Potassium Nitrate And Sodium Fluoride 5/0.315% W/W Toothpaste
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Potassium Nitrate and Sodium Fluoride 5/0.315% w/w Toothpaste
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Nitrate 5.0% w/w
Sodium Fluoride 0.315% w/w (1450 ppm fluoride)
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Toothpaste
Smooth, glossy slightly milky/translucent white to cream paste at pH 7.1
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Relief of dentinal hypersensitivity Prevention of dental caries
Protection against the effects of acid erosion of tooth enamel
4.2. Posology and method of administration
For dental use.
Use twice a day and not more than three times, in place of ordinary toothpaste. Minimise swallowing and spit out.
Not for use by children under 12 years of age unless on advice of a dental professional or doctor.
4.3 Contraindications
Known allergic reactions to any of the active ingredients or excipients.
4.4. Special warnings and precautions for use
Always follow the label directions. As with any other oral care products, if irritation occurs discontinue use.
Sensitive teeth may indicate an underlying problem which needs prompt care,, if symptoms persist or worsen see your dentist.
Keep out of the reach and sight of children.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Pregnancy and lactation
None known
4.7 Effects on ability to drive and use machines
None known
Undesirable effects
4.8.
Minor local irritations. Very rarely, isolated cases of hypersensitivity type reactions such as angioedema, oral and facial swelling have been reported in patients using potassium nitrate containing toothpastes, particularly in patients who are predisposed to hypersensitivity type reactions.
4.9 Overdose
No symptoms of overdose are known
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code Sodium Fluoride: A01AA01 ATC Code Potassium Nitrate: Not assigned
Potassium ions are thought to reduce hypersensitivity by interfering with pulpal nerve conduction.
Sodium fluoride is an established anticaries agent, which prevents dental caries. Fluoride inhibits caries and acid-erosion of dental enamel and dentine by promoting tooth remineralisation/rehardening and inhibiting tooth demineralisation/enamel softening. Fluoride in the oral cavity is incorporated into hydroxyapatite in enamel to form fluoroapatite. Fluoroapatite is less soluble than hydroxyapatite and more resistant to acid attack than the original enamel that it replaces. Fluoride also inhibits the metabolism of acid-producing bacteria which are responsible for caries.
Dental type silicas act as polishing and cleaning agents to assist in the removal of food remnants from the teeth. The grade of silica in the product provides an abrasivity level which is low relative to most other toothpastes, but is within that recommended in the International Standard ISO 11609 for dentifrice products.
5.2 Pharmacokinetic properties
The product is applied topically and so the pharmacokinetics of the active ingredients are not relevant to its efficacy.
5.3 Preclinical safety data
The active ingredients in the product are commonly used and well established. Their safety is supported by numerous published studies. Many years of clinical experience with the use of these substances in man supports the opinion that they have a favourable safety profile.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Purified Water
Sorbitol, Liquid (non-crystallising)
Silica, Dental Type
Glycerol
Macrogols
Xanthan Gum
Titanium Dioxide (E171)
Cocamidopropyl Betaine Saccharin Sodium Sodium Hydroxide Mint Flavour 10926
6.2 Incompatibilities
Not applicable
Shelf life
6.3
2 years.
After opening: 6 months
6.4 Special precautions for storage
Store below 30°C
6.5 Nature and contents of container
The product will be packaged in the following containers and pack sizes:
|
Pack Type |
Pack Size (ml) |
|
Decorated polyethylene barrier laminate tube with a tamper evident foil seal and a colour cap |
45, 75, 100 |
Not all pack sizes may be marketed
6.6 Special precautions for disposal
No special precautions.
MARKETING AUTHORISATION HOLDER
7
STAFFORD MILLER LIMITED 980 GREAT WEST ROAD BRENTFORD MIDDLESEX TW8 9GS
UNITED KINGDOM
TRADING AS: GLAXOSMITHKLINE CONSUMER HEALTHCARE, BRENTFORD, TW8 9GS, U K.
8 MARKETING AUTHORISATION NUMBER(S)
PL 00036/0307
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08/12/2010
10 DATE OF REVISION OF THE TEXT
10/04/2013