1. Name of the Medicinal Product
Duraphat 5000ppm fluoride toothpaste.
2. Qualitative and Quantitative Composition
1g of toothpaste contains 5mg fluoride (as sodium fluoride), corresponding to 5000ppm fluoride.
For excipients, see 6.1.
4.1 Therapeutic Indications
Prevention of dental caries in adolescents and adults, particularly amongst patients at risk from multiple caries (coronal and/or root caries).
4.2 Posology and Method of Administration
For use by persons aged 16 years of age and over only.
Not to be swallowed.
Brush carefully on a daily basis:
- apply a 2cm ribbon onto your toothbrush for each brushing. 2cm provides between 3mg and 5mg of fluoride
- three times daily, after each meal
- vertically, from the gum to the tip of the tooth
Careful brushing takes approximately three minutes.
Method of administration: For dental use.
This medicinal product must not be used in cases of hypersensitivity of the active substance or to any of the excipients.
4.4 Special Warnings and Precautions for Use
Duraphat 5000ppm fluoride toothpaste is not intended for use in adolescents and children under 16 years of age, see 4.2.
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 intake must be assessed before this fluoride toothpaste is ever used. Fluoride tablets, drops, chewing gum, gels or varnishes and fluoridated water or salt should be avoided during use of Duraphat toothpaste.
When carrying out overall calculations of the recommended fluoride ion intake, which is 0.05mg/kg per day from all sources, not exceeding 1 mg per day, allowance must be made for possible ingestion of toothpaste (each tube of Duraphat 5000ppm fluoride toothpaste contains 255mg of fluoride ions).
This product contains sodium benzoate. Sodium benzoate is a mild irritant to the skin, eyes and mucous membrane.
4.5 Interaction with Other Medicinal Products and Other Forms of Interaction
4.6 Pregnancy and Lactation
There is no adequate data from the use of Duraphat 5000ppm fluoride toothpaste in pregnant women. Studies in animals have shown reproductive toxicity of sodium fluoride only when administered at very high levels. Therefore, this toothpaste should not be used during pregnancy and lactation unless careful risk-benefit assessment has been carried out.
4.7 Effects on Ability to Drive and Use Machines
4.8 Undesirable Effects
Immune system disorders:
Rare (>1/10,000 <1/1,000): hypersensitivity reactions.
The toxic dose, i.e. the lowest dose at which symptoms of intoxication can be induced, is 5mg 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. 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 induced; calcium needs to be taken (large amount of milk) and the patient will need 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 1.5mg 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 8mg daily).
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: caries prophylactic agents.
ATC code: A01AA01.
The primary mode of the caries preventative action of fluoride is post-eruptive, i.e. topical. Systemic fluoride supplements are believed to act also mainly topically (e.g. during ingestion, via saliva).
There are three types of effect associated with fluoride:
- The inhibiting effect on demineralisation (lowering the enamel solubility in an acid environment)
- The promotion of remineralisation of enamel during the caries process
- A bactericidal effect upon dental plaque organisms. This inhibits the proliferation of dental plaque bacteria and prevents formation of the acids that cause caries
Fluoride alone is not enough to eliminate bacterial plaque, nor as a complete treatment for caries.
5.2 Pharmacokinetic Properties
Duraphat 5000ppm fluoride toothpaste has a local, topical action on the teeth and so the route taken within the body does not apply. However, the following information has been included in case any toothpaste is accidentally swallowed during treatment.
Any ingested fluoride is converted to hydrofluoric acid. Peak concentrations are reached within 30-60 minutes. The volume of distribution is 1l/kg. Fluoride ions are distributed to teeth and bones, and are not bound to plasma proteins. The terminal half-life is in the range two to nine hours. Fluoride ions are excreted mainly in urine, but small amounts may also be excreted in faeces and sweat. It is not known in which form.
5.3 Preclinical Safety Data
Preclinical data reveal no special hazard for humans beyond the information included in other sections of the SPC.
After oral administration of sodium fluoride to mice, rats and rabbits, reproductive and feto-toxic effects were observed only at high dose levels.
6. Pharmaceutical Particulars
6.1 List of Excipients
Liquid Sorbitol (non-crystallising)
Dental Type Silica
Dental Type Silica (precipitated)
Sodium Benzoate (E211)
Spearmint flavouring (containing Peppermint Oil, Carvone, Spearmint Oil, Menthol, Anethol and Lemon Oil)
Brilliant Blue FCF (E133)
6.3 Shelf life
6.4 Special Precautions for Storage
Do not store above 25°C.
6.5 Nature and Contents of the Container
51g in a tube (PE/PET/aluminium) with a screw cap (polypropylene). The tube is packed inside an outer carton.
6.6 Instructions for Use and Handling
No special requirements.
7. Marketing Authorisation Holder
Colgate-Palmolive (UK) Ltd
Guildford Business Park
8. Marketing Authorisation Number
9. Date of First Authorisation/Renewal of Authorisation
3 September 2003
10. Date of Revision of the Text
11. Legal Classification
12. Manufacturer's Recommended Retail Price
£6.99 (51g tube)