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LOCKETS CRANBERRY AND BLUEBERRY

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Lockets Cranberry and Blueberry

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Menthol BP 0.22% Eucalyptol BPC (1979) 0.21%

3

PHARMACEUTICAL FORM
Lozenge

4
4.1

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

4.2

Posology and method of administration Oral administration. One lozenge to be taken as required. Do not exceed a dose in any 24 hours of 3 packs for adults, 2 packs for children 6 to 12 years old or 1 pack for children 3 to 6 years old.

4.3

Contraindications The product should be contra-indicated in patients who are sensitive to menthol and/or eucalyptol.

4.4

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

4.5

Interaction with other medicinal products and other forms of interaction No interactions are known.

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
Use of this product will not affect the ability to drive/supervise machinery

4.8

Undesirable effects Dermatitis has been reported. Under rare conditions, apnoea in infants, following local application of menthol to their nostrils has been reported, particularly in overdose situations.

4.9

Overdose An overdose of menthol may cause severe abdominal pain, nausea, vomiting, vertigo, ataxia, drowsiness and even coma. 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. Glycerol is readily absorbed from the gastrointestinal tract and undergoes extensive metabolism, principally in the liver. Glycerol may be utilised in the synthesis of lipids, metabolised to either glucose or glycogen, or oxidised to carbon dioxide and water. It may also be excreted unchanged in the urine.

5.3

Preclinical safety data No relevant safety data available.

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients
Sucrose Glucose Syrup Citric Acid Anhydrous Elderberry Juice (natural colour) Lemon Oil (natural) Grapefruit Oil (natural) Lime Oil (natural) Cranberry Flavour (natural) Blueberry Flavour (natural) Pomegranate Flavour (natural) Lemon Flavour (natural) Propylene Glycol Ascorbic Acid (Vitamin C) Honey Glycerol 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 35433/0005

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
7th July1993

10

DATE OF REVISION OF THE TEXT

16/10/2012

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