Sanorin

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

Composition:

Active substance: naphazoline nitrate;

1 ml of emulsion contains 1 mg of naphazoline nitrate;

Excipients: boric acid, ethylenediamine, cetyl alcohol, methylparaben (E 218), eucalyptus oil, polysorbates, cholesterol, light mineral oil, purified water.

Pharmaceutical form. Nasal drops, emulsion.

Main physicochemical properties: white emulsion that readily disperses upon shaking.

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

Pharmacological properties.

Pharmacodynamics.

Naphazoline is an agent that stimulates the sympathetic nervous system and 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. For reduction of mucosal swelling during diagnostic procedures.

Contraindications.

Hypersensitivity to any component of the drug.

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 monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, mianserin, or within several days after their discontinuation may cause an increase in blood pressure.

Special precautions for use

Use the drug with great caution in severe cardiovascular diseases (arterial hypertension, ischemic heart disease), diabetes mellitus, hyperthyroidism, pheochromocytoma, and 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), 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 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 pass 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.

Ability to affect reaction speed when driving or operating machinery

Use of the medicinal product Sanorin at recommended doses does not affect or has almost no effect on the ability to drive or operate machinery.

Method of Administration and Dosage

For adults and children aged 15 years and older: instill 1–3 drops of the emulsion into each nostril 2–3 times daily.

The interval between administrations should be at least 4 hours.

Prolonged use of the medication for more than 5 days is not recommended.

If nasal breathing improves, treatment may be discontinued earlier.

Sanorin may be used again only after several days.

For diagnostic purposes: instill 3–4 drops into each nostril.

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

To administer the medication, instill into each nostril while slightly tilting the head backward. When administering into the left nostril, slightly incline the head to the left; when administering into the right nostril, incline 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, psychiatric disturbances, skin pallor, and myocardial infarction may occur.

Central nervous system depression may manifest as decreased body temperature, bradycardia, increased sweating, drowsiness, hypotensive-like shock, apnea, and coma. The risk of overdose is higher in children, who are more vulnerable 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 medicinal product may rarely cause burning and dryness of the nasal mucosa. In isolated cases, a sensation of pronounced nasal congestion may occur.

Systemic adverse reactions (most often due to overdose) occur only in rare instances:

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 – "sanorinism" – characterized by intense swelling of the nasal mucosa occurring after a relatively short time following administration. Long-term use of the drug may cause damage to the mucosal epithelium, suppression of ciliary activity, and may result in irreversible damage to the mucosa and development of atrophic rhinitis.

Shelf life. 4 years.

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

Packaging.

10 ml of emulsion in a bottle; 1 bottle with a dropper cap in a carton.

Availability. Over-the-counter.

Manufacturer.

Teva Czech Industries s.r.o.

Saneca Pharmaceuticals AT

Manufacturer's address and place of business.

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

Nitrianska 100, 920 27 Glogovec, Slovak Republic.