RHINAZOLIN®

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

Composition:

Active substance: oxymetazoline;

1 ml of solution contains 0.5 mg of oxymetazoline hydrochloride, calculated as 100% substance;

Excipients: benzalkonium chloride, polyethylene glycol, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, propylene glycol, povidone, purified water.

Pharmaceutical form. Nasal spray.

Main physicochemical properties: clear, colorless or slightly yellowish liquid.

Pharmacotherapeutic group. Anti-edematous and other preparations for local use in diseases of the nasal cavity. Sympathomimetics.

ATC code R01A A05.

Pharmacological Properties.

Pharmacodynamics.

Rinazolin® belongs to the group of local vasoconstrictive agents. Oxymetazoline exerts a sympathomimetic and vasoconstrictive effect, reducing swelling of the nasal mucosa. It constricts blood vessels at the site of application, reduces swelling of the nasal and upper respiratory tract mucosa, and decreases nasal discharge. It restores nasal breathing. Relief of nasal mucosal swelling promotes restoration of ventilation in the paranasal sinuses and 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 locally in therapeutic concentrations, the drug 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% through feces.

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

Clinical characteristics.

Indications.

• Acute rhinitis.
• Allergic rhinitis.
• Episodes of non-infectious vasomotor rhinitis.
• To restore drainage and nasal breathing in diseases of the nasal accessory sinuses, eustachitis associated with rhinitis.
• To reduce swelling prior to diagnostic procedures in the nasal passages.

Contraindications.

• Hypersensitivity to oxymetazoline or any other component of the drug.
• Atrophic rhinitis.
• Do not use after transsphenoidal hypophysectomy or other surgical procedures exposing the meninges.
• During treatment with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of MAOIs, and when using other drugs that increase blood pressure.
• Elevated intraocular pressure, especially in angle-closure glaucoma.
• Severe forms of cardiovascular diseases (e.g., ischemic heart disease) and arterial hypertension.
• Pheochromocytoma.
• Metabolic disorders (e.g., hyperthyroidism, diabetes mellitus).
• Prostatic hyperplasia.
• Porphyria.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of oxymetazoline with monoamine oxidase inhibitors (MAOIs) of the tranylcypromine type, tricyclic antidepressants, and hypertensive agents may lead to increased blood pressure. Therefore, these drugs should not be used concomitantly.

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 cause atrophy of the mucous membrane and reactive hyperemia, resulting in drug-induced rhinitis. Doses higher than those recommended should be used only under medical supervision.

The presence of benzalkonium chloride in the formulation at a concentration of 18 µg per dose may cause bronchospasm.

Use during pregnancy or breastfeeding.

Pregnancy.

The medication 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 lacking. The medication should be used during breastfeeding only after careful assessment of the benefit-risk ratio. During breastfeeding, the recommended dosage should not be exceeded, as overdose may reduce the amount of breast milk in women.

Ability to influence reaction rate while driving or operating machinery.

After prolonged use of the medication in 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

Method of using the preparation from glass bottles equipped with spray pumps and dosing nozzles

1. Thoroughly clean the nose before using the preparation. Immediately before administration, hold the bottle in your hand to warm it to body temperature. Remove the protective cap from the bottle.
2. Prime the spray by pressing (test spraying).
3. While standing upright, insert the nozzle alternately into each nostril and press the pump. A slight inhalation through the nose is recommended during spraying. After use, close the bottle with the cap.

Method of using the preparation from polyethylene bottles equipped with a dosing nozzle and protective cap

1. Thoroughly clean the nose before using the preparation. Immediately before administration, hold the bottle in your hand to warm it to body temperature. During administration, hold the bottle vertically with the spray nozzle pointing upwards.
2. Before use, remove the protective cap from the bottle.
3. Insert the nozzle into the nasal passage, squeeze the bottle sharply and briefly, then remove the nozzle from the nose and release the pressure. A slight inhalation through the nose is recommended during spraying.
4. After administration, close the bottle with the protective cap and store according to the recommendations provided in the instructions.

To prevent infection, each bottle of the preparation should be used by only one person.

Adults and children aged 6 years and older: 1 spray into each nostril 2–3 times daily. The single dose should not be used more than 3 times daily or for longer than 5–7 days. Doses higher than recommended should not be used.

The preparation may be used again only after several days.

Children. Indicated for children aged 6 years and older.

Overdose.

Following significant overdose or accidental ingestion, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, elevated temperature, spasms, tachycardia, palpitations, arrhythmia, cardiovascular failure, 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 potentially 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 required if necessary.

Adverse reactions.

Undesirable effects are classified by 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.

Very rare: apnea in infants and newborns.

From the musculoskeletal system.

Very rare: seizures (especially in children).

From the immune system.

Uncommon: hypersensitivity reactions (angioedema, rash, pruritus).

Shelf life. 3 years.

Do not use the medication after the expiry date stated on the packaging.

Storage conditions.

Store in a protected from light and inaccessible to children place at a temperature not exceeding 25°C.

Packaging. 15 ml in a polyethylene bottle equipped with a spray nozzle and protective cap. Or 10 ml in a glass bottle equipped with a pump-spray dispenser. One bottle per carton.

Prescription status. Over-the-counter.

Manufacturer. JSC "Farmak".

Manufacturer's address.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.