1. NAME OF THE MEDICINAL PRODUCT

Endekay Fluotabs 3-6 Years 1.1mg Tablets Sodium Fluoride 1.1mg Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium Fluoride BP 1.1 mg

3    PHARMACEUTICAL FORM

Tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For oral administration by dissolving in the mouth, in order to strengthen the tooth enamel to resist decay.

4.2    Posology and method of administration

For children from 3 - 6 years to strengthen the tooth enamel to resist decay according to the following dosage above:-

Dosage

Fluoride Ion Content of Drinking Water    Daily Dosage

Less than 0.3 ppm    1 tablet

0.3 - 0.7 ppm    /    tablet

Over 0.7 ppm    -

Should only be given to those living in areas where fluoride concentration in the water supply is between 0.3 and 0.7 ppm on the advice of a dentist. Not to be taken if the water supply contains more than 0.7 ppm fluoride.

It is desirable for supplements to be taken at a different time of day to toothbrushing. Only a smear of toothpaste should be used to brush the teeth.

Contraindications

Not to be taken if water supply contains more than 0.7 ppm fluoride, or is artificially fluoridated.

Not suitable for children under 3 years of age.

Hypersensitivity to sodium fluoride or any of the other ingredients.

4.4 Special warnings and precautions for use

Consult doctor, dentist or pharmacist before administration. Do not exceed the stated dose.

Endekay Fluotabs 3-6 years contains lactose and sorbitol. Patients with rare hereditary problems of fructose intolerance, glucose intolerance, the Lapp lactase deficiency or glucose-glactose malabsorption should not take this medicine.

4.5    Interaction with other medicinal products and other forms of interaction

None known.

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. Excessive ingestion of fluoride may lead to dental fluorosis.

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/vellowcard

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

The use of sodium fluoride to strengthen the dental enamel is well established.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

The safety of sodium fluoride is well documented in the literature. It is considered safe for use in the controlled amounts recommended for fluoridation of drinking water supplies and in fluoride supplements.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Talc

Magnesium Stearate Tartaric Acid Lactose Povidone Sorbitol

Orange Flavour E3047 Industrial Methylated Spirit

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

High density polythene container with clic-loc closure containing 200 tablets or

High density polyethylene container with tamper evident seal and snaplock closure containing 200 tablets.

6.6 Special precautions for disposal

7    MARKETING AUTHORISATION HOLDER

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

8    MARKETING AUTHORISATION NUMBER(S)

PL 15833/0009

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15 March 1999/3 March 2011

10 DATE OF REVISION OF THE TEXT

18/08/2016