Sensodyne Original / Sensodyne Toothpaste: Original Flavour 10% w / w

1. Name Of The Medicinal Product

Sensodyne Original / Sensodyne Toothpaste: Original Flavour 10% w/w

2. Qualitative And Quantitative Composition

Strontium chloride hexahydrate, 10% w/w

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

To be used 2-4 times daily, in place of ordinary toothpaste

4.3 Contraindications

None

4.4 Special Warnings And Precautions For Use

Sensitive teeth may indicate an underlying problem which needs prompt care by a dentist.

Dental advice should be sought as soon as possible after the problem develops.

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

None known

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

Hydroxyethyl cellulose

Silica, colloidal anhydrous

Sodium methyl cocoyl taurate

Polyoxyl 40 stearate

Titanium dioxide

Sodium saccharin

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

Flavour

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 diameter cap and tamper evident nozzle seal	45, 50, 75, 100
Aluminium Barrier Laminate tube with full diameter cap	45, 50, 75, 100
Cross promotional pack containing plastic laminate tube and Sensodyne	75

6.6 Special Precautions For Disposal And Other Handling

Not appropriate

Administration Data

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, UK

8. Marketing Authorisation Number(S)

PL 0036/5011R

9. Date Of First Authorisation/Renewal Of The Authorisation

23 April 1991

10. Date Of Revision Of The Text

27 March 2009