Patient leaflet - Sodium Fluoride 5000 PPM toothpaste
1. What Sodium Fluoride 5000 ppm Toothpaste is and what it is used for
Sodium Fluoride 5000 ppm 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. What you need to know before you use Sodium Fluoride 5000 ppm Toothpaste
Do not use Sodium Fluoride 5000 ppm Toothpaste
Ÿ If you are allergic (hypersensitive) to sodium fluoride or any of the other
ingredients of Sodium Fluoride 5000 ppm Toothpaste.
Warnings and precautions
Talk to your dentist or pharmacist before using Sodium Fluoride 5000 ppm Toothpaste.
Ÿ Sodium Fluoride 5000 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 Toothpaste. In order to prevent accumulation of fluoride, your total intake must be assessed before using this fluoride toothpaste. Ask your dentist, pharmacist or oral hygienist concerning this matter. Ÿ It is important to control the use of sodium fluoride toothpaste in
patients with chronic renal insufficiency, to avoid risk of fluorosis.
Children and adolescents
Sodium Fluoride 5000 ppm Toothpaste is not intended for use in adolescents and children under 16 years of age.
Other medicines and Sodium Fluoride 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, including medicines obtained without a prescription.
Sodium Fluoride 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 Sodium Fluoride Toothpaste after meals.
Pregnancy and breast-feeding
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 for advice before using this toothpaste.
Driving and using machines
Sodium Fluoride 5000 ppm Toothpaste has no or negligible influence on the ability to drive or use machines.
Sodium Fluoride 5000 ppm Toothpaste contains sorbitol solution (E420), sodium benzoate (E211) and propylene glycol (E1520)
Ÿ This medicine contains 560 mg sorbitol solution (E420) in each 1 g.
Sorbitol may cause gastrointestinal discomfort and mild laxative effect. Ÿ This medicine contains 1 mg sodium benzoate (E211) in each 1 g which is equivalent to 0.1% w/w. Sodium benzoate may cause local irritation.
Ÿ This medicine contains a maximum of 23.5 mg propylene glycol
(E1520) in each 1 g which is equivalent to 2.35% w/w. Propylene glycol may cause skin irritation.
3. How to use Sodium Fluoride 5000 ppm Toothpaste
Sodium Fluoride 5000 ppm Toothpaste is for use by persons aged 16 years and above.
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 Sodium Fluoride 5000 ppm Toothpaste 3 times a day for brushing your teeth
Ÿ apply a 2 cm ribbon onto your toothbrush for each brushing (2 cm provides between 3 mg and 5 mg of fluoride)
Ÿ brush your teeth after each meal
Ÿ vertically, from the gum to the tip of the tooth
Ÿ spit out excess foam and do not swallow.
Careful brushing takes approximately 3 minutes.
If you use more Sodium Fluoride 5000 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 5000 ppm Toothpaste
Simply use as soon as you remember. Do not use a double dose to make up for a 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 5000 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, dentist 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 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 Sodium Fluoride 5000 ppm Toothpaste
Keep this medicine out of the sight and reach of children.
Place the cap back on the tube after use.
Do not use Sodium Fluoride 5000 ppm Toothpaste after the expiry date which is stated on the tube and carton after "EXP". 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.
0272/L-10
6. Contents of the pack and other information
What Sodium Fluoride 5000 ppm Toothpaste contains
Ÿ The active substance is fluoride (as sodium fluoride). Each 1 g of toothpaste contains 5 mg fluoride (as sodium fluoride), corresponding to 5800 ppm fluoride.
Ÿ The other ingredients are sodium benzoate (E211), tetra potassium pyrophosphate, sorbitol solution (E420) (70%) (non-crystallising), precipitated silica, macrogol 600, carmellose sodium, sodium lauryl sulphate, saccharin sodium, brilliant blue FCF (E133), spearmint flavour No. 1 (propylene glycol (E1520)), mint flavour (propylene glycol (E1520)) and purified water.
What Sodium Fluoride 5000 ppm Toothpaste looks like and contents of the pack
Sodium Fluoride 5000 ppm Toothpaste is a blue, smooth, semisolid homogenous paste.
51g of toothpaste filled in white coloured lami tube fitted with white coloured 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, United Kingdom.
This leaflet was last revised in August 2026.
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