Aqua Maris® (Spray, Drops, Aerosol) Instructions for Use
ATC Code
R01AX10 (Other drugs)
Clinical-Pharmacological Group
Drug for moisturizing, cleansing, and protecting the nasal mucosa
Pharmacotherapeutic Group
Remedy for nasal conditions
Pharmacological Action
Sterilized isotonic sea water helps maintain the normal physiological state of the nasal mucosa.
The drug helps to thin mucus and normalize its production in the goblet cells of the nasal mucosa.
The trace elements included in the drug improve the function of the ciliated epithelium and have an anti-inflammatory, cleansing, stimulating, restorative effect on the nasal mucosa.
In allergic and vasomotor rhinitis, the drug helps to wash away and remove allergens and haptens from the nasal mucosa, reducing the local inflammatory process.
Aqua Maris®, used for hygienic purposes, helps cleanse the mucous membrane of street and room dust.
Pharmacokinetics
Pharmacokinetic data for the drug Aqua Maris® are not provided.
Indications
- Acute and chronic inflammatory diseases of the nasal cavity, paranasal sinuses and nasopharynx;
- Adenoiditis;
- Postoperative period after surgical interventions on the nasal cavity;
- Allergic and vasomotor rhinitis (especially in persons with increased sensitivity to drugs or a predisposition to it, including during pregnancy and lactation);
- Prevention and treatment (as part of complex therapy) of nasal cavity infections in the autumn-winter period (including during pregnancy and lactation);
- Dryness of the nasal mucosa; preservation of the physiological characteristics of the nasal mucosa in altered microclimatic conditions – in persons living and working in rooms with air conditioning and/or central heating, in people whose mucous membrane of the upper respiratory tract is constantly exposed to harmful effects (in smokers, vehicle drivers, people working in hot and dusty workshops, living in regions with harsh climatic conditions).
ICD codes
| ICD-10 code | Indication |
| J00 | Acute nasopharyngitis (common cold) |
| J01 | Acute sinusitis |
| J02 | Acute pharyngitis |
| J03 | Acute tonsillitis |
| 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 | Chronic rhinitis, nasopharyngitis and pharyngitis |
| J32 | Chronic sinusitis |
| J35.0 | Chronic tonsillitis |
| J35.8 | Other chronic diseases of tonsils and adenoids |
| Z54.0 | Convalescence following surgery |
| Z57.3 | Occupational exposure to other air contaminants |
| Z58.1 | Exposure to air pollution |
| Z58.8 | Other problems related to physical environmental factors |
| ICD-11 code | Indication |
| CA00 | Acute nasopharyngitis |
| CA01 | Acute rhinosinusitis |
| CA02.Z | Acute pharyngitis, unspecified |
| CA03.Z | Acute tonsillitis, unspecified |
| 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 | Chronic rhinitis, nasopharyngitis or pharyngitis |
| CA0A.Z | Chronic rhinosinusitis, unspecified |
| CA0F.Y | Other specified chronic diseases of the palatine tonsils and adenoids |
| CA0F.Z | Chronic diseases of tonsils and adenoids, unspecified |
| QB7Y | Other specified convalescence |
| QD70.1 | Problems related to exposure to polluted air |
| QD70.Z | Problems related to the natural environment or anthropogenic changes in the environment, unspecified |
| QD7Z | Problems related to the environment, unspecified |
| QD84.Y | Other specified exposure to occupational risk factors |
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. |
Spray
For treatment, Aqua Maris® metered nasal spray is prescribed for children aged 1 to 7 years, 2 sprays into each nostril 4 times/day; for children aged 7 to 16 years – 2 sprays into each nostril 4-6 times/day, for adults – 2-3 sprays into each nostril 4-8 times/day.
The duration of the course of therapy is 2-4 weeks (at the discretion of the attending physician). It is recommended to repeat the course after one month.
For prevention, Aqua Maris® metered nasal spray is used in children aged 1 to 7 years, 1-2 sprays into each nostril 1-2 times/day; for children aged 7 to 16 years – 2 sprays into each nostril 2-4 times/day, for adults – 2-3 sprays into each nostril 3-6 times/day.
For softening and removing contaminant accumulations and nasal secretions, Aqua Maris® is sprayed into each nostril as much as the situation requires, removing excess fluid with cotton wool or a handkerchief. The procedure can be repeated many times until the accumulations of contaminating particles are successfully softened or removed.
Drops
For treatment, Aqua Maris® nasal drops are prescribed to children from the 1st day of life, 2 drops into each nostril 4 times/day.
The duration of the course of therapy is 2-4 weeks. It is recommended to repeat the course after one month.
For prevention, it is recommended to perform a toilet in the form of instilling Aqua Maris® nasal drops for children from the 1st day of life, 1-2 drops into each nostril 2-3 times/day.
For softening and removing contaminant accumulations and nasal secretions, Aqua Maris® is instilled into each nostril as much as the situation requires, removing excess fluid with cotton wool or a handkerchief. The procedure can be repeated many times until the accumulations of contaminating particles are successfully softened or removed.
Aerosol
The product is used every time the child has excessive mucous discharge from the nose. Before using the nasal aspirator, it is recommended to rinse the nose with a sea water solution.
Side effects
When used according to the instructions, no side effects have been identified.
Contraindications
No known contraindications.
Use during pregnancy and lactation
Can be used during pregnancy and lactation.
Special instructions
After use, the nasal aspirator should be rinsed with running water.
Adverse Reactions
Possible allergic reactions.
Contraindications
- Children under 1 year of age (for metered nasal spray);
- Hypersensitivity to the components of the drug.
Use in Pregnancy and Lactation
The drug Aqua Maris® can be used during pregnancy and lactation (breastfeeding) according to indications.
Pediatric Use
Contraindicated for use in children under 1 year of age.
Special Precautions
Effect on the ability to drive vehicles and operate machinery
No data.
Overdose
No cases of overdose have been reported.
Drug Interactions
The drug does not have a systemic effect on the body, so no interactions with other drugs have been noted.
Can be used with other drugs that are used to treat rhinitis.
Storage Conditions
The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).
Shelf Life
Shelf life – 3 years. Do not use after the expiration date.
After opening the bottle, the drug should be used within 45 days.
Dispensing Status
The drug is 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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Nasal spray, metered: bottle 30 mL with dosing device
Marketing Authorization Holder
Jadran-Galenski Laboratorij, D.D. (Croatia)
Contact Information
JADRAN-GALENSKI LABORATORIJ a.o. (Croatia)
Dosage Form
| Aqua Maris® | Nasal spray, metered: bottle 30 mL with dosing device |
Dosage Form, Packaging, and Composition
Metered nasal spray in the form of a colorless transparent solution without odor.
| 100 ml | |
| Adriatic Sea water with natural trace elements | 30 ml, |
| Na+ | Not less than 2.5 mg/ml |
| Ca2+ | Not less than 0.08 mg/ml |
| Mg2+ | Not less than 0.35 mg/ml |
| Cl– | Not less than 5.5 mg/ml |
| SO42- | Not less than 0.6 mg/ml |
| HCO3– | Not less than 0.03 mg/ml |
Excipients: purified water – 70 ml.
Does not contain preservatives.
30 ml (30.36 g) – dark glass bottles (1) with a dosing device with a spray head – cardboard packs.
Nasal drops for children: 10 ml dropper bottle.
Marketing Authorization Holder
Jadran-Galenski Laboratorij, D.D. (Croatia)
Contact Information
JADRAN-GALENSKI LABORATORIJ a.o. (Croatia)
Dosage Form
| Aqua Maris® | Nasal drops for children: 10 ml dropper bottle. |
Dosage Form, Packaging, and Composition
Nasal drops for children in the form of a colorless transparent solution without odor.
| 100 ml | |
| Adriatic Sea water with natural trace elements | 30 ml, |
| Na+ | Not less than 2.5 mg/ml |
| Ca2+ | Not less than 0.08 mg/ml |
| Mg2+ | Not less than 0.35 mg/ml |
| Cl– | Not less than 5.5 mg/ml |
| SO42- | Not less than 0.6 mg/ml |
| HCO3– | Not less than 0.03 mg/ml |
Excipients: purified water – 70 ml.
Does not contain preservatives.
10 ml – polyethylene dropper bottles (1) – cardboard packs.
Nasal aspirator for children: case incl. 4 replacement nozzles or box with 3 replacement nozzles
Marketing Authorization Holder
Jadran-Galenski Laboratorij, D.D. (Croatia)
Manufactured By
Pharmalink, S.L. (Spain)
Dosage Form
| Aqua Maris® | Nasal aspirator for children: case incl. 4 replacement nozzles or box with 3 replacement nozzles |
Dosage Form, Packaging, and Composition
Nasal aspirator for children consists of a central rigid body, a flexible tube, a mouthpiece for aspiration, a replaceable disposable nozzle with an anatomically shaped tip and an absorbent filter.
The aspirator is supplied in a plastic case with 4 replacement nozzles.
