VICKS SINEX ALOE NEB 15ML0,05%

VICKS SINEX ALOE 0,05% SOLUTION TO BE MISTED

active ingredients

- Active ingredient: oxytazoline hydrochloride 0.0500% p/v. 1 ml of product contains 0.5 mg of oxytazoline hydrochloride. 1 nebulization (50 microliters) contains about 25 micrograms of oxytazoline hydrochloride. - Excipients with known effects: benzalconio chloride, benzyl alcohol For the full list of excipients, see paragraph 6.1.

Excellent

Levomentol, sodium citrate, citric acid anidro, benzalconio chloride solution, disodium edetate, eucalyptol (cineol), liquid sorbitol not crystallized, aloe vera, acesulfame potassico, Lcarvone, polysorbate 80, benzilic alcohol and purified water.

Therapeutic indications

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

Contraindications

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

Population

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

Conservation

This medicine does not require any special condition of conservation.

Warnings

Use carefully in the first months of pregnancy and, for the danger of urinary retention, in the elderly. Carefully use also in patients with angina and diabetes. If the symptoms persist you should consider a clinical revaluation, in any case, the treatment should not be protracted for over 4 consecutive days to avoid a rebound effect and rhinitis phenomena induced by the drug. Strictly adhere to the recommended doses. Accidental ingestion can cause severe sedation. It should not be used orally. Avoid liquid contact with eyes. Protracted use of vasoconstrictors can alter the normal function of the mucosa of the nose and of the paranasal breasts, also inducing addiction to the drug. Repeating applications for long periods may be harmful. The use, especially if prolonged, of topical products can give rise to phenomena of awareness; in such case it is necessary to stop the treatment and establish a suitable therapy. Important information about some excipients Vicks Sinex Aloe 0.05% Nebulizing solution contains benzalconium chloride can cause bronchospasm. This medicine contains 0.01 mg of benzalconio chloride per dose (1 nebulization) which equal to 0.2 mg/ml. Benzalconio chloride can cause irritation and swelling within the nose, especially if used for long periods. Vicks Sinex Aloe 0.05% nebulizing solution contains benzyl alcohol. This medicine contains 0.1 mg of benzilic alcohol per dose (1 nebulization), equivalent to 2 mg/ml. Benzyl alcohol can cause allergic reactions. Benzyl alcohol can cause mild local irritation

Interactions

There is the possibility of interaction between sympathomimetic amines such as oxytazoline with anti-MAO drugs so we do not recommend use during or in the two weeks following treatment with anti-MAO drugs (see paragraph 4.3). Oxytazoline could reduce the effectiveness of beta-blockers, methyl dopa or other antihypertensive drugs. Hypertension and arrhythmia phenomena may occur when antidepressants are administered with sympathomimetic drugs such as oxytazoline. An increase in cardiovascular toxicity may occur when sympathomimetic drugs are administered in conjunction with antiparchinsonian drugs such as bromocriptine.

Effects

The product if accidentally ingested or if used for a long time in excessive doses, can determine toxic phenomena. The product can locally determine sensitization phenomena, and congestion of bouncing mucosa. In general, no severe side effects were observed. For rapid absorption of oxytazoline through inflamed mucous membranes, undesirable effects can occur divided into the following frequencies: very common (≥1/10); common (≥1/100, 1/10000); not known (frequency cannot be defined on the basis of available data). Raro: Pathologies of the eye: irritation of the eyes, nuisance or redness. Respiratory, chest and mediastinic pathologies: discomfort or irritation of the nose, mouth or throat, sneez. Very rare: Heart disease: tachycardia, palpitations, increased blood pressure, reflex bradycardia. Central nervous system pathologies: insomnia, nervousness, tremor, anxiety, agitation, irritability and headache. Gastrointestinal diseases: nausea. Kidney and urinary pathologies: urination disorders. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Synonyms Symptoms due to moderate or acute overdose may include midriasis, nausea, cyanosis, fever, tachycardia, heart arrhythmias, hypertension, dispnea, cardiac arrest, photophobia, cephalea, intense thoracic oppression and, in children, severe depression of the Central Nervous System with symptoms such as decreased body temperature, bradycardia, hypotension, apnea and. Treatment Treatment must be symptomatic. In serious cases, intubation and artificial breathing is required.

There are no studies on the use of the product during pregnancy and nursing. Use carefully in the first months of pregnancy. The administration should be taken into account only if the expected benefit for the mother exceeds the risk for the child.

Source: Farmadati