SUMMARY OF PRODUCT CHARACTERISTICS

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(l040 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.

Use twice a day and not more than three times, in place of ordinary toothpaste. Minimise swallowing and spit out.

Not to be used by children under 12 years of age unless on advice of a dental professional or doctor.

4.3 Contra-Indications

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.

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 Interactions 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

Minor local irritations. 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.

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

Hydrated Silicon Dioxide

Silica, Dental Type

Sodium N-Methy-N-Cocyl 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 125ml. Tubes may be contained in an outer box-board carton.

2    Plastic barrier laminate flexible tube with either a plain screw-threaded cap or a plastic srew-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 Instruction for Use, Handling and Disposal

None.

MARKETING AUTHORISATION HOLDER

Beecham Group plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom

Trading as:

GlaxoSmithKline Cosumer Healthcare

Brentford

TW8 9GS

U.K.

8. MARKETING AUTHORISATION NUMBER(S)

PL 00079/0225

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

7^th March 1986 / 19^th April 1993 / 26^th November 1998

10 DATE OF REVISION OF THE TEXT

18/12/2013