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Sialor® Aqua (Solution, Drops) Instructions for Use

ATC Code

R01AX10 (Other drugs)

Active Substance

Sea water

Clinical-Pharmacological Group

Drug for moisturizing, cleansing, and protecting the nasal mucosa

Pharmacotherapeutic Group

Nose diseases treatment

Pharmacological Action

It helps to maintain the normal physiological state of the nasal mucosa, as well as to thin mucus and normalize its production by the goblet cells of the mucosa.

The trace elements that make up sea water have an anti-inflammatory effect, stimulate reparative processes, and improve the function of the ciliated epithelium, which increases the resistance of the mucous membrane to the invasion of pathogenic bacteria and viruses and promotes its cleansing.

Indications

  • Adenoids, acute, allergic, vasomotor rhinitis, chronic diseases of the nasal cavity, nasopharynx, paranasal sinuses, including those accompanied by dryness of the nasal mucosa;
  • Prevention of nasal infections in the autumn-winter period, when climatic conditions change (air-conditioned and/or centrally heated rooms), in the presence of polluted atmospheric air (smokers, vehicle drivers, hot and dusty workshops);
  • Washing of wounds of the nasal cavity and paranasal sinuses before and after surgical interventions;
  • Hygienic procedures of the nasal cavity (including in infants).

ICD codes

ICD-10 code Indication
J00 Acute nasopharyngitis (common cold)
J01 Acute sinusitis
J30.0 Vasomotor rhinitis
J30.1 Allergic rhinitis due to pollen
J30.3 Other allergic rhinitis (perennial allergic rhinitis)
J31.0 Chronic rhinitis (including ozaena, atrophic and hypertrophic rhinitis)
J32 Chronic sinusitis
J35.8 Other chronic diseases of tonsils and adenoids
Z29.8 Other specified prophylactic measures
Z51.4 Preparatory procedures for subsequent treatment or examination, not elsewhere classified
Z98.8 Other specified postprocedural states
ICD-11 code Indication
CA00 Acute nasopharyngitis
CA01 Acute rhinosinusitis
CA08.00 Allergic rhinitis due to pollen
CA08.03 Other allergic rhinitis
CA08.3 Vasomotor rhinitis
CA09.0 Chronic rhinitis
CA0A.Z Chronic rhinosinusitis, unspecified
CA0F.Z Chronic diseases of tonsils and adenoids, unspecified
QB6Z Surgical or postprocedural conditions, unspecified
QB9A Preparatory procedures for subsequent treatment
QC05.Z Prophylactic measures, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Drops

The drug should be applied intranasally.

For therapeutic purposes (treatment of diseases of the nasal mucosa, paranasal sinuses, nasopharynx)children under 1 year (infants) – 1-2 drops into each nasal passage 1-3 times a day; children from 1 year to 7 years – 2 drops into each nasal passage 4 times a day; children from 7 to 16 years – 2 drops into each nasal passage 4-6 times a day; adults – 2-3 drops into each nasal passage 4-8 times a day.

The course of treatment is 2-4 weeks; if necessary, the course of treatment is repeated after 1 month.

For prophylactic purposeschildren under 1 year (infants) – using turundas moistened with the drug, 2 times a day, or by instillation of 1-2 drops into each nasal passage 2-3 times a day; children from 1 year to 7 years – 1-2 drops into each nasal passage 1-3 times a day; children from 7 to 16 years – 2 drops into each nasal passage 2-4 times a day; adults – 2-3 drops into each nasal passage 3-6 times a day.

For hygienic purposes to soften and remove nasal discharge, the drug is instilled repeatedly (removing excess fluid with cotton wool or a handkerchief) into each nasal passage until the discharge is completely softened and removed. Children under 2 years of age should have their nasal cavity washed in a lying position. Turn the child’s head to the side, rinse the upper nasal passage, then repeat the procedure with the other nasal passage. Sit the child up and wipe the nasal discharge. Children over 2 years of age and adults should tilt their head to the side, rinse the upper nasal passage, and repeat the procedure with the other nasal passage.

Solution

It is used intranasally in children, starting from 2 weeks of age (in the appropriate dosage form), and in adults for therapeutic purposes 4-6 times/day, for hygienic purposes – 1-4 times/day.

Adverse Reactions

A feeling of discomfort in the nasal cavity at the beginning of use; allergic reactions are possible.

Contraindications

  • Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The drug can be used during pregnancy and breastfeeding if indicated.

Pediatric Use

Used according to indications.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

Not reported.

Overdose

No cases of overdose have been reported.

Drug Interactions

Since the drug does not have a systemic effect on the body, no interactions with other drugs have been noted. It can be used with other drugs used to treat the common cold.

Storage Conditions

In a place protected from light at a temperature from 0 to 25°C (77°F). Keep out of reach of children.

Shelf Life

The shelf life is 2 years. Do not use after the expiration date printed on the package.

Use within 14 days after opening.

Dispensing Status

Available without a prescription.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Sialor® Aqua Nasal drops: dropper tubes 10 ml 10 pcs.

Dosage Form, Packaging, and Composition

Nasal drops in the form of a transparent or slightly opalescent colorless solution.

100 ml
Sea water 5 ml

Excipients: purified water – up to 100 ml.

The solution contains

Sodium Not less than 2.5 mg/ml
Magnesium Not less than 0.35 mg/ml
Calcium Not less than 0.008 mg/ml
Potassium Not less than 0.10 mg/ml
Bicarbonates Not less than 0.03 mg/ml
Chlorides Not less than 3.5 mg/ml
Sulfates Not less than 1.5 mg/ml

10 ml – polyethylene dropper tubes (10) with a valve – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Sialor® aqua Nasal cavity wash solution: containers 100 ml

Dosage Form, Packaging, and Composition

Solution for washing the nasal cavity in the form of a transparent or slightly opalescent colorless solution.

100 ml
Sea water 5 ml

Excipients: purified water – up to 100 ml.

The solution contains:
Sodium – not less than 2.5 mg/ml
Magnesium – not less than 0.35 mg/ml
Calcium – not less than 0.008 mg/ml
Chlorides – not less than 3.5 mg/ml.

100 ml – containers (1) complete with a spray nozzle 1 pc. – cardboard packs.
100 ml – containers (1) complete with spray nozzles 2 pcs. – cardboard packs.

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