SANORIN

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

Composition:

Active substance: naphazoline nitrate;

1 ml contains 0.5 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 preparations 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 vasoconstrictive action, it reduces edema, hyperemia, and exudation, thereby facilitating relief of nasal breathing in rhinitis. Naphazoline promotes opening and dilation of the drainage pathways of the nasal accessory sinuses and the Eustachian tubes, improving secretion drainage and preventing bacterial accumulation.

Pharmacokinetics.

When applied locally, naphazoline is completely absorbed.

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

Clinical characteristics.

Indications.

Acute rhinitis. As an adjunctive agent 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.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of Sanorin with monoamine oxidase inhibitors (MAO inhibitors), tricyclic antidepressants, mапрotiline, or within several days after discontinuation of these drugs may lead to increased blood pressure (even several days after administration).

Special precautions for use.

Use this medication with extreme caution in severe cardiovascular disorders (arterial hypertension, ischemic heart disease), diabetes mellitus, hyperthyroidism, pheochromocytoma, and during concomitant use of monoamine oxidase inhibitors (MAO inhibitors) or other drugs that may produce hypertensive effects.

Caution is necessary during general anesthesia using anesthetics that increase myocardial sensitivity to sympathomimetic agents (e.g., halothane), as well as in patients with bronchial asthma.

When high doses 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 overdosage should be avoided, especially in children. Long-term use of medications intended to reduce 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 this medication to pregnant or breastfeeding women, and the drug should only be used if absolutely necessary.

Ability to affect reaction speed when driving or operating machinery.

Use of the medicinal product Sanorin at recommended doses does not impair the ability to drive vehicles or operate machinery. However, if recommended doses are exceeded, dizziness and drowsiness may occur.

Method of Administration and Dosage.

For children aged 3–6 years, instill 1–2 drops into each nostril;
for children aged 6–15 years, 2 drops into each nostril;
for adults and children aged 15 years and older, 1–3 drops into each nostril.

Administer the medication 3 times daily, with an interval of at least 4 hours.

It is not recommended to use the drug for longer than 3 days in children and longer than 5 days in adults.

If nasal breathing improves, treatment may be discontinued earlier.

Sanorin may be re-administered only after several days.

For diagnostic purposes, prior to nasal endoscopy (e.g., for diagnosis and treatment of nasal polyps), instill 3–4 drops into each nostril after nasal cleansing, or place a cotton swab moistened with Sanorin solution into the nasal passage and leave it there for 2–3 minutes.

In case of nasal bleeding, a cotton swab moistened with Sanorin solution may be placed into the nasal passage.

In case of laryngeal edema, spray 1–2 ml of the drug into the larynx using a laryngeal syringe.

To instill the medication, tilt the head slightly backward and administer drops into each nostril. 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 3 years and older.

Overdose.

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

Central nervous system depression may manifest as decreased body temperature; bradycardia; increased sweating; drowsiness; hypotensive-like shock; apnea; coma. The risk of overdose is higher in children, who are more vulnerable to adverse effects than adults.

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

Shelf life. 2 years.

After first opening – 1 year.

Storage conditions.

Store at temperatures not exceeding 25 °C in a place inaccessible to children.

Packaging. 10 ml of solution in a bottle with a dropper cap; 1 bottle per carton.

Availability. Over-the-counter.

Manufacturers.

Teva Czech Industries s.r.o.

Saneca Pharmaceuticals AT.

Manufacturer's name and address of manufacturing site.

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

Nitrianska 100, 920 27 Glogovec, Slovak Republic.