Rinazolin®

INSTRUCTIONS for medical use of the medicinal product RINAZOLINE® (RINAZOLINE®)

Composition:

Active substance: oxymetazoline;

1 ml of drops contains oxymetazoline hydrochloride equivalent to 100 % substance 0.25 mg or 0.5 mg;

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

Pharmaceutical form. Nasal drops.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Decongestants and other drugs 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 nasal mucosal edema. 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. Relief of nasal mucosal swelling promotes restoration of ventilation to 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 topically to the nose in 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% through 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.
• For restoration of drainage and nasal breathing in diseases of the nasal paranasal sinuses, eustachitis.
• To eliminate swelling prior to diagnostic procedures in the nasal passages.

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

In 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).

Prostatic hyperplasia.

Porphyria.

Interaction with other medicinal products and other forms of interactions.

Concomitant use of oxymetazoline with MAO inhibitors 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 drug should be avoided. Prolonged use of a nasal decongestant may lead to diminished drug efficacy. Misuse of this product may cause mucosal atrophy and reactive hyperemia with drug-induced rhinitis. 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 provoke bronchospasm.

Use during pregnancy or breastfeeding.

Pregnancy.

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

Breastfeeding.

Data regarding the passage of oxymetazoline into breast milk are lacking. 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 overdose may reduce the amount of breast milk in women.

Ability to affect reaction speed when driving or operating machinery.

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

Method of Administration and Dosage.

Rinazolin® 0.025%, 0.05%, drops, are intended for nasal use.

Adults and children aged 6 years and older.

Administer Rinazolin® 0.05% drops, 1–2 drops into each nostril 2–3 times daily.

Children aged 1 to 6 years.

Administer Rinazolin® 0.025% preparation, 1–2 drops into each nostril 2–3 times daily.

Rinazolin® 0.025%, 0.05% should not be used for longer than 5–7 days. The preparation may be reused only after several days.

Immediately before use, hold the bottle in the palm of the hand to warm it to body temperature. The nose must be thoroughly cleared before administration.

Method of using nasal drops in a glass bottle:

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

Method of using drops in a polyethylene bottle:

1. Unscrew and remove the cap.
2. Turn the bottle upside down and gently squeeze the body of the bottle to instill the required number of drops into each nostril.
3. After use, close the bottle with the cap.

Children. Rinazolin® 0.025% should not be used in children under 1 year of age; Rinazolin® 0.05% should not be used in children under 6 years of age.

Overdose.

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

In addition, central nervous system depression may occur, 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. Phentolamine is administered in case of decreased arterial pressure. Vasopressor agents should not be used. Anticonvulsant therapy may be indicated if necessary.

Adverse reactions.

Adverse 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%).

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 strong 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 (angioedema, rash, pruritus).

Shelf life. 3 years.

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

Storage conditions. Store in a place protected from light, at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 ml in a polyethylene bottle, sealed with a dropper plug and cap (with tamper-evident seal) or in a polyethylene bottle, sealed with a dosing pump and cap with a security seal (tamper-evident). Or 10 ml in a brown glass bottle, sealed with a dropper. One bottle per carton.

Supply category. Over-the-counter.

Manufacturer. JSC "Farmak".

Manufacturer's address and place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.