Duraphat 5000 Ppm Fluoride Toothpaste
Package leaflet: Information for the user
Duraphat® 5000 ppm Fluoride Toothpaste
(fluoride as sodium fluoride)
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your dentist or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.
The name of your medicine is Duraphat
5000 ppm Fluoride Toothpaste, but will be referred to as Duraphat Toothpaste throughout the remainder of the leaflet
In this leaflet:
1. What Duraphat Toothpaste is and what it is used for
2. Before you use Duraphat Toothpaste
3. How to use Duraphat Toothpaste
4. Possible side effects
5. How to store Duraphat Toothpaste
6. Further information
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 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 breast-feeding, ask your doctor, dentist or pharmacist before using this toothpaste as for any medicine.
Important information about some of the ingredients of Duraphat Toothpaste
This toothpaste contains Sodium Benzoate. Sodium Benzoate is a mild irritant to the skin, eyes and mucous membrane.
This product contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
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.
• vertically, from the gum to the tip of the tooth.
• spit out excess foam and do not swallow Careful brushing takes approximately 3 minutes.
POM
If you use more Duraphat 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.
Duraphat 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 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, 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.
Reporting of side effects
If you get any side effects, talk to your doctor, dentist, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Duraphat Toothpaste
Keep out of the sight and reach 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 ingredient in Duraphat Toothpaste is fluoride (as sodium fluoride);
1 g of toothpaste contains 5 mg fluoride, corresponding to 5000 ppm fluoride.
Also contains: Sorbitol Liquid (noncrystallising), Silica Dental Type, Silica Dental Type (Precipitated), Macrogol 600,
Tetrapotassium Pyrophosphate, Xanthan Gum, Sodium Benzoate (E211), Sodium Lauryl Sulphate, Saccharin Sodium, Brilliant Blue FCF (E133) and Purified Water,
Spearmint flavouring (containing Peppermint Oil, Carvone, Spearmint Oil, Menthol, Anethol and Lemon Oil)
Duraphat Toothpaste is blue coloured toothpaste, with characteristic mint smell, supplied in a 51g tube, enclosed in an outer carton.
Manufactured by
Thepenier Pharma Industrie S.A.S.
Route d'Alengon Saint-Langis-Les-Mortagne F-61400 Mortagne France or
Colgate-Palmolive (UK) Ltd,
The Dental Health Unit, Williams House, Lloyd Street North, Manchester M15 6SE, UK. or
GABA GmbH, Berner Weg 7, D-79539 Lorrach, Germany.
Procured from within the EU.
Product Licence Holder:
Ecosse Pharmaceuticals Limited,
3 Young Place, East Kilbride G75 0TD. Re-packaged by:
Munro Wholesale Medical Supplies Limited, 3 Young Place, East Kilbride G75 0TD.
PL 19065/0399
This leaflet was revised 18/06/2015
E0399/2
Duraphat® is a trademark of Colgate-Palmolive Company