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 2800 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 for the treatment of tooth decay (dental caries) of the tooth crown and root, in children and adolescents aged 10 years and older. 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 a child aged under 10 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 aged under 10. 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 sorbitol solution 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.
•
3.
propylene glycol may cause skin irritation.
How to take it
Fluoride Toothpaste
Fluoride 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 Fluoride Toothpaste daily instead of your normal toothpaste. Brush carefully and thoroughly, for one minute, morning and evening: •
apply a 1 cm ribbon of toothpaste onto your toothbrush for each brushing.
•
brush your teeth vertically, from the gum to the tip of the teeth.
•
spit out excess foam and do not swallow.
Careful brushing of your teeth takes about one minute. For best results, you should 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 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
card
scheme;
website
www.mhra.gov.uk/yellowcard. By reporting 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 2.8 mg fluoride (as sodium fluoride), which is 2800 ppm fluoride.
The other ingredients (excipients) are: Sorbitol solution (non-crystallising) (E420), glycerol (E422), macrogol 600 (E1521), saccharin sodium (E954), carmellose sodium (E466), sodium laurilsulfate, silica dental type precipitated (E551), titanium dioxide (E171), mint flavouring (containing menthol, propylene glycol, spearmint oil, carvone, anethol, ethyl maltol and vanillin) and purified water. What Fluoride Toothpaste looks like and contents of the pack Fluoride Toothpaste is a smooth, white coloured paste with the odour and taste of spearmint.
It is supplied in a 75 ml 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 2800 ppm Toothpaste
What is the active substance in Fluoride 2800 ppm Toothpaste?
The active substance in Fluoride 2800 ppm Toothpaste is sodium fluoride.
Are there equivalent medicines to Fluoride 2800 ppm Toothpaste?
Medicines with the same active substance, strength and form include: Fluoride 5000 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 2800 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 2800 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 2800 ppm Toothpaste is indicated in adolescents, and children aged 10 years and over.
Prevention and treatment of dental caries (coronal and root) adolescents and children aged ten years or more.
4.2. Posology and method of administration
Posology
Paediatric population:
Fluoride 2800 ppm Toothpaste is contraindicated in children aged under 10 years, see section 4.3.
Adolescents and children aged 10 years or more:
To be used 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 after use
- For best results do not drink or rinse for 30 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 aged under ten years, see section 4.2.
4.4. Special warnings and precautions for use
Not to be swallowed.
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 75 ml tube of Fluoride 2800 ppm Toothpaste contains 280 mg of fluoride ions).
This product contains propylene glycol. Propylene glycol may cause skin irritation.
This product also contains Sorbitol solution. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Epidemiological studies in humans indicate that fluoride has no adverse effects in pregnancy or on the health of the foetus or new born child. Fluoride 2800 ppm Toothpaste can be used during pregnancy and lactation.
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 2800 ppm Toothpaste has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
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
Symptoms:
In very high doses, fluoride can have an acute toxic effect. Doses of several milligrams of fluoride per kg of body weight may cause nausea, vomiting, and diarrhoea. Tetany and convulsion can occur, as well as cardiovascular disorders.
Increased risk of bone fracture and skeletal fluorosis (stiffness of joints and skeletal deformities) will only be observed in cases of very high chronic intake of fluoride.
Management:
Treatment and management should be symptomatic.
In case of mild gastrointestinal overdose symptoms a small glass of milk to drink should be given to bind fluoride ion.
It should be noted that gut decontamination is contraindicated. Charcoal is of no benefit
💬 Ask about this leaflet
Ask anything about Fluoride 2800 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.