RINAZOLIN®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT RINAZOLINE® (RINAZOLINE®)

Composition:

Active substance: oxymetazoline;

1 ml of drops contains 0.1 mg of oxymetazoline hydrochloride calculated as 100% substance;

Excipients: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate dihydrate, sodium hydrogen phosphate dodecahydrate, purified water.

Pharmaceutical form. Nasal drops.

Main physical and chemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Decongestants and other preparations for local use in nasal cavity disorders. Simple sympathomimetics. Oxymetazoline.

ATC code R01A A05.

Pharmacological properties.

Pharmacodynamics.

Rinazolin® belongs to the group of local vasoconstrictor agents. Oxymetazoline exerts sympathomimetic and vasoconstrictive effects, reducing swelling of the nasal mucosa. It constricts blood vessels at the site of application, decreases edema of the nasal and upper respiratory tract mucosa, and reduces nasal discharge. It restores nasal breathing. Relief of nasal mucosal swelling promotes restoration of aeration of the paranasal sinuses and the middle ear cavity, 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 symptoms of acute rhinitis (nasal congestion, rhinorrhea, sneezing, and general malaise).

Pharmacokinetics.

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

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

Clinical characteristics.

Indications.

Acute rhinitis, allergic rhinitis, attacks of non-infectious vasomotor rhinitis; to restore drainage and nasal breathing in diseases of the nasal accessory sinuses, in children under 1 year of age with eustachian tube inflammation associated with rhinitis. For relief of swelling prior to diagnostic procedures in nasal passages in children under 1 year of age.

Contraindications.

Hypersensitivity to the components of the drug.

Atrophic rhinitis.

Do not use after transsphenoidal hypophysectomy or other surgical interventions involving exposure of the meninges.

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

In cases of elevated intraocular pressure, particularly in closed-angle glaucoma.

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

Pheochromocytoma.

Metabolic disorders (e.g., hyperthyroidism, diabetes mellitus).

Prostate hyperplasia.

Porphyria.

Interaction with other medicinal products and other forms of interaction.

Do not use MAO inhibitors and other drugs that may 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

Special caution is required when treating newborns and infants. In rare cases, serious adverse reactions (e.g., apnea) have been reported in this age group following administration of the drug at therapeutic doses. Exceeding the recommended dosages must be strictly avoided.

Prolonged use and overdosing of the drug should be avoided. Long-term use of a nasal decongestant may lead to diminished effectiveness of the drug. Misuse may result in atrophy of the mucous membrane and reactive hyperemia, leading to drug-induced rhinitis. Doses higher than recommended should be administered only under medical supervision.

The presence of benzalkonium chloride in the formulation at a concentration of 18 μg per dose (4 drops: 2 drops into each nostril) may cause bronchospasm.

Use during pregnancy or breastfeeding.

Pregnancy

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

Breastfeeding

Data regarding the passage of oxymetazoline into breast milk are not available. The drug should be used during breastfeeding only after careful assessment of the benefit-risk ratio. The recommended dosage should not be exceeded during breastfeeding, as overdosing may reduce breast milk production in women.

Ability to influence reaction speed while driving or operating 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

Rynazolin® 0.01% nasal drops are intended for instillation into the nose.

Immediately before use, the bottle should be held in the palm of the hand to warm it to body temperature. The nasal passages must be thoroughly cleared before administration.

For children from birth to 4 weeks of age: administer 1 drop of Rynazolin® into each nostril 2–3 times daily.

For children aged 5 weeks to 1 year: 1–2 drops of Rynazolin® into each nostril 2–3 times daily.

The single dose of Rynazolin® should not be used more than 3 times daily or for longer than 5–7 days. Doses higher than recommended should not be used.

Rynazolin® is recommended for use in infants and children under 1 year of age. The appropriate dose for low-birth-weight infants and premature infants should be determined by a physician.

Method of administration of nasal drops in a glass bottle closed with a dropper:

1. Remove the protective cap from the bottle.
2. Turn the bottle with the nozzle downward; before first use, perform several test presses on the pump dispenser.
3. Insert the tip of the nozzle in turn into each nostril and press the pump dispenser the required number of times according to the prescribed dosage.
4. After use, close the bottle with the cap.

Method of administration of drops in a polyethylene bottle with a screw cap:

Do not tightly screw the cap before first use!

1. Before first use, rotate the cap to create an opening.
2. Unscrew the cap, remove it, and gently press the bottle body to instill 1–2 drops of the solution into the nose. During instillation, the child's head should be tilted backward. Hold the bottle inverted in front of the nostril and administer the medication into each nasal passage.
3. After instillation, tightly screw the cap back on.

Children. Rynazolin® 0.01% is indicated for use in children from birth up to 1 year of age.

Overdose.

Following significant overdose or accidental ingestion, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, elevated temperature, spasms, tachycardia, palpitations, arrhythmia, cardiovascular insufficiency, cardiac arrest, excessive sweating, agitation, seizures, arterial hypertension, pulmonary edema, respiratory disorders, pallor, miosis, hyposmia, and psychiatric disturbances.

Additionally, central nervous system depression may occur, manifesting as drowsiness, decreased body temperature, bradycardia, arterial hypotension, apnea, and potential progression to coma.

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

Adverse reactions.

Undesirable effects are classified by their frequency of occurrence into the following categories: very common (≥ 10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and < 0.1%), very rare (< 0.01%), and isolated cases.

From the nervous system.

Very rare: restlessness, insomnia, increased fatigue (drowsiness, sedation), headache, hallucinations (especially in children).

From the cardiovascular system.

Rare: palpitations, tachycardia, arterial hypertension.

Very rare: arrhythmias.

From the respiratory system.

Common: nasal discomfort (e.g., burning sensation) or dryness of the nasal mucosa, sneezing.

Uncommon: after the effect of Rinazolin® wears off – sensation of severe nasal congestion, epistaxis (nosebleed).

Very rare: apnea in infants and newborns.

From the musculoskeletal system.

Very rare: seizures (especially in children).

From the immune system.

Uncommon: hypersensitivity reactions (angioneurotic edema, rash, itching).

Shelf life.

3 years.

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

Storage conditions.

Store in a light-protected place at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 ml in a polyethylene bottle with a screw cap. Or 10 ml in a brown glass bottle stoppered with a dropper. 1 bottle per carton.

Classification of supply. Over-the-counter.

Manufacturer: JSC "Farmak".

Manufacturer's location and address of business activity.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.