Vicks sinex aloe nasal spray 0.05 decongestant

VICKS SINEX ALOE * NEB 15ML0.05%

Therapeutic indications

Decongestant of the nasal mucosa, especially in case of colds.

Dosage and method of use

Adults and children over 12 years: 1-2 sprays per nostril every 8 - 12 hours, unless otherwise indicated by the doctor. Hold the bottle upright, insert its end into the nostril and press the nebulizer with a quick and firm motion. After application, inhale deeply with your mouth closed.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, prostatic hypertrophy, heart disease and severe arterial hypertension. Glaucoma, hyperthyroidism. Do not administer during and in the two weeks following therapy with antidepressant drugs (MAOIs). Inflammation or lesions of the oral mucosa or skin around the nostrils. The drug is contraindicated in children under 12 years of age.

Side effects

The product, if accidentally ingested or if used for a long time in excessive doses, can cause toxic phenomena. The product can locally determine sensitization phenomena and congestion of the rebound mucous membranes. In general, no severe undesirable effects were observed. Due to rapid absorption of oxymetazoline through the inflamed mucous membranes, undesirable effects may occur, divided into the following frequencies: very common (≥1 / 10); common (≥1 / 100, 1/10000); not known (frequency cannot be estimated from the available data). Rare: Eye disorders: eye irritation, discomfort or redness.Respiratory, thoracic and mediastinal disorders: discomfort or irritation of the nose, mouth or throat, sneezing. Very rare: Cardiac pathologies: tachycardia, palpitations, rise in blood pressure, reflex bradycardia.Central nervous system disorders: insomnia, nervousness, tremor, anxiety, agitation, irritability and headache.Gastrointestinal disorders: nausea.Renal and urinary disorders: disorders of urination.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Use with caution in the first months of pregnancy and, due to the danger of urinary retention, in the elderly. Use with caution even in patients with angina and diabetes. If symptoms persist, a clinical re-evaluation should be considered, in any case, the treatment should not be continued for more than 4 consecutive days to avoid a rebound effect and drug-induced rhinitis phenomena. Follow the recommended doses scrupulously. Accidental ingestion can cause marked sedation. It must not be used orally. Avoid contact of liquid with eyes. Prolonged use of vasoconstrictors can alter the normal function of the mucous membrane of the nose and paranasal sinuses, also inducing addiction to the drug. Repeating applications for long periods can be harmful. The use, especially if prolonged, of topical products can give rise to sensitization phenomena; in this case it is necessary to interrupt the treatment and institute a suitable therapy.Important information about some of the ingredientsVicks Sinex Aloe 0.05% nebuliser solution contains benzalkonium chloride can cause bronchospasm. This medicinal product contains 0.01 mg benzalkonium chloride per dose (1 spray) which is equivalent to 0.2 mg / ml. Benzalkonium chloride can cause irritation and swelling inside the nose, especially when used for long periods. Vicks Sinex Aloe 0.05% nebuliser solution contains benzyl alcohol. This medicinal product contains 0.1 mg benzyl alcohol per dose (1 spray), equivalent to 2 mg / ml. Benzyl alcohol can cause allergic reactions. Benzyl alcohol can cause mild local irritation

Pregnancy and breastfeeding

There are no studies on the use of the product during pregnancy and lactation. Use with caution in the first months of pregnancy. Administration should only be considered if the expected benefit to the mother outweighs the risk to the baby.

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

There is the possibility of interaction between sympathomimetic amines such as oxymetazoline with anti-MAO drugs and therefore it is not recommended to use during or in the two weeks following treatment with anti-MAO drugs (see section 4.3). efficacy of beta-blocker drugs, methyl dopa or other antihypertensive drugs. Hypertension and arrhythmias may occur when tricyclic antidepressants are administered with sympathomimetic drugs such as oxymetazoline. Increased cardiovascular toxicity may occur when sympathomimetic drugs are administered concomitantly with antiparchinsonian drugs such as bromocriptine.

Overdose

SymptomsSymptoms due to moderate or acute overdose may include mydriasis, nausea, cyanosis, fever, tachycardia, cardiac arrhythmias, hypertension, dyspnoea, cardiac arrest, photophobia, headache, severe chest tightness and, in children, severe CNS depression with symptoms such as decreased body temperature, bradycardia, hypotension, apnea and loss of consciousness which require the adoption of adequate emergency measures.TreatmentTreatment must be symptomatic. In more serious cases, intubation and artificial respiration are required.

Active principles

- Active ingredient: oxymetazoline hydrochloride 0.0500% w / v. 1 ml of product contains 0.5 mg of oxymetazoline hydrochloride. 1 spray (50 microliters) contains approximately 25 micrograms of oxymetazoline hydrochloride. - Excipients with known effects: benzalkonium chloride, benzyl alcohol. For a full list of excipients, see section 6.1.

Excipients

Levomentol, sodium citrate, anhydrous citric acid, benzalkonium chloride solution, edetate disodium, eucalyptol (cineol), non-crystallizable liquid sorbitol, aloe vera, acesulfame potassium, Lcarvone, polysorbate 80, benzyl alcohol and purified water.