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STREPSILS CHILDREN 6+ ORANGE FLAVOUR LOZENGES

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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Strepsils Children 6+ Orange Flavour Lozenges

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Amylmetacresol 0.6mg 2,4-Dichlorobenzyl Alcohol 1.2mg Ascorbic acid and sodium ascorbate equivalent to 100.0mg ascorbic acid Excipients Also contains Ponceau 4R (E124) 0.01mg/lozenge For full list of excipients, see section 6.1

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PHARMACEUTICAL FORM
Orange flavoured and coloured circular lozenge. Strepsils brand icon is intagliated on both sides.

4
4.1

CLINICAL PARTICULARS
Therapeutic indications
For the symptomatic relief of mouth and throat infections.

4.2

Posology and method of administration
For oral administration. Adults and children (over 6 years old): One lozenge to be dissolved slowly in the mouth every 2-3 hours up to a maximum of 12 lozenges in 24 hours.

Not suitable for children under 6 years. Elderly: There is no need for dosage reduction in the elderly.

4.3

Contraindications
Hypersensitivity to any of the ingredients.

4.4

Special warnings and precautions for use
Keep all medicines out of the reach of children. If symptoms persist consult your doctor. Also Contains Ponceau 4R (E124) which may cause allergic reactions.

4.5

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

4.6

Fertility, pregnancy and lactation
The safety of Strepsils Children 6+ Orange Lozenges has not been established, but it is not considered to constitute a hazard.

4.7

Effects on ability to drive and use machines
No adverse effects are known.

4.8

Undesirable effects
Occasionally hypersensitivity reactions.

4.9

Overdose
Overdosage should not present a problem other than gastrointestinal discomfort. Treatment should be symptomatic.

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5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
2,4-Dichlorobenzyl alcohol and amylmetacresol have antiseptic properties. Ascorbic acid provides a source of Vitamin C, which may be beneficial during infection when vitamin C levels are believed to fall.

5.2

Pharmacokinetic properties
None stated.

5.3

Preclinical safety data
None available.

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients
Levomenthol Tartaric acid Bloodorange flavour Propylene glycol Sunset yellow FCF (E110) Ponceau 4R (E124) Sucrose Liquid glucose

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
36 months for lozenges packed in blister strips within a carton. 18 months for blister packs attached to a stencilled card. 24 months for lozenges packed in polypropylene tube, with an in-use shelf life of use within 3 months of opening.

6.4

Special precautions for storage
Do not store above 25C.

6.5

Nature and contents of container
A blister push-through pack consisting of hard temper aluminium foil heat-sealed to a PVC/PVDC blister. The tray contains an appropriate number of lozenges to give pack sizes of 6, 8, 10, 12, 16,20, 24, 32 and 36 lozenges in a cardboard carton. A blister push-through pack consisting of hard temper aluminium foil heat-sealed to a PVC/PVDC blister. Two, four or six blisters are attached to a stencilled card. A blister push-through pack consisting of hard temper aluminium foil heat-sealed to a PVC/PVDC blister. The tray contains an appropriate number of lozenges to give pack sizes of 8 lozenges in a wrap-round cardboard carton with tamper-evident seal. An injection moulded white pigmented polypropylene tube with an injection moulded white polyethylene cap (containing white silica gel that is sealed with a white cardboard disc). The tube contains 10 lozenges.

6.6

Special precautions for disposal
Not applicable.

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MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Ltd Slough SL1 3UH

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MARKETING AUTHORISATION NUMBER(S)
PL 00063/0708

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
13/11/2012

10

DATE OF REVISION OF THE TEXT
13/11/2012

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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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