Sensodyne Original
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