Tuesday, September 13, 2016

Sensodyne Total Care F





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 2-4 times a day, in place of ordinary toothpaste.



4.3 Contraindications



Sensitivity to any of the active ingredients or excipients.



4.4 Special Warnings And Precautions For Use



Sensitive teeth may indicate an underlying problem which needs prompt care by a dentist. See your dentist as soon as possible for advice.



For children under 6, use a pea-sized amount and supervise brushing to minimise swallowing.



If using fluoride supplements consult your dentist.



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



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.



The antibacterial formulation contains potassium ions which are thought to reduce hypersensitivity by interfering with pulpal nerve conduction.



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




Pack sizes (ml)




Decorated Polyethylene plastic barrier laminate tubes with a full diameter polypropylene cap with or without an aluminium or metallised PET tamper evident nozzle seal




20, 45, 50, 75, 100




Decorated aluminium laminate tubes with or without an aluminium or metallised PET tamper evident nozzle seal




20, 45, 50, 75, 100




Polypropylene decorated, pump actuated, tamper evident dispenser




100



Not all pack sizes may be marketed.



6.6 Special Precautions For Disposal And Other Handling



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



23/03/2011




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