maximum concentration of the drug in the blood plasma (FROMmax) is reached after 6 hours.

    Half-life of the drug (T1/2) is 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;

    - age to 18 years.

    Pregnancy and lactation:

    Taking the drug during pregnancy is not recommended.

    Therapy with fenspiride is not a reason for interrupting the pregnancy that has occurred.

    Clinical data on the fetotoxic effect of fenspiride or its ability to cause malformations during admission during pregnancy are absent.

    Do not use Eladon® 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 incidence of side effects that may occur during therapy, is given in the following gradation: very often -> 1/10 (> 10%); often from> 1/100 to <1/10 (> 1% and <10%); infrequently - from> 1/1000 to <1/100 (> 0.1% and <1%); rarely from> 1/10000 to <1/1000 (> 0.01% and <0.1%); very rarely - <1/10000 (<0.01%); an unknown frequency - the frequency can not be calculated from the available data

    From the side of the cardiovascular system

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

    From the digestive system

    Often - gastrointestinal disorders, nausea, pain in epigastrium.

    Unidentified frequency - diarrhea, vomiting.

    From the central nervous system

    Rarely, drowsiness.

    An unknown frequency is dizziness.

    From the skin

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

    Unidentified frequency - itchy skin.

    Other

    Unidentified frequency - asthenia, increased fatigue.

    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 have not been conducted.

    Because of the possible increase in sedation with the administration of histamine blockers H1-receptor is not recommended the use of the drug Eladon® in combination with drugs that have a sedative effect, or in conjunction with alcohol.

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

    Studies to study the effect of Eladon® on the ability to drive vehicles and work with mechanisms have not been conducted. Patients should be aware of the possible development of drowsiness when taking Eladon®, 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 of prolonged action, film-coated, 80 mg.

    Packaging:

    10, 15 or 30 tablets in a planar cell packaging made of a polyvinylchloride film and aluminum foil.

    30 tablets in a can of high-density polyethylene.

    3, 6 or 9 contiguous cell packs of 10 tablets, 2, 4 or 6 contiguous cell packs of 15 tablets, 1, 2 or 3 contour packs of 30 tablets or one can, together with instructions for medical use in a pack of cardboard.
    Storage conditions:

    Store in a dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002521
    Date of registration:04.07.2014 / 07.08.2015
    Expiration Date:04.07.2019
    The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia
    Manufacturer: & nbsp
    Representation: & nbspVERTEKS CJSC VERTEKS CJSC Russia
    Information update date: & nbsp21.09.2015
    Illustrated instructions
      Instructions
      Up