Fluoride 2800 ppm Toothpaste is indicated in adolescents, and children aged 10 years and over.

Prevention and treatment of dental caries (coronal and root) adolescents and children aged ten years or more.

Posology

Paediatric population:

Fluoride 2800 ppm Toothpaste is contraindicated in children aged under 10 years, see section 4.3.

Adolescents and children aged 10 years or more:

To be used daily instead of the normal toothpaste.

Brush carefully and thoroughly, for one minute, morning and evening:

- Apply a 1 cm ribbon of toothpaste onto the toothbrush for each brushing

- Brush teeth vertically, from the gum to the tip of the teeth

- Careful brushing takes approximately one minute

- Spit out after use

- For best results do not drink or rinse for 30 minutes

Not to be swallowed.

Method of administration

For dental use.

For oromucosal use only.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Use by children aged under ten years, see section 4.2.

Not to be swallowed.

When carrying out overall calculations of the recommended fluoride ion intake, which is 0.05 mg/ Kg body weight per day from all sources, not exceeding 1 mg per day, allowance must be made for possible ingestion of toothpaste (each 75 ml tube of Fluoride 2800 ppm Toothpaste contains 280 mg of fluoride ions).

This product contains propylene glycol. Propylene glycol may cause skin irritation.

This product also contains Sorbitol solution. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

No interaction studies have been performed.

Epidemiological studies in humans indicate that fluoride has no adverse effects in pregnancy or on the health of the foetus or new born child. Fluoride 2800 ppm Toothpaste can be used during pregnancy and lactation.

Studies in animals have shown reproductive toxicity of sodium fluoride only when administered at very high levels (see section 5.3).

Fluoride 2800 ppm Toothpaste has no or negligible influence on the ability to drive and use machines.

Immune system disorders:

Rare (> 1 / 10,000, < 1 / 1,000): hypersensitivity reactions.

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 national reporting system, the Yellow card scheme at: www.mhra.gov.uk/yellowcard.

Symptoms:

In very high doses, fluoride can have an acute toxic effect. Doses of several milligrams of fluoride per kg of body weight may cause nausea, vomiting, and diarrhoea. Tetany and convulsion can occur, as well as cardiovascular disorders.

Increased risk of bone fracture and skeletal fluorosis (stiffness of joints and skeletal deformities) will only be observed in cases of very high chronic intake of fluoride.

Management:

Treatment and management should be symptomatic.

In case of mild gastrointestinal overdose symptoms a small glass of milk to drink should be given to bind fluoride ion.

It should be noted that gut decontamination is contraindicated. Charcoal is of no benefit

Pharmacotherapeutic group: caries prophylactic agents

ATC code: A01AA01

This product is a toothpaste in which the active ingredient is sodium fluoride present at a level of 0.619 % w/w, which corresponds to 280 mg fluoride per 100 g toothpaste.

Sodium fluoride applied topically after tooth eruption reduces caries by inhibiting demineralisation and promoting remineralisation of the tooth surface. It is effective on both enamel and exposed dentine.

This product is not intended to be swallowed and therefore only minimal systemic exposure is expected.

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.

After oral administration of sodium fluoride to mice, rates and rabbits, reproductive and foeto– toxic effects were observed only at high dose levels.

The total amount of fluoride in a 75 ml tube of Fluoride 2800 ppm Toothpaste is about 620 mg which equates to 280 mg fluoride. This is within the acceptable limits for the amount to be supplied at one time for safety purposes.

Sorbitol solution (non-crystallising), E420

Glycerol, E422

Dental type silica (precipitated), E551

Macrogol 600, E1521

Sodium laurilsulphate

Carmellose sodium, E466

Sodium saccharin, E954

Titanium dioxide, E171

Mint flavour (947093 Optamint Spearmint) containing menthol, propylene glycol, spearmint oil, carvone, anethol, ethyl maltol, vanillin

Purified water

Not applicable.

Thirty six (36) months unopened.

6 months after opening.

This product requires no special storage conditions.

Polyethylene/copolymer/aluminium/copolymer/polyethylene laminated tube with a polypropylene flip top closure. 75ml.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.