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
Mucosamin® Vaginal Cream
Mucosamin® vaginal cream (Sodium hyaluronate and synthetic amino acids – glycine, L-Proline, L-Leucine, L-Lysine HCL) Prescribing Information
Presentation: Vaginal cream (Sodium hyaluronate and synthetic amino acids – glycine, L-Proline, L-Leucine, L-Lysine HCL).
Indications: Actinic vulvovaginitis caused by radiation treatment of the pelvic region and vulvovaginitis caused during chemotherapy or a combination of both treatments (chemotherapy and radiotherapy).
Dosage and method of use: Apply vaginal cream, using applicator, once or several times a day, depending on the extent of symptoms, in accordance with medical advice. Please refer to package leaflet for full instructions.
Contraindications: Known hypersensitivity to ingredients. No reports of side effects or interactions with drugs or medicinal substances. During pregnancy and breastfeeding; use at physician’s discretion.
Legal category: Class IIb Medical Device.
Cost: £27.50 for 30g tube with six 5g single-use applicators.
CE number: CE 0373
Legal 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 2019.
Version number: 1010461482 v 3.0
Mucosamin® Rectal Gel
Mucosamin® Rectal Gel (Sodium hyaluronate and synthetic amino acids – glycine, L-Proline, L-Leucine, L-Lysine HCL) Prescribing Information
Presentation: Rectal Gel (Sodium hyaluronate and synthetic amino acids – glycine, L-Proline, L-Leucine, L-Lysine HCL).
Indications: Actinic proctitis caused by radiation treatment of the pelvic region and proctitis caused during chemotherapy or a combination of both treatments (chemotherapy and radiotherapy).
Dosage and method of use: Apply Rectal Gel, using applicator, once or several times a day, depending on the extent of symptoms, in accordance with medical advice. Please refer to package leaflet for full instructions.
Contraindications: Known hypersensitivity to ingredients. No reports of side effects or interactions with drugs or medicinal substances. During pregnancy and breastfeeding; use at physician’s discretion.
Legal category: Class IIb Medical Device.
Cost: £27.50 for six 7g single-use micro-enemas.
CE number: CE 0373
Legal 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: July 2019.
Version number: 1010461577 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.