Rint nasal spray® with menthol

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT RINT NASAL SPRAY® WITH MENTHOL (RINTNASALSPRAYWITHMENTHOL)

Composition:

Active substance: oxymetazoline;

1 ml of the preparation contains 0.5 mg of oxymetazoline hydrochloride, calculated as 100% dry substance;

Excipients: racemic camphor, menthol (levomenthol), benzalkonium chloride, disodium edetate (Trilon B), benzyl alcohol, polyethylene glycol 400 (macrogol 400), povidone, microcrystalline cellulose, sodium carboxymethylcellulose – microcrystalline cellulose, sodium dihydrogen phosphate dihydrate; sodium hydrogen phosphate dodecahydrate; water for injections.

Pharmaceutical form. Nasal spray.

Main physicochemical properties: opaque, whitish, gel-like liquid or solution with a specific odor and thixotropic properties (becomes thicker when standing and liquefies upon shaking).

Pharmacotherapeutic group.

Anti-edematous and other preparations for local use in nasal cavity disorders. Sympathomimetics, simple preparations. ATC code R01A A05.

Pharmacological properties.

Pharmacodynamics.

Rin nasal spray® with menthol belongs to the group of local vasoconstrictive agents. Oxymetazoline exerts sympathomimetic and vasoconstrictive effects, reducing swelling of the nasal mucosa. It constricts blood vessels at the site of application, decreases swelling of the nasal and upper respiratory tract mucosa, and reduces nasal discharge. It restores nasal breathing. Reduction of nasal mucosal swelling promotes re-establishment of sinus and middle ear cavity aeration, thus preventing the development of bacterial complications.

Oxymetazoline exerts antiviral, anti-inflammatory, immunomodulatory, and antioxidant effects. Due to this combined mechanism of action, clinical studies have demonstrated faster and more effective relief of acute rhinitis symptoms (nasal congestion, rhinorrhea, sneezing, and general malaise).

Pharmacokinetics.

The effect of the drug begins rapidly (within a few minutes after application).

When applied locally to the nasal mucosa at therapeutic concentrations, it does not irritate the nasal mucosa or cause hyperemia. The elimination half-life is approximately 35 hours after administration. About 2.1% of the drug is excreted via the kidneys, and approximately 1.1% is excreted in feces.

Duration of action of the drug is up to 12 hours.

Clinical characteristics.

Indications.

• Acute respiratory diseases accompanied by nasal congestion.
• Allergic rhinitis.
• Vasomotor rhinitis.
• To restore drainage and nasal breathing in diseases of the nasal sinus cavities, eustachitis.
• To eliminate swelling prior to diagnostic procedures in the nasal passages.

Contraindications.

Hypersensitivity to the components of the drug.

Atrophic rhinitis.

During treatment with monoamine oxidase inhibitors (MAO inhibitors) and within 2 weeks after discontinuation of MAO inhibitors, as well as other drugs that increase blood pressure.

In case of elevated intraocular pressure, especially in closed-angle glaucoma.

In severe forms of cardiovascular diseases (e.g., ischemic heart disease, arterial hypertension).

Pheochromocytoma.

Metabolic disorders (hyperthyroidism, diabetes mellitus, porphyria).

Prostate hypertrophy.

After transsphenoidal hypophysectomy or other surgical interventions exposing the dura mater.

Interaction with other medicinal products and other forms of interaction.

Do not use MAO inhibitors and other drugs that increase blood pressure due to the risk of elevated blood pressure. Concomitant use of other vasoconstrictive medicinal agents increases the risk of adverse effects.

Special precautions for use.

Prolonged use and overdosing of the medication should be avoided. Long-term use of a nasal decongestant may lead to diminished effectiveness of the drug. Misuse of this product may result in mucosal atrophy and reactive hyperemia, leading to drug-induced rhinitis.

Special monitoring is required for patients with chronic rhinitis after administration of the medication, as well as when reducing swelling prior to diagnostic procedures. Doses higher than recommended should be used only under medical supervision.

The presence of benzalkonium chloride in the formulation at a concentration of 10 mcg per dose may cause bronchospasm.

Use during pregnancy or breastfeeding.

The medication should be used with particular caution during pregnancy or breastfeeding. Exceeding the recommended dosage is not permitted.

Effect on the ability to drive or operate machinery.

After prolonged use of doses exceeding the recommended levels, a systemic effect on the cardiovascular system cannot be ruled out. In such cases, the ability to drive or operate machinery may be reduced.

Method of administration and dosage.

Before each use, shake the bottle vigorously. Remove the protective cap. Before first use of the dosing device, press it several times until a spray mist appears. Insert the nozzle into the nostril and press the dosing device while inhaling deeply through the nose; there is no need to tilt the head backward. Then repeat the procedure by inserting the nozzle into the other nostril. After use, wipe the nozzle clean and cover the bottle with the protective cap.

The medication is indicated for adults and children aged 6 years and older – 1 spray into each nostril 2–3 times daily. Doses higher than those recommended should be used only under medical supervision.

The medication should not be used for longer than 5–7 days. Repeated use should be performed only after several days.

Children. The drug should not be used in children under 6 years of age.

Overdose.

After a significant overdose or accidental ingestion, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, elevated temperature, spasms, tachycardia, palpitations, arrhythmia, cardiovascular failure, cardiac arrest, increased sweating, agitation, convulsions, arterial hypertension, pulmonary edema, respiratory disorders, pallor, miosis, hyposmia, and psychiatric disorders.

In addition, central nervous system depression may develop, manifested by drowsiness, decreased body temperature, bradycardia, arterial hypotension, apnea, and possible progression to coma.

Therapeutic measures in case of overdose: gastric lavage, administration of activated charcoal, lung ventilation. In case of decreased arterial pressure, administer phentolamine. Vasopressor agents should not be used. Anticonvulsant therapy may be indicated if necessary.

Side effects.

Respiratory system.

Common (≥1% - <10%): nasal discomfort, burning or dryness of the nasal mucosa, sneezing.

Rare (≥0.01% - <0.1%): after the effect of oxymetazoline ends, a sensation of strong nasal congestion may occur (rebound hyperemia).

Frequency unknown / isolated cases: nasal bleeding. Apnea in newborns and young children (especially in case of overdose).

Nervous system.

Rare (≥0.01% - <0.1%): headache, drowsiness, fatigue, seizures, hallucinations (especially in children).

Cardiovascular system.

Uncommon (≥0.1% - <1%): local nasal application may cause systemic effects such as palpitations, tachycardia, arterial hypertension.

Immune system.

Allergic reactions are possible, including rash, itching, angioneurotic edema.

Shelf life.

3 years. Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 10 ml in a glass bottle with a pump dispenser and nasal spray nozzle, placed in a carton.

Availability. Over-the-counter.

Manufacturer.

JSC "Farmak".

Manufacturer's address and place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.