SODIUM FLUORIDE

Posology Paediatric population:

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

Gastrointestinal disorders:

Frequency not known (cannot be estimated from the available data): burning oral sensation Immune system disorders: Rare (≥1/10,000 to <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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

This toothpaste has 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. e. drinking water, fluoridated salt, others fluoride medicines - tablets, drops, gum or toothpaste) should be done.

Fluoride tablets, drops, chewing gum, gels or varnishes and fluoridated water or salt should be avoided during use of Sodium Fluoride Toothpaste. 05mg/kg per day from all sources, not exceeding 1mg per day, allowance must be made for possible ingestion of toothpaste (each tube of Sodium Fluoride 5000 ppm Toothpaste contains 255mg of fluoride ions).

It is important to control the use of sodium fluoride toothpaste in patients with chronic renal insufficiency, to avoid a risk of fluorosis. 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.

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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.

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