Erispirus^® (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

A drug with bronchodilator and anti-inflammatory action. It reduces the manifestations of bronchospasm and inflammation in the airways.

The mechanism of action is associated with antagonistic activity against histamine H₁ receptors and with myotropic antispasmodic activity.

It reduces the production of a number of biologically active substances involved in the development of inflammation and contributing to increased bronchial tone (including cytokines, TNFα, arachidonic acid derivatives, free radicals).

Pharmacokinetics

It is well absorbed from the gastrointestinal tract. C_max is reached 6 hours after administration and decreases 3-fold after 12 hours.

It is excreted mainly by the kidneys (90%), and 10% via the intestines. T_1/2 is 12 hours.

Indications

Rhinopharyngitis, laryngitis, otitis, sinusitis, rhinotracheobronchitis, bronchitis, maintenance therapy for isolated and complicated bronchial asthma, respiratory symptoms in measles, whooping cough, influenza; infectious diseases of the respiratory tract accompanied by cough, when standard antibiotic therapy is indicated.

ICD codes

Dosage Regimen

Administer the drug orally before meals to ensure optimal absorption.

For adult patients, the standard dosage is 80 mg taken two to three times per day.

For pediatric patients over 2 years of age, calculate the dose based on body weight at 4 mg/kg per day.

Divide the total daily pediatric dose into multiple administrations as directed.

Use only the age-appropriate dosage form for children, such as the syrup formulation.

The maximum daily dose for adults should generally not exceed 240 mg.

Adhere strictly to the prescribed dosing schedule to maintain stable therapeutic blood levels.

Do not crush or chew the tablets; swallow them whole with a sufficient amount of water.

For syrup, use the measuring device provided to ensure accurate dosing.

The duration of treatment is determined by the treating physician based on clinical response.

Do not discontinue therapy abruptly without medical consultation.

If a dose is missed, take it as soon as remembered unless it is almost time for the next scheduled dose.

Adverse Reactions

From the cardiovascular system rarely – tachycardia, the severity of which decreases with dose reduction; frequency unknown – palpitations, decreased blood pressure, possibly associated with tachycardia.

From the digestive system often – dyspeptic phenomena, nausea, pain in the epigastric region; frequency unknown – diarrhea, vomiting.

From the nervous system rarely – drowsiness; frequency unknown – dizziness.

From the skin and subcutaneous tissues: rarely – erythema, rash, urticaria, angioedema, fixed pigmentary erythema; frequency unknown – skin itching, toxic epidermal necrolysis, Stevens-Johnson syndrome.

Other: frequency unknown: asthenia – increased fatigue.

Contraindications

Hypersensitivity to fenspiride; pregnancy, lactation period (breastfeeding); childhood – depending on the dosage form.

With caution

Concomitant use of sedative drugs.

Use in Pregnancy and Lactation

Fenspiride is contraindicated for use during pregnancy and during the lactation period (breastfeeding).

Pediatric Use

Use in children is possible according to indications, in age-recommended doses and dosage forms.

It is necessary to strictly follow the instructions in the prescribing information for fenspiride drugs regarding contraindications for the use of specific fenspiride dosage forms in children of different ages.

Special Precautions

Treatment with fenspiride does not replace antibacterial therapy and cannot be a reason for delaying the adequate prescription of antibacterial drugs.

Fenspiride should be used with caution simultaneously with sedative drugs.

Influence on the ability to drive vehicles and mechanisms

During the use of fenspiride, patients should exercise caution when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

When using fenspiride in combination with drugs that have a sedative effect, or together with alcohol, an enhancement of the sedative effect is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.