- Approval Id
- 2e01e7b33b6cbfb0
- Drug Approval Emc Name
- Fluoride 2800 ppm Toothpaste
- Drug Name
- Fluoride 2800 ppm Toothpaste
- Company Address
- Morningside House, Unit C Harcourt Way, Meridian Business Park, Leicester, LE19 1WP
- Company Website
- http://www.morningsidehealthcare.com
- Company Telephone
- +44 (0)116 204 5950
- Company Medical Info Direct Line
- +44 (0)116 478 0322
- Company Medical Info Email
- medicalenquiry@morningsidehealthcare.com
- Company Customer Care Direct Line
- +44 (0)116 204 5950
- Company Stock Availability
- +44 (0)1509 217 705
- Atc Code
- A01AA01
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Morningside Healthcare Ltd.
Unit C, Harcourt Way,
Leicester,
LE3 1WP
United Kingdom
- Authorisation Number
- PL 20117/0239
- Authorisation Date
- 10/12/2014
- Instruction Authorisation Holder
- Morningside Healthcare Ltd.
Unit C, Harcourt Way,
Leicester,
LE3 1WP
United Kingdom
- Instruction Authorisation Number
- PL 20117/0239
- Instruction Authorisation Date
- 10/12/2014
- Instruction Composition
- 1 g of toothpaste contains contains 2.8 mg fluoride (as sodium fluoride), corresponding to 2800 ppm fluoride, sodium fluoride 0.619 % w/w.
\*\*Excipient(s) with known effect\*\*:
Sorbitol solution (non-crystallising)
Propylene glycol
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Toothpaste.
For dental use.
Smooth, white coloured paste with the odour and taste of spearmint.
- Instruction Clinical Particulars
- 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
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
\*\*Pharmacotherapeutic group:\*\* caries prophylactic agents
\*\*ATC code:\*\* A01AA01
This product is a toothpaste in which the active ingredient is sodium fluoride present at a level of 0.619 % w/w, which corresponds to 280 mg fluoride per 100 g toothpaste.
Sodium fluoride applied topically after tooth eruption reduces caries by inhibiting demineralisation and promoting remineralisation of the tooth surface. It is effective on both enamel and exposed dentine.5.2 Pharmacokinetic properties
This product is not intended to be swallowed and therefore only minimal systemic exposure is expected.5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
After oral administration of sodium fluoride to mice, rates and rabbits, reproductive and foeto–toxic effects were observed only at high dose levels.
The total amount of fluoride in a 75 ml tube of Fluoride 2800 ppm Toothpaste is about 620 mg which equates to 280 mg fluoride. This is within the acceptable limits for the amount to be supplied at one time for safety purposes.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Sorbitol solution (non-crystallising), E420
Glycerol, E422
Dental type silica (precipitated), E551
Macrogol 600, E1521
Sodium laurilsulphate
Carmellose sodium, E466
Sodium saccharin, E954
Titanium dioxide, E171
Mint flavour (947093 Optamint Spearmint) containing menthol, propylene glycol, spearmint oil, carvone, anethol, ethyl maltol, vanillin
Purified water6.2 Incompatibilities
Not applicable.6.3 Shelf life
Thirty six (36) months unopened.
6 months after opening.6.4 Special precautions for storage
This product requires no special storage conditions.6.5 Nature and contents of container
Polyethylene/copolymer/aluminium/copolymer/polyethylene laminated tube with a polypropylene flip top closure. 75ml.6.6 Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
- Instruction Content
- ## Composition
1 g of toothpaste contains contains 2.8 mg fluoride (as sodium fluoride), corresponding to 2800 ppm fluoride, sodium fluoride 0.619 % w/w.
\*\*Excipient(s) with known effect\*\*:
Sorbitol solution (non-crystallising)
Propylene glycol
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Toothpaste.
For dental use.
Smooth, white coloured paste with the odour and taste of spearmint.
## Clinical Particulars
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
## Pharmacological Properties
5.1 Pharmacodynamic properties
\*\*Pharmacotherapeutic group:\*\* caries prophylactic agents
\*\*ATC code:\*\* A01AA01
This product is a toothpaste in which the active ingredient is sodium fluoride present at a level of 0.619 % w/w, which corresponds to 280 mg fluoride per 100 g toothpaste.
Sodium fluoride applied topically after tooth eruption reduces caries by inhibiting demineralisation and promoting remineralisation of the tooth surface. It is effective on both enamel and exposed dentine.5.2 Pharmacokinetic properties
This product is not intended to be swallowed and therefore only minimal systemic exposure is expected.5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
After oral administration of sodium fluoride to mice, rates and rabbits, reproductive and foeto–toxic effects were observed only at high dose levels.
The total amount of fluoride in a 75 ml tube of Fluoride 2800 ppm Toothpaste is about 620 mg which equates to 280 mg fluoride. This is within the acceptable limits for the amount to be supplied at one time for safety purposes.
## Pharmaceutical Particulars
6.1 List of excipients
Sorbitol solution (non-crystallising), E420
Glycerol, E422
Dental type silica (precipitated), E551
Macrogol 600, E1521
Sodium laurilsulphate
Carmellose sodium, E466
Sodium saccharin, E954
Titanium dioxide, E171
Mint flavour (947093 Optamint Spearmint) containing menthol, propylene glycol, spearmint oil, carvone, anethol, ethyl maltol, vanillin
Purified water6.2 Incompatibilities
Not applicable.6.3 Shelf life
Thirty six (36) months unopened.
6 months after opening.6.4 Special precautions for storage
This product requires no special storage conditions.6.5 Nature and contents of container
Polyethylene/copolymer/aluminium/copolymer/polyethylene laminated tube with a polypropylene flip top closure. 75ml.6.6 Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
- Company Detail Path
- /organization/morningside-healthcare-ltd
