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LEMON & HONEY THROATIES ANTI-BACTERIAL PASTILLES

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Lemon & Honey Throaties Anti-bacterial Pastilles

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION Amylmetacresol BP 0.6 mg/lozenge

3.

PHARMACEUTICAL FORM Lozenge (pastille)

4. 4.1

CLINICAL PARTICULARS Therapeutic indications For the relief of sore throat and coughs.

4.2

Posology and method of administration For oromucosal use. For Adults and children aged 3 years and over:Suck one lozenge slowly as required. Do not take more than 12 lozenges in 24 hours. Not to be given to children under 3 years. For the Elderly:The normal adult dosage may be followed.

4.3

Contra-indications Patients with hypersensitivity to any of the ingredients.

4.4

Special warnings and precautions for use

Keep out of reach and sight of children. If symptoms persist consult your doctor. Not to be given to children under 3 years. Contains a total of 2.1g of sucrose and glucose per lozenge. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 4.5 Interactions with other medicinal products and other forms of interaction None Known

4.6.

Fertility, Pregnancy and Lactation
Pregnancy There is no or inadequate evidence of the safety of the active ingredients in this medicine in human pregnancy. The potential risk for humans is unknown. In the absence of sufficient data, the use during pregnancy is not recommended. Lactation It is not known whether the active ingredients of this product are excreted in human breast milk. In the absence of sufficient data, the use during lactation is not recommended. Fertility Studies on the effects on fertility have not been investigated.

4.7

Effects on ability to drive and use machines None known.

4.8.

Undesirable Effects
The following adverse events have been reported during post-marketing experience with amylmetacresol-containing products: Immune system disorders Frequency unknown Hypersensitivity Gastrointestinal disorders Frequency unknown Glossodynia

4.9

Overdose

Theoretically symptoms are possible in children if at least 50 lozenges (more than 4 packs) are consumed in a short space of time. In such extreme overdose, related to menthol ingestion, symptoms may include nausea and vomiting, diarrhoea, profuse sweating and intense thirst. Treatment is symptomatic.

5
5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Amylmetacresol is an antiseptic. The product base has a demulcent action.

5.2

Pharmacokinetic properties Pharmacokinetic considerations do not arise since the pharmacological action is local to the oro-pharangeal cavity and the constituents are systemically innocuous in the concentrations used.

5.3

Preclinical safety data No relevant data on the product are available.

6
6.1

PHARMACEUTICAL PARTICULARS
List of excipients Sucrose Liquid Glucose Dextrose Gelatin Honey Citric acid monohydrate Levomenthol

Oil of Lemon Honey flavour Beta-carotene Caramel E150c Carnauba wax (E903) Vegetable oil 6.2 Incompatibilities None known.

6.3

Shelf life 24 months

6.4

Special precautions for storage Do not store above 30C

6.5

Nature and contents of container Blisters of 250mic PVC coated 40gsm PVDC lidded with HT aluminium foil 20mic.1 or 2 blisters packed in secondary pack of carton or flexible laminate pack. Pack size: 8, 10, 12, 20, 24

6.6

Special precautions for disposal None specific to the pack/product

7.

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

8.

MARKETING AUTHORISATION NUMBER PL 00094/0035

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24th March 1999

10

DATE OF REVISION OF THE TEXT
07/08/2012

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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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