Mucosamin Treatment for Oral Mucositis PI 2019-07-31T13:44:25+00:00

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

Presentation: Topical oral solution (Sodium hyaluronate and synthetic amino acids – glycine, L-Proline, L-Leucine, L-Lysine HCL). Indications: 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. Dosage and method of use: 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. 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: £19 for 250ml 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: September 2018. Version number: 1010461476 v 1.0

Mucosamin? spray (Sodium hyaluronate and synthetic amino acids – glycine, L-Proline, L-Leucine, L-Lysine HCL) oral solution Prescribing Information

Presentation: Topical fluid gel (Sodium hyaluronate and synthetic amino acids – glycine, L-Proline, L-Leucine, L-Lysine HCL). Indications: Oral mucositis due to radiotherapy or chemotherapy. Dosage and method of use: 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: £19 for 30ml bottle with spray nozzle. 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: September 2018. Version number: 1010462477 v 1.0

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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
Reporting of Side Effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the product’s package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Revision reference – Mucosamin_3_31/07/2019
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