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Prescribing Information

 

Mucosamin® Mouthwash and Mucosamin® Oral Spray

Mucosamin® mouthwash and Mucosamin® Spray (Sodium hyaluronate and synthetic amino acids – glycine, L-Proline, L-Leucine, L-Lysine HCL) Prescribing Information

Presentation: Mouthwash Topical oral solution Spray Topical fluid gel

Indications: Mouthwash At start of radiological therapy or chemotherapy to help reduce incidence of oral mucositis; treatment of oral mucositis due to radiotherapy or chemotherapy; ulcerative pathologies of oral cavity (e.g. pemphigus, pemphigoid, erosive lichen planus); recurrent aphthous stomatitis; following surgical operations on tongue and oral mucosa; burning mouth syndrome. Spray Oral mucositis due to radiotherapy or chemotherapy.

Dosage and method of use: Mouthwash Pour 5-10 ml into mouth, distributing product evenly throughout oral cavity and keeping in mouth for at least one minute. Use 3 or 4 times a day. Do not rinse after treatment. For rear sections of oral cavity, product can be gargled. May be diluted with water, according to severity of symptoms. Spray Apply uniform layer into oral cavity by repeatedly spraying until the entire affected area is covered, 3 or 4 times a day according to severity of symptoms.

Contraindications: Known hypersensitivity to ingredients. No reports of side effects or interactions with drugs or medicinal substances. No known secondary effects during pregnancy and breastfeeding; use at physician’s discretion.

Legal category: Class IIa Medical Device.

Cost: Mouthwash £19 for 250ml bottle. Spray £19 for 30ml spray nozzle bottle.

CE number: CE 0373.

Manufacturer: Professional Dietetics S.p.A. – Via Ciro Menotti, 1/A – 20129 Milan – Italy

Distributor: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire GU32 3QG, UK.

Date last reviewed: October 2020.

Version number: 1010461476 v 2.0

 

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Aspire Pharma Ltd on 01730 231148.