Sanorinchik (Drops) Instructions for Use

Marketing Authorization Holder

IVAX Pharmaceuticals, s.r.o. (Czech Republic)

ATC Code

R01AA05 (Oxymetazoline)

Active Substance

Oxymetazoline (Rec.INN registered by WHO)

Dosage Forms

	Sanorinchik	Children’s nasal drops 100 mcg/1 ml: 10 ml bottle with dropper
		Children’s nasal drops 250 mcg/1 ml: 10 ml bottle with dropper
		Nasal drops 500 mcg/1 ml: 10 ml bottle with dropper
		Nasal spray 500 mcg/1 ml: 10 ml bottle with sprayer

Dosage Form, Packaging, and Composition

Children’s nasal drops are a transparent, colorless, odorless liquid, free from mechanical impurities.

Excipients: boric acid, sodium tetraborate, benzalkonium chloride, disodium edetate dihydrate, sterile purified water.

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

Children’s nasal drops are a transparent, colorless, odorless liquid, free from mechanical impurities.

Excipients: boric acid, sodium tetraborate, benzalkonium chloride, disodium edetate dihydrate, sterile purified water.

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

Nasal drops are a transparent, colorless, odorless liquid, free from mechanical impurities.

Excipients: boric acid, sodium tetraborate, benzalkonium chloride, disodium edetate dihydrate, sterile purified water.

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

Nasal spray is a transparent, colorless, odorless liquid, free from mechanical impurities.

10 ml – plastic bottles (1) with a mechanical sprayer – cardboard packs.

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Decongestant – vasoconstrictor (alpha-adrenomimetic)

Pharmacological Action

An alpha-adrenomimetic for topical use. It has a vasoconstrictive effect. When administered intranasally, it reduces swelling of the mucous membrane of the upper respiratory tract. The effect appears 10-15 minutes after application and lasts for 6-8 hours.

Pharmacokinetics

Pharmacokinetic data for the drug Sanorinchik are not available.

Indications

• Acute infectious and inflammatory rhinitis;
• Sinusitis;
• Eustachitis;
• Allergic rhinitis (including hay fever).

ICD codes

Dosage Regimen

Sanorinchik in the form of a 0.5 mg/ml nasal spray and 0.5 mg/ml nasal drops is intended for children over 8 years of age and adults; 1-2 drops or 1 spray dose are administered into each nostril 2-3 times/day.

0.25 mg/ml nasal drops are intended for use in children aged from 1 year to 8 years; 1-2 drops are administered 2-3 times/day.

0.1 mg/ml nasal drops are intended for use in children under 1 year of age. Newborns (up to 4 weeks) are administered 1 drop into each nostril 2-3 times/day, children aged from 5 weeks to 1 year – 1-2 drops 2-3 times/day.

The duration of use should not exceed 7 days; if nasal breathing improves, the use of the drug can be stopped earlier. Re-prescription is possible only after several days.

Adverse Reactions

Local reactions: transient dryness and burning of the nasal mucosa, dryness in the oral cavity and pharynx, sneezing.

Systemic reactions: increased blood pressure, headache, dizziness, palpitations, sleep disorders, increased anxiety, nausea, insomnia.

With prolonged (more than 7 days) use of the drug: reactive hyperemia of the nasal mucosa, atrophy of the mucous membrane, tachyphylaxis.

Contraindications

• Atrophic (dry) rhinitis;
• Pregnancy (for 0.5 mg/ml nasal drops and nasal spray);
• Lactation (for 0.5 mg/ml nasal drops and nasal spray);
• Children under 8 years of age (for 0.5 mg/ml nasal drops and nasal spray);
• Children under 1 year of age and over 8 years of age (for 0.25 mg/ml nasal drops);
• Children over 1 year of age (for 0.1 mg/ml nasal drops);
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The drug in the form of 0.5 mg/ml nasal drops and nasal spray is contraindicated for use during pregnancy and lactation.

The other dosage forms are intended for use in children under 8 years of age.

Pediatric Use

0.25 mg/ml nasal drops are intended for use in children aged from 1 year to 8 years; 1-2 drops are administered 2-3 times/day.

0.1 mg/ml nasal drops are intended for use in children under 1 year of age. Newborns (up to 4 weeks) are administered 1 drop into each nostril 2-3 times/day, children aged from 5 weeks to 1 year – 1-2 drops 2-3 times/day.

Special Precautions

Use with caution in patients with cardiovascular diseases (arterial hypertension, coronary artery disease), carbohydrate metabolism disorders (diabetes mellitus), thyroid gland dysfunction (hyperthyroidism), and angle-closure glaucoma.

The patient should be warned that without a doctor’s prescription, the drug can be used at the recommended dose for no more than 3 days.

Contact of the drug with the eyes should be avoided.

Effect on the ability to drive vehicles and operate machinery

Patients engaged in activities requiring increased attention and speed of psychomotor reactions should take into account that the drug may affect vision and reduce the speed of psychomotor reactions.

Overdose

Symptoms: with prolonged or frequent use of the drug, nausea, increased blood pressure, and tachycardia are possible.

Treatment: if necessary, symptomatic therapy is carried out.

Drug Interactions

When used concomitantly with MAO inhibitors and tricyclic antidepressants, an increase in blood pressure is possible.

With simultaneous use, the drug slows down the absorption of local anesthetics from the mucous membrane and prolongs their action.

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

Storage Conditions

The drug should be stored in a place protected from light and out of the reach of children at a temperature between 10°C (50°F) and 25°C (77°F).

Shelf Life

The shelf life is 2 years.

Pharmacy dispensing terms

The drug is approved for use as an over-the-counter product.

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.