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Name of the medicinal product

Fluoride 2800 ppm Toothpaste

2. Qualitative and quantitative composition

1 g of toothpaste contains contains 2.8 mg fluoride (as sodium fluoride), corresponding to 2800 ppm fluoride, sodium fluoride 0.619 % w/w.

Excipient(s) with known effect:

Sorbitol solution (non-crystallising)

Propylene glycol

For the full list of excipients, see section 6.1.

3. Pharmaceutical form


For dental use.

Smooth, white coloured paste with the odour and taste of spearmint.

4. Clinical particulars
4.1 Therapeutic indications

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.

4.2 Posology and method of administration


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.

4.3 Contraindications

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.

4.4 Special warnings and precautions for use

Not to be swallowed.

An increased number of potential fluoride sources may lead to fluorosis. In order to prevent the accumulation of fluoride, the total fluoride intake must be assessed before this fluoride toothpaste is used.

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.

Paediatric population

This product should not be used by children aged under ten years, see sections 4.2 and 4.3.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

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).

4.7 Effects on ability to drive and use machines

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

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