Vicks Sinex Aloe Solution to Nebulize 15 ml 0.05%

WARNINGS
Use with caution in the first months of pregnancy and in the elderly. Use with caution even in patients with angina and diabetes. The treatment should not be continued for more than 4 consecutive days to avoid a rebound effect and rhinitis phenomena induced by the drug. Follow the recommended doses scrupulously. Accidental ingestion can cause marked sedation. It must not be used orally. Avoid contact of liquid with eyes.
PHARMACOTHERAPEUTIC CATEGORY
Decongestants and other nasal preparations for topical use, unassociated sympathomimetics.
STORAGE
No special storage precautions.
CONTRAINDICATIONS / SECONDARY EFFECT
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 therapy with antidepressant drugs (MAOIs). Inflammation or lesions of the oral mucosa or skin around the nostrils. The drug is contraindicated in children younger than 12 years.
NAME
VICKS SINEX ALOE 0.05% SOLUTION TO NEBULIZE
EXCIPIENTS
Levomentol, sodium citrate dihydrate, isoctyl polyoxyethylphenol polymer (tiloxapol), anhydrous citric acid, chlorhexidine gluconate, benzalkonium chloride, ethylenediaminetetraacetic acid (disodium salt), eucalyptol, sodium hydroxide, purified water, sorbitol, aloe vera, ac- carvone.
SIDE EFFECTS
If accidentally ingested or if used for a long time in excessive doses, the product 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. Eye disorders. Rare: eye irritation, discomfort or redness. Respirators. Rare: discomfort or irritation of the nose, mouth or throat, Sneezing. Cardiovascular. very rare: tachycardia, palpitations, raised blood pressure, reflex bradycardia. Central nervous system. Very rare: insomnia, nervousness, tremor, anxiety, agitation, irritability and headache. Gastrointestinal. Very rare: nausea. Urogenital apparatus. Very rare: urination disturbances. 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 the applications for long periods can be harmful. The use, especially if prolonged, can give rise to sensitization phenomena; in this case it is necessary to interrupt the treatment and institute a suitable therapy.
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.
INDICATIONS
Decongestant of the nasal mucosa, especially in case of colds.
INTERACTIONS
There is the possibility of interaction between sympathomimetic amines such as oxymetazoline with anti-MAO drugs and therefore it is not recommended to use it during or in the two weeks following treatment with anti-MAO drugs. Oxymetazoline may reduce the effectiveness of beta-blocking drugs, methyldopa, or other antihypertensive drugs. Hypertension and arrhythmias may occur when tricyclic antidepressants are administered with sympathomimetic drugs such as oxymetazoline. An increase in cardiovascular toxicity may occur when sympathomimetic drugs are administered concomitantly with antiparchinsonian drugs such as bromocriptine.
DOSAGE
Adults and children over 12 years: 1-2 sprays per nostril every 6-8 hours. Hold the bottle upright, insert its tip into the nostril and press the nebulizer with a quick and firm motion. After application, inhale deeply with your mouth closed.
ACTIVE PRINCIPLES
Oxymetazoline hydrochloride 0.0500% w / v.