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

This toothpaste has a high fluoride content. Therefore, the opinion of a dental specialist must be sought before the product is used.

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 ever used. Fluoride tablets, drops, chewing gum, gel or varnishes, and fluoridted water or salt should be avoided during use of Fluoride 5000 ppm Toothpaste.

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 51 g tube of Fluoride 5000 ppm Toothpaste contains 225 mg of fluoride ions).

This product contains sodium benzoate. Sodium benzoate is a mild irritant to the skin, eyes, and mucous membrane.

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

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

Paediatric population

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

No interaction studies have been performed.

Pregnancy

There is no adequate data from the use of Fluoride 5000 ppm Toothpaste in pregnant women. Studies in animals have shown reproductive toxicity of sodium fluoride only when administered at very high levels (see section 5.3). Therefore this toothpaste should not be used during pregnancy unless careful risk – benefit assessment has been carried out.

Breast-feeding

There is no adequate data from the use of Fluoride 5000 ppm Toothpaste in lactating women, and it is unknown if fluoride is excreted in breast milk. Therefore this toothpaste should not be used during lactation unless careful risk – benefit assessment has been carried out.

Fertility

There is no adequate data on the use of Fluoride 5000 ppm Toothpaste and effects on fertility. Studies in animals have shown reproductive toxicity of sodium fluoride only when administered at very high levels (see section 5.3).

Fluoride 5000 ppm Toothpaste has no or negligible influence on the ability to drive and use machines.

Gastrointestinal disorders

Frequency not known (cannot be estimated from the available data): burning oral sensation

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.

Not applicable.