Merelis

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT MERALYS®

Composition:

Active substance: xylometazoline hydrochloride;

1 ml of solution contains xylometazoline hydrochloride 0.5 mg or 1 mg;

Excipients: Adriatic Sea water, potassium dihydrogen phosphate, purified water.

Pharmaceutical form. Nasal spray, solution.

Main physicochemical properties: clear, colorless solution.

Pharmacotherapeutic group. Agents used in nasal disorders. Simple sympathomimetics. ATC code R01A A07.

Pharmacological properties.

Pharmacodynamics.

Xylometazoline is a sympathomimetic agent acting on α-adrenergic receptors.

Meralis**®** causes constriction of nasal blood vessels, reducing swelling of the nasal mucosa and that of the paranasal sinuses, thereby improving nasal breathing in cases of nasal and paranasal sinus congestion.

The effect begins within 2 minutes after administration and lasts up to 12 hours. The product is well tolerated, including by patients with sensitive mucous membranes.

The product does not impair mucociliary function. Meralis**®** has a balanced pH value within the range typical for the nasal cavity.

Pharmacokinetics.

When applied locally, it is practically not absorbed, and plasma concentrations are so low that they cannot be detected by modern analytical methods.

Clinical characteristics.

Indications.

Symptomatic treatment of nasal congestion due to colds, hay fever, allergic rhinitis, and sinusitis.

Facilitation of secretion drainage in diseases of the nasal accessory sinuses.

Adjunctive therapy in cases of otitis media (to reduce mucosal swelling).

Facilitation of rhinoscopy.

Contraindications.

• Hypersensitivity to xylometazoline or to any of the excipients;
• Dryness of the nasal mucosa with crust formation (dry rhinitis);
• Transsphenoidal hypophysectomy or surgical interventions with exposure of the meninges in medical history.

Interaction with other medicinal products and other forms of interaction.

Monoamine oxidase inhibitors (MAO inhibitors): xylometazoline may potentiate the effect of monoamine oxidase inhibitors and induce a hypertensive crisis. Xylometazoline must not be used in patients receiving or who have received MAO inhibitors within the previous two weeks.

Tricyclic and tetracyclic antidepressants: concomitant use of tricyclic or tetracyclic antidepressants and sympathomimetic agents may enhance the sympathomimetic effect of xylometazoline; therefore, concomitant use of these agents is not recommended.

Concomitant use with β-blockers may cause bronchospasm or reduction in blood pressure.

Special precautions for use

The product should not be used for longer than 5 consecutive days. Prolonged or excessive use may lead to rebound nasal congestion and/or atrophy of the nasal mucosa.

Like other sympathomimetics, this product should be used with caution in patients who experience strong reactions to adrenergic agents, such as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure.

Patients with long QT syndrome who receive xylometazoline may be at increased risk of serious ventricular arrhythmias.

The recommended dose of the product should not be exceeded, especially when treating children and elderly patients.

The product should be prescribed with caution to patients with cardiovascular disorders, arterial hypertension, diabetes mellitus, hyperthyroidism, pheochromocytoma, prostatic hypertrophy, increased intraocular pressure, particularly in patients with closed-angle glaucoma. It should also not be used in patients receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs) or within 2 weeks after discontinuation of such treatment.

Use during pregnancy or breastfeeding

The product should not be used during pregnancy due to its potential vasoconstrictive effects.

There is no evidence of any adverse effect on the infant. It is unknown whether xylometazoline is excreted in breast milk; therefore, caution is required, and the product should be used during breastfeeding only under medical supervision.

Ability to influence reaction speed when driving or operating machinery

Generally, the product has no effect or only a negligible effect on the ability to drive or operate machinery.

Method of Administration and Dosage

Before using the medication, the nose should be thoroughly cleaned.

Meralis**®**, 0.05% nasal spray, should be administered to children aged 2 to 12 years at a dose of 1 spray into each nostril 1–2 times daily.

Meralis**®**, 0.1% nasal spray, should be administered to adults and children aged 12 years and older at a dose of 1 spray into each nostril 2–3 times daily.

The medication should not be used for more than 5 days unless otherwise recommended by a physician.

Meralis**®** may be resumed after a break of several days.

Prolonged use of the medicinal product may lead to atrophy of the nasal mucosa. In cases of chronic disorders, the medication should be used only under medical supervision.

Before the first use, the spray should be primed by spraying several times (4 times) into the air to ensure consistent dosing. The bottle must be held in an upright position. If the product has not been used for several days or more, one spray should be released into the air to ensure consistent dosing before administration. The nose should be thoroughly cleaned before using the medication.

Children.

The 0.05% spray is intended for children aged 2 to 12 years. The 0.1% spray is intended for children aged 12 years and older.

Overdose.

Excessive local use of xylometazoline hydrochloride or its accidental ingestion may result in pronounced dizziness, excessive sweating, significant decrease in body temperature, headache, bradycardia, arterial hypertension, respiratory depression, coma, and convulsions. Elevated blood pressure may subsequently shift to hypotension. Younger children are more sensitive to toxicity than adults.

All patients suspected of overdose should receive appropriate supportive measures and, if necessary, immediate symptomatic treatment under medical supervision. Medical care should include patient observation for several hours. In cases of severe overdose accompanied by cardiac arrest, resuscitation efforts should continue for at least 1 hour.

Side effects.

Side effects that may occur during the use of the medicinal product are classified into the following groups according to their frequency: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000), including isolated cases, frequency not known.

Immune system disorders:

very rare: hypersensitivity reactions, including angioneurotic edema, rash, pruritus.

Nervous system disorders:

rare: headache, insomnia, fatigue.

Eye disorders:

very rare: transient visual disturbances.

Cardiovascular system disorders:

very rare: irregular or rapid heartbeat, hypertension.

Respiratory, thoracic and mediastinal disorders:

common: dryness or discomfort of the nasal mucosa, reactive hyperemia after the effect of the medicinal product ends; uncommon: epistaxis.

Gastrointestinal disorders:

common: nausea.

General disorders and administration site conditions:

common: burning sensation at the site of application.

Shelf life. 3 years.

Storage conditions. Store at a temperature not exceeding 25 °C, protected from light and out of reach of children.

Packaging. 10 ml or 15 ml of solution in a bottle with a dosing device; 1 bottle in a cardboard box.

Pharmaceutical category. Over-the-counter (without prescription).

Manufacturer.

Jadran-Galenski Laboratorij d.d.

Address of manufacturer and place of business.

Svilno 20, 51000 Rijeka, Croatia.