Patient leaflet - Fluoride 2800 PPM toothpaste
1. WHAT FLUORIDE TOOTHPASTE IS AND WHAT IT IS USED FOR
Fluoride toothpaste contains fluoride as sodium salt, which belongs to a group of medicines called caries preventing agents. This toothpaste is used for the treatment of tooth decay (dental caries) of the tooth crown and root, in adolescents and children over 10 years.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLUORIDE TOOTHPASTES
Do not use Fluoride toothpastes;
- If you are allergic to sodium fluoride or any of the other ingredients of this medicine (listed in section 6)
- If you are a child less than 10 years old.
Warnings and precautions
Talk to your doctor, dentist or pharmacist before using Fluoride toothpastes;
Fluoride Toothpaste has high fluoride content. In order to prevent build up of fluoride, your total intake must be assessed before using this Fluoride toothpaste.
Children and adolescents
Fluoride Toothpaste is not intended for use by children aged less than 10 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.
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 adequate data from 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.
Important information about some of the ingredients of Fluoride toothpaste
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This toothpaste contains Sodium Benzoate. Sodium Benzoate is a mild irritant to the skin, eyes and mucous membrane.
3. HOW TO USE FLUORIDE TOOTHPASTE
Always take this medicine exactly as your doctor, dentist or pharmacist has told you or as described in this leaflet. Check with your doctor, dentist or pharmacist if you are not sure.
Fluoride toothpaste is only for use by adults and children over 10 years old: Use this toothpaste daily instead of the normal toothpaste. The usual dosage is to apply a 1 cm ribbon 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
Use in children and adolescents:
Fluoride toothpaste is not for use by children aged less than 10 years.
If you use more toothpaste than you should or if you have swallowed the toothpaste:
Consult your doctor immediately, 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 as you may require treatment.
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 take Fluoride toothpaste:
Use as soon as you remember, but do not use a double dose to make up for a missed dose. 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, 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 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 FLUORIDE TOOTHPASTE
Keep this medicine out of the sight and reach of children.
Replace the tube cap after use. This medicinal product does not require any special storage conditions.
Do not use Fluoride toothpaste after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of the month. Discard 6 months after opening.
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
Each 1gm of toothpaste contains 2.8 mg fluoride (as sodium fluoride), which is 2800 ppm fluoride. The other ingredients are; glycerol E422, sorbitol liquid (non-crystallising) E420, carmellose sodium, sodium saccharine, sodium benzoate E211, macrogols 600, dental type silicas, titanium dioxide E171, sodium laurilsulfate, flavour mint sc and purified water.
What Fluoride toothpaste looks like and contents of the pack
Fluoride toothpaste is a white homogenous paste and available in a 75 ml of laminated tube. Enclosed in an outer carton.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
QP Services Ltd, 46 High Street, Yatton, Bristol, Somerset, BS49 4HJ, United Kingdom
Manufacturer
Rx Farma Limited, Unit 3, Colonial Way, Watford, Hertfordshire, WD24 4YR
If you would like this leaflet in different format or want to report any side effects please contact marketing authorisation holder listed above.