Description
Non-sterile solution indicated for sino-nasal pathologies and their complications (acute rhinosinusitis, chronic purulent rhinosinusitis, sino-nasal polyposis, allergic rhinopathy, fungal sinusitis, secretory otitis media) characterized by: edema of the sino-nasal mucosa, altered pneumatization of the paranasal sinuses, reduction or loss of ciliary mobility, and accumulation of muco-purulent secretions in the sino-nasal tract and auditory tubes.
Mechanism of action: the solution containing cucurbitacins B-D-I-E, administered in micro-drops into the nostrils via nasal spray, produces an action on the surface of the mucosal epithelium that causes an electrolytic and osmotic alteration, followed by a physiological process of expulsion of the muco-purulent secretions present in the sino-nasal tract and auditory tubes, the restoration of ciliary mobility and motility, the reduction of sino-nasal mucosal edema, the restoration of paranasal sinus pneumatization, and the reduction of the size of sino-nasal polyps.
Composition
Functional substances: cucurbitacins B-D-I-E 50 mcg/ml extracted from Ecballium elaterium.
Excipients: purified water, mint flavoring, methyl parahydroxybenzoate, propyl parahydroxybenzoate.
Directions for use
Adults and children (age >10 years): perform 2 spray doses per nostril, twice a day (morning and evening), for 7 consecutive days. The treatment may be prolonged up to 14 days or repeated 6-7 days after the first (depending on the symptoms and the muco-purulent secretions present).
For the use of the product in chronic sino-nasal pathologies or post-surgery, it is recommended to repeat the treatment for at least 2 cycles, interspersed with 6 days of no treatment.
Drug interactions: SinuClean nasal spray 50 mcg/ml, being limited to a mechanical and non-systemic action, does not interfere with drugs used for the treatment of rhinological conditions. SinuClean can be combined with antibiotics and corticosteroids for inhalation and systemic use.
Warnings
All described operations must be carried out gently, avoiding inserting the spray nozzle too deeply into the nostrils and maintaining an upright position during administration. Close the bottle after each application. The product must not be administered to children under 10 years of age or pregnant women. The use of SinuClean nasal spray 50 mcg/ml in combination with sympathomimetic drugs is not recommended, as it may cause a decrease in the product's effectiveness.
Contraindicated in cases of hypersensitivity to any of the components of SinuClean nasal spray 50 mcg/ml.
The tests performed have not shown any particular undesirable effects; mild signs of irritation and congestion of the nasal mucosa, with a temporary feeling of a stuffy nose, may rarely occur. Other rare undesirable effects may be rhinorrhea and mild throat irritation. Overdosage of the product, frequent and continuous over time, does not in any case put the user's health at risk, although it increases the probability of the already described undesirable effects occurring. Rarely, an overdose may cause a low-grade fever (for only 3-4 hours). However, it is advisable to report any undesirable effects to your doctor or pharmacist.
Storage
Avoid exposing the product to light and store away from direct heat sources.
After opening, the product can be used for a period of 60 days.
Shelf life in unopened packaging: 36 months.
Format
15 ml bottle.
Code 001