- sodium fluoride
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 20117/0240 .
Fluoride 5000 ppm Toothpaste
Package leaflet: Information for the user
Fluoride 5000 ppm Toothpaste
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
This medicine is available as Fluoride 5000 ppm Fluoride Toothpaste but will be called Fluoride Toothpaste throughout the rest of this leaflet.
What is in this leaflet
1.What Fluoride Toothpaste is and what it is used for
2.What you need to know before you use Fluoride Toothpaste
3.How to use Fluoride Toothpaste
4.Possible side effects
5.How to store Fluoride Toothpaste
6.Contents of the pack and other information
1. WHAT FLUORIDE TOOTHPASTE IS AND WHAT IT IS USED FOR
Sodium Fluoride Toothpaste is used to help prevent tooth decay (dental caries) in adolescents aged 16 years and older, and adults, particularly amongst patients at risk from multiple caries. The toothpaste contains fluoride as sodium salt, which belongs a group of medicines called caries preventing agents.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLUORIDE TOOTHPASTE
Do not use Fluoride Toothpaste:
Warnings and precautions
Talk to your doctor or dentist, or pharmacist before using Fluoride Toothpaste:
Children and adolescents
Sodium Fluoride Toothpaste is not intended for use by children and adolescents aged younger than 16 years.
Other medicines and Fluoride Toothpaste
No interactions with other medicines are known.
Tell your doctor, dentist or pharmacist if you are taking or using, or have recently taken or used, or might take or use any other medicines, including medicines obtained without a prescription.
Sodium Fluoride Toothpaste with food and drink
Fluoridated water and salt should be avoided while using this toothpaste. Food and drink, if taken immediately after brushing your teeth, may reduce the amount of tooth remineralisation that occurs. You should therefore brush your teeth with Fluoride Toothpaste after meals.
Pregnancy, breast-feeding, and fertility
There is no experience with the use of Fluoride Toothpaste 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 taking this medicine.
Driving and using machines
Using Fluoride Toothpaste will not affect your ability to drive or use machinery.
Sodium Fluoride Toothpaste contains sodium benzoate, sorbitol solution and propylene glycol:
3. HOW TO USE FLUORIDE TOOTHPASTE
Sodium Fluoride Toothpaste is only for use by persons aged sixteen years and older.
Always use this medicine exactly as described in this leaflet or as your doctor, dentist, or pharmacist has told you. Check with your doctor, dentist or pharmacist if you are not sure.
Use Fluoride Toothpaste three (3) times a day for brushing your teeth:
Careful brushing of your teeth takes about three minutes.
Use in children and adolescents
This toothpaste is not for use by adolescents and children aged less than 16 years.
If you use more Fluoride 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 being sick, diarrhoea, and pain in the stomach or abdomen, you must tell a doctor immediately as treatment may be required. Please take this leaflet with you.
If you constantly swallow too much of the toothpaste over several months, or years, you may get stained or speckled appearance of tooth enamel, and enamel fragility (dental fluorosis), or increased bone density, osteosclerosis (bone fluorosis).
If you forget to use Fluoride Toothpaste
Use as soon as you remember, but do not use a double dose to make up for a missed dose. Continue treatment as usual after the next meal.
If you have any further questions on the use of this medicine, ask your doctor, 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 (less than 1 in 1,000 users) allergic (hypersensitivity) reactions can occur, such as 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, or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system, the Yellow card scheme; website 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 FLUORIDE 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 Exp. The expiry date refers to the last day of that month. Discard 6 months after opening.
Replace the tube cap after use. This product requires no special storage conditions.
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 Fluoride Toothpaste contains
The other ingredients (excipients) are: Sorbitol solution (non — crystallising) (E420), dental type silica (precipitated) (E551), macrogol 600 (E1521), tetrapotassium pyrophosphate (E340), xanthan gum (E415), sodium benzoate (E211), sodium laurilsulphate, spearmint flavouring (containing menthol, propylene glycol, carvone, spearmint oil, peppermint oil, anethol, and vanillin), saccharin sodium (E954), brilliant blue FCF (E133) and purified water.
What Fluoride Toothpaste looks like and contents of the pack
Sodium Fluoride Toothpaste is a smooth, blue coloured translucent paste with the odour and taste of spearmint.
It is supplied in a 51 g collapsible tube enclosed in an outer carton.
Marketing Authorisation Holder:
This leaflet was last revised in 11 /2014.
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