Patient leaflet - Duraphat Protify 5000 PPM toothpaste
1. WHAT DURAPHAT® PROTIFY 5000 PPM TOOTHPASTE IS AND WHAT IT IS USED FOR
This medicine 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® PROTIFY 5000 PPM TOOTHPASTE
Do not use this medicine
- if you are allergic to Sodium Fluoride or any of the other ingredients of this medicine (listed in section 6).
Warnings and Precautions
- This medicine 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 this medicine. In order to prevent accumulation of fluoride, your total intake must be assessed before using this medicine. Ask your dentist or pharma- cist concerning this matter.
- This medicine is not intended for use in adolescents and children under 16 years of age.
Other medicines and Duraphat® Protify 5000 ppm Toothpaste
No interactions with other medicines are known. Tell your dentist or pharmacist if you are taking, have recently taken or might take any other medicines.
Duraphat® Protify 5000 ppm 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 this medicine after meals.
Pregnancy and breast-feeding
There is no experience from the use of this medicine in pregnant women. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, dentist or pharmacist for advice before using this toothpaste as for any medicine.
This medicine contains 2 mg benzyl alcohol in each g of toothpaste. Benzyl Alcohol may cause mild local irritation.
This medicine contains a flavouring with limonene, linalool, citral, geraniol, and citronellol which may cause allergic reactions.
3. HOW TO USE DURAPHAT® PROTIFY 5000 PPM TOOTHPASTE
This medicine is for use by persons aged 16 years and above. Always use this medicine exactly as your dentist or
pharmacist has told you. You should check with your dentist or pharmacist if you are not sure.
Use this medicine 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.
- vertically, from the gum to the tip of the tooth.
spit out excess foam and do not swallow
Careful brushing takes approximately 3 minutes.
If you use more Duraphat® Protify 5000 ppm Toothpaste than you should, or if you have swallowed the toothpaste
If you swallowed a large amount of toothpaste by mistake, and if you experience digestive problems such as: vomiting, diarrhoea, and abdominal pain, you must tell a doctor immediately as treatment may be required. Please take this leaflet with you.
This medicine contains menthol which if accidentally ingested at excessive amounts may cause convulsions, particularly in infants and children. If you constantly swallow too much of the toothpaste over several months and years, you may experience dental fluorosis (stained or speckled appearance of the dental enamel and enamel fragility) or bone fluorosis (osteosclerosis; increased density of your bones).
If you forget to use Duraphat® Protify 5000 ppm Toothpaste
Simply use as soon as you remember, but do not use a double dose to make up for the missed dose. Continue treatment as usual after the next meal.
If you have any further questions on the use of this product, ask your dentist or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or dentist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE DURAPHAT® PROTIFY 5000 PPM TOOTHPASTE
Keep this medicine out of the sight and reach of children. Do not use this medicine 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Duraphat® Protify 5000 ppm Toothpaste contains
- The active substance is fluoride (as Sodium Fluoride). 1 g of toothpaste contains 5 mg fluoride, corresponding to 5000 ppm fluoride.
The other ingredients are 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.
What Duraphat® Protify 5000 ppm Toothpaste looks like and contents of the pack
Duraphat® Protify 5000 ppm Toothpaste is a green 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.
Marketing Authorisation Holder
Colgate-Palmolive (U.K.) Limited
Goldsworth Place, 1 Forge End, Woking, Surrey, England, GU21 6DB
Manufacturer
Thepenier Pharma & Cosmetics,
Route Départementale 912
61400 Saint-Langis-Lès-Mortagne France
This leaflet was last revised in June 2024.
PS0072430 - 214016101 Duraphat®Protify 5000 ppm Toothpaste
170mm