Sialor^® rhino (Drops) Instructions for Use

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

ATC Code

R01AA05 (Oxymetazoline)

Active Substance

Oxymetazoline (Rec.INN registered by WHO)

Dosage Forms

	Sialor® rhino	Nasal drops 0.01%: dropper tubes 1 ml 2 or 5 pcs.
		Nasal drops 0.05%: dropper tube 2 ml 1, 5 or 10 pcs., 10, 15 or 20 ml 1 or 20 pcs.,
		Nasal drops 0.025%: dropper tubes 2 ml 2 or 5 pcs.

Dosage Form, Packaging, and Composition

Nasal drops as a transparent colorless or slightly colored liquid.

Excipients : benzalkonium chloride – 0.1 mg, disodium edetate (Trilon B) – 0.5 mg, sodium hydroxide (0.1M sodium hydroxide solution) – to pH 6.0-7.0, sodium dihydrogen phosphate dihydrate (sodium phosphate monobasic dihydrate) – 1.29 mg, disodium hydrogen phosphate dodecahydrate (sodium phosphate dibasic dodecahydrate) – 1.76 mg, purified water – to 1 ml.

1 ml – dropper tubes (2) – cardboard packs.
1 ml – dropper tubes (5) – cardboard packs.

Nasal drops as a transparent, colorless or slightly colored liquid.

Excipients : benzalkonium chloride – 0.15 mg, disodium edetate (Trilon B) – 0.5 mg, sodium hydroxide (0.1M sodium hydroxide solution) – to pH 6.0-7.0, sodium dihydrogen phosphate dihydrate (sodium phosphate monobasic dihydrate) – 1.29 mg, disodium hydrogen phosphate dodecahydrate (sodium phosphate dibasic dodecahydrate) – 1.76 mg, purified water – to 1 ml.

10 ml – dropper tube (1) – cardboard packs.

Nasal drops as a transparent, colorless or slightly colored liquid.

Excipients : benzalkonium chloride – 0.15 mg, disodium edetate (Trilon B) – 0.5 mg, sodium hydroxide (0.1M sodium hydroxide solution) – to pH 6.0-7.0, sodium dihydrogen phosphate dihydrate (sodium phosphate monobasic dihydrate) – 1.29 mg, disodium hydrogen phosphate dodecahydrate (sodium phosphate dibasic dodecahydrate) – 1.76 mg, purified water – to 1 ml.

2 ml – dropper tubes (2) – cardboard packs.
2 ml – dropper tubes (5) – cardboard packs.

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Decongestant – vasoconstrictor (alpha-adrenomimetic)

Pharmacological Action

Adrenomimetic agent for topical use. It has a vasoconstrictive effect. When applied intranasally, it reduces swelling of the mucous membrane of the upper respiratory tract.

Pharmacokinetics

When applied intranasally, T_1/2 is 35 hours.

Indications

Difficulty in nasal breathing during colds, inflammation of the nasal sinuses, eustachitis, hay fever, allergic rhinitis.

To relieve swelling before diagnostic procedures in the nasal passages.

ICD codes

Dosage Regimen

Administer intranasally after clearing the nasal passages.

Select the appropriate concentration based on patient age: use the 0.01% solution for infants, the 0.025% solution for children, and the 0.05% solution for adults and adolescents over 12 years.

For adults and children over 6 years, instill 1-2 drops into each nostril. For children aged 1 to 6 years, instill 1 drop into each nostril.

Repeat the application 2-3 times per day as needed for nasal congestion. The maximum duration of continuous use is 3 to 5 days.

Do not exceed the recommended frequency or duration of use to avoid rebound congestion (medication-induced rhinitis).

For diagnostic procedures, a single application is sufficient to reduce mucosal swelling prior to the examination.

If symptoms persist beyond 5 days, discontinue use and consult a physician for further evaluation.

Adverse Reactions

Local reactions possibly – burning, dryness of the nasal mucosa, sneezing; rarely – after the effect of application wears off, the development of a strong feeling of nasal congestion (reactive hyperemia).

Systemic reactions multiple overdoses with topical application can lead to tachycardia and increased blood pressure; very rarely – anxiety, insomnia, fatigue, headaches, nausea.

Contraindications

Atrophic rhinitis, closed-angle glaucoma, hypersensitivity to oxymetazoline.

With caution

Use of MAO inhibitors and the period up to 10 days after their intake; use of drugs that promote increased blood pressure and the period up to 10 days after their intake; increased intraocular pressure; severe forms of cardiovascular diseases (arterial hypertension, coronary artery disease), thyrotoxicosis, diabetes mellitus, pregnancy, period of breastfeeding.

Use in Pregnancy and Lactation

Use with caution during pregnancy and during lactation (breastfeeding).

Pediatric Use

Used in children according to indications in appropriate dosage forms.

Geriatric Use

Use with caution in elderly patients to avoid exacerbation of chronic diseases.

Special Precautions

Avoid prolonged use and overdose, especially in children.

Effect on the ability to drive vehicles and mechanisms

When used in doses exceeding the recommended ones, a general effect on the cardiovascular system and CNS cannot be excluded. In such cases, a decrease in the ability to drive vehicles and engage in other potentially hazardous activities is possible.

Drug Interactions

With simultaneous use of MAO inhibitors and tricyclic antidepressants, an increase in blood pressure is possible.

Oxymetazoline slows down the absorption of local anesthetics, prolongs their action.

Concomitant use of other vasoconstrictor drugs increases the risk of side effects.

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.