Vicks Sinex Aloe Nasal Spray 15ml

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

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

ACTIVE INGREDIENTS

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

EXCIPIENTS

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

CONTRAINDICATIONS AND SIDE EFFECTS

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

DOSAGE

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

CONSERVATION

This medicinal product does not require any special storage conditions.

WARNINGS

Use with caution in the first months of pregnancy and, due to the risk of urinary retention, in the elderly. Also use with caution in patients with angina and diabetes. If symptoms persist, a clinical reassessment must be considered; in any case, treatment must not be continued for more than 4 consecutive days to avoid a rebound effect and rhinitis phenomena induced by the drug. Carefully follow the recommended doses. Accidental ingestion may cause severe sedation. It should not be used orally. Avoid contact of the liquid with the eyes. Prolonged use of vasoconstrictors can alter the normal function of the mucosa 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 suitable therapy. Important information about some excipients Vicks Sinex Aloe 0.05% nebulizer solution contains benzalkonium chloride may cause bronchospasm. This medicine contains 0.01 mg of 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 if used for long periods. Vicks Sinex Aloe 0.05% spray solution contains benzyl alcohol. This medicine contains 0.1 mg of benzyl alcohol per dose (1 spray), equivalent to 2 mg/ml. Benzyl alcohol can cause allergic reactions. Benzyl alcohol may cause mild local irritation

INTERACTIONS

There is the possibility of interaction between sympathomimetic amines such as oxymetazoline with anti-MAO drugs, therefore use is not recommended during or in the two weeks following treatment with anti-MAO drugs (see section 4.3). Oxymetazoline could reduce the effectiveness of beta-blocking 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 bromocriptines.

SIDE EFFECTS

If accidentally ingested or if used for a long period in excessive doses, the product can cause toxic phenomena. The product can locally cause sensitization phenomena and rebound congestion of the mucous membranes. In general, no serious side effects were observed. Due to rapid absorption of oxymetazoline through inflamed mucous membranes, side effects may occur divided into the following frequencies: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (>1/10000); not known (frequency cannot be estimated from the available data). Rare: Eye pathologies: eye irritation, discomfort or redness. Respiratory, thoracic and mediastinal disorders: discomfort or irritation of the nose, mouth or throat, sneezing. Very rare: Cardiac diseases: tachycardia, palpitations, increased blood pressure, reflex bradycardia. Central nervous system disorders: insomnia, nervousness, tremor, anxiety, agitation, irritability and headache. Gastrointestinal disorders: nausea. Renal and urinary disorders: urination disorders. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance 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.

OVERDOSE

Symptoms Symptoms due to moderate or acute overdose may include mydriasis, nausea, cyanosis, fever, tachycardia, cardiac arrhythmias, hypertension, dyspnea, cardiac arrest, photophobia, headache, intense chest tightness and, in children, severe Central Nervous System depression with symptoms such as decreased body temperature, bradycardia, hypotension, apnea and loss of consciousness requiring the adoption of appropriate emergency measures. Treatment Treatment should be symptomatic. In more serious cases, intubation and artificial respiration are required.

PREGNANCY AND BREASTFEEDING

There are no studies on the use of the product during pregnancy and breastfeeding. 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.

EFFECTS ON DRIVING ABILITY

No effects on the ability to drive and use machines have been observed.