Summary of Product Characteristics (SmPC) - Sodium Fluoride 5000 PPM toothpaste
1 NAME OF THE MEDICINAL PRODUCT
Sodium Fluoride 5000 ppm Toothpaste
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of toothpaste contains 5 mg fluoride (as sodium fluoride), corresponding to 5000 ppm fluoride (sodium fluoride 1.1% w/w).
Excipients with known effect
Sorbitol solution (non-crystalising)…….56% w/w
Sodium benzoate………………………….0.1% w/w Propylene glycol…………………................2.35% w/w For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Toothpaste.
For dental use.
A blue coloured, smooth, semisolid homogenous 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).
4.2 Posology and method of administration
Posology
Paediatric population
Sodium Fluoride 5000 ppm Toothpaste is contraindicated in children and adolescents aged under 16 years, see section 4.3.
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.
- Brush teeth vertically, from the gum to the tip of the teeth
- Careful brushing takes approximately three minutes
Not to be swallowed
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 listed in section 6.1.
Sodium Fluoride 5000 ppm Toothpaste is contraindicated in children and adolescents under 16 years of age, see section 4.2.
4.4 Special warnings and precautions for use
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 Sodium Fluoride, 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 Sodium Fluoride 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 Sodium Fluoride 5000 ppm Toothpaste contains 255 mg 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 medicine contains 1 mg sodium benzoate (E211) in each 1 g which is equivalent to 0.1% w/w. Sodium benzoate may cause local irritation.
This product contains 560 mg sorbitol solution (E420) in each 1 g. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
This medicine contains a maximum of 23.5 mg propylene glycol (E1520) in each 1 g which is equivalent to 2.35% w/w. Propylene glycol may cause skin irritation.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
Pregnancy
There is no adequate data from the use of Sodium 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 Sodium 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 Sodium 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).
4.7 Effects on ability to drive and use machines
Sodium Fluoride 5000 ppm Toothpaste has no or negligible influence on the ability to drive and use machines.
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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Acute intoxication: Fluoride
The toxic dose, i.e. the lowest dose at which symptoms of intoxication can be induced, is 5 mg 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 1.5 mg 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 8 mg 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
Sodium Fluoride 5000 ppm 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.
Absorption
Ingested fluoride is converted to hydrofluoric acid. Peak concentrations are achieved within 30 – 60 minutes.
Distribution
The volume of distribution is 1 L/kg. Fluoride ions are distributed to teeth and bones, and are not bound to plasma proteins.
Biotransformation
Ingested fluoride is converted to hydrofluoric acid.
Elimination
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
Sodium benzoate (E211)
Tetra potassium pyrophosphate
Sorbitol solution (E420) (70 per cent) (non-crystallising) Precipitated silica
Macrogol 600
Carmellose sodium
Sodium lauryl sulphate
Sodium saccharin (E954)
Brilliant blue FCF (E133)
Spearmint flavour No. 1 (propylene glycol) Mint flavour (propylene glycol)
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
24 months.
In use shelf-life: 6 months.
6.4 Special precautions for storage
Do not store above 25ºC.
6.5 Nature and contents of container
51 g of toothpaste filled in a white coloured lami tube fitted with a white coloured cap, enclosed in an outer carton.
6.6 Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Dawa Limited,
5 Sandridge Close,
Harrow, Middlesex,
HA1 1XD, United Kingdom.
8 MARKETING AUTHORISATION NUMBER(S)
PL 30684/0272
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27/01/2021
10 DATE OF REVISION OF THE TEXT
08/09/2026