DURAPHAT 500 mg/100 g, toothpaste 51g

ANSM - Updated on : 28/08/2017

1. DRUG NAME

DURAPHAT 500 mg/100 g, toothpaste

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Elemental fluoride ........................................................................................................................ 0.50 g

As sodium fluoride ......................................................................................... 1.10 g

Per 100 g.

1 g toothpaste contains 5 mg elemental fluoride corresponding to 5000 ppm fluoride

Excipient: 1 g toothpaste contains 5 mg sodium benzoate.

For full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Toothpaste.

Blue paste.

4. CLINICAL DATA

4.1. therapeutic indications

Prevention of dental caries in adolescents and adults, particularly in patients at risk of multiple caries (coronal and/or root caries)

4.2. Dosage and administration

For adults and adolescents over 16 years of age

To be taken by mouth.

Do not swallow.

Brush thoroughly every day:

- apply a 2 cm strip to your toothbrush every time you brush. 2 cm delivers between 3 and 5 mg fluoride,

3

times a day, after each meal,

in a vertical direction from gum to tooth tip

Careful brushing takes around 3 minutes.

4.3. Contraindications

This medicine must NEVER BE USED:

- in the event of hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

DURAPHAT 500 mg/100 g toothpaste is not indicated for use in adolescents and children under 16 years of age, see section 4.2

This toothpaste contains a high fluoride content. The advice of a dental specialist should be sought before using this product

The multiplication of potential sources of fluorine can lead to fluorosis. Before using fluoride-containing products such as DURAPHAT 500 mg/100 g, toothpaste, you should assess your total fluoride intake (drinking water, fluoride salts, other fluoride-containing products - tablets, drops, chewing gum or toothpaste). Fluoride in the form of tablets, drops, chewing gum, gels or varnish, as well as salt or fluoridated water, should be avoided when using DURAPHAT 500 mg/100 g, toothpaste

In calculating the recommended fluoride ion intake of 0.05 mg/kg/day, all intakes combined, but not exceeding 1 mg/day, account must be taken of possible doses from toothpaste ingestion (each tube of DURAPHAT 500 mg/100 g, toothpaste, contains 255 mg fluoride ions)

This product contains sodium benzoate. Sodium benzoate is a moderate skin, eye and mucous membrane irritant

4.5. Interactions with other drugs and other forms of interaction

Not applicable.

4.6. Fertility, pregnancy and lactation

There are no adequate data on the use of DURAPHAT 500 mg/100 g, toothpaste, in pregnant women. Animal studies have shown that very high doses of sodium fluoride have a toxic effect on reproductive functions. This toothpaste should therefore not be used during pregnancy and lactation unless the risk/benefit ratio has been assessed

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

Gastrointestinal disorders

Unknown frequency (cannot be estimated from available data): oral burning sensation.

Immune system disorders

Rare (≥ 1/10,000, <1/1,000): hypersensitivity reactions

Reporting suspected adverse reactions

Reporting suspected adverse reactions after drug approval is important. It enables ongoing monitoring of the drug's benefit/risk ratio. Healthcare professionals report any suspected adverse reaction via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

4.9. Overdose

Acute intoxication: Fluorine

The toxic dose, i.e. the minimum dose that can induce symptoms of intoxication, is 5 mg of fluorine per kg of body weight

It manifests itself in digestive disorders: vomiting, diarrhea, abdominal pain, and can exceptionally lead to death

accidental ingestion, immediate treatment consists of stomach pumping or induced vomiting, ingestion of calcium (large quantities of milk) and medical supervision for several hours

Acute poisoning: Menthol

DURAPHAT 500 mg/100 g, toothpaste contains menthol, which may cause convulsions, particularly in infants and children, if accidentally ingested in excessive quantities

Chronic intoxication: fluorosis

A mottled or speckled appearance of tooth enamel which may appear after a daily intake of fluoride in excess of 1.5 mg/day for several months or years, depending on the extent of the overdose.

severe forms, this is accompanied by enamel brittleness

Bone fluorosis (osteosclerosis) is only observed with chronic high fluoride intakes (over 8 mg/day)

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic class: anticaries prophylactics

ATC code: A01AA01.

The main effect of fluoride in the prevention of dental caries is post-eruptive, i.e. topical. Systemic fluoride supplements are also considered to act mainly topically (e.g. during ingestion, via saliva)

Fluoride has three types of effect:

a reduction in demineralization (lowering of enamel solubility threshold in acidic media)

remineralization of initial carious enamel lesions

- a bactericidal effect on plaque germs.

consequences are inhibition of bacterial proliferation in dental plaque and inhibition of the formation of cariogenic acids

Fluoride alone is not sufficient to eliminate dental plaque, nor is it a complete treatment for caries

5.2. Pharmacokinetic properties

DURAPHAT 500 mg/100 g, toothpaste, exerts a local, topical action on the teeth, and therefore its fate in the body is not envisaged

However, the following information has been included in the event that toothpaste is accidentally ingested during treatment

Ingested fluoride is converted into hydrofluoric acid. Peak concentration is obtained between 30 and 60 minutes after ingestion. The volume of distribution is 1 L/kg. Fluoride ions are concentrated in teeth and bones, and are not bound to plasma proteins. Half-life is 2-9 hours. Fluoride ions are mainly eliminated via the urinary tract, but small quantities may also be excreted in faeces and sweat. The form of elimination is not known.

5.3. Preclinical safety data

Preclinical data do not reveal any particular risk in humans beyond the information presented in the other sections of this summary of product characteristics

Following oral administration of sodium fluoride to mice, rats and rabbits, reproductive and fetal toxicity was observed only at very high doses

6. PHARMACEUTICAL DATA

6.1. List of excipients

Liquid sorbitol (non-crystallizable), silica for dental use, silica for dental use (precipitated), macrogol 600, tetrapotassium pyrophosphate, xanthan gum, sodium benzoate (E 211), sodium laurilsulfate, mint flavor (peppermint essential oil, carvone, spearmint essential oil, menthol, anethol, lemon essential oil), sodium saccharin, FCF brilliant blue (E133), purified water.

6.2 Incompatibilities

Not applicable.

6.3. Shelf life

3 years

6.4. Special storage precautions

a temperature not exceeding 25°C

6.5. Nature and contents of packaging

1 x 51 g tube (PE/PET/Aluminium) with screw cap (Polypropylene). The tube is packed in an outer carton.

3 tubes of 51 g (PE/PET/Aluminium) with screw cap (Polypropylene). The tube is packed in an outer box

6.6. Special precautions for disposal and handling

No special requirements

7. MARKETING AUTHORIZATION HOLDER

COLGATE-PALMOLIVE

9-11 RUE DU DEBARCADERE

92700 COLOMBES

8. MARKETING AUTHORIZATION NUMBER(S)

- 34009 358 499 3 9 : 51 g tube (PE/PET/Aluminium). Box of 1.

- 34009 363 990 3 7: 51 g tube (PE/PET/Aluminium). Box of 3.

9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION

to be completed by holder]

10. TEXT UPDATE DATE

to be completed by the holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

Not subject to medical prescription.