Sinucil (Drops) Instructions for Use

Marketing Authorization Holder

Vita Line, LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, 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

Sinucil

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

Dosage Form, Packaging, and Composition

Nasal drops in the form of a clear solution from colorless to light yellow, with a faint lavender odor.

Excipients : anhydrous sodium 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.
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

Combined drug 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), 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 the drug intranasally only. Use the shortest duration necessary to relieve symptoms.

For adults and children over 6 years: instill 1-2 drops into each nostril. Repeat this dose 3-4 times daily as needed. Maintain an interval of at least 4 hours between applications.

For children aged 2 to 6 years: instill 1 drop into each nostril. Repeat this dose 3 times daily as needed. Maintain an interval of at least 4 hours between applications.

Do not use in children under 2 years of age due to the risk of severe systemic adverse effects.

Limit the duration of continuous use to 5-7 days. Prolonged use beyond one week is not recommended. Discontinue use if symptoms persist or worsen.

Before administration, clear the nasal passages gently. Tilt the head back slightly during instillation. Avoid the dropper tip touching the nasal surface to prevent contamination.

If a dose is missed, apply it as soon as remembered. If it is nearly time for the next dose, skip the missed dose. Do not double the dose to catch up.

In cases of chronic rhinitis or sinusitis, use strictly as directed by a physician. For pre-operative preparation or post-operative edema management, follow the specific regimen prescribed by the surgeon.

Monitor for signs of systemic effects, especially in children and elderly patients. Discontinue use immediately and seek medical advice if symptoms of overdose occur, such as headache, dizziness, tremor, insomnia, or hypertension.

Adverse Reactions

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

Local reactions: rarely – burning at the application site.

Contraindications

Atrophic rhinitis (including with foul-smelling discharge – ozena); concomitant 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

Prolonged or excessive use of the drug may cause tachyphylaxis and a “rebound” effect, associated with the re-development of nasal congestion (medication 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.

Should not be prescribed simultaneously 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.