Mucosamin® Spray Instructions for Use (IFU)

Intended use

Mucosamin® Spray is a medical device which conforms to EU Directive 93/42/EEC and has a predominantly protective action on the oral mucosa. The product contains hyaluronic acid, a key component of connective tissue, and amino acids aimed to promote the formation of collagen. The protective action of the ingredients is intended to help the process of regeneration of the oral mucosa in order to promote the rapid healing of areas of ulceration, resulting in a corresponding reduction in pain. The special spray formulation allows easy application to difficult to reach areas of the mouth. Mucosamin® Spray is indicated in the treatment of mucositis due to radiotherapy or chemotherapy.

Description

Mucosamin® Spray is a fluid gel used to hydrate the oral mucosa, on which it exerts a protective effect. It helps to alleviate the irritation of the oral cavity that has been caused by mucositis.

Mucosamin® Spray also aids the process of repair of damaged mucosal tissues of the oral cavity, helping to reduce local sensitivity within the mouth while at the same time promoting maintenance and restoration of normal physiological conditions.

Composition

Purified Water, Sodium Hyaluronate, Glycine, L-Proline, L-Leucine, L-Lysine HCl, Sodium Methyl Parahydroxybenzoate, Sodium Propyl Parahydroxybenzoate, Propylene Glycol, Tetrasodium EDTA.

Packaging

30 ml glass bottle with spray nozzle.

Mode of action

Oral mucositis caused by radiotherapy or chemotherapy is a common side effect in patients with cancer. The damage of mucosa develops with an initiation phase followed by a phase of damage amplification: the outcome is a phase of ulceration followed by a phase of tissue repair. Lesions of the oral cavity are characterised by erythema and recurrent ulcers of the mucosa with burning pain of varying severity. Severe forms of mucositis have a heavy impact on quality of life and may compromise the ability of a patient to tolerate the scheduled therapeutic treatment plan. Mucosamin® Spray, by creating a protective layer, acts on the ulcerative phase of mucositis and promotes a faster reduction of pain and burning. Hyaluronic acid and amino acids act in the regeneration phase of mucositis and promote repair of oral mucosa.

Instructions for use

After cleaning the oral cavity as described in the section on ‘precautions’ below, apply a uniform layer of the product to the whole oral cavity, concentrating on the damaged area. Direct the tip of the device onto the damaged areas and spray repeatedly until the entire area is covered. It is advisable to combine the use of Mucosamin® Spray with a diet free from acidic or spicy foods.

Precautions for use

Before treatment, remove any foreign matter from the ulcerated area by rinsing or gently cleaning with gauze. After cleaning of the area, spray the product on the area to be treated. Do not stop using any antifungal therapies that have been prescribed. It is advisable to eliminate the remainder of the product from the spray nozzle by cleaning with a wet gauze after each application.

Contraindications

Contraindicated in the event of known hypersensitivity to the ingredients.

There have been no reports of overdose.

There have been no reports of side effects.

There have been no reports of interactions with drugs or medicinal substances.

Although there are no known secondary effects during pregnancy and breastfeeding, it is left to the physician to decide whether prescribing is appropriate.

Mucosamin® Spray is generally well tolerated.

Warnings

• Expiry refers to product that is sealed and properly stored.
• Do not use after the expiry date.
• Do not sterilise.
• Do not use if the packaging has been opened or damaged.
• Do not use in the event of known hypersensitivity to any of the ingredients.
• Keep out of reach of children.
• In the event of adverse reactions, stop using the treatment and consult a physician.

Dosage and administration

Apply a uniform layer by repeatedly spraying until the entire affected area is covered, three or four times a day according to the severity of the symptoms.

Disposal

Please dispose of carefully.

Storage

Mucosamin® Spray should be stored between 8 °C and 30 °C.

Do not keep in the refrigerator.

Store in a cool dry place, away from damp and sources of heat.

Manufacturer

Professional Dietetics S.p.A.

Via Ciro Menotti, 1/A - 20129 Milan – Italy