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DURAPHAT 5000PPM FLUORIDE TOOTHPASTE - Patient leaflet, side effects, dosage

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

Patient leaflet - DURAPHAT 5000PPM FLUORIDE TOOTHPASTE

Duraphat® 5000ppm fluoride toothpaste

(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 5000ppm fluoride toothpaste but will be referred to as Duraphat toothpaste throughout this 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 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 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.

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 2cm ribbon onto your toothbrush for each brushing (2cm provides between 3mg and 5mg 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 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, 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:.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 toothpaste

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not use Duraphat toothpaste after the expiry date which is stated on the carton and tube label after ‘Exp’. The expiry date refers to the last day of that month.

  • 6. FURTHER INFORMATION

What Duraphat toothpaste contains

  • – The active substance in Duraphat toothpaste is fluoride (as sodium fluoride). 1g of toothpaste contains 5mg fluoride (as sodium fluoride), corresponding to 5000ppm fluoride.

What Duraphat toothpaste looks like and contents of the pack

Duraphat toothpaste is a blue coloured toothpaste with a mint odour. Duraphat is available in tubes containing 51g toothpaste.

Manufactured by: Thepenier Pharma & Cosmetics, Route d'Alencon, Saint-Langis-Les-Mortagne, 61400 Mortagne, France.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Duraphat® 5000ppm fluoride toothpaste; PL 18799/2868 i pg^ I

Leaflet date: 17.09.2021 ।1

Duraphat is a registered trademark of Colgate-Palmolive Company.

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 0208 515 3763 to obtain the leaflet in a format suitable for you.

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

Frequently Asked Questions

What is Duraphat 5000ppm fluoride toothpaste used for?

Duraphat 5000ppm fluoride toothpaste is specially formulated to help prevent tooth decay and strengthen teeth. It is particularly beneficial for individuals at higher risk of cavities.

How does Duraphat toothpaste work?

The high concentration of fluoride in Duraphat helps to remineralize teeth, making them more resistant to acid attacks from plaque and sugary foods.

Can I use Duraphat toothpaste every day?

Yes, Duraphat toothpaste can be used daily, but it's important to follow your dentist's recommendations on how often to use it.

Is Duraphat suitable for children?

Duraphat is generally recommended for children over the age of 6 who are at risk of tooth decay. Always consult with a dentist before use.

What if I swallow Duraphat toothpaste?

If swallowed in small amounts, it's usually not harmful, but if a large amount is ingested, contact your healthcare provider or poison control center immediately.

How long should I brush my teeth with Duraphat toothpaste?

Brush your teeth with Duraphat toothpaste for at least two minutes twice a day for optimal results.

Can I eat or drink after using Duraphat toothpaste?

It's best to wait at least 30 minutes after brushing before eating or drinking to allow the fluoride to have maximum effect on your teeth.

What flavors does Duraphat toothpaste come in?

Duraphat typically comes in mint flavor, which helps freshen breath while providing cavity protection.

Is Duraphat safe during pregnancy?

Consult your healthcare provider before using any fluoride products during pregnancy to ensure it’s appropriate for your situation.

How should I store Duraphat toothpaste?

Store Duraphat toothpaste at room temperature in a cool, dry place away from direct sunlight.

Can I use other fluoride products while using Duraphat toothpaste?

Using multiple fluoride products simultaneously can lead to overexposure. Consult your dentist for personalized advice.

Will using Duraphat help with sensitive teeth?

While Duraphat primarily helps prevent cavities, some patients report improved sensitivity due to the strengthening effects of fluoride.

What should I do if I miss a dose of Duraphat?

If you miss brushing with Duraphat, just resume your usual routine the next time you brush. Don’t double up on the next application.

Can I use mouthwash after brushing with Duraphat?

If you're using mouthwash, wait at least 30 minutes after brushing with Duraphat to ensure the fluoride remains effective.

Do I need a prescription for Duraphat toothpaste?

In many cases, yes. You may need a prescription from your dentist or healthcare provider, as this is a high-fluoride formulation.

How long does one tube of Duraphat last if used daily?

Depending on usage and amount squeezed out each time, a tube may last anywhere from 1-2 months when used regularly.

Will my insurance cover the cost of Duraphat toothpaste?

Coverage can vary by insurance plan. Check with your provider to see if they cover prescription dental products like Duraphat.

What should I do if I experience any side effects from using Duraphat?

If you notice any adverse effects such as mouth irritation or allergic reactions, discontinue use and contact your healthcare provider immediately.

Does using Duraphat guarantee that I won't get cavities?

While using Duraphat significantly reduces the risk of cavities, it does not guarantee complete prevention. Regular dental check-ups and good oral hygiene are also important.