Demefecil (Drops) Instructions for Use

Marketing Authorization Holder

Petrovax Pharm NPO, 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

Demefecil

Nasal drops 0.25 mg+2.5 mg/1 ml: bottle 10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 40 ml or 50 ml

Dosage Form, Packaging, and Composition

Nasal drops in the form of a transparent, colorless to pale yellow solution with a faint specific lavender odor.

Excipients: anhydrous disodium hydrogen phosphate – 4.4 mg, citric acid monohydrate – 2.6 mg, sorbitol – 35 mg, benzalkonium chloride – 0.1 mg, lavender oil – 0.2 mg, purified water – up to 1 ml.

10 ml – bottles (1) – cardboard packs.
15 ml – bottles (1) – cardboard packs.
20 ml – bottles (1) – cardboard packs.
25 ml – bottles (1) – cardboard packs.
30 ml – bottles (1) – cardboard packs.
40 ml – bottles (1) – cardboard packs.
50 ml – 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 ENT diseases.

Phenylephrine is a sympathomimetic agent; 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 common cold); allergic rhinitis (including 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. The dosage regimen is individual, determined by the indication, patient age, and clinical situation.

For children aged 6 to 12 years, instill 1-2 drops into each nasal passage. Do not exceed 3 applications per day.

For adolescents over 12 years and adults, instill 3-4 drops into each nasal passage. The maximum frequency of application is 4 times per day.

Adhere strictly to the recommended dosage and duration of treatment. The course of therapy should not exceed 5-7 days unless directed by a physician.

For preparation for diagnostic procedures or surgery in the nasal area, follow the specific instructions provided by the attending physician.

To administer, tilt the head slightly back. Insert the dropper tip into the nostril without deep insertion. Squeeze the bottle to deliver the prescribed number of drops. Avoid contact of the dropper with the nasal mucosa to prevent contamination.

If symptoms persist beyond 7 days, discontinue use and consult a physician. Do not use in children under 6 years of age.

Adverse Reactions

From the respiratory system: rarely – nasal discomfort, nasal dryness, epistaxis.

Local reactions: rarely – burning at the application site.

Contraindications

Atrophic rhinitis (including with foul-smelling discharge – ozaena); concurrent use 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.

Use with caution 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 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

Long-term or excessive use of the drug may cause tachyphylaxis and a “rebound” effect associated with the re-development of nasal congestion (medication-induced rhinitis), and may 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 currently receiving MAO inhibitors or who have received them within the previous 2 weeks.

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

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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.