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Sensodyne Original

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Sensodyne Original

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Strontium chloride hexahydrate, 10% w/w For excipients, see 6.1

3    PHARMACEUTICAL FORM

Toothpaste

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Relief from the pain of dentine sensitivity.

4.2.    Posology and method of administration

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

Hypersensitivity to the active ingredients or to any of the other constituents.

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.

This product does not contain fluoride. Consult your dentist in the event of continuous 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.

4.9 Overdose

No symptoms of Sensodyne overdose are known.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Dentine sensitivity results from exposure of dentinal tubules to external stimuli. The hydrodynamic theory proposes that fluid movement within tubules stimulates mechanoreceptors in or near the pulp, causing pain. It is postulated that Sensodyne Original relieves pain by reducing fluid movement by occlusion of the tubules.

5.2 Pharmacokinetic properties

Sensodyne Original is applied topically and so the pharmacokinetics of strontium chloride hexahydrate are not relevant to its efficacy.

5.3 Preclinical safety data

None stated.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Purified Water Glycerol

Sorbitol Liquid (non-crystallising)

Calcium carbonate Hydroxyethylcellulose Colloidal Anhydrous Silica Sodium Methyl Cocoyl Taurate Polyoxyl 40 stearate Titanium dioxide Sodium saccharin

F, D & C Red no. 3 (E127, Erythrosine)

Flavour mix constituents:

Spearmint oil Peppermint oil Levomenthol Methyl Salicylate Oil of Cassia

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Store below 25°C

6.5 Nature and contents of container

Sensodyne Original will be packaged in the following containers and pack sizes.

Container    Pack size (ml)

Plastic laminate tube with full    45, 50, 75, 100

diameter cap and tamper evident nozzle seal

Aluminium Barrier Laminate tube with    45, 50, 75, 100

full diameter cap

Cross promotional pack containing    75

plastic laminate tube and Sensodyne toothbrush

6.6 Special precautions for disposal

Not appropriate.

7 MARKETING AUTHORISATION HOLDER

Stafford Miller Limited 980 Great West Road Brentford, Middlesex TW8 9GS

UNITED KINGDOM

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Trading as: GlaxoSmithkline Consumer Healthcare, Brentford, TW8 9GS, UK


MARKETING AUTHORISATION NUMBER(S)

PL 00036/5011R


DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

23 April 1991 / 12 March 1997


DATE OF REVISION OF THE TEXT

11/04/2013