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 vasoconstrictive agents. Oxymetazoline exerts sympathomimetic and vasoconstrictive effects, reducing swelling of the nasal mucosa. It constricts blood vessels at the site of application, reduces swelling of the nasal mucosa and upper respiratory tract, and decreases nasal discharge. It restores nasal breathing. Reduction of nasal mucosal swelling promotes restoration of ventilation in 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 locally via the nasal route 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 by 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.
• For restoration of drainage and nasal breathing in diseases of the nasal accessory sinuses, eustachian tube inflammation (eustachitis).
• For relief of swelling prior to diagnostic procedures in nasal passages.

Contraindications.

Hypersensitivity to the components of the drug.

Atrophic rhinitis.

Do not use after transphenoidal hypophysectomy or other surgical interventions exposing 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 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).

Prostatic hyperplasia.

Porphyria.

Interaction with other medicinal products and other types 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 effectiveness of the drug. Misuse of this product may cause atrophy of the mucous membrane and reactive hyperemia with medication-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 cause 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 penetration 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 influence reaction rate while driving or operating machinery.

After prolonged use of the drug in doses exceeding the recommended ones, a general 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

Rhinazoline® 0.025%, 0.05%, eye drops, is intended for nasal use.

Adults and children aged 6 years and older.

Administer 1–2 drops of Rhinazoline® 0.05% into each nostril 2–3 times daily.

Children aged 1 to 6 years.

Administer Rhinazoline® 0.025% 1–2 drops into each nostril 2–3 times daily.

Rhinazoline® 0.025% and 0.05% should not be used for longer than 5–7 days. The product may be re-administered only after several days.

Immediately before use, the bottle should be held in the palm of the hand to warm it to body temperature. The nose must be thoroughly cleaned 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 presses on the pump dispenser.
3. Insert the tip of the nozzle sequentially into each nostril and press the pump dispenser 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 pressing the bottle body, instill the required number of drops into each nostril.
3. After use, close the bottle with the cap.

Children. Rhinazoline® 0.025% must not be used in children under 1 year of age; Rhinazoline® 0.05% must 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.

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 blood pressure, phentolamine should be administered. Vasopressor agents must 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 severe nasal congestion, epistaxis (nosebleed).

Very rare: apnea in infants and newborns.

From the musculoskeletal system.

Very rare: cramps (especially in children).

From the immune system.

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

Shelf life. 3 years.

Do not use the drug after the expiry date stated on the package.

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

Availability. Over-the-counter.

Manufacturer. JSC "Farmak".

Manufacturer's name and address of manufacturing site.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.