Instruction for use: Eladon

Dosage form: Syrup; Film coated Tablets of prolonged action

Active substance: Fenspiride*

ATX

R03DX03 Fenspiride

Pharmacological group:

Anti-inflammatory, anti-bronchoconstrictive agent [H1-antihistamines]

The nosological classification (ICD-10)

A37 Pertussis: Bacterial transport of pertussis pathogens; Whooping cough

B05 Measles: Koplik Spots; Koryvyaya rash on the mucous cheek

H60.9 External otitis, unspecified: Inflammation of external auditory canal; Otitis; Chronic external otitis media

H66.9 Otitis media, unspecified: Chronic otitis media; Otitis; Average otitis media; Middle ear infection; Otitis media in children

J00 Acute nasopharyngitis [rhinitis]: Viral rhinitis;Inflammation of the nasopharynx; Inflammatory Nose Disease; Purulent rhinitis; Nasal congestion; Nasal congestion due to cold and flu; Difficulty with nasal breathing; Difficulty with nasal breathing for colds; Difficult nasal breathing; Difficult nasal breathing for colds; Nasal hypersecretion; Coryza; ARI with phenomena of rhinitis; Acute rhinitis; Acute rhinitis of various origins; Acute rhinitis with thick purulent-mucous exudate; Acute rhinopharyngitis; Edema of the mucous membrane of the nasopharynx; Rhinitis; Rhinorrhea; Infectious-inflammatory disease of ENT organs;Severe cold; Rhinopharyngitis

J01 Acute sinusitis: Inflammation of the paranasal sinuses; Inflammatory diseases of the paranasal sinuses; Purulent-inflammatory processes of the paranasal sinuses; Infectious-inflammatory disease of ENT organs; Infection of the paranasal sinuses; Combined sinusitis; Exacerbation of sinusitis; Acute inflammation of the paranasal sinuses; Acute bacterial sinusitis; Acute sinusitis in adults; Subacute sinusitis; Sinusitis acute; Sinusitis

J04.0 Acute laryngitis: Lecter's laryngitis; Laryngitis acute catarrhal; Laryngitis acute phlegmonous

J06 Acute upper respiratory tract infections of multiple and unspecified locations: Frequent colds of viral diseases; Infections of ENT organs; Acute respiratory illness of influenza nature; Pain for colds; Acute catarrhal disease; Cold; Colds; Colds; Respiratory infection; Seasonal catarrhal disease; Seasonal colds; Pain in infectious and inflammatory diseases of the upper respiratory tract; Bacterial infections of the upper respiratory tract; Bacterial infections of the respiratory system; Viral respiratory disease; Viral respiratory tract infections; Inflammatory disease of the upper respiratory tract; Inflammatory diseases of the upper respiratory tract; Inflammatory diseases of the upper respiratory tract with difficult to separate sputum; Inflammatory respiratory disease; Secondary infections for colds; Difficult sputum separation in acute and chronic respiratory diseases; Upper respiratory tract infections; Infections of the upper respiratory tract; Respiratory tract infections; Respiratory and lung infections; Infectious-inflammatory diseases of the upper respiratory tract; Infectious-inflammatory diseases of the upper respiratory tract and ENT organs; Infectious-inflammatory diseases of the upper respiratory tract in adults and children; Infectious-inflammatory diseases of the upper respiratory tract; Infectious inflammation of the respiratory tract; Respiratory tract infection; Qatar upper respiratory tract; Catarrh of the upper respiratory tract; Catarrh of the upper respiratory tract; Catarrhal phenomena from the upper respiratory tract; Cough in diseases of the upper respiratory tract; Cough for colds; ARVI; ARI; ARI with phenomena of rhinitis; Acute respiratory infection; Acute infectious-inflammatory disease of the upper respiratory tract; Acute respiratory disease; Persecution in the throat or nose; Respiratory and viral infections; Respiratory diseases; Respiratory infections; Recurrent respiratory tract infections; Secondary infections with influenza; Influenza states; Feverish conditions for influenza

J11 Influenza, virus not identified: Influenza; Influenza in the early stages of the disease; Influenza in children; cold in the chest; Begins flu-like condition; Acute disease parainfluenza; parainfluenza; parainfluenza state; influenza epidemics; The pains of the influenza

J22 Acute respiratory infection of lower respiratory tract, unspecified: Bacterial respiratory disease; Bacterial infections of the lower respiratory tract; Bacterial infections of the respiratory system; Viral respiratory disease; Viral respiratory tract infections; Inflammatory respiratory disease;; Difficult sputum separation in acute and chronic respiratory diseases; Respiratory tract infections; Respiratory and lung infections; Lower respiratory tract infections; Infections of the lower respiratory tract; Infectious inflammation of the respiratory tract; Infectious diseases of the respiratory tract; Infectious diseases of the lungs; Infectious diseases of the respiratory system; Respiratory tract infection; Cough for colds; Pulmonary infection; Acute respiratory tract infection; Acute respiratory viral infection; Acute inflammatory airway disease; Acute respiratory disease; Respiratory infection; Respiratory and viral infections; Respiratory syncytial viral infection in young children; Respiratory diseases; Respiratory infections

J31 Chronic rhinitis, nasopharyngitis and pharyngitis: Allergic rhinosinusopathy; Inflammation of the nasal mucosa; Infectious and inflammatory diseases of ENT organs; Catarrh of the nasopharyngeal region; Year-round rhinitis; Ozena; Persecution in the throat or nose; Rhinitis hyperplastic; Rhinitis chronic; Pharyngoesophagitis; Chronic Bacterial Rhinitis

J32 Chronic sinusitis: Allergic rhinosinusopathy; Purulent sinusitis; Catarrh of the nasopharyngeal region; Catarrhal inflammation of the paranasal sinuses; Exacerbation of sinusitis; Sinusitis chronic

J37.0 Chronic laryngitis: Chronic atrophic laryngitis

J40 Bronchitis not specified as acute or chronic: Asthmatic bronchitis; Allergic bronchitis; Bronchitis allergic; Asthmatic bronchitis; Rhinotraheobronchitis; Asthmatic bronchitis; Bacterial bronchitis; Bronchitis; Bronchitis of the smoker; Bronchitis of smokers; Inflammation of the lower respiratory tract; Disease of the bronchi; Qatar smoker; Cough smokers; Cough with inflammatory diseases of the lungs and bronchi; Disturbance of bronchial secretion; Impaired bronchial function; Acute tracheobronchitis; Subacute bronchitis; Tracheobronchitis; Chronic lung diseases

J45 Asthma: Asthma of physical effort; Asthmatic conditions; Bronchial asthma; Bronchial asthma of light course; Bronchial asthma with difficulty in sputum discharge; Bronchial asthma of severe course; Bronchial asthma physical effort; Hypersecretory asthma; The hormone-dependent form of bronchial asthma; Curbing asthma attacks with bronchial asthma; Non-allergic bronchial asthma; Night Asthma; Exacerbation of bronchial asthma; Attack of bronchial asthma; Endogenous forms of asthma; Night attacks of asthma; Cough with bronchial asthma

J96.1 Chronic respiratory failure: chronic respiratory failure; Chronic respiratory insufficiency; Chronic pulmonary insufficiency; Pulmonary dyspnea

R05 Cough: Severe cough; Cough; Cough in the preoperative period; Cough in allergic conditions; Cough with bronchitis; Cough with inflammatory diseases of the lungs and bronchi; Cough in diseases of the upper respiratory tract; Cough for colds; Cough with hard-to-remove viscous sputum; Cough with hard-to-recover sputum; Cough dry; Unproductive cough; Paroxysmal cough; Paroxysmal non-productive cough; Productive cough; Reflex cough; Coughing; Spasmodic cough; Dry cough; Dry, painful cough; Dry non-productive cough; Dry irritating cough; Cough with bronchial asthma; Cough with tuberculosis

R49.8 Other and unspecified voice disorders: Loss of voice; Hoarseness; Hoarseness of voice

Composition

Tablets of prolonged action, covered with a film membrane 1 tab.

active substance: Fenspiride hydrochloride 80 mg

Auxiliary substances: kollidon SR (polyvinyl acetate - 80%, povidone - 19%, sodium lauryl sulfate - 0.8%, silicon dioxide - 0.2%) - 120 mg; Calcium hydrophosphate dihydrate - 95.5 mg; Silicon dioxide colloidal - 1.5 mg; Magnesium stearate - 3 mg

Film membrane: hypromellose - 4.5 mg; Talc - 1,764 mg; Giprolose (hydroxypropylcellulose) - 1,746 mg; Titanium dioxide 0.99 mg or dry film coating mixture (hypromellose 50%, giprolose (hydroxypropylcellulose) 19.4%, talc 19.6%, titanium dioxide 11%) 9 mg

Description of dosage form

Tablets: round, biconcave, film-coated white or almost white. On the cross-section - the core is white or almost white.

Pharmachologic effect

Mode of action - anti-inflammatory, H1-antihistamine.

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 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 is potentiated by its H1-antihistamine action, t. Histamine stimulates the metabolism of arachidonic acid with the formation of PG and LT. Fenspiride blocks α-adrenergic receptors, stimulation of which is accompanied by an increase in the secretion of bronchial glands. Thus, fenspiride reduces the effect of a number of factors that contribute to the hypersecretion of pro-inflammatory factors, the development of inflammation and bronchial obstruction. Fenspiride also has an antispasmodic effect.

Pharmacokinetics

After oral administration of Tmax drug in blood plasma - 6 h. T1 / 2 of the drug is 12 hours. It is excreted mainly by the kidneys.

Indications of the Eladon®

Diseases of the upper and lower respiratory tract:

- Rhinopharyngitis and laryngitis;

- tracheobronchitis;

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

- bronchial asthma (as part of complex therapy);

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

- Infectious diseases of the respiratory tract accompanied by coughing, when standard antibiotic therapy is shown;

Otitis and sinusitis of various etiologies.

Contraindications

Hypersensitivity to fenspiride or other components of the drug;

pregnancy;

The period of breastfeeding;

Age to 18 years.

With caution: simultaneous use of sedatives, ethanol.

Application in pregnancy and breastfeeding

Data on the use of fenspiride in pregnant women are absent. 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 Eladon® during breastfeeding because of the lack of data on the penetration of fenspiride into breast milk. If it is necessary to use the drug during breastfeeding, it is necessary to resolve the issue of stopping breastfeeding.

Side effects

Classification of the incidence of adverse events according to WHO recommendations: very often -> 1/10; Often from> 1/100 to <1/10; Infrequently - from> 1/1000 to <1/100; Rarely - from> 1/10000 to <1/1000; Very rarely - <1/10000, including individual messages; The frequency is unknown - it is not possible to establish the frequency of occurrence from the available data.

From the CVS: rarely - a moderate tachycardia, the severity of which decreases with a decrease in the dose of the drug; The frequency is unknown - a feeling of palpitations, a decrease in blood pressure, possibly associated with tachycardia.

From the digestive system: often - gastrointestinal disorders, nausea, pain in epigastrium; Frequency unknown - diarrhea, vomiting.

From the side of the central nervous system: rarely - drowsiness; Frequency unknown - dizziness.

From the skin: rarely - erythema, rash, hives, angioedema, fixed erythema pigmentosa; Frequency is unknown - skin itch, toxic epidermal necrolysis, Stevens-Johnson syndrome.

Other: frequency unknown - asthenia, increased fatigue.

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 H1 receptor blockers, the use of Eladon® in combination with drugs with sedative effect or with ethanol is not recommended.

Dosing and Administration

Inside. According to 1 table. 2-3 times a day. The maximum daily dose is 240 mg. The duration of treatment is determined by the doctor.

Overdose

When an overdose of the drug (noted cases of overdose when taking the drug at a dose of more than 2320 mg) should immediately seek medical help.

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

Treatment: gastric lavage, ECG monitoring, symptomatic therapy. Maintaining vital body functions.

Special instructions

In the event of an infection of the respiratory system caused by bacteria or fungi, fenspiride is recommended to be used only in combination with antibacterial or antifungal therapy.

Influence on the ability to drive vehicles and work with machinery. 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 and dizziness while taking Eladon®, especially at the beginning of therapy or when combined with ethanol intake. Care must be taken when driving vehicles and performing work that requires a high rate of psychomotor reactions.

Release form

Tablets of prolonged action, film-coated, 80 mg. In the outline of the cell packaging of a PVC film and aluminum foil, 10, 15 or 30 tab.

30 tab. In a bank of HDPE.

3, 6 or 9 contour cell packs of 10 tablets, 2, 4 or 6 contour cell packs of 15 tables, 1, 2 or 3 contourcell packs of 30 tablets. Or 1 bank in a pack of cardboard.

Manufacturer

ZAO VERTEX, Russia.

Conditions of leave from pharmacies

On prescription.

Storage conditions of the drug Eladon

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Eladon

2 years.

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