Sensodyne Mint

1. Name Of The Medicinal Product

Macleans Sensitive/Sensodyne Mint

2. Qualitative And Quantitative Composition

Macleans Sensitive/Sensodyne Mint contains the active ingredients Strontium acetate hemihydrate 8.0% w/w and Sodium Fluoride 0.23% w/w (1040 ppm fluoride).

For excipients, see 6.1.

3. Pharmaceutical Form

Toothpaste

4. Clinical Particulars

4.1 Therapeutic Indications

Macleans Sensitive/Sensodyne Mint is recommended for the relief of tooth sensitivity and the prevention of dental caries.

4.2 Posology And Method Of Administration

For external administration to the teeth.

To be used in the normal manner of toothpastes, morning and night.

Not to be used by children under 7 years unless recommended by a dentist.

4.3 Contraindications

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

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

At the active ingredient levels in the toothpaste, no interactions are expected.

4.6 Pregnancy And Lactation

No adverse effects known.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

When used in the normal manner of toothpastes the product is not expected to cause side-effects, except rarely allergic reactions of a non-serious nature.

4.9 Overdose

No symptoms of strontium acetate hemihydrate overdose are known.

Theoretically, acute overdosage is possible in children but symptoms of fluoride toxicity would only arise after ingestion of large quantities of the product. Symptoms may include salivation, nausea, vomiting and diarrhoea.

Treatment would be by provision of a calcium containing drink e.g. milk or lime water.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Strontium acetate hemihydrate desensitises dentine. Sodium fluoride is a well known anti-caries agent.

5.2 Pharmacokinetic Properties

Not applicable as the product activity is by local action in the oral cavity only.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glycerol

Sorbitol liquid (non-crystallising)

Xanthan Gum

Silica, Dental Type

Precipitated Silica

Sodium N-Methy-N-Cocoyl Taurate

Titanium Dioxide (E171)

Flavour

Saccharin Sodium

Sodium Methy-p-Hydroxybenzoate (E219)

Sodium Propyl-p-Hyrdroxybenzoate (E217)

Purified Water

Composition of Flavour

Peppermint Oil

Menthol

Anethole

L-Carvone

L-Menthyl Acetate

Limonene

Eucalyptol

L-Menthone

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

1. Aluminium laminate tube with either a plain plastic screw-threaded cap or a plastic screw-threaded cap with a flip-top lid containing 17, 25, 45, 50, 55, 75 or 125 ml. Tubes may be contained in an outer box-board carton.

2. Plastic barrier laminate flexible tube with either a plain plastic screw-threaded cap or a plastic screw-threaded cap with a flip-top lid containing 17, 25, 45, 50, 55, 75 or 125 ml. Tubes may be contained in an outer box-board carton.

3. Polypropylene pump pack with a polyethylene piston and a polypropylene cap. The pack is covered with a tamper-evident, shrink-wrap seal. The pump contains 100ml of toothpaste.

6.6 Special Precautions For Disposal And Other Handling

None.

Administrative Data

7. Marketing Authorisation Holder

Beecham Group plc

980 Great West Road

Brentford

Middlesex TW8 9GS

U.K.

Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.

8. Marketing Authorisation Number(S)

PL 00079/0225

9. Date Of First Authorisation/Renewal Of The Authorisation

7 March 1986 / 19 April 1993 / 26 November 1998

10. Date Of Revision Of The Text

June 2007