SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

'    Endekay Daily Fluoride Mouthrinse

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium Fluoride BP 0.05% w/v

3.    PHARMACEUTICAL FORM

Mouthrinse Solution

4    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

An aid to the prevention of dental caries. To strengthen tooth enamel to resist decay. To help resolve early caries lesions by promoting remineralisation.

4.2.    Posology and Method of Administration

Adults and children over 6 years of age:

Half fill measuring cap and rinse teeth thoroughly for one minute and spit out. Use only one daily.

4.3    Contraindications

Hypersensitivity to sodium fluoride or any of the other ingredients.

4.4    Special Warnings and Special Precautions for Use

Not for use by children under six years of age. Do not swallow. Use only once daily.

Endekay Daily Fluoride Mouthrinse contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

4.5    Interaction with other medicinal products and other forms of interaction

No Data Held

4.6. Pregnancy and Lactation

Not applicable.

4.7. Effects on ability to Drive and Use Machines

None.

4.8    Undesirable effects

None at recommended dose.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9    Overdose

Symptoms

Doses of fluoride of 5mg/kg (equivalent to 11mg/kg sodium fluoride) and greater may cause serious or life-threatening symptoms. Severe nausea, vomiting and diarrhoea have been reported.

Electrolyte disturbances including hypocalcaemia can occur, followed by rhythm disturbances and circulatory collapse.

Life-threatening symptoms may occur several hours after apparent recovery. Fatalities have been reported.

Treatment

Fluoride is rapidly absorbed from the stomach and intestines. Absorption of fluoride may be reduced by the oral administration of milk (minor effect) or

stomach antacid tablets containing e.g. aluminium hydroxide or calcium/ magnesium.

Monitoring of serum Ca and administration of IV calcium gluconate in case of hypocalcaemia is necessary in cases of potentially severe poisoning. Urea, LFTS and other electrolytes should be monitored also. If symptoms occur, appropriate supportive measures should be employed.

Patients should be observed for several hours after ingestion even if there had been vomiting.

Contact the National Poisons Information Service (NPIS) for specific advice, especially for cases of severe poisoning.

5.1. Pharmacodynamic Properties

Sodium fluoride in solution in a mouthwash reduces the incidence of caries. It helps to resolve early caries lesions and strengthens tooth enamel to resist decay by promoting remineralisation.

5.2. Pharmacokinetic Properties

Not applicable.

5.3. Preclinical Safety Data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1. List of Excipients

Purified Water Sorbitol solution Sodium saccharin Sodium benzoate Poloxamer 407 Peppermint oil L-menthol Ethanol (96%)

Patent Blue V (E131)

6.2.    Incompatibilities

None known.

6.3.    Shelf Life

36 months.

6.4.    Special Precautions for Storage

Store below 25°C.

6.5.    Nature and Contents of Container

PET bottle with polypropylene cap containing 250ml, 400ml or 500ml.

6.6.    Instructions for Use, Handling and Disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Manx Pharma Limited Taylor Group House Wedgnock Lane Warwick CV34 5YA United Kingdom

8. MARKETING AUTHORISATION NUMBER

PL 15833/0012

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15 March 1999/3 March 2011

DATE OF REVISION OF THE TEXT

14/03/2016