Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Fluoride 5000 ppm Toothpaste
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Sodium fluoride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Fluoride Toothpaste is used to help prevent tooth decay (dental caries) in adolescents aged 16 years and older, and adults, particularly amongst patients at risk from multiple caries. The 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 take it
e Fluoride Toothpaste
Do not use Fluoride Toothpaste: •
if you are allergic to sodium fluoride or any of the other ingredients of this medicine, listed in section 6.
•
if you are an adolescent or child aged under 16 years.
Warnings and precautions Talk to your doctor or dentist, or pharmacist before using Fluoride Toothpaste:
•
Fluoride 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 Fluoride Toothpaste. In order to prevent build up of fluoride, your total intake must be assessed before using this fluoride toothpaste. Ask your doctor, dentist, or pharmacist about this.
Children and adolescents Fluoride Toothpaste is not intended for use by children and adolescents aged younger than 16 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 experience with 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. Fluoride Toothpaste contains sodium benzoate, sorbitol solution and propylene glycol: •
sodium benzoate is a mild irritant to the skin, eyes, and mucous membranes.
•
if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicinal product.
• 3.
propylene glycol may cause skin irritation.
How to take it
Fluoride Toothpaste
Fluoride Toothpaste is only for use by persons aged sixteen 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 Fluoride Toothpaste three (3) times a day for brushing your teeth: •
apply a 2 cm ribbon of toothpaste onto your toothbrush for each brushing (2 cm provides between 3 mg and 5 mg of fluoride).
•
brush your teeth after each meal.
•
brush your teeth vertically, from the gum to the tip of the tooth.
•
spit out excess foam and do not swallow.
Careful brushing of your teeth takes about three minutes. Use in children and adolescents This toothpaste is not for use by adolescents and children aged less than 16 years. If you use more Fluoride 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 being sick, diarrhoea, and pain in the stomach or abdomen, 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, 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 use Fluoride Toothpaste Use as soon as you remember, but 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 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, dentist, or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system, the Yellow card scheme; website www.mhra.gov.uk/yellowcard. By reporting
Possible side effects
you can help provide more information on the safety of this medicine. 5.
How to store it
Fluoride 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 Exp. The expiry date refers to the last day of that month. Discard 6 months after opening. Replace the tube cap after use. This product requires no special storage conditions. 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
•
The active substance is fluoride, as sodium fluoride. Each 1 g of toothpaste contains 5 mg fluoride (as sodium fluoride), which is 5,000 ppm fluoride.
The other ingredients (excipients) are: Sorbitol solution (non – crystallising) (E420), dental type silica (precipitated) (E551), macrogol 600 (E1521), tetrapotassium pyrophosphate (E340), xanthan gum (E415), sodium benzoate (E211), sodium laurilsulfate, spearmint flavouring (containing menthol, propylene glycol, carvone, spearmint oil, peppermint oil, anethole, and vanillin), saccharin sodium (E954), brilliant blue FCF (E133) and purified water. What Fluoride Toothpaste looks like and contents of the pack Fluoride Toothpaste is a smooth, blue coloured translucent paste with the odour and taste of spearmint. It is supplied in a 51 g collapsible tube enclosed in an outer carton. Marketing Authorisation Holder: Morningside Healthcare Ltd., Unit C, Harcourt Way, Leicester, LE19 1WP, UK Manufacturer: Morningside Pharmaceuticals Ltd., 5 Pavilion Way, Loughborough, LE11 5GW, UK This leaflet was last revised in 10/2020.
Frequently asked questions about Fluoride 5000 ppm Toothpaste
What is the active substance in Fluoride 5000 ppm Toothpaste?
The active substance in Fluoride 5000 ppm Toothpaste is sodium fluoride.
Are there equivalent medicines to Fluoride 5000 ppm Toothpaste?
Medicines with the same active substance, strength and form include: Fluoride 2800 ppm Toothpaste. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Fluoride 5000 ppm Toothpaste, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Fluoride 5000 ppm Toothpaste without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: sodium fluoride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Fluoride 5000 ppm Toothpaste is indicated in adults and adolescents aged 16 years and over.
Prevention of dental caries in adolescents and adults, particularly amongst patients at risk from multiple caries (coronal and / or root caries).
4.2. Posology and method of administration
Paediatric population:
Fluoride 5000 ppm Toothpaste is contraindicated in children and adolescents aged under 16 years, see section 4.3.
Adult and adolescents and children aged 16 years or more:
To be used three times daily, after each meal., while brushing the teeth.
Brush carefully, on a daily basis, three times daily, following each meal:
- Apply a 2 cm ribbon of toothpaste onto the toothbrush for each brushing. A 2 cm ribbon provides between 3 mg and 5 mg of fluoride.
- Brush teeth vertically, from the gum to the tip of the teeth
- Careful brushing takes approximately three minutes
Not to be swallowed.
Method of administration
For dental use.
For oromucosal use only.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Use by children and adolescents aged under sixteen years, see section 4.2.
4.4. Special warnings and precautions for use
This toothpaste has a high fluoride content. Therefore, the opinion of a dental specialist must be sought before the product is used.
An increased number of potential fluoride sources may lead to fluorosis. In order to prevent the accumulation of fluoride, the total fluoride intake must be assessed before this fluoride toothpaste is ever used. Fluoride tablets, drops, chewing gum, gel or varnishes, and fluoridted water or salt should be avoided during use of Fluoride 5000 ppm Toothpaste.
When carrying out overall calculations of the recommended fluoride ion intake, which is 0.05 mg / Kg body weight per day from all sources, not exceeding 1 mg per day, allowance must be made for possible ingestion of toothpaste (each 51 g tube of Fluoride 5000 ppm Toothpaste contains 225 mg of fluoride ions).
This product contains sodium benzoate. Sodium benzoate is a mild irritant to the skin, eyes, and mucous membrane.
This product contains sorbitol solution. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
This product contains propylene glycol. Propylene glycol may cause skin irritation.
Paediatric population
This product should not be used by children and adolescents aged under sixteen years, see sections 4.2 and 4.3.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is no adequate data from the use of Fluoride 5000 ppm Toothpaste in pregnant women. Studies in animals have shown reproductive toxicity of sodium fluoride only when administered at very high levels (see section 5.3). Therefore this toothpaste should not be used during pregnancy unless careful risk – benefit assessment has been carried out.
Breast-feeding
There is no adequate data from the use of Fluoride 5000 ppm Toothpaste in lactating women, and it is unknown if fluoride is excreted in breast milk. Therefore this toothpaste should not be used during lactation unless careful risk – benefit assessment has been carried out.
Fertility
There is no adequate data on the use of Fluoride 5000 ppm Toothpaste and effects on fertility. Studies in animals have shown reproductive toxicity of sodium fluoride only when administered at very high levels (see section 5.3).
4.7. Effects on ability to drive and use machines
Fluoride 5000 ppm Toothpaste has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Gastrointestinal disorders:
Frequency not known (cannot be estimated from the available data): burning oral sensation
Immune system disorders:
Rare (> 1/10,000, < 1/1,000): hypersensitivity reactions
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system, the Yellow card scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Acute Intoxication:
The toxic dose, i.e the lowest dose at which symptoms of intoxication can be induced, is 5 mg fluoride per Kg body weight. Such intoxication appears in the form of digestive problems: vomiting, diarrhoea, abdominal pain. In extremely rare cases it can prove fatal.
Treatment: where a substantial quantity of the medicinal product is ingested accidentally, the patient will need to undergo gastric lavage immediately, or vomiting will need to be induceed; calcium needs to be taken (large amount of milk), and the patient will require to be kept under medical observation for several hours.
Chronic Intoxication (Fluorosis):
The dental enamel will take on a stained or speckled appearance once a fluoride dosage in excess of 1.5 mg per day is absorbed daily over several months or years, depending on the extent of overdose. This will be accompanied by increased enamel fragility in severe forms. Bone fluorosis (osteosclerosis) will only be seen where there is high chronic absorption of fluoride (over 8 mg daily).
💬 Ask about this leaflet
Ask anything about Fluoride 5000 ppm Toothpaste. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.