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STREPSILS STRAWBERRY SUGAR FREE LOZENGES

Active substance(s): AMYLMETACRESOL / DICHLOROBENZYL ALCOHOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Strepsils Strawberry Sugar Free Lozenges

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredients Amylmetacresol EP 0.6mg/lozenge 2,4-Dichlorobenzyl alcohol 1.2mg/lozenge

3

PHARMACEUTICAL FORM
Lozenge

4
4.1

CLINICAL PARTICULARS
Therapeutic indications As an antiseptic for the relief of sore throat and its associated pain.

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 Strepsils Strawberry Sugar Free Lozenges are contraindicated in persons who have previously shown hypersensitivity to any of the ingredients. The product contains a small amount of butylated hydroxyanisole (BHA; E320)

4.4

Special warnings and precautions for use Keep all medicines out of the reach and sight of children. Not to be given to children under 6 years. If symptoms persist consult your doctor. Warning, Do not exceed the stated dose. Consult your doctor if symptoms persist or are accompanied by a high fever or headache. Contains isomaltitol and maltitol syrup, which may have a mild laxative effect if several are taken a day. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

4.5

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

4.6

Pregnancy and lactation The product is not contraindicated during pregnancy and lactation. However, as with all medicines during this period, caution should be exercised.

4.7

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

4.8

Undesirable effects Occasional hypersensitivity reactions.

4.9

Overdose In view of the nature and presentation of Strepsils Strawberry Sugar Free Lozenges, accidental or deliberate overdosage is highly unlikely. Overdosage should not present a problem other than gastrointestinal discomfort. Treatment should be symptomatic.

5
5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties 2,4-Dichlorobenzyl alcohol and amylmetacresol have antiseptic properties.

5.2

Pharmacokinetic properties

No data available.

5.3

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

6. 6.1.

PHARMACEUTICAL PARTICULARS List of excipients Flav P Strawberry Flavour Anthocyanins (E163) Saccharin sodium Ph Eur (E954) Tartaric acid Ph Eur Isomalt (Isomaltitol E953) Maltitol syrup (E965)

6.2

Incompatibilities Not applicable

6.3

Shelf life 2 years

6.4

Special precautions for storage Do not store above 25C

6.5

Nature and contents of container
The lozenges are contained in a strip pack containing either 6, 8, 12, 16, 20, 24, 32 or 36 lozenges packed into a cardboard carton. The lozenges are contained in a strip pack containing 8 lozenges packed into a wrap around cardboard carton with tamper-evident seal. Not all pack sizes may be marketed.

6.6

Special precautions for disposal None

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0395

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/04/2010

10

DATE OF REVISION OF THE TEXT
10/12/2012

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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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