SODIUM FLUORIDE 2800 PPM TOOTHPASTE - patient leaflet, side effects, dosage

Patient leaflet - SODIUM FLUORIDE 2800 PPM TOOTHPASTE

Sodium Fluoride 2800 ppm Toothpaste

fluoride (as sodium fluoride)

Read all of this leaflet carefully before you start using 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, ask your 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 symptoms are the same as yours.
If you get any side effects, talk to your dentist or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
1. What Sodium Fluoride 2800 ppm Toothpaste is and what it is used for
2. What you need to know before you use Sodium Fluoride 2800 ppm Toothpaste
3. How to use Sodium Fluoride 2800 ppm Toothpaste
4. Possible side effects
5. How to store Sodium Fluoride 2800 ppm Toothpaste
6. Contents of the pack and other information

1. what sodium fluoride 2800 ppm toothpaste is and what it is used for

Sodium Fluoride 2800 ppm Toothpaste is used to treat and help prevent dental caries (tooth decay) in children aged 10 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. what you need to know before you use sodium fluoride 2800 ppm toothpaste

Do not use Sodium Fluoride 2800 ppm Toothpaste

If you are allergic (hypersensitive) to sodium fluoride or any of the other ingredients of this medicine, listed in section 6.
If you are a child aged under 10 years.

Warnings and precautions

Talk to your doctor or dentist, or pharmacist before using Sodium Fluoride 2800 ppm Toothpaste.

Sodium Fluoride 2800 ppm Toothpaste has 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 Sodium Fluoride 2800 ppm 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.
Sodium Fluoride 2800 ppm Toothpaste is not intended for use in children under 10 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 Sodium Fluoride 2800 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 Sodium Fluoride 2800 ppm Toothpaste after meals.

Pregnancy, breast-feeding and fertility

There is no experience with the use of sodium fluoride 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 before using this toothpaste as for any medicine.

Driving and using machines

Sodium Fluoride 2800 ppm Toothpaste has no or negligible influence on the ability to drive or use machines.

Sodium Fluoride 2800 ppm Toothpaste contains sorbitol solution, sodium benzoate and propylene glycol:

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicinal product.
Sodium benzoate is a mild irritant to the skin, eyes and mucous membrane.
Propylene glycol may cause skin irritation.

3. how to use sodium fluoride 2800 ppm toothpaste

Sodium Fluoride 2800 ppm Toothpaste is only for use by persons aged ten 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 daily instead of the normal toothpaste.

Brush carefully and thoroughly, for one minute, morning and evening:

apply a 1 cm ribbon of toothpaste onto the toothbrush for each brushing brush teeth vertically, from the gum to the tip of the teeth
careful brushing takes approximately one minute
spit out excess foam and do not swallow
for best results do not drink or rinse for 30 minutes.

Use in children and adolescents

This toothpaste is not for use by children aged less than 10 years.

If you use more Sodium Fluoride 2800 ppm Toothpaste than you should, or if you have swallowed the toothpaste

If you swallow 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.

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 Sodium Fluoride 2800 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, Sodium Fluoride 2800 ppm 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 or pharmacist. 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 MHRAYellow 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 sodium fluoride 2800 ppm toothpaste keep out of sight and reach of children.

Place the cap back on the tube after use

Do not use Sodium Fluoride 2800 ppm Toothpaste 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.

Discard 6 months after opening.

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 what sodium fluoride 2800 ppm toothpaste contains

The active substance is fluoride (as sodium fluoride). 1 g of toothpaste contains 2.8 mg fluoride (as sodium fluoride), corresponding to 2800 ppm fluoride.
The other ingredients are: glycerol, sodium benzoate (E211), sorbitol Solution (70 per cent) (Non-crystallising), precipitated silica (MFIL P), precipitated silica (ABSIL 100), macrogol 600, sodium lauryl sulphate, carmellose sodium (DVPS), flavour mint FLV 8020 (propylene glycol), titanium dioxide (E171), saccharin sodium and purified water.

What Sodium Fluoride 2800 ppm Toothpaste looks like and contents of the pack

Sodium Fluoride 2800 ppm Toothpaste is a white colour smooth semisolid homogenous paste.

75 ml of toothpaste filled in white coloured lami tube fitted with white coloured flip top cap enclosed in an outer carton.

Marketing Authorisation Holder

DAWA Limited, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD,

United Kingdom

Manufacturer

Drugsrus Limited, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD,