Summary of Product Characteristics (SmPC) - Duraphat Protify 5000 PPM toothpaste

1 NAME OF THE MEDICINAL PRODUCT

Duraphat Protify 5000 ppm Toothpaste

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 g of toothpaste contains 5 mg fluoride (as sodium fluoride), corresponding to 5000 ppm fluoride.

Excipient with known effect:

1 g of toothpaste contains 2 mg benzyl alcohol. This medicine also contains a flavouring with limonene, linalool, citral, geraniol, and citronellol.

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Toothpaste.

Green 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

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.

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.

4.4 Special warnings and precautions for use

This medicine 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 Protify 5000ppm Toothpaste, an assessment of overall fluoride intake (i.e. drinking water, fluoridated salt, others fluoride medicines

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 Duraphat Protify 5000 ppm Toothpaste contains 255 mg of fluoride ions).

This product contains Benzyl Alcohol. Benzyl Alcohol may cause mild local irritation.

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 this medicine 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

This medicine has no 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 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

This medicine 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 1.5 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

This medicine 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 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)

Macrogol 600

Tetrapotassium Pyrophosphate

Xanthan Gum

Benzyl Alcohol

Cocamidopropyl Betaine

Spearmint flavouring (containing Peppermint Oil, Carvone, Spearmint Oil, Menthol, Anethol, and Lemon Oil)

Saccharin Sodium

Brilliant Blue FCF (E133),

Sunset Yellow FYE3 (E110) - 10% Glycerin slurry, and

Purified Water.

6.2 Incompatibilities

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

51 g in a tube (PE/PET/aluminium) with a screw cap (polypropylene). The tube is packed inside an outer carton. Pack sizes: 1 x 51 g tube or 3 x 51 g tubes.

Not all pack sizes may be marketed.

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

Colgate-Palmolive (U.K.) Limited

Goldsworth Place

1 Forge End

Woking

Surrey

England

GU21 6DB

8 MARKETING AUTHORISATION NUMBER(S)

PL 00049/0057

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

28/01/2025

10 DATE OF REVISION OF THE TEXT