Vibrocil

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VIBROCIL® (Vibrocil®)

Composition:

Active substances: dimetindene maleate, phenylephrine;

1 ml of the preparation contains dimetindene maleate 0.25 mg, phenylephrine 2.5 mg;

Excipients: sorbitol (E 420), anhydrous sodium hydrogen phosphate, citric acid monohydrate, lavender oil, benzalkonium chloride, purified water.

Pharmaceutical form. Nasal spray, metered.

Main physicochemical characteristics: clear solution, not more intensely coloured than Y3.

Pharmacotherapeutic group. Nasal decongestants and other preparations for topical use in nasal conditions. Sympathomimetics, combinations, excluding corticosteroids.

ATC Code: R01AB01.

Pharmacological Properties.

Vibrocil is a combination drug containing phenylephrine and dimetindene.

Pharmacodynamics. The drug reduces nasal secretions and promotes nasal passage clearance without impairing the physiological functions of the ciliated epithelium and nasal mucosa.

Phenylephrine belongs to sympathomimetic amines. It is used as a nasal decongestant with moderate vasoconstrictive action, selectively stimulating alpha1-adrenergic receptors of the cavernous venous tissue of the nasal mucosa. Thus, it rapidly and persistently reduces swelling of the nasal mucosa and that of the paranasal sinuses.

Dimetindene maleate is an H1-histamine receptor antagonist with antiallergic activity.

It is effective at low doses and is well tolerated.

Pharmacokinetics. Vibrocil is administered locally; therefore, its activity does not correlate with plasma concentrations of the active substances.

Following accidental oral administration, the bioavailability of phenylephrine is reduced, amounting to approximately 38% due to first-pass metabolism in the intestine and liver; elimination half-life is about 2.5 hours.

Systemic bioavailability of dimetindene after oral administration in solution is about 70%, with an elimination half-life of approximately 6 hours.

Clinical characteristics.

Indications.

In adults and children aged 6 years and older:

symptomatic treatment of common cold, nasal congestion, acute and chronic rhinitis, seasonal (hay fever) and non-seasonal allergic rhinitis, acute and chronic sinusitis, vasomotor rhinitis. Adjunctive therapy in acute otitis media.

Preparation prior to nasal surgery and reduction of mucosal edema of the nasal cavity and paranasal sinuses following surgical intervention.

Contraindications.

Hypersensitivity to phenylephrine, dimetindene maleate, or to any of the excipients.

Due to the presence of phenylephrine, the product, like other vasoconstrictive agents, is contraindicated in atrophic rhinitis (including ozena), closed-angle glaucoma, transsphenoidal hypophysectomy, and transnasal or transoral surgical procedures involving exposure of the meninges or with such procedures in the patient's history. It is also contraindicated in patients receiving monoamine oxidase inhibitors (MAOIs) or who have received them within the previous 14 days.

Interaction with other medicinal products and other forms of interaction.

Monoamine oxidase inhibitors (MAOIs). Phenylephrine is contraindicated in patients receiving MAOIs or who have received them within the previous 14 days. Concomitant use of MAOIs and sympathomimetic amines such as phenylephrine may provoke a hypertensive reaction.

Tricyclic and tetracyclic antidepressants. Vasoconstrictors should be used with caution in patients receiving tricyclic and tetracyclic antidepressants, as concomitant use may potentiate the hypertensive effect of phenylephrine.

Beta-blockers and other antihypertensive agents. Vasoconstrictors should be used with caution in patients receiving beta-blockers and other antihypertensive agents. Phenylephrine may reduce the effectiveness of beta-blockers and other antihypertensive agents. There is an increased risk of hypertension and other cardiovascular adverse reactions; therefore, concomitant use is not recommended.

Special precautions for use

Vibrocil, like other sympathomimetics, should be used with caution in patients who show pronounced reactions to adrenergic agents, manifested by symptoms such as insomnia, dizziness, tremor, cardiac arrhythmias, or increased arterial pressure.

Vibrocil should not be used continuously for more than 3 days. If symptoms persist or worsen after 3 days, medical advice should be sought. Prolonged or excessive use of the drug may lead to tachyphylaxis and rebound effect (drug-induced rhinitis, hyperemia).

As with other vasoconstrictive agents, the recommended dosage should not be exceeded. Excessive use of the drug, particularly in children and elderly patients, may result in systemic effects.

The drug should be prescribed with caution to patients with cardiovascular disorders, arterial hypertension, hyperthyroidism, diabetes mellitus, or those with bladder neck obstruction (e.g. prostate hypertrophy).

Due to the presence of the H1-antihistamine dimetindene maleate, Vibrocil should be used with caution in patients with epilepsy.

The product contains benzalkonium chloride, which may cause irritation of the nasal mucosa.

Use during pregnancy or breastfeeding

Studies on the use of phenylephrine and dimetindene maleate during pregnancy or breastfeeding have not been conducted. As a precautionary measure, the medicinal product should not be used during pregnancy.

Phenylephrine and dimetindene maleate may be excreted in breast milk.

As a precautionary measure, the medicinal product should not be used during breastfeeding.

Fertility. There are no adequate data on the effects of phenylephrine and dimetindene maleate on human fertility.

Ability to influence reaction speed when driving or operating machinery

Data on influence are lacking.

Dosage and Administration

Do not exceed the recommended dose or frequency of administration. The lowest effective dose for the shortest duration of time should be used.

Adults and children aged 6 years and older (under adult supervision):

1-2 sprays into each nostril 3-4 times daily.

Administration of the metered-dose spray:

• Before administration, the nasal passages should be thoroughly cleared.
• Take care to avoid spraying the liquid into the eyes.
• Before use, remove the protective cap. Prior to the first use, prime the pump by releasing 5 sprays into the air until a fine, uniform mist is produced. After this, the bottle will be ready for use. If the spray has not been used for an extended period, repeat the priming step (5 sprays into the air) before the next use to prepare the pump.
• Insert the spray nozzle into one nostril and press firmly on the pump; after removing the nozzle from the nose, release the pump. Optimal distribution of the spray in the nasal cavity is achieved by gently inhaling through the nose during spraying. Repeat the process in the other nostril.
• After spraying, clean and dry the nozzle, then cover the spray pump with the cap.

To avoid possible spread of infection, the spray bottle should be used by only one person.

The metered-dose spray ensures accurate dosing and proper distribution of the solution over the nasal mucosal surface. Each spray delivers an average of 140 microliters of solution.

Children.

This pharmaceutical form of the drug is indicated for children aged 6 years and older. Children aged 6 to 12 years should use it under adult supervision.

This formulation should not be used in children under 6 years of age. An alternative pharmaceutical form, Vibrocil nasal drops, should be used instead.

Overdose.

Overdose of Vibrocil nasal spray may cause sympathomimetic and anticholinergic effects such as increased heart rate, premature ventricular contractions, occipital headache, tremor or shaking, mild tachycardia, elevated blood pressure, mydriasis, confusion, numbness, excitation, hallucinations, seizures, insomnia, and pallor. Overdose may also lead to moderate sedation, dizziness, increased fatigue, coma, stomach pain, nausea, and vomiting.

No serious adverse effects have been reported following accidental use of Vibrocil. Accidental ingestion of dimetindene doses up to 20 mg did not result in severe symptoms.

Treatment: administration of activated charcoal; in younger children, laxatives may be considered (gastric lavage is not required); adults and older children should drink large amounts of fluids.

Phenylephrine-induced arterial hypertension, which does not respond adequately to benzodiazepines, can be managed with an alpha-adrenergic blocker.

Central anticholinergic symptoms can be treated with physostigmine. Consultation with a physician regarding antidote use is advisable. Since data on gastrointestinal absorption of dimetindene doses exceeding 20 mg are lacking, medical supervision is recommended for significant overdoses, and a single dose of activated charcoal may be administered as directed by a physician.

Severe cases of agitation, altered consciousness, and seizures should be treated with benzodiazepines.

Side effects

The medicinal product is usually well tolerated. The adverse reactions listed below are categorized by frequency as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000), frequency not known (cannot be estimated from the available data).

Disorders of the respiratory system, thoracic organs and mediastinum: rare – nasal discomfort, dryness of the nasal cavity, epistaxis.

General disorders and administration site conditions: rare – burning sensation at the application site; very rare – general weakness, development of allergic reactions (including local skin reactions, body pruritus, eyelid edema, facial swelling).

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows ongoing monitoring of the benefit-risk balance of the product. Suspected adverse reactions can be reported via the national reporting system: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of the reach and sight of children.

Packaging. 15 ml of solution in a bottle with a spray pump; 1 bottle per cardboard box.

Availability category. Over-the-counter.

Manufacturer.

Haleon CH S.a.r.l. / Haleon CH S.a.r.l.

Manufacturer's address and place of business.

Route de l’Etraz 2, Nyon, 1260, Switzerland / Route de l’Etraz 2, Nyon, 1260, Switzerland.