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

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

Patient leaflet - DURAPHAT PROTIFY 5000 PPM TOOTHPASTE

1. what duraphat protify 5000 ppm toothpaste is and what it is used for

This medicine 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 protify 5000 ppm toothpaste- if you are allergic to sodium fluoride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

  • – This medicine 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 this medicine. In order to prevent accumulation of fluoride, your total intake must be assessed before using this medicine. Ask your dentist or pharmacist concerning this matter.

  • – This medicine is not intended for use in adolescents and children under 16 years of age.

Other medicines and Duraphat Protify 5000 ppm Toothpaste

No interactions with other medicines are known. Tell your dentist or pharmacist if you are taking, have recently taken or might take any other medicines.

Duraphat Protify 5000 ppm 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 this medicine after meals.

Pregnancy and breast-feeding

There is no experience from the use of this medicine 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 using this toothpaste as for any medicine.

This medicine contains Sodium Benzoate

This toothpaste contains Sodium Benzoate. Sodium Benzoate is a mild irritant to the skin, eyes and mucous membrane.

3. how to use duraphat protify 5000 ppm toothpaste

This medicine is for use by persons aged 16 years and above.

Always use this medicine exactly as your dentist or pharmacist has told you. You should check with your dentist or pharmacist if you are not sure.

Use this medicine 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.

If you use more Duraphat Protify 5000 ppm 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.

This medicine 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 Protify 5000 ppm 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, this medicine 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 dentist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

United Kingdom

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 duraphat protify 5000 ppm 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 „Expiry date“. The expiry date refers to the last day of that month.

Do not store above 25°C.

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- the active substance is fluoride (as sodium fluoride). 1 g of toothpaste contains 5 mg fluoride, corresponding to 5000 ppm fluoride.

  • – The other ingredients are Liquid Sorbitol (Non-crystallising), Dental Type Silica, Dental Type Silica (Precipitated), Macrogol 600, Tetrapotassium Pyrophosphate, Xanthan Gum, Sodium Benzoate (E211), Sodium Laurilsulfate, Spearmint flavouring (containing Peppermint Oil, Carvone, Spearmint Oil, Menthol, Anethol, and Lemon Oil), Saccharin Sodium, Brilliant Blue FCF (E133), and Purified Water.

What Duraphat Protify 5000 ppm Toothpaste looks like and contents of the pack

Duraphat Protify 5000ppmToothpaste is a blue coloured toothpaste.

It is supplied in a 51g tube, enclosed in an outer carton.

Pack sizes: 1 × 51g tube or 3 × 51g tubes.

Marketing Authorisation Holder

Colgate-Palmolive (UK) Limited

Guildford Business Park

Middleton Road, Guildford

Surrey GU2 8JZ

United Kingdom

Manufacturer

Colgate-Palmolive Manufacturing (Poland) Sp. z o. o.

Al. Colgate 2

58 – 100 Swidnica

Poland

or

Thepenier Pharma & Cosmetics S.A.S.

Route D’Alengon,

Samt-Langis-Les-Mortagne

61400 Mortagne

France

This leaflet was last revised in May 2021.

May 2021

Page 4/4

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

The drug is classified in the ATC tree:

A ALIMENTARY TRACT AND METABOLISM DRUGS

A01 STOMATOLOGICAL PREPARATIONS

A01A STOMATOLOGICAL PREPARATIONS

A01AA Caries prophylactic agents

A01AA01 sodium fluoride

Frequently Asked Questions

What is Duraphat Protify 5000 PPM Toothpaste used for?

Duraphat Protify 5000 PPM Toothpaste is used primarily for the prevention of dental caries (tooth decay) by providing high levels of fluoride.

Who should use Duraphat Protify 5000 PPM Toothpaste?

This toothpaste is especially recommended for individuals at higher risk of tooth decay, including those with dry mouth, orthodontic appliances, or a history of cavities.

How does the 5000 PPM fluoride concentration work?

The 5000 parts per million (PPM) fluoride concentration helps to strengthen tooth enamel and makes it more resistant to acid attacks from plaque bacteria and sugars.

Can I use Duraphat toothpaste daily?

Yes, Duraphat Protify 5000 PPM Toothpaste can be used daily, but it is important to follow your dentist's advice regarding its frequency of use.

Is Duraphat toothpaste safe for children?

Duraphat Protify is generally not recommended for children under the age of six unless directed by a dentist due to the high fluoride content.

How should I use Duraphat Protify 5000 PPM Toothpaste?

Brush your teeth with a small amount of Duraphat toothpaste twice daily, ideally in the morning and before bed, and avoid rinsing immediately after brushing.

What should I do if I swallow Duraphat toothpaste?

If you accidentally swallow a small amount, it's usually not harmful. However, if a large amount is ingested or you experience symptoms, contact your doctor or poison control center.

Are there any side effects associated with Duraphat toothpaste?

Some users may experience mild side effects such as a change in taste or a temporary white staining on teeth. If you notice persistent issues, consult your dentist.

Can I use Duraphat toothpaste alongside other dental products?

Yes, but be cautious with other fluoride products. It's best to consult with your dentist about combining different oral care products.

How long does a tube of Duraphat last?

The lifespan of a tube depends on your usage frequency. Typically, a tube lasts about one month if used as directed.

Where can I buy Duraphat Protify 5000 PPM Toothpaste?

You can purchase this toothpaste at pharmacies and online retailers. It's often available by prescription or over-the-counter in some regions.

Should I continue seeing my dentist while using Duraphat toothpaste?

Absolutely! Regular dental check-ups are crucial for maintaining oral health, even when using high-fluoride toothpaste like Duraphat.

Can pregnant women use Duraphat toothpaste?

It’s advisable for pregnant women to consult their healthcare provider before using high-fluoride products like Duraphat.

What if I forget to brush with Duraphat one day?

If you miss a day, just resume your regular brushing routine with Duraphat the next day. Don't double up on usage.

Can I eat or drink immediately after using Duraphat toothpaste?

It’s best to wait at least 30 minutes after brushing before eating or drinking to allow the fluoride to absorb effectively into your teeth.

Is there an alternative to Duraphat toothpaste if I'm allergic to fluoride?

If you have a fluoride allergy or sensitivity, discuss alternative anti-cavity options with your dentist tailored to your needs.

Does Duraphat toothpase have an expiry date?

Yes, like all medications and dental products, check the packaging for an expiry date and do not use after this date has passed.

How can I improve my oral health while using Duraphat toothpaste?

In addition to using Duraphat toothpaste, maintain regular dental check-ups, floss daily, limit sugary snacks, and drink plenty of water!

What happens if I don’t see results after using Duraphat?

If you don’t notice improvement in your dental health within a few months of consistent use, consult your dentist for further evaluation and advice.

Is there any special storage guidance for Duraphat toothpaste?

Store the toothpaste in a cool place away from direct sunlight and keep it out of reach of children to ensure its effectiveness.