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FLUORIDE EMBEDDED SIGNAL PROCESSING LTD 2800 PPM TOOTHPASTE - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - FLUORIDE EMBEDDED SIGNAL PROCESSING LTD 2800 PPM TOOTHPASTE

Package leaflet: Information for the patient

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Fluoride Embedded Signal Processing Ltd 2800 ppm Toothpaste

Fluoride (as Sodium Fluoride)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, please ask your doctor, dentist or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

This medicine is available as Fluoride Embedded Signal Processing Ltd 2800 ppm 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

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.

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: 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

Embedded Signal Processing Ltd, Lunna House, Lunna, Vidlin, Shetland, ZE2 9QF, UK

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.

This leaflet was last revised in December 2019. #

V3.0 12/122019

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is fluoride embedded signal processing toothpaste used for?

Fluoride embedded signal processing toothpaste is designed to help prevent cavities, strengthen tooth enamel, and enhance oral health through advanced fluoride technology.

How does 2800 ppm fluoride toothpaste differ from regular toothpaste?

2800 ppm fluoride toothpaste contains a higher concentration of fluoride, which can provide greater protection against tooth decay and is often recommended for those at higher risk of cavities.

Can I use fluoride embedded signal processing toothpaste every day?

Yes, you can use this toothpaste daily as part of your regular oral hygiene routine. However, consult your dentist if you have specific concerns.

Is fluoride safe for children?

Fluoride is safe for children in appropriate amounts. It's important to supervise young children while brushing to ensure they don't swallow the toothpaste.

What are the benefits of using high-fluoride toothpaste?

High-fluoride toothpaste can help remineralize enamel, reduce sensitivity, and prevent cavities more effectively than standard toothpaste.

Can I use this toothpaste if I have sensitive teeth?

Yes, many users with sensitive teeth find that high-fluoride toothpaste helps reduce sensitivity over time. If issues persist, consult your dentist.

Should I avoid eating or drinking after brushing with this toothpaste?

It's generally recommended to avoid eating or drinking for at least 30 minutes after brushing to allow the fluoride to work effectively.

What is the best way to apply fluoride embedded signal processing toothpaste?

Apply a pea-sized amount of the toothpaste on your toothbrush and brush thoroughly for at least two minutes, ensuring all surfaces of your teeth are clean.

How often should I visit my dentist while using this toothpaste?

Regular dental visits every six months are recommended. Your dentist may suggest more frequent visits if you're using high-fluoride products.

Is there an age limit for using 2800 ppm fluoride toothpaste?

While adults can safely use it, it's usually recommended for adolescents and adults. Consult a pediatric dentist before using it on children.

Can this toothpaste help with bad breath?

Yes, it can help freshen breath as part of an overall oral hygiene routine, but it's important to address the underlying causes of bad breath.

How long does it take to see results from using this toothpaste?

Results may vary, but many users notice improvements in cavity prevention and enamel strength within a few weeks of consistent use.

Is there any side effect from using high-fluoride toothpaste?

Overuse can lead to dental fluorosis in children; however, when used as directed by adults or older children, side effects are rare. Consult your dentist if concerned.

Can I use this product with braces?

Yes, this high-fluoride toothpaste can be beneficial for those with braces as it helps strengthen enamel around brackets and wires.

Are there any dietary restrictions while using this toothpaste?

There are no specific dietary restrictions; however, maintaining good overall oral hygiene practices is important. Avoid excessive sugary foods and beverages.

Does it have a strong taste compared to regular toothpaste?

Some users report that high-fluoride toothpastes have a different taste. However, many brands offer flavors designed to be appealing while still providing effective care.

What should I do if I accidentally swallow some of the toothpaste?

If a small amount is swallowed accidentally, there's usually no cause for alarm. However, contact your healthcare provider or poison control if large amounts are ingested.

Can I use other oral care products with this toothpaste?

Yes! You can safely use mouthwash or dental floss in conjunction with this high-fluoride toothpaste for comprehensive oral care.

Where should I store my fluoride embedded signal processing toothpaste?

Store it in a cool, dry place away from direct sunlight or moisture to preserve its effectiveness.

Is there a specific brushing technique recommended with this type of toothpaste?

Use gentle circular motions and ensure that you brush all surfaces—including front, back, and chewing surfaces—for optimal effectiveness.