Summary of Product Characteristics (SmPC) - Duraphat 5000 PPM Fluoride toothpaste
1 NAME OF THE MEDICINAL PRODUCT
Duraphat 5000 ppm Fluoride Toothpaste
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of toothpaste contains 5 mg fluoride (as sodium fluoride), corresponding to 5000 ppm fluoride.
Excipient: 1 g of toothpaste contains 5 mg sodium benzoate. This medicine also contains a flavouring with limonene, linalool, citral, geraniol, and citronellol.
3 PHARMACEUTICAL FORM
Toothpaste
Blue paste
4 CLINICAL PARTICULARS
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).
For use by person aged 16 years of age and over only.
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 2 cm ribbon onto your toothbrush for each brushing.
2 cm provides between 3 mg and 5 mg of fluoride.
- 3 times daily, after each meal.
- vertically, from the gum to the tip of the tooth.
Careful brushing takes approximately 3 minutes.
Spit out the excess foam.
Method of administration: For dental use.
4.3 Contraindications
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 5000 ppm Fluoride Toothpaste is not intended for use in adolescents and children under 16 years of age, see section 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. Before using fluoride medicines such as Duraphat, an assessment of overall fluoride intake (i.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 Duraphat Toothpaste.
When carrying out overall calculations of the recommended fluoride ion intake, which is 0.05 mg/kg per day from all sources, not exceeding 1 mg per day, allowance must be made for possible ingestion of toothpaste (each tube of Fluoride 500 mg/100 g Toothpaste contains 255 mg of fluoride ions).
This product contains Sodium Benzoate. Sodium Benzoate is a mild irritant to the skin, eyes and mucous membrane.
This medicine contains a flavouring with limonene, linalool, citral, geraniol, and citronellol which may cause allergic reactions.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
There is no adequate data from the use of Duraphat 5000 ppm 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
Not relevant.
4.8 Undesirable effects
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Acute intoxication: Fluoride
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.
Acute intoxication: Menthol
Duraphat 500mg/100g Toothpaste contains menthol which if accidentally ingested at excessive amounts may cause convulsions, particularly in infants and children.
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 5000 ppm 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 1 L/kg. Fluoride ions are distributed to teeth and bones, and are not bound to plasma proteins. The terminal half-life is in the range 2-9 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 foeto-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)
Macrogol 600
Tetrapotassium Pyrophosphate
Xanthan Gum
Sodium Benzoate (E211)
Sodium Laurilsulfate
Spearmint flavouring (containing Peppermint Oil, Carvone, Spearmint Oil, Menthol, Anethol, and Lemon Oil)
Saccharin Sodium
Brilliant Blue FCF (E133), and
Purified Water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25ºC.
6.5 Nature and contents of container
51g in a tube (PE/PET/aluminium) with a screw cap (polypropylene). The tube is packed inside an outer carton. Pack sizes: 1x51g tubes or 3 x 51g tubes.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Colgate-Palmolive (U.K.) Limited
Goldsworth Place
1 Forge End
Woking
Surrey
England
GU21 6DB
8 MARKETING AUTHORISATION NUMBER(S)
PL 00049/0050
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
03/09/2003 / 28/01/2012
10 DATE OF REVISION OF THE TEXT
15/07/2024