Multingrip nasal

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MULTIGRIP® NASAL (MULTIGRIP® NASAL)

Composition:

Active substance: xylometazoline hydrochloride;

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

Excipients: benzalkonium chloride; potassium dihydrogen phosphate; sodium hydrogen phosphate dodecahydrate; sorbitol (E 420); disodium edetate; sodium chloride; purified water.

Pharmaceutical form. Nasal spray, solution.

Main physicochemical properties: clear, colorless, odorless liquid.

Pharmacotherapeutic group.

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

Pharmacological properties.

Pharmacodynamics.

Xylometazoline is a sympathomimetic agent (an imidazole derivative) acting on α-adrenergic receptors of the nasal mucosa. After nasal administration, xylometazoline causes vasoconstriction, thereby reducing swelling of the nasal mucosa.

The effect of the drug begins within 2 minutes after application and lasts up to 12 hours.

The drug is well tolerated, including by patients with sensitive mucosa. The drug does not impair mucociliary function. Laboratory test results have shown that xylometazoline reduces the infectious activity of human rhinovirus associated with the common cold.

Pharmacokinetics.

After nasal administration, the amount of absorbed substance may sometimes be sufficient to produce systemic effects, for example on the central nervous and cardiovascular systems.

No metabolites or their excretion pathways have been identified.

Clinical characteristics.

Indications.

• Symptomatic treatment of nasal congestion due to colds, hay fever, sinusitis, and allergic rhinitis;
• to facilitate drainage of secretions in diseases of the nasal sinuses;
• as an adjunctive therapy in otitis media (to reduce mucosal swelling of the nasopharynx);
• to facilitate rhinoscopy.

Contraindications.

Hypersensitivity to xylometazoline or to any component of the medicinal product; closed-angle glaucoma, transsphenoidal hypophysectomy, and surgical procedures involving exposure of the meninges in medical history; dry rhinitis (rhinitis sicca) or atrophic rhinitis. Concomitant use with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of such treatment.

Special precautions.

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

Repeated use of xylometazoline carries a risk of tachyphylaxis and iatrogenic rhinitis.

Repeated and/or prolonged instillations may lead to systemic absorption of xylometazoline in amounts sufficient to cause systemic adverse reactions.

The drug should be prescribed with caution to patients with cardiovascular disorders, arterial hypertension, diabetes mellitus, hyperthyroidism, pheochromocytoma, benign prostatic hyperplasia, history of stroke, or presence of stroke risk factors (use of vasoconstrictive agents, history of seizures, urinary retention due to urethral or prostatic disorders related to direct action of sympathomimetic agents).

Decongestant sympathomimetics may cause reactive hyperemia of the nasal mucosa, especially after prolonged treatment or when high doses are used. Repeated or chronic use of this drug may lead to rebound congestion syndrome and narrowing of the upper airways. This may manifest as chronic hyperemia of the nasal mucosa (which may subsequently lead to atrophic rhinitis). In cases of moderate severity, treatment with the drug in one nasal passage may be paused or, alternatively, not administered into both nasal passages until symptom intensity decreases, in order to partially preserve nasal passage patency.

Prolonged treatment with xylometazoline may cause drug-induced rhinitis and swelling of the nasal mucosa, with symptoms resembling the common cold.

Multigrip Nasal contains benzalkonium chloride. This substance is an irritant and may cause undesirable skin reactions.

Multigrip Nasal contains sorbitol. Patients with rare hereditary fructose intolerance should not use this medicinal product.

Patients with prolonged QT interval syndrome who receive xylometazoline are at increased risk of severe ventricular arrhythmias.

Interaction with other medicinal products and other forms of interaction.

Monoamine oxidase inhibitors (MAOIs). Xylometazoline may potentiate the effect of monoamine oxidase inhibitors and induce a hypertensive crisis. Xylometazoline is not recommended for patients taking or who have taken MAOIs 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.

Xylometazoline may affect the action of certain antihypertensive agents, such as β-blockers.

Special precautions for use

For hygienic reasons and to avoid infections, the bottle should be used by only one person.

Use during pregnancy or breastfeeding.

This medicinal product must not be used during pregnancy due to its potential vasoconstrictive effect.

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

Fertility.

There are no adequate data on the effect of MultiGripp Nasal on fertility. Since systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is extremely small.

Ability to affect reaction speed when driving or operating machinery.

Xylometazoline has a negligible influence on the ability to drive or operate machinery; however, there is a risk of adverse reactions that may affect psychomotor performance.

Method of Administration and Dosage.

MultiGrip Nasal, nasal spray, solution 0.05%.

Children aged 2 to 12 years.

One spray into each nostril as needed, but not more than 3 times daily.

MultiGrip Nasal, nasal spray, solution 0.1%.

Adults and children aged 12 years and older.

The recommended dose is one spray into each nostril 3 times daily.

Do not use in doses exceeding the recommended doses.

Duration of Use.

MultiGrip Nasal should not be used for longer than 5 consecutive days unless otherwise advised by a physician.

Method of Administration.

Before use, remove the protective cap. Before first use, prime the pump by pressing 2–3 times until a proper spray is achieved. The spray is then ready for use.

Before using the nasal spray, the nasal cavity should be thoroughly cleared. It is recommended to administer the last daily dose before bedtime.

After removing the protective cap, insert the nozzle into the nostril and press once for gentle nasal inhalation.

During administration, the bottle must be held in an upright position. Do not use the bottle in a horizontal position.

After use, cover the nozzle with the protective cap.

Children.

Use in children aged 2 to 12 years should be under adult supervision.

MultiGrip Nasal, nasal spray, solution 0.05%.

For treatment of children aged 2 to 12 years. Contraindicated in children under 2 years of age.

MultiGrip Nasal, nasal spray, solution 0.1%.

For treatment of children aged 12 years and older. Contraindicated in children under 12 years of age.

Overdose.

Excessive local use of xylometazoline hydrochloride or accidental ingestion may lead to sympatholytic effects, including central nervous system depression (e.g., drowsiness, coma), pronounced dizziness, excessive sweating, significant decrease in body temperature, pallor, headache, tachycardia, bradycardia, arterial hypertension, respiratory depression, miosis, seizures, ataxia, and agitation. Elevated blood pressure may be followed by a drop in pressure. Gastrointestinal symptoms such as nausea and vomiting may also occur. Younger children are more sensitive to toxicity than adults. Severe symptoms after accidental use have not been commonly observed; however, in neonates (2 weeks of age), administration of 1 drop of 0.1% solution into each nostril may lead to coma.

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. There is no specific antidote; atropine may be used in cases of bradycardia. In cases of severe overdose associated with cardiac arrest, resuscitation efforts should continue for at least 1 hour.

Adverse Reactions

Disorders of the immune system:

Very rare (<1/10,000): hypersensitivity reactions, including angioneurotic edema, rash, itching.

Disorders of the nervous system:

Common (≥1/100 — <1/10): headache.

Disorders of the visual system:

Very rare (<1/10,000): transient visual disturbances.

Disorders of the cardiovascular system:

Very rare (<1/10,000): irregular or rapid heartbeat, hypertension, arrhythmia.

Disorders of the respiratory system, thorax and mediastinum:

Common (≥1/100 — <1/10): dryness or discomfort of the nasal mucosa, burning sensation, drug-induced rhinitis;

Uncommon (≥1/1,000 — <1/100): epistaxis.

Gastrointestinal disorders:

Common (≥1/100 — <1/10): nausea.

General disorders and administration site reactions:

Common (≥1/100 — <1/10): burning sensation at the site of application.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after drug registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national pharmacovigilance system.

Shelf life.

3 years.

Use within 30 days after first opening the bottle.

Storage conditions.

Store in the original packaging to protect from light at a temperature not exceeding 25 °C. Keep out of reach and sight of children.

Packaging. 10 ml solution in a brown glass bottle with a spray pump, 1 bottle per cardboard box.

Prescription status. Over-the-counter.

Manufacturer. K.O. Biopharm S.A., Romania

Manufacturer's address and location of operations.

99 Logofetului Street, Sector 3, 031212, Bucharest, Romania.