Aqua Maris^® Extra strong (Otolaryngological product) Instructions for Use

Marketing Authorization Holder

Jadran-Galenski Laboratorij, D.D. (Croatia)

Dosage Form

Aqua Maris^® Extra strong

Product for nasal congestion: 50 ml, 125 ml, or 150 ml canisters with tip

Dosage Form, Packaging, and Composition

Product for nasal congestion (hypertonic sea water solution) is a transparent, colorless liquid with a salty taste.

	100 ml
Sea water*	61.2±3.0 ml
With hypertonic concentration of NaCl – 17-23 g/l

* contains ions Cl^–, Na⁺, SO₄^2-, Mg²⁺, Ca²⁺, K⁺, HCO₃^–, Br^–, as well as trace elements Zn, Se, I, etc.

Excipients: purified water – up to 100 ml.
Does not contain chemical additives or preservatives.

150 ml – metal canisters (1) with a tip – cardboard packs.

Therapeutic Category

Medical device for moisturizing, cleansing, and protecting the nasal mucosa

Properties

Hypertonic sea water solution. The sea water included in the solution contains ions Cl^–, Na⁺, SO₄^2-, Mg²⁺, Ca²⁺, K⁺, HCO₃^–, Br^–, as well as trace elements, including zinc, selenium, iodine.

The hypertonic sea water solution has an increased sodium chloride (NaCl) content of 17-23 g/l.

It helps reduce swelling of the nasal mucosa by removing excess fluid from the intercellular space due to the difference in osmotic pressure.

The trace elements of the Adriatic Sea water improve the function of the ciliated epithelium, exerting a stimulating, restorative, cleansing, anti-inflammatory effect on the nasal mucosa, and increase its resistance to the penetration of pathogenic microorganisms.

Calcium and magnesium ions stimulate the movement of the ciliated cells of the mucosa, which contribute to the removal of microorganisms and foreign particles from the nasal cavity, and normalize the rheological properties of mucus.

Iodine, sodium ions, and chloride ions have an antiseptic effect and also activate the production of protective mucus.

Zinc and selenium ions stimulate the local immunity of the nasal mucosa and paranasal sinuses.

Calcium ions have an anti-allergic effect.

Carbonates, sulfates, and chlorides normalize the production of nasal mucus.

Scope of Application

Relief of nasal congestion of various origins and facilitation of nasal breathing in inflammatory diseases of the nose, paranasal sinuses, and nasopharynx, including those of an allergic nature: acute and chronic rhinitis; acute and chronic sinusitis; nasopharyngitis; allergic rhinitis; adenoiditis.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
J00	Acute nasopharyngitis (common cold)
J01	Acute sinusitis
J06.9	Acute upper respiratory infection, unspecified
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

ICD-11 code	Indication
CA00	Acute nasopharyngitis
CA01	Acute rhinosinusitis
CA07.0	Acute upper respiratory tract infection of unspecified site
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

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.

The product is applied intranasally.

For children from 2 years of age and adults – 1-2 sprays into each nostril 2-3 times/day. Can be used more frequently if necessary.

The duration of use is not limited.

Side Effects

In rare cases, allergic reactions are possible.

Contraindications

Children under 2 years of age; hypersensitivity to sea water.

Use During Pregnancy and Breastfeeding

Pregnancy and breastfeeding are not contraindications for use.

Special Instructions

If use during pregnancy and breastfeeding is necessary, a doctor’s consultation is required.

Storage Conditions

Store at 15°C (59°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.

Medical Disclaimer