Colgate<sup>®</sup> Duraphat<sup>®</sup> 5000ppm Fluoride Toothpaste (1.1% Sodium Fluoride) (Rx only)

Colgate® Duraphat® 5000ppm Fluoride Toothpaste (1.1% Sodium Fluoride) (Rx only)

A dental caries preventive for three times daily self-applied topical use.

Ingredients

Active ingredients

Sodium fluoride 1.1% (w/w)

Inactive ingredients

Liquid Sorbitol (Non-crystallising), Dental Type Silica, Dental Type Silica (Precipitated), Macrogol 600, Tetrapotassium, Pyrophosphate, Xanthan Gum, Sodium Benzoate (E211), Sodium Lauryl Sulfate, Spearmint flavouring (containing Peppermint Oil, Carvone, Spearmint Oil, Menthol, Anethol, and Lemon Oil), Saccharin Sodium, Brilliant Blue FCF (E133) and Purified Water.

Mode of Action

Optimized fluoride delivery system that produces a temporary shift in pH, resulting in an 86% improvement in fluoride uptake.1

Reference: 1. Joziak MT, et al. J Dent Res. 2003;82(Sp Issue);Abs. 1355.

Proof of Efficacy

  • Duraphat® provides significant remineralization of root caries in as little as 3 months (38%) and 6 months (57%) 1

References:

1. Baysan A, et al. Caries Res. 2001;35:41-46.

Prescribing Information

Colgate® Duraphat® 5000ppm Fluoride Toothpaste (1.1% Sodium Fluoride) (Rx Only)

Description

Colgate® Duraphat® 5000ppm fluoride toothpaste is a high fluoride toothpaste for the prevention of dental caries in adults over 16 years — particularly amongst patients at high risk from caries.

Instructions and Usage

1. WHAT DURAPHAT® TOOTHPASTE IS AND WHAT IT IS USED FOR

Duraphat® Toothpaste is used to help prevent dental caries (tooth decay) in adolescents aged 16 years and over and adults, particularly amongst patients at risk from multiple caries. This toothpaste contains fluoride as sodium salt, which belongs to a group of medicines called caries preventing agents.

2. BEFORE YOU USE DURAPHAT® TOOTHPASTE

Do not use Duraphat® Toothpaste

- If you are allergic (hypersensitive) to Sodium Fluoride or any of the other ingredients of Duraphat® Toothpaste.

Take special care with Duraphat® Toothpaste

- Duraphat® Toothpaste has a high fluoride content. Fluoride tablets, drops, chewing gum, gels or varnishes, as well as fluoridated water or salt, should be avoided during the use of Duraphat® Toothpaste. In order to prevent accumulation of fluoride, your total intake must be assessed before using this fluoride toothpaste. Ask your dentist or pharmacist concerning this matter.

- Duraphat® Toothpaste is not intended for use in adolescents and children under 16 years of age.

Using other medicines

No interactions with other medicines are known. Please tell your dentist or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using Duraphat® Toothpaste with food and drink

Fluoridated water and salt should be avoided during the use of this toothpaste. Food and drink, if taken immediately after brushing, may have an inhibitory effect on the remineralisation of the teeth. Therefore brush your teeth with Duraphat® Toothpaste after meals.

Pregnancy and breast-feeding

There is no experience from the use of Duraphat® in pregnant women. If you are pregnant or breastfeeding, ask your doctor, dentist or pharmacist before using this toothpaste as for any medicine.

Important information about some of the ingredients of Duraphat® Toothpaste

3. HOW TO USE DURAPHAT® TOOTHPASTE

Duraphat® Toothpaste is for use by persons aged 16 years and above. Always use Duraphat® Toothpaste exactly as your dentist or pharmacist has told you. You should check with your dentist or pharmacist if you are not sure. Use Duraphat® Toothpaste 3 times a day for brushing your teeth

  • apply a 2 cm ribbon onto your toothbrush for each brushing (2 cm provides between 3 mg and 5 mg of fluoride).
  • brush your teeth after each meal.
  • rtically, from the gum to the tip of the tooth.
  • spit out excess foam and do not swallow
    Careful brushing takes approximately 3 minutes.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Duraphat® Toothpaste can cause side effects, although not everybody gets them. In some rare cases (i.e. less than 1 in 1000 people treated) allergic (hypersensitivity) reactions can occur e.g. rash, itching, swelling and redness. Burning oral sensation has also been reported. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your dentist or pharmacist.

5. HOW TO STORE DURAPHAT® TOOTHPASTE

Keep out of the reach and sight of children
Do not use Duraphat® Toothpaste after the expiry date which is stated on the tube and carton after “Expiry date”. The expiry date refers to the last day of that month. Do not store above 25°C.

6. FURTHER INFORMATION

What Duraphat® Toothpaste contains
- The active substance is fluoride (as sodium fluoride).
1 g of toothpaste contains 5 mg fluoride, corresponding to 5000ppm fluoride.
- The other ingredients are Liquid Sorbitol (Non-crystallising), Dental Type Silica, Dental Type Silica (Precipitated), Macrogol 600, Tetrapotassium Pyrophosphate, Xanthan Gum, Sodium Benzoate
(E211), Sodium Laurilsulfate, Spearmint flavouring (containing Peppermint Oil, Carvone,
Spearmint Oil, Menthol, Anethol, and Lemon Oil), Saccharin Sodium, Brilliant Blue FCF (E133),
and Purified Water.

What Duraphat® Toothpaste looks like and contents of the pack

Duraphat® Toothpaste is a blue coloured toothpaste.
It is supplied in a 51g tube, enclosed in an outer carton.
Pack sizes: 1 x 51g tube or 3 x 51g tubes.