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:
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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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