Sodium Fluoride 2.2mg Tablets
1. NAME OF THE MEDICINAL PRODUCT
Endekay Fluotabs 6+ Years 2.2mg Tablets Sodium Fluoride 2.2mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Fluoride BP 2.2 mg
3 PHARMACEUTICAL FORM
Tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Oral.
To strengthen the tooth enamel to resist decay in children over 6 years of age.
4.2 Posology and method of administration
For children of 6+ years of age:
Dosage is dependent on the fluoride of the drinking water according to the following table.
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 and on the advice of a dentist.
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.
Suck the tablet or allow it to dissolve slowly in the mouth.
4.3 Contraindications
Not to be taken if water supply contains more than 0.7 ppm fluoride, or is artificially fluoridated.
Not suitable for children under 6 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 6+ years 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.
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 flourosis.
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 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
6.1 List of excipients
Talc
Magnesium Stearate Tartaric Acid Orange Flavour E3047 Sorbitol
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
Pharmapac container with child proof 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
Not applicable.
MARKETING AUTHORISATION HOLDER
7
Manx Pharma Limited Taylor Group House Wedgnock Lane Warwick CV34 5YA United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 15833/0008
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15 March 1999/3 March 2011