Nokspray maluyk

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NOXPREY MALYUK (NOXPREYMALYUK)

Composition:

Active substance: oxymetazoline;

1 ml of the preparation contains oxymetazoline hydrochloride 0.1 mg;

Excipients: benzalkonium chloride, sodium dihydrogen phosphate monohydrate, sodium hydrogen phosphate dihydrate, disodium edetate, purified water.

Pharmaceutical form. Nasal drops.

Main physicochemical characteristics: colorless or slightly yellowish clear liquid.

Pharmacotherapeutic group. Anti-edematous and other preparations for local use in nasal cavity diseases. Sympathomimetics.

ATC code R01A A05.

Pharmacological properties.

Pharmacodynamics.

NOXSPRAY MALYUK belongs to the group of local vasoconstrictive agents. Oxymetazoline exerts sympathomimetic and vasoconstrictive effects, reducing swelling of the nasal mucosa. It constricts blood vessels at the site of application, reduces swelling of the nasal mucosa and upper respiratory tract, and decreases nasal discharge. It restores nasal breathing. Relief of nasal mucosal swelling promotes restoration of ventilation in the paranasal sinuses and the middle ear cavity, thus preventing the development of bacterial complications.

Oxymetazoline exerts antiviral, anti-inflammatory, immunomodulatory, and antioxidant effects. Due to this combined mechanism of action, clinical studies of the original oxymetazoline have demonstrated faster and more effective relief of symptoms of acute rhinitis (nasal congestion, rhinorrhea, sneezing, and general malaise).

Pharmacokinetics.

When nasal drops of the drug are administered, the effects of oxymetazoline manifest within several minutes after instillation.

With local nasal application at therapeutic concentrations, it does not irritate the nasal mucosa or cause hyperemia. The elimination half-life is approximately 35 hours after administration of the drug. 2.1% of the drug is excreted by the kidneys, about 1.1% – in feces.

The effect of the drug lasts several hours (on average 6–8 hours), up to a maximum of 12 hours.

Clinical characteristics.

Indications.

• Acute respiratory diseases accompanied by nasal congestion.

• Allergic rhinitis.

• Vasomotor rhinitis.

• For restoration of drainage and nasal breathing in diseases of the nasal sinus cavities, eustachitis.

• To relieve swelling prior to diagnostic procedures in the nasal passages.

Contraindications.

Hypersensitivity to the components of the drug, dry rhinitis.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of oxymetazoline with tricyclic antidepressants, monoamine oxidase inhibitors such as tranylcypromine, or hypertensive agents may lead to increased blood pressure. These drugs should not be combined if possible. In cases of oxymetazoline overdose, accidental ingestion, or when used simultaneously or immediately after tricyclic antidepressants and/or MAO inhibitors, an increase in blood pressure may occur.

Special precautions for use

The drug should be used only after careful assessment of the benefit/risk ratio in the following cases:

• Elevated intraocular pressure, especially in angle-closure glaucoma;
• Severe cardiovascular disorders (e.g., ischemic heart disease) and arterial hypertension;
• Pheochromocytoma;
• Metabolic disorders (e.g., hyperthyroidism, diabetes mellitus, porphyria);
• Benign prostatic hyperplasia;
• Concomitant use of monoamine oxidase inhibitors (MAOIs) and other medicinal products that may increase blood pressure;

Prolonged use and overdosage of the drug should be avoided, especially when administered to children. Doses exceeding the recommended should be used only under medical supervision. The preservative (benzalkonium chloride) contained in the drug may cause swelling of the nasal mucosa, particularly with prolonged use. Medical monitoring is recommended for premature newborns or infants with low body weight to avoid the risk of overdosage. Prolonged use and overdosage of nasal decongestants may lead to reduced drug efficacy and produce clinical symptoms similar to vasomotor rhinitis. Misuse of this product may result in drug-induced rhinitis, atrophy of the nasal mucosa, and reactive hyperemia (rebound effect).

Use during pregnancy or breastfeeding

Oxymetazoline should be used during pregnancy or breastfeeding only with particular caution, following a careful benefit/risk assessment. Exceeding the recommended dosage is not recommended. It is unknown whether oxymetazoline passes into breast milk. Therefore, the use of oxymetazoline during breastfeeding should be considered only after a careful benefit/risk evaluation. Exceeding the recommended dosage is not recommended, as it may reduce breast milk production.

Ability to influence reaction rate while driving or operating machinery

When oxymetazoline is used at recommended doses, no effect on reaction speed while driving or operating machinery is expected. However, after prolonged use of doses exceeding the recommended levels, a systemic effect on the cardiovascular system cannot be ruled out. In such cases, the ability to drive or operate machinery may be impaired.

Method of Administration and Dosage.

NOXSPRAY MALYUK is intended for nasal use. For infants up to 4 weeks of age, administer 1 drop into each nostril 2–3 times daily. For children aged 5 weeks to 1 year, administer 1–2 drops into each nostril 2–3 times daily. The single dose should not be used more than 3 times per day. The effect of the drug develops within several minutes after administration and lasts for several hours (on average 6–8 hours, maximum up to 12 hours). Doses higher than recommended should be used only under medical supervision. NOXSPRAY MALYUK should not be used for longer than 5–7 days.

Children.

NOXSPRAY MALYUK is indicated for use in children under 1 year of age.

Overdose.

Overdose may occur following nasal or accidental oral ingestion. The clinical picture caused by intoxication with imidazole derivatives may be complex, as hyperexcitability phases may alternate with phases of depression of the central nervous system, cardiovascular system, and respiratory system. Stimulation of the central nervous system may manifest as: anxiety, agitation, hallucinations, and seizures. Depression of the central nervous system may manifest as: decreased body temperature, lethargy, somnolence, and coma. Other possible symptoms include: arterial hypertension, tachycardia, bradycardia, miosis, mydriasis, seizures, increased body temperature, spasms, sweating, pallor, lethargy, decreased body temperature, cyanosis, palpitations, arrhythmia, cardiac arrest, hypotension with shock, nausea and vomiting, respiratory depression, apnea, and psychogenic disorders. In children, overdose often leads to predominant central nervous system effects such as seizures and coma, bradycardia, apnea, as well as arterial hypertension, which may be followed by hypotension.

Treatment measures are indicated in cases of severe overdose. Administration of activated charcoal (adsorbent), sodium sulfate (laxative), or gastric lavage (in case of ingestion of a large amount of the drug) should be performed immediately, as oxymetazoline can be rapidly absorbed. Vasopressor agents are contraindicated. Non-selective alpha-adrenergic blockers may be used as an antidote. If necessary, anticonvulsant therapy, lung ventilation, and antipyretic measures should be initiated.

Side effects.

Respiratory system, thoracic and mediastinal disorders.

Common (≥1% - <10%): burning sensation or dryness of nasal mucous membranes, sneezing.

Uncommon (≥0.1% - <1%): increased swelling of the mucous membrane, nasal bleeding after discontinuation of use.

Very rare (<0.01%): apnea in newborns and infants.

Skeletal muscle system.

Very rare (<0.01%): convulsions (mainly in children).

Nervous system.

Very rare (<0.01%): restlessness, insomnia, fatigue (drowsiness, sedative effect), headache, hallucinations (especially in children).

Cardiovascular system.

Rare (≥0.01% - <0.1%): palpitations, tachycardia, arterial hypertension.

Very rare (<0.01%): arrhythmia.

Immune system.

Uncommon (≥0.1% - <1%): hypersensitivity reactions (rash, pruritus, angioneurotic edema).

Shelf life.

2 years. Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

5 ml in a glass container with a dropper cap in a cardboard box.

Prescription status.

Over-the-counter.

Manufacturer.

Ukrainian-Spanish joint venture "Sperco Ukraine".

Manufacturer's address and location of business activity.

21027, Ukraine, Vinnytsia, vul. 600-richchya, 25.

Tel.: + 38(0432)52-30-36. E-mail: [email protected]

www.sperco.com.ua