Rhinazal® extra

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT RINASAL® EXTRA (RINASAL EXTRA)

Composition:

Active substance: oxymetazoline;

1 ml of solution contains oxymetazoline hydrochloride 0.5 mg;

Excipients: sodium citrate; citric acid monohydrate; disodium edetate; polysorbate 20; sorbitol liquid, non-crystallizing; levomenthol; cineole; chlorhexidine digluconate solution; benzalkonium chloride; aloe extract, dry; (−)-carvone; sodium hydroxide; purified water.

Pharmaceutical form. Nasal spray, metered.

Main physicochemical properties: clear liquid ranging from slightly yellowish to yellow. It foams when shaken.

Pharmacotherapeutic group. Decongestants and other agents for local use in nasal cavity disorders. Sympathomimetics.

ATC code R01A A05.

Pharmacological properties.

Pharmacodynamics.

Oxymetazoline is a direct-acting sympathomimetic amine. It acts on α-adrenergic receptors of nasal mucosal blood vessels, causing vasoconstriction and reduction of mucosal edema. Oxymetazoline constricts vessels at the site of application, reducing swelling of the nasal mucosa and upper respiratory tract. Reduction of nasal mucosal swelling promotes restoration of aeration 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, faster and more effective reduction of nasal mucosal swelling caused by acute rhinitis has been demonstrated. The duration of action of the medicinal product is up to 12 hours.

Pharmacokinetics.

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 of the medicinal product.

2.1% of the medicinal product is excreted by the kidneys, and approximately 1.1% is excreted in feces.

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 sinus cavities, eustachian tube inflammation (eustachitis).

For relief of swelling prior to diagnostic procedures in the nasal passages.

Contraindications.

• Hypersensitivity to the active substance, other adrenergic agents, or to any of the excipients;
• atrophic rhinitis;
• inflammation or damage of the nasal mucosa or skin around the nostrils;
• concomitant use with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of MAOI therapy, as well as concomitant use with other medicinal products that increase blood pressure;
• elevated intraocular pressure, especially closed-angle glaucoma;
• severe forms of cardiovascular diseases (e.g., ischemic heart disease, arterial hypertension);
• cardiac asthma, tachysystolic cardiac rhythm disorders, angina pectoris;
• pheochromocytoma;
• metabolic disorders (hyperthyroidism, diabetes mellitus, porphyria);
• history of surgeries involving disruption of the dura mater (e.g., transsphenoidal hypophysectomy);
• complicated urination due to enlarged prostate gland (prostatic hypertrophy).

Interaction with other medicinal products and other forms of interaction.

Do not use MAO inhibitors or other medicinal products with hypertensive effects due to the risk of increased blood pressure.

Concomitant use of other vasoconstrictive medicinal products increases the risk of adverse effects.

This medicinal product interacts with tricyclic antidepressants, increasing the risk of arterial hypertension and arrhythmia.

The medicinal product should be used with caution in patients receiving bromocriptine, as cardiovascular disorders may occur.

May reduce the effect of β-blockers or other antihypertensive medicinal products, such as methyldopa, betanidine, debrisoquin, and guanethidine.

Special precautions for use.

Prolonged use and overdosing of the medicinal product should be avoided. Prolonged use of a nasal decongestant may lead to diminished effectiveness. Misuse of this product may cause atrophic rhinitis, mucosal atrophy, and reactive hyperemia with rebound (medication-induced) rhinitis. Patients with chronic rhinitis require special monitoring. Doses higher than recommended should be used only under medical supervision.

If symptoms worsen or improvement does not occur within 3 days, medical advice should be sought.

Benzalkonium chloride, an ingredient of the medicinal product, may cause nasal mucosal swelling, particularly with prolonged use. If such a reaction is suspected (persistent nasal congestion), a medicinal product without preservatives should be used. If a preservative-free formulation is not available, consideration should be given to using an alternative dosage form.

Use during pregnancy or breastfeeding.

The use of this medicinal product in pregnant women is possible only if, in the opinion of the physician, the benefit to the mother outweighs the potential risk to the fetus/child. The product should be used with caution during pregnancy, and with particular caution in patients with hypertension or signs of reduced placental perfusion. Frequent or prolonged use of high doses may lead to decreased placental blood flow.

It is unknown whether oxymetazoline passes into breast milk. Due to the lack of data, the medicinal product should not be used during breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

After prolonged use of the medicinal product at doses exceeding the recommended levels, a systemic effect on the cardiovascular and nervous systems cannot be ruled out. In such cases, the ability to drive or operate machinery may be impaired.

Method of Administration and Dosage

One metered dose (50 µL) contains approximately 25 µg of oxymetazoline hydrochloride.

Adults and children aged 6 years and older: 1 spray into each nostril 2–3 times daily.

The medicinal product should not be used for longer than 5–7 days. Doses higher than those recommended should not be used.

The medicinal product may be used again only after several days.

Children

The medicinal product 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, bradycardia, palpitations, arrhythmia, cardiovascular collapse, cardiac arrest, increased sweating, agitation, convulsions, arterial hypertension, pulmonary edema, respiratory disorders, pallor, miosis, hyposmia, psychiatric disorders, and shock hypotension.

Stimulation of the central nervous system may manifest as anxiety, excitement, hallucinations, and convulsions.

In addition, depression of central nervous system function may occur, presenting as drowsiness, lethargy, decreased body temperature, bradycardia, arterial hypotension, apnea, and possible progression to coma.

Clinical manifestations of overdose in children include central nervous system effects such as convulsions and coma, hallucinations, bradycardia, apnea, and hypertension followed by hypotension.

Treatment: gastric lavage, administration of activated charcoal, lung ventilation. In case of decreased arterial pressure, administer phentolamine. Vasopressor agents should not be used. If necessary, carry out anticonvulsant therapy. In severe cases, endotracheal intubation and artificial ventilation of the lungs may be required.

Adverse reactions.

Eye disorders: eye irritation, redness, or discomfort, blurred vision.

Respiratory, thoracic and mediastinal disorders: nasal discomfort, burning sensation or dryness of the nasal mucosa, dryness and irritation in mouth and throat, sneezing, epistaxis. After the effect of the medicinal product wears off, a sensation of severe nasal congestion may occur (rebound hyperemia). Apnea in newborns and young children (especially in cases of overdose).

Nervous system disorders: headache, insomnia, anxiety, drowsiness, restlessness, tremor, sedation, irritability, seizures, hallucinations (especially in children), increased fatigue.

Cardiac and vascular disorders: tachycardia, palpitations, arterial hypertension, arrhythmia, chest pain, facial flushing.

Immune system disorders: allergic reactions, including rash, pruritus, angioneurotic edema.

General disorders and administration site conditions: rebound hyperemia, headache, nausea, exanthema, and visual disturbances.

Reporting suspected adverse reactions.

Reporting suspected adverse reactions after medicinal product authorization is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and/or lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

3 years.

After first opening, do not store for more than 2 months.

Storage conditions.

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

Keep out of reach and sight of children.

Packaging.

10 ml in a bottle with a metered pump; 1 bottle per carton.

Supply category. Over-the-counter.

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and place of business.

13, Boryspylska Street, Kyiv, 02093, Ukraine.