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ERNEST JACKSON ANTISEPTIC THROAT LOZENGES

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Ernest Jackson Antiseptic Throat Lozenges

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION 0.012% w/w 0.023% w/w

Amylmetacresol 2,4 dichlorobenzyl alcohol

Excipient: sucrose/liquid glucose solids 2.4 g For full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Lozenge. Red, cylindrical lozenge.

4
4.1

CLINICAL PARTICULARS
Therapeutic indications For the symptomatic relief of sore throats, coughs and colds.

4.2

Posology and method of administration ADULT, ELDERLY AND CHILDREN OVER 12 YEARS : One lozenge to be sucked slowly every hour until relief is obtained Do not take more than 24 lozenges in 24 hours.

CHILDREN 6 TO 12 YEARS : One lozenge to be sucked slowly every two hours until relief is obtained. Do not take more than 12 lozenges in 24 hours. Do not give to children to children under 6 unless on medical advice. For oral administration.

4.3

Contraindications Patients with known hypersensitivity to amylmetacresol, 2,4 dichlorobenzyl alcohol or other product ingredients.

4.4

Special warnings and precautions for use If symptoms worsen consult your doctor. Keep medicines out of reach and sight of children. Restricted by age in any 24 hour period. Contains a total of 2.4g of sucrose and liquid glucose solids per lozenge. Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction There are no known interactions between the active ingredients and other drugs. Menthol is incompatible with oxidising agents.

4.6

Pregnancy and lactation There is no data to contraindicate the use of the active ingredients or menthol during pregnancy.

4.7

Effects on ability to drive and use machines None.

4.8

Undesirable effects None when used at the dosage advised.

4.9

Overdose Overdose due to menthol is very unlikely unless the product is grossly abused. Overdose may cause irritation of the urinary tract and aggravation of preexisting inflammatory conditions. Severe poisoning may cause the CNS to be depressed, leading to stupor and respiratory failure, or leading to excitement and convulsions. In acute poisoning the stomach may be emptied by aspiration and lavage. Give a saline purgative such as sodium sulphate, 30g in 250ml of water, unless catharsis is already present. Demulcent drinks may be given and large volumes of fluid should be given, provided renal function is adequate.

5
5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties ATC Code: R02AA20. Both amylmetacresol and 2,4 dichlorobenzyl alcohol are antiseptic agents. The base has demulcent properties.

5.2

Pharmacokinetic properties No product specific data is available.

5.3

Preclinical safety data There is no preclinical data available specific to the product.

6
6.1

PHARMACEUTICAL PARTICULARS
List of excipients Glucose Sucrose Carmine E120 Citric Acid Monohydrate Star Anise Oil Levomenthol Cherry Flavour A 727 Propylene Glycol Water

6.2

Incompatibilities None known.

6.3

Shelf life 2 years for the unopened pack.

6.4

Special precautions for storage Do not store above 25 C.

6.5

Nature and contents of container Lozenges in blisters, lidded with foil, contained within a carton printed with full details. Pack sizes: 6, 12, 14, 16, 20, 24, 30, 36. Not all pack sizes may be marketed.

6.6

Special precautions for disposal None specific to the product or pack.

7

MARKETING AUTHORISATION HOLDER
Ernest Jackson & Co Ltd High Street Crediton Devon EX17 3AP, UK

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MARKETING AUTHORISATION NUMBER(S)
PL 0094/0252

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/05/2010

10

DATE OF REVISION OF THE TEXT
21/05/2010

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