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STREPSILS LOZENGE

Active substance(s): 2 4-DICHLOROBENZYL ALCOHOL / AMYLMETACRESOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Strepsils

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Amylmetacresol BP 2,4-Dichlorobenzyl alcohol HSE 0.6mg 1.2mg

3

PHARMACEUTICAL FORM
A red circular lozenge.

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.

4.5

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

4.6

Pregnancy and lactation The safety of Strepsils Original Flavour has not been established, but is not expected to constitute a hazard.

4.7

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

4.8

Undesirable effects Occasional hypersensitivity reactions.

4.9

Overdose 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

None available.

5.3

Preclinical safety data None available.

6
6.1

PHARMACEUTICAL PARTICULARS
List of excipients Star anise oil, peppermint oil, menthol natural or menthol synthetic, tartaric acid gran 571 GDE, ponceau 4R edicol E124, carmoisine edicol E122, solids from liquid sugar demin, (or from liquid sugar T & L T1001) and from liquid glucose, water (potable).

6.2

Incompatibilities Not applicable.

6.3

Shelf life 36 months for lozenges packed in blister strips within a carton. 24 months for blister packs attached to a stencilled card.

6.4

Special precautions for storage Do not store above 25 C.

6.5

Nature and contents of container A blister push-through pack consisting of 15 or 20 m hard temper aluminium foil heat-sealed to a 250 m PVC/40gms PVDC blister. The tray contains an appropriate number of lozenges to give pack sizes of 6, 8, 10, 12, 16, 20, 24, 32, 36 and 720 lozenges in a cardboard carton or a flow wrap composed of PET/aluminium foil/polyethylene. A blister push-through pack consisting of 15 or 20 m hard-temper aluminium foil heat-sealed to a 250 m PVC/40gms PVDC blister. Two, four or six blisters are attached to a stencilled card. Jar of polypropylene/ethyl-vinyl hydroxide (EVOH) barrier/ polypropylene laminate with a polypropylene cap fitted with an aluminium faced pulpboard liner, or a HDP jar with a tinplate cap fitted with an aluminium faced pulpboard liner. Pack size 1800 lozenges.
A blister push-through pack consisting of 15 or 20 m hard temper aluminium foil heat-sealed to a 250 m PVC/40gms PVDC blister. The tray contains an appropriate number of lozenges to give a pack size of lozenges in a wrap around cardboard carton with tamper-evident seal.





6.6

Special precautions for disposal Not applicable.

7

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

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MARKETING AUTHORISATION NUMBER(S)
PL 00063/0396

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19/03/2010

10

DATE OF REVISION OF THE TEXT
19/03/2010

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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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