Sanorin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SANO RIN (SANORINÒ)

Composition:

Active substance: naphazoline nitrate;

10 ml of solution contain 10 mg of naphazoline nitrate;

Excipients: boric acid, ethylenediamine, methylparaben (E 218), purified water.

Pharmaceutical form. Nasal spray, solution.

Main physico-chemical characteristics: clear, colorless, odorless solution.

Pharmacotherapeutic group. Decongestants and other drugs for local use in nasal cavity diseases. Sympathomimetics. ATC code R01A A08.

Pharmacological properties.

Pharmacodynamics.

Naphazoline is a sympathomimetic agent that acts on α-adrenergic receptors, exerting minimal effect on β-adrenergic receptors. Due to its vasoconstrictive action, it reduces edema, hyperemia, and exudation, thereby facilitating nasal breathing in rhinitis. Naphazoline promotes opening and dilation of the drainage pathways of the nasal sinuses and Eustachian tubes, improving secretion drainage and preventing bacterial colonization.

Therapeutic effect after intranasal administration begins within 5 minutes and lasts for 4–6 hours.

Pharmacokinetics.

When applied locally, naphazoline is completely absorbed.

Clinical characteristics.

Indications.

Acute rhinitis. As an adjunctive agent in inflammation of the paranasal sinuses and the middle ear.

Contraindications.

Hypersensitivity to the active substance or to any component of the medicinal product.

Dry inflammation of the nasal mucosa.

Not to be used in children under 15 years of age.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of Sanorin with MAO inhibitors, tricyclic antidepressants, maprotiline, or within several days after discontinuation of these agents may cause an increase in blood pressure (even several days after administration).

Special precautions for use.

Use the drug with great caution in severe cardiovascular disorders (arterial hypertension, ischemic heart disease), diabetes mellitus, hyperthyroidism, pheochromocytoma, and during concomitant use of MAO inhibitors or other drugs that may exert a hypertensive effect.

Caution is required during general anesthesia with anesthetics that increase myocardial sensitivity to sympathomimetics (e.g., halothane), as well as in bronchial asthma, and during pregnancy and breastfeeding.

When large doses are used, adverse effects on the cardiovascular and nervous systems such as palpitations, arterial hypertension, arrhythmia, headache, dizziness, drowsiness, or insomnia may occur.

Prolonged use and overdosage should be avoided, especially in children. Prolonged use of drugs intended to relieve mucosal swelling may lead to edema and subsequent atrophy of the nasal mucosa.

This medicinal product contains methylparaben, which may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding.

There are no data regarding the ability of naphazoline to cross the placental barrier or to be excreted in breast milk. Therefore, the potential risks and benefits of treatment should be carefully evaluated before prescribing the drug to pregnant or breastfeeding women, and the drug should be used only if absolutely necessary.

Ability to influence reaction speed when driving vehicles or operating machinery.

Use of Sanorin at recommended doses does not affect or has negligible effect on the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

For adults and children aged 15 years and older: administer 1–3 sprays into each nostril 3 times daily, with an interval of at least 4 hours between doses.

Use should not exceed 3 days in children aged 15 years and older, or 5 days in adults.

If nasal breathing improves, treatment may be discontinued earlier.

Sanorin may be used again only after several days.

Children

For use in children aged 15 years and older.

Overdose

Overdose or accidental ingestion of the medication may cause systemic adverse effects: nervousness, increased sweating, headache, tremor, tachycardia, palpitations, arterial hypertension. Cyanosis, nausea, elevated body temperature, spasms, cardiac arrest, pulmonary edema, psychiatric disturbances, skin pallor, and heart attack may also occur.

Depressive effects on the central nervous system may manifest as symptoms including decreased body temperature, bradycardia, increased sweating, drowsiness, hypotensive-like shock, apnea, and coma. The risk of overdose is higher in children, who are more susceptible to adverse effects than adults.

Treatment is symptomatic.

Side effects.

When used at recommended doses, Sanorin is generally well tolerated. In patients with increased sensitivity, the drug may rarely cause burning and dryness of the nasal mucosa. In isolated cases, a sensation of severe nasal congestion may occur.

Systemic adverse effects occur only in rare cases (most often due to overdose):

Immune system disorders: allergic reactions, including Quincke's edema, burning sensation.

Nervous system disorders: nervousness, headache, tremor.

Cardiac disorders: tachycardia, palpitations.

Vascular disorders: arterial hypertension.

Skin and subcutaneous tissue disorders: increased sweating.

Prolonged use (more than 5 days in adults and more than 3 days in children) or frequent use of the drug may lead to drug-induced rhinitis (rebound congestion, also known as "rhinitis medicamentosa" or "sanorinism"), characterized by intense swelling of the nasal mucosa occurring after a relatively short time interval following administration. Long-term use of the drug may cause damage to the mucosal epithelium, suppression of ciliary activity, and lead to irreversible mucosal damage and development of atrophic (dry) rhinitis.

Shelf life. 4 years.

Storage conditions.

Store in the original packaging protected from light at temperatures not exceeding 25 °C, in a place inaccessible to children. Do not freeze.

Packaging. 10 mL solution in a bottle with a mechanical spray pump; 1 bottle with a nasal applicator, in a carton.

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

Manufacturer.

Teva Czech Industries s.r.o.

Sanochemia Pharmazeutika AG.

Manufacturer's address and location of operations.

Ostravska 29/305, Opava-Komarov, 747 70, Czech Republic.

Nitrianska 100, 920 27 Golgovec, Slovak Republic.