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Reckitt Benckiser Healthcare (UK) Ltd
Freepost, RSBU-TEBT-GSTU, Reckitt Benckiser, Kingston Upon Thames, KT2 6LZ, UK
Telephone: +44 (0)500 455 456
WWW: http://www.reckittbenckiser.com
Medical Information Direct Line: +44 (0)500 455 456
Customer Care direct line: +44 (0)500 455 456

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Summary of Product Characteristics last updated on the eMC: 19/08/2010
SPC Strepsils


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1. NAME OF THE MEDICINAL PRODUCT

Strepsils


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Amylmetacresol BP

0.6mg

2,4-Dichlorobenzyl alcohol HSE

1.2mg


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3. PHARMACEUTICAL FORM

A red circular lozenge.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the symptomatic relief of mouth and throat infections.


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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.


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4.3 Contraindications

Hypersensitivity to any of the ingredients.


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4.4 Special warnings and precautions for use

Keep all medicines out of the reach of children.

If symptoms persist consult your doctor.


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4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions are known.


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4.6 Pregnancy and lactation

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


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4.7 Effects on ability to drive and use machines

No adverse effects are known.


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4.8 Undesirable effects

Occasional hypersensitivity reactions.


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4.9 Overdose

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


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

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


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5.2 Pharmacokinetic properties

None available.


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5.3 Preclinical safety data

None available.


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6. PHARMACEUTICAL PARTICULARS

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6.1 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

Liquid Sucrose

Liquid Glucose


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6.2 Incompatibilities

Not applicable.


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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.


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6.4 Special precautions for storage

Do not store above 25°C.


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6.5 Nature and contents of container

A blister push-through pack consisting of 15 or 20µm hard temper aluminium foil heat-sealed to a 250µm PVC/40gms PVDC blister. The tray contains an appropriate number of lozenges to give pack sizes of 6, 8, 10, 12, 16, 18, 20, 22, 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 20µm hard-temper aluminium foil heat-sealed to a 250µm 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 20µm hard temper aluminium foil heat-sealed to a 250µm PVC/40gms PVDC blister. The tray contains an appropriate number of lozenges to give a pack size of 8 lozenges in a wrap around cardboard carton with tamper-evident seal.


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6.6 Special precautions for disposal and other handling

Not applicable.


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7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Ltd

Slough

SL1 3UH


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00063/0396


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19th March 2010


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10. DATE OF REVISION OF THE TEXT

March 2010



More information about this product

  • Patient Information Leaflets (PILs):

    Strepsils

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/23391/SPC/


Active Ingredients/Generics

 
  amylmetacresol
  2,4-dichlorobenzyl alcohol