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Reckitt Benckiser Ireland Limited
7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 468 9200
Fax: +353 1 468 9299


Summary of Product Characteristics last updated on medicines.ie: 27/08/2007
SPC Strepsils Sore Throat & Blocked Nose Lozenges



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1. NAME OF THE MEDICINAL PRODUCT

Strepsils Sore Throat & Blocked Nose Lozenges


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredients:

Amylmetacresol 0.6 mg

2,4-Dichorobenzyl alcohol 1.2 mg

Levomethol Ph.Eur 8.0 mg

For excipients, see 6.1


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3. PHARMACEUTICAL FORM

Lozenge.

A blue, circular lozenge with a characteristic taste, embossed on both sides with strepsils brand icon.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the symptomatic relief of mouth and throat infections and nasal congestion.


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4.2 Posology and method of administration
Adults and ChildrenOne lozenge to be dissolved slowly in the mouth every 2-3 hours.

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.

Consult your doctor if symptoms persist or if anything unusual happens.


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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 Sore Throat and Blocked Nose has not been established in pregnancy or lactation, but it is not expected to constitute a hazard.


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4.7 Effects on ability to drive and use machines

No adverse events 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

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


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5.2 Pharmacokinetic properties

No data available.


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5.3 Preclinical safety data

No data available.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Tartaric Acid

Eucalyptus Oil

Indigo Carmine (E132)

Solids from

Liquid Sugar Dimineralised

Or Liquid Sugar


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

3 years.


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6.4 Special precautions for storage

Do not store above 25ºC


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6.5 Nature and contents of container

The lozenges are contained in a strip pack of 250 micron PVC/coated 40 gsm PVDC with 20 micron hard temper aluminium foil, containing either 2 or 24 lozenges packed in a cardboard carton.


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6.6 Special precautions for disposal and other handling

No special requirements


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7. MARKETING AUTHORISATION HOLDER

Crookes Healthcare Limited,

1 Thane Road West

Nottingham NG2 3AA,

UK


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8. MARKETING AUTHORISATION NUMBER(S)

PA 43/11/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30th January 1991 / 30th January 2006


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10. DATE OF REVISION OF THE TEXT

April 2007



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Active Ingredients

 
  Levomenthol
  Amylmetacresol
  Dichlorobenzyl alcohol