Fridifinil (Drops) Instructions for Use

Marketing Authorization Holder

Gerta, LLC (Russia)

Manufactured By

Grotex, LLC (Russia)

ATC Code

R01AB01 (Phenylephrine in combination with other drugs)

Active Substances

Phenylephrine (Rec.INN registered by WHO)

Dimetindene (Rec.INN registered by WHO)

Dosage Form

Fridifinil

Nasal drops 0.25 mg+2.5 mg/1 ml: bottle or dropper bottle 10 ml or 15 ml

Dosage Form, Packaging, and Composition

Nasal drops in the form of a transparent solution from colorless to yellow or brown-yellow.

Excipients: sodium phosphate dibasic dihydrate, anhydrous citric acid, sorbitol, benzalkonium chloride, purified water.

10 ml – dark glass bottles (1) with a dropper cap or with a dropper – cardboard packs.
15 ml – dark glass bottles (1) with a dropper cap or with a dropper – cardboard packs.
10 ml – polyethylene dropper bottles (1) – cardboard packs.
15 ml – polyethylene dropper bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with vasoconstrictive and antiallergic action for topical use in ENT practice

Pharmacotherapeutic Group

Drugs for the treatment of nasal diseases; decongestants and other drugs for topical use; sympathomimetics, combinations without corticosteroids

Pharmacological Action

A combined medicinal product with vasoconstrictive and antiallergic action for topical use in diseases of the ENT organs.

Phenylephrine is a sympathomimetic; with topical application it has a moderate vasoconstrictive effect (due to stimulation of α₁-adrenergic receptors located in the venous vessels of the nasal mucosa), it eliminates swelling of the nasal mucosa and its paranasal sinuses.

Dimetindene is an antiallergic agent – an antagonist of histamine H₁-receptors; it does not reduce the activity of the ciliated epithelium of the nasal mucosa.

Pharmacokinetics

For topical use

Indications

Acute rhinitis (including with colds); allergic rhinitis (including with hay fever); vasomotor rhinitis; chronic rhinitis; acute and chronic sinusitis; acute otitis media (as an auxiliary agent); preparation for surgical interventions in the nasal area and elimination of edema of the nasal mucosa and paranasal sinuses after surgical intervention in this area.

ICD codes

Dosage Regimen

Administer intranasally. Instill drops into each nostril with the head tilted back.

For adults and children over 6 years, use 3-4 drops in each nostril. Do not exceed 4 applications per day.

For children aged 2 to 6 years, use 1-2 drops in each nostril. Do not exceed 3 applications per day.

The duration of continuous treatment should not exceed 7 days for adults and 3-5 days for children.

For pre-operative preparation or post-operative edema, follow the specific regimen prescribed by the physician.

If symptoms persist beyond the recommended treatment duration, discontinue use and consult a physician.

Avoid exceeding the stated dose and frequency to prevent systemic effects and rebound congestion.

Adverse Reactions

From the respiratory system: rarely – discomfort in the nose, dryness in the nose, nosebleed.

Local reactions: rarely – burning at the application site.

Contraindications

Atrophic rhinitis (including with foul-smelling discharge – ozaena); simultaneous administration of MAO inhibitors and the period up to 14 days after their withdrawal; children under 6 years of age; closed-angle glaucoma; hypersensitivity to phenylephrine, dimetindene maleate or other components of the drug.

With caution should be used in cardiovascular diseases (arterial hypertension, arrhythmias, generalized atherosclerosis), hyperthyroidism, prostate adenoma, diabetes mellitus, obstruction of the bladder neck (for example, due to prostate hypertrophy), epilepsy; in patients with severe reactions to sympathomimetics, manifested as insomnia, dizziness, tremor, cardiac arrhythmia or increased blood pressure.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during lactation (breastfeeding).

Pediatric Use

In children under 6 years of age, only nasal drops are used. If the recommended dose is exceeded, manifestations of the systemic action of the drug may develop.

Geriatric Use

If the recommended dose is exceeded, manifestations may develop in elderly patients.

Special Precautions

Prolonged or excessive use of the drug may cause tachyphylaxis and a “rebound” effect associated with the re-development of nasal congestion (medicinal rhinitis), and lead to the development of systemic vasoconstrictive action.

If the recommended dose is exceeded, manifestations of the systemic action of the drug may develop, especially in children and elderly patients.

Drug Interactions

Contraindicated in patients receiving MAO inhibitors at the present time or who have received them within the previous 2 weeks.

The drug should not be prescribed simultaneously with tri- and tetracyclic antidepressants, beta-blockers.

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

Over-the-Counter

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.