SUMMARY OF PRODUCT CHARACTERISTICS 1    NAME OF THE MEDICINAL PRODUCT

Fluor-a-day Tablets 1.1 mg

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Constituent :

Quantity per tablet

Sodium Fluoride Ph.Eur.    1.1 mg

3.    PHARMACEUTICAL FORM

Circular, buff, biconvex uncoated tablet with one side unmarked and the reverse side with a breakline.

4.    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

Prophylaxis of dental caries in areas of low fluoride content of drinking water.

4.2.    Posology and Method of Administration

'Fluor-a-day' Tablets 1.1 mg are for oral administration. They should be sucked or chewed, preferably at a different time of day to toothbrushing.

Six months to three years of age:

Half a tablet daily where the fluoride content of the drinking water is less than 0.3 ppm.

Should not be taken where the fluoride content of the drinking water is 0.3 ppm or more.

Three years to six years of age:

One tablet daily where the fluoride content of the drinking water is less than 0.3 ppm.

Half a tablet daily where the fluoride content of the drinking water is between 0.3 - 0.7ppm.

Should not be taken where the fluoride content of the drinking water is 0.7 ppm or more.

Six years of age and over:

Two tablets daily where the fluoride content of the drinking water is less than 0.3 ppm.

One tablet daily where the fluoride content of the drinking water is between 0.3 - 0.7ppm.

Should not be taken where the fluoride content of the drinking water is 0.7 ppm or more.

4.3 Contra-Indications

Do not use in children under the age of three years if the fluoride content of the drinking water is 0.3 ppm or more. Fluoride supplements should not normally be given to children in areas where the fluoride content of the drinking water is 0.7 ppm or more.

4.4 Special warnings and precautions for use

Fluoride supplements should not be administered in areas where the fluoride content of the water exceeds 0.7 ppm. Furthermore, fluoride supplements should only be given to children under the age of three years and those living in areas where the fluoride content of the drinking water is between 0.3 - 0.7 ppm on the advice of a dentist. Do not exceed the stated dose. In children aged six years and under, only a pea-sized amount of fluoride toothpaste should be used to brush the teeth. It is desirable for fluoride supplements to be given at a different time of day to tooth brushing.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose 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

No contra-indications in pregnancy are known. Fluorides are excreted in breast milk and the daily intake of fluoride by an infant consuming 1 liter of milk and living in a 1 ppm fluoride area will be less than 0.01 mg.

4.7. Effects on Ability to Drive and Use Machines

None known.

4.8 Undesirable effects

Excessive intake of fluoride by children during tooth development can lead to dental fluorosis. Nausea may be experienced if recommended doses are exceeded.

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

Although unlikely at the quantities available to the patient, acute poisoning with sodium fluoride may produce metabolic and electrolyte disturbances, including hypocalcaemia. Systemic effects include tremors, hyper-reflexia, paraesthesia, tetany, convulsions, cardiac arrythmias, shock, respiratory arrest, and cardiac failure. Death may occur within 2 - 4 hours. Although there is much interindividual variation, a single dose of 5 to 10 g of sodium fluoride may be considered lethal in an adult and as little as 0.5 g in a child. However, dangerous poisoning has been reported after much lower doses.

Treatment of acute poisoning involves gastric lavage with lime water or weak solution of another calcium salt to precipitate fluoride, maintenance of high urine output, slow iv injection of calcium gluconate 10% for tetany, and symptomatic and supportive measures. Aluminum hydroxide administered after gastric lavage may reduce fluoride absorption. Haemodialysis may be considered.

5.    PHARMACOLOGICAL PROPERTIES

Pharmacodynamic Properties

At the beginning of dental enamel formation the enamel forming cells, ameloblasts, lay down a proteinaceous organic matrix. This determines the external form of the tooth. The matrix is partially mineralised even during the early stages of enamel formation. There is already a detectable background level of fluoride and, if relatively high concentrations of fluoride are administered in diet or drinking water, the small crystallites in this region take up fluoride readily. When the ameloblasts have produced the full thickness of enamel the organic matrix is progressively withdrawn and the tissue becomes porous. The resulting space fills temporarily with fluid and, when dried in vitro, the porous enamel becomes chalky white. Such porous enamel imbibes ions and molecules preferentially. The porous enamel appears to absorb fluoride preferentially and a fluoride peak is usually found just before the enamel begins to mineralize rapidly.

Even at the early stages of development, fluoride is not homogeneously distributed across the thickness of the enamel and seems largely restricted to the surface region. Fluoride concentrations increase exponentially from a plateau level in the enamel interior to a relatively high concentration at the tooth surface. This general pattern holds for both permanent and deciduous teeth.

5.2. Pharmacokinetic Properties

The gastro-intestinal tract is the major site of absorption. After intake of a sodium fluoride tablet or solution the absorption of fluoride occurs rapidly; within just a few minutes after the dose is swallowed there is a detectable rise in plasma fluoride concentration. The height of the plasma peak is proportional to the fluoride dose ingested and the rate of absorption, but is also determined by the body weight of the subject. The plasma peak usually occurs within 30 minutes; the time for its occurrence is independent of the amount of fluoride ingested. Soluble salts such as sodium fluoride are nearly completely absorbed. The ingestion of fluoride with food retards its absorption. The absorptive process occurs by passive diffusion and there is no convincing evidence that active transport processes are involved. The mechanism and rate of gastric absorption of fluoride is related to gastric activity. In plasma, fluoride

exists in two general forms - ionic or free fluoride, and non-ionic or bound fluoride. Ionic fluoride is the one significant in dentistry and medicine, the biological significance of the non-ionic forms has not been determined.

In the blood, the ion is asymmetrically distributed between plasma and blood cells so that the plasma concentration is approximately twice as high as that associated with the cells. Fluoride is distributed from the plasma to all tissues and organs. Fluoride is concentrated to high levels within the kidney tubules, so that - taken as a whole - this organ has a higher concentration than that of the plasma. The blood-brain barrier is effective in restricting the passage of fluoride into the CNS where the fluoride concentration is, like that of fat, only about 20% of that of plasma.

Fluoride is an avid calcified tissue seeker; its clearance rate from plasma by bone is even higher than of calcium. Approximately 99% of all fluoride in the body is found in calcified tissues. The major route for excretion is through the kidney. After entering the tubules, a variable amount of the ion will be reabsorbed and returned to the systemic circulation. The remainder will be excreted in the urine.

Several studies have shown that if the glomerular filtration rate is severely reduced (to about 30% of normal or less) on a chronic basis, the plasma fluoride levels are markedly elevated. Fluorides are also excreted via breast milk. The fluoride content of colostrum and mature breast milk is the same, and there is little difference in fluoride concentration of breast milk from mothers living in a 1 ppm or a 0.2 ppm area, even though the plasma concentration would be substantially different. Since the fluoride concentration in breast milk is less than half that of plasma, the daily fluoride intake by an infant consuming 1 liter of fluid and living in a 1 ppm fluoride area will be less than 0.01 mg.

5.3. Pre-clinical Safety Data

No remarks.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Lactose monohydrate

Pregelatinized starch

Maize starch

Brown iron oxide (E172)

Magnesium stearate Sodium laurilsulfate Potable Water

6.2. Incompatibilities

None known.

Shelf-Life

Three years from the date of manufacture.

6.4.    Special Precautions for Storage

Store below 25°C.

6.5.    Nature and Contents of Container

The product containers are 30 cc polypropylene 'Pharmapac' tablet containers with 28 mm polyethylene Clic-Loc closures containing 200 tablets.

6.6    Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

DHP Healthcare Limited 26 Pickering Street Maidstone Kent ME15 9RS United Kingdom

8.    MARKETING AUTHORISATION NUMBER(S)

PL 00111/0002

9.    DATE OF FIRST AUTHORISATION / RENEWAL    OF

AUTHORISATION

28th January 1991/19th December 1997

10 DATE OF REVISION OF THE TEXT

27/01/2016