VICKS SINEX * SPRAY NAS FL 15ML

VICKS SINEX * SPRAY NAS FL 15ML

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 6-8 hours, unless otherwise indicated by the doctor. Hold the bottle upright, insert its tip into the nostril and press with a quick and firm motion. After application, inhale deeply with your mouth closed.

Contraindications

Known hypersensitivity to the components of the product, prostatic hypertrophy, heart disease and severe arterial hypertension. Glaucoma, hyperthyroidism. Do not administer during and in the two weeks following antidepressant drug therapy (MAOI). 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 may locally determine sensitization phenomena, and congestion of the rebound mucous membranes. In general, no severe undesirable effects have been observed. Due to the rapid absorption of oxymetazoline through the inflamed mucous membranes, systemic effects can occur, divided as follows: Rare Eye disorders: eye irritation, discomfort or redness. Respiratory: discomfort or irritation of the nose, mouth or throat; sneezing. Very rare Cardiovascular: tachycardia, palpitations, rise in blood pressure, reflex bradycardia. Central Nervous System: insomnia, nervousness, tremor, anxiety, agitation, irritability and headache. Gastrointestinal: nausea. Urogenital system: urination disorders. 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.

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. However, in the absence of a complete therapeutic response within a few days, consult your doctor; in any case, the treatment must not be continued for more than 4 consecutive days to avoid a rebound effect and phenomena of rhinitis induced by the drug. Follow the recommended doses scrupulously. The product should be kept out of the reach and sight of children, as accidental ingestion can cause marked sedation. It must not be used orally. Avoid contact of liquid with eyes.

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. Use the product only under medical supervision.

Expiration and retention

None.

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). Oxymetazoline may reduce efficacy 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.Treatment of overdoseTreatment must be symptomatic. In more serious cases, intubation and artificial respiration are required.

Active principles

Active principle:oxymetazoline hydrochloride 0.0500% w / v Excipients: levomenthol, sodium citrate dihydrate, isoctylpolyoxyethylphenol polymer (tiloxapol), etc. For the full list of excipients, see section 6.1

Excipients

Levomenthol, sodium citrate dihydrate, isoctyl polyoxyethylphenol polymer (tiloxapol), anhydrous citric acid, chlorhexidine gluconate, benzalkonium chloride, camphor, ethylenediaminetetraacetic acid (disodium salt), eucalyptol, sodium hydroxide, purified water.