1. Name of the Medicinal Product
Duraphat 2800 ppm fluoride toothpaste.
2. Qualitative and Quantitative Composition
Sodium fluoride 0.619 %w/w (2800ppm F).
3. Pharmaceutical Form
Toothpaste.
For dental use.
4.1 Therapeutic Indications
For the prevention and treatment of dental caries (coronal and root) in adults and children over 10 years old.
4.2 Posology and Method of Administration
Adults and children over 10 years old: use daily instead of the normal toothpaste. The usual dosage is to apply a 1cm line of paste across the head of a toothbrush and brush the teeth thoroughly for one minute, morning and evening. Spit out after use; for best results do not drink or rinse for 30 minutes.
Children under 10 years old: not recommended.
Elderly: use as for adults.
4.3 Contraindications
-
None known
-
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.
4.5 Interactions with Other Medicinal Products and Other Forms of Interaction
None known.
4.6 Pregnancy and Lactation
Epidemiological studies in humans indicate that fluoride has no adverse effects in pregnancy or on the health of the foetus or newborn child. Duraphat 2800 fluoride toothpaste can be used during pregnancy.
4.7 Effects on Ability to Drive and Use Machines
Not applicable.
4.8 Undesirable Effects
When used as recommended there are no side effects.
4.9 Overdose
Not applicable.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
This product is a toothpaste in which the active ingredient is sodium fluoride present at a level of 0.619% which corresponds to 280mg fluoride per 100g 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
This product is not intended to be swallowed and therefore only minimal systemic exposure is expected.
5.3 Preclinical Safety Data
The total amount of sodium fluoride in a 75ml tube of Duraphat 2800ppm fluoride toothpaste is about 620mg which equates to 280mg fluoride. This is within the acceptable limits for the amount to be supplied at one time for safety purposes. Preclinical studies indicate that fluoride is not teratogenic, mutagenic or carcinogenic.
6. Pharmaceutical Particulars
6.1 List of Excipients
Glycerol
Purified Water
Sorbitol
Silicas
Polyethylene glycol 600
Sodium lauryl sulphate
Sodium carboxymethylcellulose
Mint Flavour
Titanium dioxide
Sodium saccharin
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
Three years.
6.4 Special Precautions for Storage
Do not store above 25°C.
6.5 Nature and Contents of Container
75ml polyethylene/aluminium/polyethylene laminated tube with a polypropylene flip top closure. Pack sizes: 1 x 75ml tube or 2 x 75ml tubes.
6.6 Instructions for Use and Handling
Not applicable.
7. Marketing Authorisation Holder
Colgate-Palmolive (UK) Ltd
Guildford Business Park
Middleton Road
Guildford
Surrey GU2 8JZ
United Kingdom
8. Marketing Authorisation Number
PL 00049/0039
9. Date of First Authorisation/Renewal of the Authorisation
4 December 2000
19 July 2006
10. Date of Revision of the Text
July 2006
11. Legal Classification
POM
12. Manufacturer's Recommended Retail Price
£4.99 (75ml tube)
£8.49 (Dual pack containing 2 x 75ml tubes)
