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GlaxoSmithKline Consumer Healthcare
980 Great West Road, Brentford, Middlesex, TW8 9GS
Telephone: +44 (0)20 8047 5000
Medical Information Direct Line: +44 (0)20 8047 2500
Medical Information e-mail: customer.relations@gsk.com
Customer Care direct line: +44 (0)20 8047 2700
Medical Information Fax: +44 (0)20 8047 6860

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Summary of Product Characteristics last updated on the eMC: 12/01/2012
SPC Sensodyne Total Care F


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1. NAME OF THE MEDICINAL PRODUCT

Sensodyne Total Care F Toothpaste


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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


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3. PHARMACEUTICAL FORM

Toothpaste.

White paste.


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4. CLINICAL PARTICULARS

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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.


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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.


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4.3 Contraindications

Sensitivity to any of the active ingredients or excipients.


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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.


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4.5 Interaction with other medicinal products and other forms of interaction

None known.


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4.6 Pregnancy and lactation

No adverse effects known.


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4.7 Effects on ability to drive and use machines

None known.


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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.


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4.9 Overdose

No symptoms of overdose are known.


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5. PHARMACOLOGICAL PROPERTIES

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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.


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5.2 Pharmacokinetic properties

The product is applied topically and so the pharmacokinetics of the active ingredients are not relevant to its efficacy.


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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.


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6. PHARMACEUTICAL PARTICULARS

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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


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6.2 Incompatibilities

None known.


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6.3 Shelf life

24 months

Shelf-life after opening: 6 months


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6.4 Special precautions for storage

Store below 30°C.


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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.


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6.6 Special precautions for disposal and other handling

None.


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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.


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00036/0103


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15/08/2007


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10. DATE OF REVISION OF THE TEXT

24/06/2011



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/22737/SPC/


Active Ingredients/Generics

 
  sodium fluoride
  potassium nitrate