Summary of Product Characteristics (SmPC) - Endekay daily Fluoride Mouthrinse
1 NAME OF THE MEDICINAL PRODUCT
Endekay Daily Fluoride Mouthrinse
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Fluoride BP 0.05% w/v
Excipients with known effect:
Sorbitol 101.64 mg/ml
Ethanol 60.37 mg/ml
Sodium benzoate 1.02 mg/ml
For the full list of excipients, see section 6.1
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 to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Not for use by children under six years of age. Do not swallow. Use only once daily.
Excess dosage may cause nausea, and in children under seven, dental fluorosis.
Endekay Daily Fluoride Mouthrinse contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
This medicine contains 755 mg of alcohol (ethanol) in each daily dose which is equivalent to 60.37 mg/ml. It may cause burning sensation on damaged skin.
This medicine contains 1.02 mg/ml of Sodium benzoate. Sodium benzoate may cause local irritation.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Caries prophylactic agents
ATC code: A01AA01
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
Fluoride is absorbed locally by the teeth. When swallowed, fluoride is absorbed rapidly and extensively (90-100%). Peak fluoride plasma levels are achieved within 30 to 60 minutes. Fluoride is widely distributed through the body and concentrates in the bone and tooth. About 50% of the intake is stored. Excretion is primarily through the kidneys with less than 10% being excreted in the faeces and less than 1% in sweat and saliva.
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 HDPE or polypropylene cap containing 250ml, 400ml or 500ml.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Tillomed Laboratories Limited
220 Butterfield
Great Marlings
Luton
LU2 8DL
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 11311/0799
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15 March 1999/3 March 2011
10 DATE OF REVISION OF THE TEXT
27/06/2025