Rhinorus^® (Drops) Instructions for Use

Marketing Authorization Holder

Sintez PJSC (Russia)

ATC Code

R01AA07 (Xylometazoline)

Active Substance

Xylometazoline (Rec.INN registered by WHO)

Dosage Forms

	Rhinorus®	Nasal drops 0.1%: bottle or dropper bottle 5 ml or 10 ml
		Nasal drops 0.05%: bottle or dropper bottle 5 ml or 10 ml
		Nasal spray 0.1%: bottle with spray nozzle 10 ml or 20 ml
		Nasal spray 0.05%: bottle with spray nozzle 10 ml or 20 ml

Dosage Form, Packaging, and Composition

Nasal drops 0.05% as a clear, colorless or slightly yellowish liquid.

Excipients: benzalkonium chloride – 0.1 mg, sodium chloride – 5 mg, disodium edetate (disodium salt of ethylenediaminetetraacetic acid [Trilon B]) – 0.5 mg, sodium dihydrogen phosphate dihydrate (sodium phosphate monobasic dihydrate) – 6 mg, disodium hydrogen phosphate dodecahydrate (sodium phosphate dibasic dodecahydrate) – 3.5 mg, eucalyptus oil (oil from the leaves of Eucalyptus globulus) – 0.85 mg, purified water – up to 1 ml.

5 ml – bottles with a dosing nozzle (1) – cardboard packs.
5 ml – dropper bottles (1) – cardboard packs.
10 ml – bottles with a dosing nozzle (1) – cardboard packs.
10 ml – dropper bottles (1) – cardboard packs.

Nasal drops 0.1% as a clear, colorless or slightly yellowish liquid.

Excipients: benzalkonium chloride – 0.1 mg, sodium chloride – 5 mg, disodium edetate (disodium salt of ethylenediaminetetraacetic acid [Trilon B]) – 0.5 mg, sodium dihydrogen phosphate dihydrate (sodium phosphate monobasic dihydrate) – 6 mg, disodium hydrogen phosphate dodecahydrate (sodium phosphate dibasic dodecahydrate) – 3.5 mg, eucalyptus oil (oil from the leaves of Eucalyptus globulus) – 0.85 mg, purified water – up to 1 ml.

5 ml – bottles with a dosing nozzle (1) – cardboard packs.
5 ml – polymer dropper bottles (1) – cardboard packs.
10 ml – bottles with a dosing nozzle (1) – cardboard packs.
10 ml – polymer dropper bottles (1) – cardboard packs.

Nasal spray 0.05% as a clear, colorless or slightly yellowish liquid.

Excipients: benzalkonium chloride, sodium chloride, disodium edetate (disodium salt of ethylenediaminetetraacetic acid [Trilon B]), sodium dihydrogen phosphate dihydrate (sodium phosphate monobasic dihydrate), disodium hydrogen phosphate dodecahydrate (sodium phosphate dibasic dodecahydrate), eucalyptus oil (oil from the leaves of Eucalyptus viminalis), purified water.

10 ml – bottles with a spray nozzle and a cap-cover (1) – cardboard packs.
20 ml – bottles with a spray nozzle and a cap-cover (1) – cardboard packs.

Nasal spray 0.1% as a clear, colorless or slightly yellowish liquid.

Excipients: benzalkonium chloride, sodium chloride, disodium edetate (disodium salt of ethylenediaminetetraacetic acid [Trilon B]), sodium dihydrogen phosphate dihydrate (sodium phosphate monobasic dihydrate), disodium hydrogen phosphate dodecahydrate (sodium phosphate dibasic dodecahydrate), eucalyptus oil (oil from the leaves of Eucalyptus viminalis), purified water.

10 ml – bottles with a spray nozzle (1) – cardboard packs.
20 ml – bottles with a spray nozzle (1) – cardboard packs.

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Drugs for the treatment of nasal diseases; decongestants and other drugs for topical use; sympathomimetics

Pharmacological Action

Vasoconstrictor drug for topical use in ENT practice. Xylometazoline (an imidazoline derivative) is an alpha-adrenergic agonist, causes constriction of the blood vessels of the nasal mucosa, eliminating its edema and hyperemia, restores the patency of the nasal passages, facilitates nasal breathing and improves the discharge of secretions from the nose in rhinitis (runny nose) of various origins.

The effect of the drug occurs a few minutes after its application and lasts up to 10 hours.

Pharmacokinetics

When applied topically, the drug is practically not absorbed, so its concentration in blood plasma is very low (not determined by modern analytical methods).

Indications

• Acute rhinitis (including against the background of acute respiratory diseases and allergic rhinitis);
• Sinusitis;
• Eustachitis;
• Otitis media (as part of combination therapy to reduce swelling of the nasopharyngeal mucosa);
• To facilitate rhinoscopy;
• Preparation of patients for diagnostic manipulations in the nasal passages.

ICD codes

Dosage Regimen

Nasal drops

Adults and children over 6 years instill nasal drops 0.1%, 2-3 drops into each nasal passage 3-4 times/day.

Children from 2 to 6 years instill nasal drops 0.05%, 1-2 drops into each nasal passage 1-2 times/day. Should not be used more than 3 times/day.

Duration of treatment – no more than 3-5 days (without interruption).

Before using the drug, unscrew the bottle cap and instill into the nose by lightly pressing the bottom of the bottle.

Nasal spray

Adults and children over 6 years – 1 spray of nasal spray 0.1% into each nasal passage 3 times/day. If necessary, the spray can be repeated (no more than two sprays at the same time).

Children from 2 to 6 years – 1 spray of nasal spray 0.05% into each nasal passage 1-2 times/day.

The drug should not be used more than 3 times/day. Duration of treatment – no more than 5-7 days (without interruption).

After completion of therapy, the drug can be re-prescribed only after a few days.

The duration of use of the drug in children is determined by the doctor.

Rules for using the drug in the form of a nasal spray

Remove the protective cap from the bottle. Before first use, press the spray nozzle several times until a jet with a “cloud of mist” appears. The bottle is ready for use. When spraying, press the spray nozzle once. Inhale the drug through the nose. If possible, hold the spray bottle vertically. Do not spray the spray horizontally or downward. After use, close the spray bottle with the protective cap.

Adverse Reactions

Local reactions: with frequent and/or prolonged use – irritation and/or dryness of the nasopharyngeal mucosa, burning, paresthesia, sneezing, hypersecretion; rarely – swelling of the nasal mucosa.

Systemic reactions: vomiting, headache, palpitations, increased blood pressure, insomnia, blurred vision, depression (with long-term use of high doses).

Contraindications

• Arterial hypertension;
• Tachycardia;
• Severe atherosclerosis;
• Glaucoma;
• Atrophic rhinitis;
• Hyperthyroidism;
• Surgical interventions on the meninges (in history);
• Pregnancy (for nasal drops);
• Children under 2 years of age;
• Children under 6 years of age (for nasal drops 0.1% and nasal spray 0.1%);
• Hypersensitivity to the components of the drug (including eucalyptus oil).

Do not use during therapy with MAO inhibitors and tricyclic antidepressants, as well as with other drugs that increase blood pressure.

With caution, the drug should be prescribed for diabetes mellitus, coronary artery disease, angina pectoris III-IV functional class, prostatic hyperplasia, during lactation.

Use in Pregnancy and Lactation

The drug Rhinorus^® in the form of nasal drops is contraindicated for use during pregnancy.

The drug Rhinorus^® in the form of nasal spray during pregnancy should be used only after a thorough assessment of the benefit-to-risk ratio for the mother and fetus, exceeding the recommended doses is not allowed.

During breastfeeding, the drug should be prescribed with caution.

Pediatric Use

Nasal drops

Children over 6 years instill nasal drops 0.1%, 2-3 drops into each nasal passage 3-4 times/day.

Children from 2 to 6 years instill nasal drops 0.05%, 1-2 drops into each nasal passage 1-2 times/day. Should not be used more than 3 times/day.

Duration of treatment – no more than 3-5 days (without interruption).

Nasal spray

Children over 6 years – 1 spray of nasal spray 0.1% into each nasal passage 3 times/day. If necessary, the spray can be repeated (no more than two sprays at the same time).

Children from 2 to 6 years – 1 spray of nasal spray 0.05% into each nasal passage 1-2 times/day.

The drug should not be used more than 3 times a day. Duration of treatment – no more than 5-7 days (without interruption).

After completion of therapy, the drug can be re-prescribed only after a few days.

The duration of use of the drug in children is determined by the doctor.

Contraindicated

• Children under 6 years of age (for nasal drops 0.1% and nasal spray 0.1%);
• Children under 2 years of age (for nasal drops 0.05% and nasal spray 0.05%).

Special Precautions

Should not be used for more than 7 days. Do not exceed the recommended doses and use for a long time.

Before use, it is necessary to clean the nasal passages.

Effect on the ability to drive vehicles and mechanisms

In doses exceeding the recommended ones, it may affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, which requires caution.

Overdose

Symptoms: decreased body temperature, bradycardia, increased blood pressure.

Treatment: symptomatic therapy is carried out.

Drug Interactions

Enhancement of the systemic action of xylometazoline is possible with simultaneous use of MAO inhibitors and tricyclic antidepressants.

Storage Conditions

The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life of nasal drops – 3 years, nasal spray – 2 years.

Dispensing Status

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

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.