Pharmaluce Munatoril Aerosol 15F 2Ml

Sterile nebulizing solution based on N-acetylcysteine and hyaluronic acid (obtained biotechnologically, free from animal-derived proteins), indicated to protect and create a barrier effect against the mucosa of the nose, throat, and pharynx subject to redness and infections. N-acetylcysteine reduces mucus viscosity, lubricates, and provides relief in case of symptoms related to inflammation such as difficulty swallowing, sensation of a foreign body in the throat, tickling, or dryness. Hyaluronic acid adheres to the surface of the mucosa and, by retaining physiologically present water, forms a protective film, providing relief to irritated mucosa. Thanks to its barrier effect, the mucosa maintains its integrity and is protected from external aggressors and pathogens.
Munatoril aerosol is a sterile nebulizable solution, used in case of acute or chronic respiratory tract conditions (tonsillitis, pharyngitis, laryngitis, rhinitis, tracheobronchitis, bronchitis), cough of various types, flu or cold syndromes, inflammation of the vocal cords, redness, hoarseness, respiratory issues due to gastroesophageal reflux, post-ENT surgical effects.
Medical device.

Directions for use
Adults and children over 6 years of age: one single-dose vial per session, 2 times a day. Children aged 2-6 years: half of a single-dose vial per session, 2 times a day. The container has a graduation mark corresponding to half the dose. Administer the solution using aerosol therapy devices (piston type, not ultrasonic).
Wash hands before and after using the medical device. To use, perform the following steps:
- bend the single-dose vial and detach it from the strip to which it is attached; - gently shake the single-dose vial before use; - open the vial by rotating the tab; - apply moderate pressure on the sides of the vial to release the solution according to the indicated amount and insert it into the nebulizer’s chamber. Dilute with physiological saline at a 1:1 ratio. Deliver the product through the nasal cavity using the device; - if using half dose, the container can be reclosed by turning and pressing the cap. The closed single-dose vial should be stored at room temperature and used within 24 hours of first opening.
It can be used at any time of the day without specific time restrictions. The treatment duration should not exceed 30 days; the length of use depends on the symptom evolution; if symptoms persist after some time, consult a 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 recommended doses. Keep out of reach and sight of children. Avoid contact with eyes. The presence of a sulfurous odor does not indicate spoilage but is characteristic of a component of the formulation. Do not use beyond the expiration date or if the packaging is open or damaged. Since N-acetylcysteine can chemically react with certain materials (rubber, iron, copper), it is advisable to use glass or plastic aerosol devices; for devices with metal or rubber parts, wash immediately after use. Administration of N-acetylcysteine, especially via aerosol, may thin and increase the volume of bronchial mucus, especially at the beginning of treatment. If this happens and bronchial secretions cannot be expelled by coughing, consult a doctor. N-acetylcysteine can be taken together with bronchodilator or vasoconstrictor medications; in such cases, the product should be used as soon as possible. N-acetylcysteine should be used with caution and always under medical supervision in the following cases:
- if suffering from bronchial asthma. Stop taking the product immediately if bronchial muscle contraction (bronchospasm) occurs;
- if suffering from or having suffered from peptic ulcers, especially if taking drugs with known gastrolesive effects.
There are no known interactions with other products. Before using the product with other medications or medical devices, consult a doctor. Contact a doctor if taking the following medications:
- nitroglycerin, which when used together with N-acetylcysteine, can cause a drop in blood pressure (hypotension) and headache (cephalalgia), requiring blood pressure monitoring;
- antibiotics, as in vitro tests have shown reduced antibiotic effectiveness when combined with N-acetylcysteine.
Laboratory tests: N-acetylcysteine may interfere with some blood and urine tests (colorimetric dosage for salicylates determination and ketone tests). Inform your doctor before undergoing these tests.
Product is contraindicated for use in children under two years of age. Do not use in case of individual hypersensitivity to any of the components. The safety of the product during pregnancy and breastfeeding has not been demonstrated. In such circumstances, consult your doctor.
As a precaution, avoid taking other medications simultaneously with N-acetylcysteine, especially:
- cough suppressants, because reducing the cough reflex may lead to mucus build-up in the bronchi;
- medications that can inhibit and decrease bronchial secretions volume (anticholinergics), as they may have an opposite effect to N-acetylcysteine.
Prolonged use of topical products may cause sensitization phenomena. If so, stop treatment and consult a doctor for appropriate therapy. If side effects are observed, listed or not in the leaflet, inform your doctor or pharmacist. The administration of N-acetylcysteine may cause possible side effects such as hypersensitivity, bronchospasm, rhinorrhea, bronchial obstruction, stomatitis, vomiting, nausea, urticaria, skin rash, itching. Very rarely, severe skin reactions (Stevens-Johnson syndrome or Lyell syndrome) have been reported. In most cases, at least one other suspected drug, likely involved in causing these reactions, was identified; in any case, if such skin reactions occur, stop taking N-acetylcysteine and seek medical advice. Some studies suggest a possible reduction in platelet aggregation during N-acetylcysteine use.

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

Format
15 single-dose vials of 2 ml