Summary of Product Characteristics (SmPC) - Sodium Fluoride 2800 PPM toothpaste
1 NAME OF THE MEDICINAL PRODUCT
Sodium Fluoride 2800 ppm Toothpaste
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of toothpaste contains 2.8 mg fluoride (as sodium fluoride), corresponding to 2800 ppm fluoride (sodium fluoride 0.619% w/w).
Excipients with known effect
Sodium benzoate…………………………..0.1% w/w Sorbitol solution (non-crystalising)………..23.1% w/w Propylene glycol………………………..…..0.125% w/w For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Toothpaste.
For dental use.
A white coloured, smooth, semisolid homogenous paste.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the prevention and treatment of dental caries (coronal and root) for adolescents and children aged over 10 years old.
4.2 Posology and method of administration
Posology
Paediatric population
Sodium Fluoride 2800 ppm Toothpaste is contraindicated in children aged under 10 years. See section 4.3.
Adolescents and children aged 10 years or more
To be used daily instead of normal toothpaste.
- Apply a 1 cm ribbon of toothpaste onto the toothbrush for each brushing
- Brush teeth vertically, from the gum to the tip of the teeth
- Careful brushing takes approximately one minute
- Spit out after use
- For best results do not drink or rinse for 30 minutes
Not to be swallowed
Method of administration
For dental use.
4.3 Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Individuals with known sensitivities should consult their dentist before using.
- Not to be used in children under 10 years old.
4.4 Special warnings and precautions for use
Not to be swallowed.
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 used.
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 75 ml tube of Sodium Fluoride 2800 ppm Toothpaste contains 280 mg of fluoride ions).
This medicine contains 231 mg sorbitol solution (E420) in each 1 g. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
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 medicine contains a maximum of 1.25 mg propylene glycol (E1520) in each 1 g which is equivalent to 0.125% w/w. Propylene glycol may cause skin irritation.
It is important to control the use of sodium fluoride toothpaste in patients with chronic renal insufficiency, to avoid a risk of fluorosis.
Paediatric population
This product should not be used by children aged under ten years. See sections 4.2 and 4.3.
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
Epidemiological studies in humans indicate that fluoride has no adverse effects in pregnancy or on the health of the foetus or newborn child.
No effects during pregnancy are anticipated, since systemic exposure to Sodium Fluoride is negligible.
Sodium Fluoride 2800 ppm Toothpaste can be used during pregnancy.
Breast-feeding
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Sodium Fluoride is negligible.
Sodium Fluoride 2800 ppm Toothpaste can be used during breast-feeding.
Fertility
There is no adequate data on the use of Fluoride 2800 ppm Toothpaste and the 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 2800 ppm Toothpaste has no or negligible influence on the ability to drive or 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 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 8 mg daily).
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: caries prophylactic agents, ATC code: A01AA01.
This product is a toothpaste in which the active ingredient is sodium fluoride present at a level of 0.619% w/w, which corresponds to 280 mg fluoride per 100 g paste.
Sodium fluoride applied topically after tooth eruption reduces caries by inhibiting demineralisation and promoting remineralisation of the tooth surface. It is effective on both enamel and exposed dentine.
5.2 Pharmacokinetic properties
Fluoride 2800 ppm Toothpaste has a local, topical action on the teeth and so the route taken within the body does not apply. This product is not intended to be swallowed and therefore only minimal systemic exposure is expected. However, the following information has been included in case any toothpaste is accidentally ingested 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 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: caries prophylactic agents, ATC code: A01AA01.
This product is a toothpaste in which the active ingredient is sodium fluoride present at a level of 0.619% w/w, which corresponds to 280 mg fluoride per 100 g paste.
Sodium fluoride applied topically after tooth eruption reduces caries by inhibiting demineralisation and promoting remineralisation of the tooth surface. It is effective on both enamel and exposed dentine.
5.2 Pharmacokinetic properties
Fluoride 2800 ppm Toothpaste has a local, topical action on the teeth and so the route taken within the body does not apply. This product is not intended to be swallowed and therefore only minimal systemic exposure is expected. However, the following information has been included in case any toothpaste is accidentally ingested 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
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycerol (E422)
Sodium benzoate (E211)
Sorbitol solution (E420) (70%) (non-crystallising)
Precipitated silica
Macrogol 600
Sodium lauryl sulphate
Carmellose sodium
Mint flavour (propylene glycol)
Titanium dioxide (E171)
Sodium saccharin (E954)
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
75 ml of toothpaste filled in a white coloured lami tube fitted with a white coloured flip top 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 30684/0271
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27/01/2021
10 DATE OF REVISION OF THE TEXT
08/09/2026