Vicks Sinex Aloe orrspray 15 ml

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

JAVASLATOK

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

AKTÍV ÖSSZETEVŐK

- 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.

SEGÉDANYAGOK

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.

ELLENJAVALLATOK ÉS MELLÉKHATÁSOK

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1, prostatic hypertrophy, severe heart disease and arterial hypertension. Glaukóma, pajzsmirigy-túlműködés. 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.

ADAGOLÁS

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.

MEGŐRZÉS

Ez a gyógyszer nem igényel különleges tárolást.

FIGYELMEZTETÉSEK

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. Gondosan kövesse az ajánlott adagokat. Véletlen lenyelése súlyos szedációt okozhat. Nem szabad szájon át alkalmazni. Kerülje a folyadék szembe jutását. 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. Fontos információk egyes segédanyagokról 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. A benzil-alkohol allergiás reakciókat válthat ki. A benzil-alkohol enyhe helyi irritációt okozhat

INTERAKCIÓK

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.

MELLÉKHATÁSOK

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); gyakori (≥1/100, <1/10); nem gyakori (≥1/1000, <1/100); ritka (≥1/10000, <1/1000); very rare (>1/10000); nem ismert (a gyakoriság a rendelkezésre álló adatokból nem becsülhető meg). Rare: A szem patológiái: szemirritáció, kellemetlen érzés vagy vörösség. Légzőrendszeri, mellkasi és mediastinalis betegségek: discomfort or irritation of the nose, mouth or throat, sneezing. Nagyon ritka: Szívbetegségek: tachycardia, palpitations, increased blood pressure, reflex bradycardia. Központi idegrendszeri rendellenességek: insomnia, nervousness, tremor, anxiety, agitation, irritability and headache. Emésztőrendszeri rendellenességek: nausea. Vese- és húgyúti rendellenességek: vizelési zavarok. Feltételezett mellékhatások jelentése A gyógyszer engedélyezése után fellépő feltételezett mellékhatások bejelentése fontos, mivel ez lehetővé teszi a gyógyszer előny/kockázat arányának folyamatos nyomon követését. Az egészségügyi szakembereket arra kérik, hogy jelentsenek minden feltételezett mellékhatást a nemzeti jelentési rendszeren keresztül, a https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse címen.

TÚLADAGOLÁS

Tünetek 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. Kezelés A kezelésnek tünetinek kell lennie. In more serious cases, intubation and artificial respiration are required.

TERHESSÉG ÉS SZOPTATÁS

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.

HATÁSOK A VEZETÉSI KÉPESSÉGRE

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