Pharmaluce Munatoril Aerosol 15F 2Ml

Sterile solution to be nebulized based on N-acetylcysteine and hyaluronic acid (obtained biotechnologically, free of animal-derived proteins), indicated to protect and create a barrier effect against the rhino-oro-pharyngeal mucosa subject to redness and infections. N-acetylcysteine decreases the viscosity of mucus, lubricates, and provides relief in case of symptoms related to inflammation such as difficulty swallowing, the sensation of a foreign body in the throat, tickling, or dryness. Hyaluronic acid adheres to the surface of the mucosa and, retaining the physiologically present water, forms a protective film, providing relief to the irritated mucosa. Thanks to the barrier effect, the mucosa maintains its integrity and is protected from the aggression of external agents and pathogens.
Munatoril aerosol is a sterile solution to be nebulized, to be used in case of acute or chronic affections of the respiratory tract (tonsillitis, pharyngitis, laryngitis, rhinitis, tracheobronchitis, bronchitis), cough of various natures, flu-like syndromes or colds, inflammation of the vocal cords, redness, hoarseness, respiratory issues due to gastroesophageal reflux, postoperative repercussions in ENT.
Medical device.

Mode of use
Adults and children over 6 years: one single-dose vial per session 2 times a day. Children aged 2-6 years: half the content of a single-dose vial per session 2 times a day. The container is equipped with a graduation corresponding to half a dose. Administer the solution using aerosol therapy devices (piston type and not ultrasonic).
Wash hands before and after using the medical device. To use, perform the following operations:
- bend the single-dose vial and detach it from the strip to which it is welded; - gently shake the single-dose vial before use; - open the single-dose vial by rotating the flap; - exert moderate pressure on the walls of the single-dose vial to release the solution according to the indicated quantity and insert it into the nebulizer chamber. Add saline solution in a 1:1 ratio. Deliver the product through the nasal cavity, using the device; - in case of using half a dose, the container can be resealed by turning it upside down and pressing the cap. The resealed single-dose vial should be stored at room temperature and used within 24 hours of the first opening.
It can be used at any time of the day without particular time restrictions. The duration of treatment should not exceed 30 days; the duration of use depends on the evolution of symptoms; if symptoms persist after a certain period of time, consult the doctor.

Components
N-acetylcysteine, sodium hyaluronate, thyme essential oil, disodium EDTA, polysorbate 20, monosodium phosphate dihydrate, disodium phosphate heptahydrate, sodium hydroxide, water.

Warnings
Do not exceed the recommended doses. Keep out of reach and sight of children. Avoid contact with eyes. The possible presence of a sulfurous odor does not indicate alterations of the preparation but is typical of a component of the formulation. Do not use after the expiration date or if the packaging is open or damaged. Since N-acetylcysteine can chemically react with certain types of materials (rubber, iron, copper), it is advisable to use aerosol devices made of glass or plastic; for devices with metal or rubber parts, it is necessary to wash the devices with water immediately after use. The administration of N-acetylcysteine, especially by aerosol route, may liquefy and increase the volume of bronchial mucus, especially at the beginning of treatment. Therefore, if this occurs and the bronchial secretions cannot be eliminated by coughing, contact a physician. N-acetylcysteine can be taken with bronchodilator or vasoconstrictor medications, in this case, the product should be used as quickly as possible. N-acetylcysteine should be taken with caution and always under medical supervision in the following cases:
- if you suffer from bronchial asthma. Immediately discontinue the use of the product if bronchial muscle contraction (bronchospasm) occurs;
- if you suffer from or have suffered from peptic ulcer, especially if taking medications with known gastric irritative effects.
No interactions with other products are known. Before using the product in combination with other medications or medical devices, consult your doctor. Consult your doctor if you are taking any of the following medications:
- nitroglycerin, which when used concurrently with N-acetylcysteine, may cause a decrease in blood pressure (hypotension) and headache (cephalalgia), necessitating blood pressure monitoring;
- antibiotics, as in vitro tests have shown reduced activity of the antibiotic in the presence of N-acetylcysteine.
Laboratory tests: N-acetylcysteine may interfere with some blood and urine tests (colorimetric dosage for salicylate determination and tests for ketones). Inform your doctor before undergoing these tests.
Product contraindicated for use in children under two years. Do not use in case of individual hypersensitivity to any component of the product. The safety of using the product during pregnancy and breastfeeding has not been demonstrated. In such circumstances, it is advisable to consult your physician's opinion.
As a precaution, it is advisable not to take other medications concurrently with N-acetylcysteine, particularly the following should not be taken:
- antitussive drugs, as the reduction of the cough reflex can lead to mucus accumulation within the bronchi;
- drugs that may inhibit and decrease the volume of bronchial secretions (anticholinergics), as they may have the opposite effect to that of N-acetylcysteine.
The use, especially if prolonged, of all topical products may lead to sensitization phenomena. In this case, discontinue treatment and consult a physician to establish appropriate therapy. If you experience any undesirable effects, described or not in the package leaflet, inform your doctor or pharmacist. The administration of N-acetylcysteine may cause possible undesirable effects, such as hypersensitivity, bronchospasm, rhinorrhea, bronchial obstruction, stomatitis, vomiting, nausea, urticaria, skin rash, itching. In very rare cases, serious skin reactions (Stevens-Johnson syndrome or Lyell syndrome) have occurred. In most cases, at least one other suspected medication was identified and more likely involved in the genesis of the aforementioned reactions. In any case, if such microcutaneous alterations occur, discontinue taking N-acetylcysteine and contact your doctor. Some studies have highlighted a possible reduction of platelet aggregation during the intake of N-acetylcysteine.

Storage
Store in a cool, dry place away from heat sources at a temperature below 25°C. The expiration date is indicated on the packaging, on the aluminum bag, and on the individual single-dose vials and refers to the intact product, properly stored. Single-dose vials must be stored inside the protective bag, away from light and heat. In the case of using half a dose, the resealed single-dose vial should be stored at room temperature and used within 24 hours of opening. Medical devices must not be disposed of in wastewater and domestic waste. To protect the environment, ask the pharmacist how to dispose of used medical devices.

Format
15 single-dose vials of 2 ml