Nazol®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NAZOL®

Composition:

Active substance: oxymetazoline hydrochloride;

1 ml of solution contains oxymetazoline hydrochloride 0.5 mg (0.05 % solution);

Excipients: benzalkonium chloride; disodium edetate dihydrate; macrogol 400; povidone; propylene glycol; sodium dihydrogen phosphate dihydrate; sodium hydrogen phosphate dihydrate; purified water.

Pharmaceutical form. Nasal spray.

Main physicochemical properties: clear, colorless, odorless liquid.

Pharmacotherapeutic group. Anti-edematous and other locally acting agents for nasal cavity disorders. Sympathomimetics, simple preparations.

ATC Code R01A A05.

Pharmacological properties.

Pharmacodynamics.

Oxymetazoline hydrochloride is a synthetic adrenomimetic agent. By stimulating vascular α-adrenergic receptors, it produces pronounced and prolonged vasoconstrictive effects. The vasoconstriction reduces blood flow, decreases swelling of the mucous membranes of the nose, paranasal sinuses, and Eustachian tube, thereby restoring nasal breathing impaired during influenza, colds, and allergic conditions.

Local vasoconstriction of the nasal and paranasal sinus mucosa occurs within 5–10 minutes after intranasal administration of the drug. The decongestant effect lasts up to 12 hours. The drug has a soothing effect on the irritated nasal mucosa and protects it from excessive drying.

Pharmacokinetics.

The elimination half-life is 5–8 hours. It is excreted mainly unchanged in urine and feces.

Clinical characteristics.

Indications.

Symptomatic treatment of colds, influenza, allergic diseases (hay fever), accompanied by acute rhinitis, sinusitis (frontal, ethmoid), other sinusitis (frontitis, ethmoiditis), and acute otitis media.

Contraindications.

Hypersensitivity to oxymetazoline, other adrenergic agents or any component of the drug, severe forms of arterial hypertension, pronounced atherosclerosis, acute cardiovascular disorders or cardiac asthma, tachysystolic cardiac arrhythmias, angina pectoris, renal failure, marked benign prostatic hyperplasia, pheochromocytoma, metabolic disorders (hyperthyroidism, diabetes mellitus), atrophic rhinitis, increased intraocular pressure, especially in closed-angle glaucoma, after transsphenoidal hypophysectomy or other surgical interventions involving opening of the dura mater; inflammation or damage to the skin around nasal passages or nasal mucosa; use of drugs that increase blood pressure; concomitant use with monoamine oxidase inhibitors (MAOIs) and use within 2 weeks after discontinuation of MAOIs.

Interaction with other medicinal products and other forms of interaction.

Before using other medicinal products, consult a physician. Concomitant use of this drug with other vasoconstrictive agents (by any route of administration) or with other nasal decongestants, as well as with tricyclic antidepressants or maprotiline, should be done only after consultation with a physician due to possible increase in blood pressure.

Concomitant use of MAO inhibitors and oxymetazoline may lead to increased blood pressure. Therefore, this medicinal product should not be used simultaneously or within 2 weeks after discontinuation of MAOI therapy.

Concomitant use of oxymetazoline with tricyclic antidepressants may increase the risk of elevated blood pressure and arrhythmias.

Oxymetazoline may reduce the effectiveness of β-adrenergic blockers, methyldopa, or other antihypertensive drugs.

Concomitant use of sympathomimetic agents and antiparkinsonian drugs may result in additive toxic effects on the cardiovascular system.

Special precautions for use.

When spraying into the nasal cavity, do not tilt the head back or invert the bottle. It is not recommended that several individuals use the same bottle to avoid the spread of infection.

Persistent nasal congestion after the third day of treatment may indicate the presence of nasal septum deviation, purulent sinusitis, adenoids, allergic rhinitis, persistent bacterial infection, or other undiagnosed conditions requiring medical consultation and specialized comprehensive therapy.

Medical advice should be sought before starting treatment with this medication in the following cases: high arterial pressure, cardiovascular diseases, liver or kidney disorders, porphyria.

Prolonged use and overdosing should be avoided. Long-term use of decongestants may lead to diminished effectiveness. Abuse of this product may cause atrophy of the mucous membrane and reactive hyperemia leading to medication-induced rhinitis, as well as damage to the mucosal epithelium and inhibition of epithelial activity. Doses higher than recommended should be used only under medical supervision. The recommended dosage should not be exceeded.

Use during pregnancy or breastfeeding.

Oxymetazoline has not been associated with adverse pregnancy outcomes. It should be used with caution in patients with hypertension or signs of reduced placental blood supply. Frequent or prolonged use of high doses may reduce placental blood flow. Use during pregnancy is possible only if, in the opinion of the physician, the benefit to the mother outweighs the potential risk to the fetus/child.

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

Ability to affect reaction rate when driving or operating machinery.

After prolonged use of doses exceeding the recommended amounts, 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

For adults and children aged 12 years and older: administer 2 sprays into each nostril. For children aged 6 to 12 years: administer 1 spray into each nostril. The bottle should be held vertically. Repeat spraying no sooner than every 12 hours.

Duration of treatment should not exceed 3 days. Prolonged use up to 7–10 days at a dose of 2 sprays per day is possible only under medical supervision.

Children

Do not use in children under 6 years of age.

Overdose

When used locally, systemic adverse reactions usually do not occur.

Symptoms of oxymetazoline overdose vary. Stages of hyperexcitability and depression may be distinguished. Stimulation of the central nervous system (CNS) clinically manifests as fear, excitement, hallucinations, and seizures.

Symptoms of moderate or severe overdose include miosis (pupil constriction), mydriasis (pupil dilation), nausea, vomiting, cyanosis, fever, sweating, spasms, tachycardia, arrhythmia, cardiac arrest, elevated arterial blood pressure, pulmonary edema, dyspnea, and physical discomfort.

Suppression of central nervous system function clinically manifests as drowsiness, decreased body temperature, bradycardia, arterial hypotension, collapse, shock, respiratory disturbances, respiratory arrest, loss of consciousness, and coma.

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

Emergency Treatment. In case of suspected oxymetazoline overdose, immediate hospitalization to an intensive care unit is required. Activated charcoal and laxatives should be administered. Gastric lavage is necessary. To reduce elevated arterial blood pressure, α-adrenoblockers (phentolamine) should be administered. Vasopressor agents should not be used. Anticonvulsant therapy may be indicated if necessary. In severe cases, endotracheal intubation and artificial ventilation of the lungs may be required.

Adverse reactions.

With frequent and prolonged use, sensations of burning, tingling in the nose, facial flushing, sneezing, and dryness of the nasal mucosa may occur. Rarely, after the effect of the medication has worn off, a sensation of severe nasal congestion may occur (rebound hyperemia). Prolonged continuous use of vasoconstrictive agents may lead to tachyphylaxis or development of drug-induced rhinitis. Generally, severe adverse effects are not expected.

Cardiovascular system. Very rarely, tachycardia, palpitations, increased arterial pressure, or chest pain may occur.

Eye disorders. Rarely, eye irritation, discomfort, redness, or blurred vision may be observed.

Gastrointestinal tract. Rarely, nausea may occur.

Immune system. In isolated cases, hypersensitivity reactions may occur, including rash, itching, and angioedema (Quincke's edema).

Respiratory, thoracic and mediastinal disorders. Rarely, discomfort or irritation in the nose, mouth, and throat, as well as nasal bleeding, may occur.

Nervous system. Restlessness, nervousness, anxiety, insomnia, drowsiness, tremor, hallucinations (especially in children), increased fatigue, headache, dizziness.

Skin and subcutaneous tissue disorders. Rash.

Musculoskeletal and connective tissue disorders. Convulsions (especially in children).

General disorders. Weakness.

Shelf life. 3 years.

After opening the bottle, the shelf life is 12 months. Do not use the medication after the expiry date stated on the packaging.

Storage conditions.

Store at temperatures not exceeding 30 °C.

Keep out of reach of children.

Packaging.

A 10 ml plastic bottle with a spray pump in a cardboard box.

Availability.

Over-the-counter (without prescription).

Manufacturer.

Istituto De Angeli S.r.l.

Manufacturer's address.

Località Prulli n. 103/c - 50066 Reggello (FI), Italy.