Nazik® for children

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NASIC® FOR KIDS

Composition:

Active substances: xylometazoline hydrochloride and dexpanthenol;

1.0 g of solution contains 0.5 mg of xylometazoline hydrochloride, 50 mg of dexpanthenol;

one spray of 0.1 ml of solution (equivalent to 0.10 g) contains 0.05 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol;

Excipients: benzalkonium chloride solution, potassium dihydrogen phosphate, disodium hydrogen phosphate dodecahydrate, purified water.

Pharmaceutical form. Nasal spray, solution.

Main physicochemical characteristics: colorless clear liquid.

Pharmacotherapeutic group. Decongestants and other nasal preparations for local use. Sympathomimetics, combinations, excluding corticosteroids.

ATC code R01A B06.

Pharmacological Properties

Pharmacodynamics

A nasal preparation combining an alpha-sympathomimetic agent with a vitamin analogue for local application to the nasal mucosa. Xylometazoline has vasoconstrictive activity, thereby reducing swelling of the mucous membrane. Dexpanthenol is a derivative of pantothenic acid (vitamin B5) that promotes wound healing and protects mucous membranes.

Xylometazoline hydrochloride

Xylometazoline hydrochloride, an imidazole derivative, is an alpha-adrenergic sympathomimetic agent. The onset of action usually occurs within 5–10 minutes, manifested as improved nasal breathing due to reduction of swelling and enhanced drainage of secretions.

Dexpanthenol

Dexpanthenol (D-(+)-pantol alcohol) is an alcohol analog of pantothenic acid and, through intermediate conversion, exhibits the same biological activity as pantothenic acid, although only the dextrorotatory D-configuration is biologically active. Pantothenic acid and its salts are water-soluble vitamins that, as coenzyme A, participate in numerous metabolic processes, including supporting the synthesis of proteins and corticoids, as well as antibody production. Coenzyme A also participates in the formation of lipids, including those that constitute sebaceous gland secretions, which play an important protective role. Furthermore, coenzyme A plays a role in the acetylation of aminosugars, which are key building blocks for various mucopolysaccharides.

Dexpanthenol protects epithelial layers and promotes wound healing.

Pharmacokinetics

Xylometazoline hydrochloride

In some cases, intranasal administration results in significant absorption, leading to systemic effects, for example on the central nervous and cardiovascular systems.

Pharmacokinetic data in humans are lacking.

Dexpanthenol

Dexpanthenol is absorbed through the skin and undergoes enzyme-catalyzed oxidation to pantothenic acid in the body and skin cells. The vitamin is transported in the blood plasma in protein-bound form. As an essential structural component, pantothenic acid combines with coenzyme A and is distributed throughout the body. Detailed studies on metabolism in the skin and mucous membranes are lacking. 60–70% of an orally administered dose is excreted in urine and 30–40% in feces.

Clinical characteristics.

Indications.

• Nasal congestion during acute rhinitis;
• promoting healing of the skin around the nasal passages and injuries of the mucous membrane in the nasal cavity;
• vasomotor rhinitis;
• impaired nasal breathing after surgical interventions in the nasal cavity.

Contraindications.

Hypersensitivity to any component of the drug, dry inflammation of the nasal mucosa, acute coronary conditions including cardiac asthma, hyperthyroidism, closed-angle glaucoma, transsphenoidal hypophysectomy, and surgical interventions involving exposure of the meninges in medical history. Concomitant use of MAO inhibitors and within 2 weeks after discontinuation of their use.

The drug should not be administered to children under 2 years of age.

Nazik® for children contains benzalkonium chloride; therefore, it should not be used in patients with known hypersensitivity to this substance.

Interaction with other medicinal products and other forms of interaction.

Xylometazoline hydrochloride

Concomitant use of the drug with tranylcypromine, monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants, or β-adrenoblockers may lead, due to the effects of these drugs on the cardiovascular system, to increased arterial pressure.

Special precautions for use

This medicinal product should be used only after careful assessment of the risk/benefit ratio:

• in patients taking medicinal products capable of increasing blood pressure;
• in patients with increased intraocular pressure;
• in patients with phaeochromocytoma;
• in patients with benign prostatic hyperplasia;
• in patients with porphyria.

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

The product contains benzalkonium chloride, which may cause irritation of the nasal mucosa.

Decongestant sympathomimetics may, especially with prolonged use or in cases of overdose, lead to reactive hyperemia of the nasal mucosa.

This rebound effect results in narrowing of the airways, forcing the patient to reapply the medicinal product.

This may lead to chronic edema and eventually to atrophy of the nasal mucosa.

In mild cases, it may be sufficient to discontinue the sympathomimetic agent first in one nostril, and then, as soon as symptoms subside, repeat this in the other nostril, to maintain at least partial nasal breathing.

The product, like other products in this group, should be used with caution in patients who experience strong reactions to sympathomimetics, manifested as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure.

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, thyroid disorders, or prostate hyperplasia.

Each package should be used by only one person to avoid infection.

Use during pregnancy or breastfeeding.

Nasik® for children should not be used during pregnancy, as there are insufficient data on the use of xylometazoline hydrochloride for treatment in pregnant women.

Use of the product should be avoided during lactation, as it is unknown whether the active ingredient xylometazoline hydrochloride passes into breast milk.

Ability to affect reaction speed when driving or operating machinery.

When used according to instructions, no effect is expected.

Method of Administration and Dosage

Nazik® for Children is intended for use in children aged 2 to 6 years.

For nasal use in children. Nazik® for Children should be administered as 1 spray into each nostril no more than 3 times daily. Dosage depends on individual sensitivity and clinical response. When using Nazik® for Children, the bottle should be held vertically. The patient should gently inhale through the nose during spraying. Nazik® for Children should not be used for longer than 7 days, except when otherwise recommended by a physician.

Regarding duration of use, consultation with a physician is always advised. For bottles equipped with a detachable spray nozzle, remove the long protective cap before use. Unscrew the cap from the bottle and screw the spray nozzle onto the bottle. Remove the protective cap from the spray nozzle. Before first use, prime the nasal spray by pressing the nozzle several times until a fine, uniform mist appears. Insert the nozzle into the nostril and press once, then repeat for the other nostril. After use, cover the nozzle with the protective cap.

Children

For use in children aged 2 to 6 years.

Overdose

Symptoms of intoxication with imidazole derivatives may be clinically unclear, as periods of stimulation may alternate with periods of depression of the central nervous and cardiovascular systems.

Overdose, especially in children, may lead to significant effects on the central nervous system, including convulsions, coma, bradycardia, apnea, and arterial hypertension, which may later shift to arterial hypotension.

Symptoms of central nervous system stimulation include anxiety, agitation, hallucinations, and seizures.

Symptoms of central nervous system depression manifest as decreased body temperature, lethargy, drowsiness, and coma.

Additional possible symptoms include miosis, mydriasis, sweating, nausea, cyanosis, fever, pallor, tachycardia, bradycardia, cardiac arrest, cardiac arrhythmia, arterial hypertension, shock-like hypotension, pulmonary edema, respiratory depression, apnea, and occasionally impaired consciousness.

Treatment in case of overdose

Severe overdose requires hospitalization and treatment. Since xylometazoline hydrochloride is rapidly absorbed, activated charcoal (adsorbent), sodium sulfate (laxative), or gastric lavage (in case of high doses) should be administered immediately. Reduction of arterial pressure can be achieved using non-selective alpha-blockers. Vasoconstrictors are contraindicated. If necessary, administer antipyretics and anticonvulsants, as well as artificial oxygen respiration.

Pantothenic acid and its derivatives, such as dexpanthenol, have very low toxicity. In case of overdose, no specific therapeutic measures are required.

Adverse Reactions

The following frequency categories are used to assess adverse effects:

Very common (≥ 1/10)
Common (≥ 1/100 to <1/10)
Uncommon (≥ 1/1,000 to <1/100)
Rare (≥ 1/10,000 to <1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from available data)

Nervous system:
Very rare: anxiety, insomnia, fatigue (drowsiness, sedative effect), headache, hallucinations (mainly in children).

Cardiovascular system:
Rare: palpitations, tachycardia, hypertension.
Very rare: arrhythmia.

Respiratory system:
Very rare: increased nasal mucosal swelling after effect wears off, epistaxis (nosebleed).
Frequency not known: burning and dryness of nasal mucosa, sneezing.

Musculoskeletal and connective tissue disorders:
Very rare: convulsions (especially in children).

Immune system:
Occasional: hypersensitivity reactions (angioneurotic edema, rash, pruritus).

Shelf life. 3 years.
After first opening – 12 weeks.

Storage conditions.
No special storage conditions required. Keep out of reach of children.

Packaging.
10 ml solution in a bottle, 1 bottle with detachable spray nozzle, in a cardboard box, or 10 ml solution in a bottle, 1 bottle with fixed spray nozzle, in a cardboard box.

Availability.
Over-the-counter (without prescription).

Manufacturer. Klosterfrau Berlin GmbH.

Manufacturer's address.
Motzener Strasse 41, 12277 Berlin, Germany.

Marketing Authorisation Holder. Cassella-med GmbH & Co. KG.

Address of the Marketing Authorisation Holder.
Gereonsmühlenstrasse 1, 50670 Cologne, Germany.