Nokspray aktiv

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NOXPREY ACTIV (NOXPREY ACTIV)

Composition:

Active substance: oxymetazoline;

1 ml of solution contains 0.5 mg of oxymetazoline hydrochloride;

Excipients: benzalkonium chloride, levomenthol, racemic camphor, eucalyptol, sodium dihydrogen phosphate monohydrate, disodium edetate, propylene glycol, purified water.

Pharmaceutical form. Nasal spray.

Main physicochemical properties: colorless or slightly yellowish transparent liquid with a specific odor.

Pharmacotherapeutic group. Anti-edematous and other agents for local use in nasal cavity disorders. Sympathomimetics.

ATC code R01A A05.

Pharmacological properties.

Pharmacodynamics.

Noksprey Aktiv is an α-adrenomimetic, an imidazole derivative belonging to the group of local vasoconstrictors. When administered into the nasal cavity, the drug constricts arterioles of the nasal mucosa, thereby reducing edema, hyperemia, exudation, restoring nasal breathing, and decreasing nasal discharge. Noksprey reduces swelling of the mucosa around the opening of the Eustachian tube, improving drainage in cases of eustachitis and otitis media. The essential oils contained in the formulation help relieve the sensation of nasal mucosa irritation and protect it from excessive drying. Local vasoconstriction of the nasal mucosa and paranasal sinuses occurs within 5–10 minutes after spraying the drug into the nasal cavity and lasts for 10–12 hours.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Acute respiratory diseases accompanied by nasal congestion, allergic rhinitis, vasomotor rhinitis, for restoration of drainage and nasal breathing in diseases of nasal accessory sinuses and eustachitis, for elimination of swelling prior to diagnostic procedures in nasal passages.

Contraindications.

Hypersensitivity to oxymetazoline, other adrenomimetics, or to any component of the drug; atrophic rhinitis; increased intraocular pressure, especially in closed-angle glaucoma; pheochromocytoma; severe forms of cardiovascular diseases (arterial hypertension, ischemic heart disease), marked atherosclerosis, acute cardiovascular disorders or cardiac asthma, tachysystolic cardiac rhythm disorders, angina pectoris; metabolic disorders (hyperthyroidism, diabetes mellitus, porphyria); renal insufficiency; after transsphenoidal hypophysectomy or other surgical interventions involving opening of the dura mater; inflammation or damage of the skin around nasal passages or nasal mucosa. Concomitant use of monoamine oxidase inhibitors (MAOIs) is contraindicated, as well as within 2 weeks after discontinuation of MAOI therapy, and also with other drugs causing increased blood pressure. Prostate hypertrophy.

Interaction with other medicinal products and other forms of interactions.

Before using other medicinal products, consultation with a physician is recommended. The drug should not be used simultaneously with other vasoconstrictive agents (regardless of the route of administration), with other nasal decongestants, or with tricyclic antidepressants and maprotiline, due to possible increase in blood pressure. Such combined use is possible only after consultation with a physician. Concomitant use with MAO inhibitors may lead to increased blood pressure. Noksprey Active should not be used simultaneously or within 2 weeks after discontinuation of MAOI therapy (see section "Contraindications"). Concomitant use of oxymetazoline with tricyclic antidepressants may increase the risk of developing arterial hypertension and arrhythmia. Oxymetazoline may reduce the effectiveness of β-adrenoblockers, methyldopa, or other antihypertensive drugs. Concomitant use of sympathomimetics and antiparkinsonian agents may increase toxic effects on the cardiovascular system.

Special precautions for use.

For proper use of the spray, the following steps should be taken:

• Remove the protective cap from the atomizer. Before the first use, prime the spray pump by pressing it several times until a fine mist appears.
• Insert the tip of the atomizer into the nostril and administer the spray by firmly pressing the applicator with the index and middle fingers. Administer the required number of sprays into each nostril (see section "Dosage and administration"), without tilting the head backward. During administration, gently inhale through the nose.
• After use, cover the spray nozzle with the protective cap.

To prevent the spread of infection, the same bottle should not be used by more than one person.

Prolonged use and overdosing of the medication should be avoided. Long-term use of nasal decongestants may lead to reduced effectiveness. Abuse of such products may result in atrophy of the mucous membrane, reactive hyperemia, drug-induced rhinitis, as well as damage to the epithelium and inhibition of its activity. Special monitoring is required in patients with chronic rhinitis and when reducing swelling prior to diagnostic procedures. Doses higher than recommended should be used only under medical supervision. Continuous use of the medication should not exceed 7 days.

Persistent nasal congestion after three days of treatment may indicate a deviated nasal septum, purulent sinusitis, adenoids, allergic rhinitis, persistent bacterial infection, or other undiagnosed conditions requiring medical consultation and specialized comprehensive therapy.

Consult a physician before starting treatment with this medication in cases of high blood pressure, cardiovascular disorders, or liver or kidney impairment.

Use during pregnancy or breastfeeding.

Oxymetazoline has not been associated with adverse pregnancy outcomes. However, the medication should be used with caution in patients with arterial hypertension or signs of reduced placental perfusion. Frequent or prolonged use of high doses may reduce placental blood flow. During pregnancy or breastfeeding, the medication should be used only with special caution when, in the opinion of the physician, the expected benefit to the mother outweighs the potential risk to the fetus/child. The recommended dosage must not be exceeded.

It is unknown whether oxymetazoline is excreted in breast milk. Due to the lack of data, oxymetazoline should not be used during breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

Prolonged use of the medication at doses exceeding the recommended levels may not exclude systemic effects on the cardiovascular system. In such cases, the ability to drive or operate machinery may be impaired.

Method of Administration and Dosage.

For adults and children aged 6 years and older: administer 1 spray into each nostril 2–3 times daily. Doses higher than recommended should be used only under medical supervision. The medication should not be used for longer than 5–7 days. Repeated use should be initiated only after several days.

Children.

The medication is indicated for children aged 6 years and older.

Overdose.

In cases of significant overdose or accidental ingestion, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, elevated temperature, spasms, tachycardia, arrhythmia, palpitations, cardiovascular insufficiency, arterial hypertension, dyspnea, respiratory disorders, pulmonary edema, cardiac arrest, excessive sweating, agitation, fear sensation, seizures, pallor, miosis, hyposmia, hallucinations, psychiatric disorders, physical discomfort; very rarely – central nervous system (CNS) depression manifested as drowsiness, decreased body temperature, bradycardia, arterial hypotension, collapse, shock, respiratory disorders, apnea, loss of consciousness with possible progression to coma.

Clinical manifestations of overdose in children include CNS-related symptoms: seizures and coma, hallucinations, bradycardia, apnea, arterial hypertension changing to hypotension.

Emergency measures: in case of suspected oxymetazoline overdose, immediate hospitalization to an intensive care unit is required. Gastric lavage, administration of activated charcoal, and artificial ventilation of the lungs if necessary are indicated. In case of arterial hypertension, vasodilators should be administered (phentolamine, sodium nitroprusside). Vasopressor agents must not be used. If necessary, benzodiazepines should be administered in case of agitation; anticonvulsant therapy should be carried out with benzodiazepines and/or barbiturates. In severe cases, tracheal intubation and artificial ventilation of the lungs may become necessary.

Side effects.

Respiratory, thoracic and mediastinal disorders: discomfort or irritation in the nose, mouth and throat, burning or dryness of the nasal mucosa, sneezing, nasal bleeding, apnea in newborns and young children (especially in cases of overdose). After the effect of the drug subsides, a sensation of severe nasal congestion may occur (rebound hyperemia).

Nervous system disorders: headache, nausea, dizziness, drowsiness or insomnia, restlessness, nervousness, anxiety, tremor, increased fatigue, seizures (especially in children), hallucinations (especially in children).

Eye disorders: irritation, discomfort or redness of the eyes, blurred vision.

Cardiovascular system disorders: local nasal application may cause systemic effects (tachycardia, increased blood pressure, palpitations, sensation of heartbeat, chest pain), facial flushing.

Immune system disorders: allergic reactions, including rash, itching, angioedema.

General disorders: weakness.

Shelf life.

3 years.

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

Storage conditions.

Store at a temperature not exceeding 30 °C. Keep out of reach of children.

Packaging.

10 ml in a polymer container with a spray pump, in a cardboard box.

Classification.

Over-the-counter (without prescription).

Manufacturer.

Ukrainian-Spanish joint venture "Sperco Ukraine".

Manufacturer's address and place of business.

21027, Vinnytsia, 600-richchia St., 25, Ukraine.

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

www.sperco.ua