Rinomaris^® Advance (Spray) Instructions for Use

Marketing Authorization Holder

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

ATC Code

R01AA07 (Xylometazoline)

Active Substances

Xylometazoline (Rec.INN registered by WHO)

Sodium hyaluronate (USAN adopted for use in the USA)

Dosage Forms

	Rinomaris® Advance	Nasal spray 0.5 mg+0.1 mg/ml: 10 ml or 15 ml bottle with a spray device
		Nasal spray 1 mg+0.1 mg/ml: 10 ml or 15 ml bottle with a spray device

Dosage Form, Packaging, and Composition

Nasal spray as a clear, colorless solution.

Excipients: purified sea water, potassium dihydrogen phosphate, purified water.

10 ml – polyethylene bottles (1) with a spray device – cardboard packs.
15 ml – polyethylene bottles (1) with a spray device – cardboard packs.

Nasal spray as a clear, colorless solution.

Excipients: purified sea water, potassium dihydrogen phosphate, purified water.

10 ml – polyethylene bottles (1) with a spray device – cardboard packs.
15 ml – polyethylene bottles (1) with a spray device – cardboard packs.

Pharmacotherapeutic Group

Decongestant – alpha-adrenomimetic

Pharmacological Action

Xylometazoline belongs to the group of decongestants with alpha-adrenomimetic activity, it causes constriction of the blood vessels of the nasal mucosa, thereby eliminating swelling and hyperemia of the nasal mucosa, restores the patency of the nasal passages and facilitates nasal breathing.

Sodium hyaluronate maintains the moisture of the mucous membrane at a physiological level and creates optimal conditions for its healing process.

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

Pharmacokinetics

Xylometazoline

When applied topically, it is practically not absorbed; insignificant amounts of the drug are detected in plasma.

Sodium hyaluronate

It has a high molecular weight and does not penetrate into plasma when applied topically.

Indications

Acute respiratory diseases with symptoms of rhinitis, acute allergic rhinitis, hay fever, sinusitis, eustachitis, otitis media (as part of combination therapy to reduce swelling of the nasopharyngeal mucosa); for preparing the patient for diagnostic manipulations in the nasal passages.

ICD codes

Dosage Regimen

Administer the spray intranasally.

For the 0.5 mg/ml + 0.1 mg/ml strength, use in adults and children over 6 years.

For the 1.0 mg/ml + 0.1 mg/ml strength, use in adults only.

Before first use, prime the pump by pressing the actuator several times until a fine spray appears.

Tilt head slightly forward.

Insert the tip of the applicator into one nostril.

Spray one dose into each nostril.

The recommended frequency is 1 to 3 times per day, as needed for symptom relief.

Do not exceed three applications in 24 hours.

The maximum duration of continuous treatment is 5 to 7 days.

Do not use for more than 7 days due to the risk of medication-induced rhinitis and rebound congestion.

For children under 12 years, use only on the recommendation and under the supervision of a physician.

The 0.5 mg/ml strength is contraindicated in children under 2 years.

The 1.0 mg/ml strength is contraindicated in children under 6 years.

If no improvement is seen after 3 days of treatment, discontinue use and consult a physician.

To avoid contamination, do not share the bottle with another person.

Clean the spray tip regularly with a clean tissue.

Adverse Reactions

Xylometazoline

Immune system disorders very rarely – allergic reactions (rash, itching, angioedema).

Nervous system disorders: often – headache; rarely – insomnia, depression (with long-term use in high doses), very rarely – anxiety, fatigue, paresthesia, hallucinations and convulsions (mainly in children).

Sensory organ disorders: very rarely – blurred vision.

Cardiovascular system disorders rarely – palpitations, increased blood pressure; very rarely – arrhythmia, tachycardia.

Respiratory system disorders: often – irritation and/or dryness of the nasal mucosa, burning, tingling, sneezing, hypersecretion of the nasopharyngeal mucosa; rarely – after application of the drug, increased swelling of the nasal mucosa (reactive hyperemia), nosebleeds may be observed.

Gastrointestinal system disorders often – nausea; rarely – vomiting.

Local reactions often – burning at the application site.

Sodium hyaluronate

Immune system disorders frequency unknown – local allergic reactions.

Contraindications

Hypersensitivity to the components of the combination; arterial hypertension, tachycardia, severe atherosclerosis; glaucoma; hyperthyroidism; atrophic rhinitis; inflammatory diseases of the skin or mucous membrane of the nasal vestibule; surgical interventions on the meninges (in history); condition after transsphenoidal hypophysectomy; pregnancy; use of MAO inhibitors, including 14 days after their withdrawal, tricyclic or tetracyclic antidepressants; children under 2 years of age (for the dosage form with a dosage of 0.5 mg/ml + 0.1 mg/ml); children under 6 years of age (for the dosage form with a dosage of 1.0 mg/ml + 0.1 mg/ml).

With caution

Diabetes mellitus; severe cardiovascular diseases (including coronary artery disease, angina pectoris); prostatic hyperplasia, pheochromocytoma, porphyria; hypersensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure; long QT syndrome.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is contraindicated.

Pediatric Use

Contraindication: children under 2 years of age (for the dosage form with a dosage of 0.5 mg/ml + 0.1 mg/ml); children under 6 years of age (for the dosage form with a dosage of 1.0 mg/ml + 0.1 mg/ml).

Use of this combination in children on the recommendation and under the supervision of a physician.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Xylometazoline

Xylometazoline should not be used continuously for more than 7 days. Do not exceed the recommended doses. It is recommended to rinse the nasal cavity with saline solutions before use.

With long-term use of xylometazoline and overdose, a weakening of the therapeutic effect is possible, and the risk of drug-induced rhinitis and atrophy of the nasal mucosa increases. Patients with long QT syndrome receiving xylometazoline may be at risk of serious ventricular arrhythmia.

Avoid contact of the product with the eyes. Do not use simultaneously with other vasoconstrictors. It is recommended to monitor blood pressure levels during treatment.

Sodium hyaluronate

No special precautions are specified for sodium hyaluronate.

Effect on ability to drive vehicles and machinery

If adverse reactions from the nervous system develop, caution should be exercised when performing activities requiring increased concentration and speed of psychomotor reactions.

Drug Interactions

Xylometazoline

The use of xylometazoline is contraindicated in patients receiving MAO inhibitors or tricyclic antidepressants, including 14 days after their withdrawal. Simultaneous administration of xylometazoline and tricyclic and/or tetracyclic antidepressants, MAO inhibitors such as tranylcypromine, drugs that promote increased blood pressure, therefore simultaneous administration of these drugs should be avoided.

Sodium hyaluronate

No interactions or incompatibilities have been identified with the simultaneous use of xylometazoline and sodium hyaluronate.

Data on the interaction of sodium hyaluronate with other drugs are not available.

Storage Conditions

Store at 2°C (36°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.