Sensodyne Total Care F Toothpaste
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sensodyne Total Care F Toothpaste
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Nitrate 5.0% w/w Sodium Fluoride 0.306% w/w For full list of excipients see 6.1
3 PHARMACEUTICAL FORM
Toothpaste.
White paste.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Relief from the pain of dentinal sensitivity, an aid for the prevention of dental caries. Prevention of the pain of dentinal hypersensitivity.
Ongoing protection from dentinal hypersensitivity.
4.2. Posology and method of administration
For dental use.
For oromucosal use only.
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.
Contraindications
4.3
Sensitivity 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
No adverse effects known.
4.7 Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
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.
5.1 Pharmacodynamic properties
ATC Code Sodium Fluoride: A01AA01 ATC Code Potassium Nitrate: Not assigned.
The antibacterial formulation contains potassium ions which are thought to reduce hypersensitivity by interfering with pulpal nerve conduction. With twice daily tooth brushing, Sensodyne Total Care F Toothpaste delivers the regular doses of potassium ions required to build up and then maintain its depolarising activity, thereby providing ongoing protection from, and prevention of dentinal hypersensitivity. Once regular use is discontinued, the desensitising activity of the potassium ions within the dentine tubules will slowly be lost and sensitivity pain will return.
It also contains sodium fluoride which is an established anticaries agent.
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
Sorbitol
Glycerol
Silica, Dental Type Purified Water Sodium Laurilsulfate Titanium Dioxide (E 171)
Saccharin Sodium Mint Flavour 826473
Cocamidopropyl Betaine Xanthan Gum Macrogol
6.2 Incompatibilities
None known.
6.3 Shelf life
24 months
Shelf-life 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:
Container
Decorated aluminium laminate tubes with or without an aluminium or metallised PET tamper evident nozzle seal.
Pack sizes (ml)
20, 45, 50, 75, 100
Container
Polypropylene decorated, pump actuated, tamper evident dispenser. Pack size (ml)
100
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
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 00036/0103
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15/08/2007
10 DATE OF REVISION OF THE TEXT
05/12/2013