FLUORIDE 5000 ppm Toothpaste Ref.[9147] Active ingredients: Sodium fluoride

Paediatric population

Fluoride 5000 ppm Toothpaste is contraindicated in children and adolescents aged under 16 years, see section 4.3.

Adult and adolescents and children aged 16 years or more

To be used three times daily, after each meal., while brushing the teeth.

Brush carefully, on a daily basis, three times daily, following each meal:

• Apply a 2 cm ribbon of toothpaste onto the toothbrush for each brushing. A 2 cm ribbon provides between 3 mg and 5 mg of fluoride.
• Brush teeth vertically, from the gum to the tip of the teeth.
• Careful brushing takes approximately three minutes.

Not to be swallowed.

Method of administration

For dental use.

For oromucosal use only.

Acute Intoxication

The toxic dose, i.e the lowest dose at which symptoms of intoxication can be induced, is 5 mg fluoride per Kg body weight. Such intoxication appears in the form of digestive problems: vomiting, diarrhoea, abdominal pain. In extremely rare cases it can prove fatal.

Treatment: where a substantial quantity of the medicinal product is ingested accidentally, the patient will need to undergo gastric lavage immediately, or vomiting will need to be induceed; calcium needs to be taken (large amount of milk), and the patient will require to be kept under medical observation for several hours.

Chronic Intoxication (Fluorosis)

The dental enamel will take on a stained or speckled appearance once a fluoride dosage in excess of 1.5 mg per day is absorbed daily over several months or years, depending on the extent of overdose. This will be accompanied by increased enamel fragility in severe forms. Bone fluorosis (osteosclerosis) will only be seen where there is high chronic absorption of fluoride (over 8 mg daily).

Shelf life:

• 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. 51g.

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