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LOCKETS EXTRA STRONG

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Lockets Extra Strong

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Menthol BP 0.36% Eucalyptol BPC (1979) 0.15%

3

PHARMACEUTICAL FORM
Lozenge

4
4.1

CLINICAL PARTICULARS
Therapeutic indications For the relief of sore throats and nasal congestion.

4.2

Posology and method of administration Oral administration. Dissolve one in the mouth. Do not exceed a dose in any 24 hours of one pack for adults and older children (6 to 12 years old).

4.3

Contraindications

The product should be contra-indicated in patients who are sensitive to the active ingredients.

4.4

Special warnings and precautions for use If symptoms persist or worsen, seek medical advice.

4.5

Interaction with other medicinal products and other forms of interaction None stated.

4.6

Pregnancy and lactation There have been no reports of adverse effects when used during pregnancy either in animals or in humans.

4.7

Effects on ability to drive and use machines None stated.

4.8

Undesirable effects Dermatitis has been reported.

4.9

Overdose An overdose of menthol may cause severe abdominal pain, nausea, vomiting, vertigo, ataxia, drowsiness.

Treatment of suspected overdose should be to reduce absorption e.g. gastric lavage and provision of general supportive measures.

5
5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Menthol is reported to have a mild analgesic activity and, together with the presence of a flavoured lozenge in the mouth, promotes salivation which makes swallowing easier and subjectively relieves the symptoms of a sore throat. Whilst the lozenge dissolves, menthol vapours enter the nasal passages either via the nostrils or, on swallowing, the posterior nares. Menthol creates the sensation of increased nasal airflow via an increase in the sensitivity of the trigeminal sensory nerve endings responsible for the detection of the sensation of airflow. This provides subjective relief of nasal congestion. Eucalyptol has been taken by mouth for catarrh and coughs and is a common ingredient of many simple remedies for cough and cold relief. It is often used in combination with other volatile substances.

5.2

Pharmacokinetic properties After absorption, menthol is excreted in the urine and via the bile as the glucuronide.

5.3

Preclinical safety data No relevant safety data available.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sucrose Glucose Syrup Honey Glycerol Citric Acid Anhydrous Propylene Glycol Ascorbic Acid (Vitamin C) Water Processing aids: Talc; Medium Chain Triglycerides

6.2

Incompatibilities None known

6.3

Shelf life The shelf-life is 52 weeks.

6.4

Special precautions for storage
Sore below 30C

6.5

Nature and contents of container

Stick pack. Each sweet is individually wrapped in waxed paper. Ten wrapped sweets are together in a paper, foil, wax and tissue sealed sleeve.

6.6

Special precautions for disposal None.

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MARKETING AUTHORISATION HOLDER

The Wrigley Company Limited Estover Plymouth Devon PL6 7PR United Kingdom

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MARKETING AUTHORISATION NUMBER(S)
PL 35433/0004

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23/09/2005

10

DATE OF REVISION OF THE TEXT
16/10/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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