Sanorin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SANORIN (SANORINÒ)

Composition:

Active substance: naphazoline nitrate;

1 ml of solution contains 1 mg of naphazoline nitrate;

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

Pharmaceutical form. Nasal drops, solution.

Main physicochemical properties: clear, colorless, odorless solution.

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

Pharmacological properties.

Pharmacodynamics.

Naphazoline is a sympathomimetic agent that acts on α-adrenergic receptors and exerts minimal effect on β-adrenergic receptors. Due to its vasoconstrictor 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 accumulation.

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 adjunct in inflammation of the paranasal sinuses and of the middle ear. For reduction of mucosal swelling during diagnostic procedures.

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 Xynadin with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, mianserin, or within several days after their discontinuation may lead to increased 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 when co-administering MAO inhibitors or other drugs that may exert a hypertensive effect.

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

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

Prolonged use and overdosing should be avoided, especially in children. Prolonged use of medications 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 on the ability of naphazoline to cross the placental barrier or excrete into breast milk. Therefore, the decision to prescribe the drug to women during pregnancy or breastfeeding should be made only after careful consideration of all potential risks and benefits of treatment, and the drug should be prescribed only if absolutely necessary.

Effect on the ability to drive or operate machinery.

The use of the medicinal product Sanorin at recommended doses does not affect or has negligible effect on the ability to drive or operate machinery.

Dosage and Administration.

For adults and children aged 15 years and older: instill 1–3 drops into each nostril 3 times daily, at intervals of not less than 4 hours.

Prolonged use for more than 5 days is not recommended in adults.

If nasal breathing improves, treatment may be discontinued earlier.

Sanorin may be used again only after several days.

For diagnostic purposes during nasal endoscopy (e.g., for diagnosis and treatment of nasal polyps): instill 3–4 drops into each nostril after cleaning the nose.

To administer the medication, instill drops into each nostril with the head slightly tilted backward. When administering into the left nostril, slightly tilt the head to the left; when administering into the right nostril, tilt the head to the right.

Children.

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, respiratory disturbances, and psychiatric disorders may occur, as well as skin pallor and myocardial infarction.

Depressive effects on the central nervous system may manifest as symptoms including decreased body temperature; bradycardia; increased sweating; drowsiness; hypotensive-like shock; apnea; coma.

Treatment is symptomatic.

Adverse reactions.

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

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

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

Nervous system: nervousness, headache, tremor.

Cardiac system: tachycardia, palpitations.

Vascular system: arterial hypertension.

Skin and subcutaneous tissues: increased sweating.

Prolonged use (longer than 5 days in adults and longer than 3 days in children) or frequent use of the drug may lead to development of dependence—so-called "sanorinism"—accompanied by intense swelling of the nasal mucosa, which occurs after a relatively short period following administration. Long-term use of the drug may result in damage to the mucosal epithelium, suppression of ciliary epithelial activity, and may cause irreversible mucosal damage and development of atrophic rhinitis.

Shelf life. 3 years.

After first opening, store for no more than 28 days at a temperature of 25 °C.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C, protected from light and out of reach of children. Do not freeze.

Packaging. 10 mL solution in a bottle; 1 bottle with dropper cap in a carton.

Supply category. Over-the-counter.

Manufacturer.

Teva Czech Industries s.r.o.

Saneka Pharmaceuticals AT.

Manufacturer's address and place of business.

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

Nitrianska 100, 920 27 Golgofc, Slovak Republic.