SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

Endekay Fluodrops 0.55mg/0.15ml Oral Solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient    Quantity per dose

Sodium fluoride    0.55mg/0.15ml

3. PHARMACEUTICAL FORM

Oral Solution

4 CLINICAL PARTICULARS

4.1    Therapeutic indications

Endekay Fluodrops are for oral administration in order to strengthen tooth enamel to resist decay.

4.2    Posology and method of administration

For infants and children from 6 months to 3 years, served on a spoon or mixed with food or drink.

Fluoride ion content of water supply (ppm)

Number of drops daily

< 0.3ppm    7

0.3ppm and over    0

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

4.3    Contraindications

Not to be taken if the water supply contains 0.3ppm fluoride or over. Hypersensitivity to sodium fluoride or any of the other ingredients.

4.4    Special warnings and precautions for use

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

Endekay Fluodrops 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

None known at recommended dosage

4.6    Pregnancy and lactation

Not applicable

4.7    Effects on ability to drive and use machines

None known

4.8. Undesirable Effects

None known at recommended dosage. 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/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 PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

The use of sodium fluoride in the prevention of dental caries 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 oral use in the controlled amount recommended for fluoridation of drinking water supplies and in fluoride supplements.

6    PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Citric acid    BP

Sorbitol solution    BPC

Sodium methylhydroxybenzoate    BP

Sodium propylhydroxybenzoate    BP

Purified water    EP

6.2 Incompatibilities

None known