Eladon^® (Tablets, Syrup) Instructions for Use

ATC Code

R03DX03 (Fenspiride)

Active Substance

Fenspiride (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Agent with anti-inflammatory and anti-bronchoconstrictor activity

Pharmacotherapeutic Group

Anti-inflammatory anti-bronchoconstrictor agent

Pharmacological Action

The anti-inflammatory and anti-bronchoconstrictor activity of fenspiride is due to a reduction in the production of a number of biologically active substances (cytokines, especially TNFα, arachidonic acid derivatives, free radicals), which play an important role in the development of inflammation and bronchospasm.

Fenspiride’s inhibition of arachidonic acid metabolism is potentiated by its H₁-antihistamine action, since histamine stimulates the metabolism of arachidonic acid with the formation of prostaglandins and leukotrienes. Fenspiride blocks α-adrenergic receptors, stimulation of which is accompanied by an increase in the secretion of bronchial glands. Thus, Fenspiride reduces the action 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, C_max in blood plasma is reached after 6 hours.

T_1/2 is 12 hours. It is excreted mainly by the kidneys.

Indications

Diseases of the upper and lower respiratory tract:

• Rhinopharyngitis and laryngitis;
• Tracheobronchitis;
• Bronchitis (against the background of chronic respiratory failure or without it);
• Bronchial asthma (as part of complex therapy);
• Respiratory phenomena (cough, hoarseness, sore throat) with measles, whooping cough and influenza;
• For infectious diseases of the respiratory tract accompanied by cough, when standard antibiotic therapy is indicated.

Otitis and sinusitis of various etiologies.

ICD codes

Dosage Regimen

Administer all forms of Eladon^® orally.

For Adults, the standard dosage is 80 mg two to three times daily.

The maximum daily dose for adults is 240 mg; do not exceed this limit.

For Syrup administration, take the dose before meals.

For pediatric patients, use only the Syrup formulation.

The dosage for children over 2 years of age is 4 mg per kilogram of body weight per day.

Divide the total daily dose for children into multiple administrations.

The exact frequency of administration and duration of therapy must be determined by the physician.

Adjust the treatment course based on the underlying condition and clinical response.

For Tablets, the standard adult dose is one tablet (80 mg) two to three times daily.

Adverse Reactions

The frequency of adverse effects that may occur during therapy is presented in the following gradation: very common – ≥1/10 (>10%); common – from ≥1/100 to <1/10 (>1% and <10%); uncommon - from ≥1/1000 to <1/100 (>0.1% and <1%); rare - from ≥1/10 000 to <1/1000 (>0.01% and <0.1%); very rare - <1/10 000 (<0.01%); frequency not known - frequency cannot be calculated from available data.

Cardiovascular system: rare – moderate tachycardia, the severity of which decreases when the drug dose is reduced.

Digestive system: common – gastrointestinal disorders, nausea, epigastric pain; frequency not known – diarrhea, vomiting.

CNS: rare – drowsiness; frequency not known – dizziness.

Skin: rare – erythema, rash, urticaria, angioedema, fixed pigmentary erythema; frequency not known – skin itching.

Other: frequency not known – asthenia, increased fatigue.

Contraindications

• Age under 18 years;
• Hypersensitivity to the active substance and/or any of the components of the drug.

Use in Pregnancy and Lactation

Use of the drug during pregnancy is not recommended.

Therapy with fenspiride is not a reason for termination of an established pregnancy.

There are no clinical data on the fetotoxic effect of fenspiride or its ability to cause malformations when taken during pregnancy.

Eladon^® should not be used during breastfeeding due to the lack of data on the penetration of fenspiride into breast milk.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

Effect on ability to drive vehicles and operate machinery

Studies on the effect of Eladon^® on the ability to drive vehicles and operate machinery have not been conducted. Patients should be informed about the possible development of drowsiness when taking Eladon^®, especially at the beginning of therapy or in combination with alcohol intake, and should exercise caution when driving vehicles and performing work that requires high speed of psychomotor reactions.

Overdose

In case of drug overdose (cases of overdose have been noted when taking the drug at a dose of more than 2320 mg), seek medical help immediately.

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

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

Drug Interactions

Special studies on the interaction of fenspiride with other drugs have not been conducted.

Due to the possible enhancement of the sedative effect when taking histamine H₁-receptor blockers, the use of Eladon^® in combination with drugs that have a sedative effect, or together with alcohol, is not recommended.

Storage Conditions

The drug should be stored in a place protected from light, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.