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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: 30/06/2011
SPC Strepsils +Plus anaesthetic Throat Spray



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1. NAME OF THE MEDICINAL PRODUCT

Strepsils +Plus anaesthetic Throat Spray

Amylmetacresol 0.58mg

2,4-Dichlorobenzyl Alcohol 1.16mg

Lidocaine 1.56mg


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Strepsils +Plus anaesthetic Throat Spray contains the following active substances:

Amylmetacresol

0.223% w/v (0.580 mg /dose)

2, 4-Dichlorobenzyl alcohol

0.446% w/v (1.160 mg/dose)

Lignocaine

0.6% w/v (1.560 mg /dose)

There are two sprays per dose (each spray is 0.13ml) and each dose is 0.26 ml.

Excipients:

 

Ethanol (96 per cent)

40.0% v/v

Liquid sorbitol (non-crystallising) (E420)

10.0% v/v

Carmoisine (E122)

0.0006% w/v

For full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Oromucosal spray

Clear, pink liquid.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the symptomatic relief of throat infections, including severe sore throats.


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4.2 Posology and method of administration

Adults: Two sprays, if necessary, repeat every two hours, up to 8 times daily.

Oromucosal use.

Not recommended for children


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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

Not recommended for children.

Do not exceed the stated dose.

Keep all medicines out of the reach of children.

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

Asthmatics should consult their doctor before first using this product.


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4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions.


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4.6 Pregnancy and lactation

The safety of Strepsils +Plus anaesthetic Throat Spray for use in human pregnancy and lactation has not yet been established. The product is, therefore, not recommended during pregnancy and lactation except under medical supervision.


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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

Rarely, hypersensitivity reactions may occur.


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4.9 Overdose

In view of the nature of the container, it is believed that overdosage would not be a problem.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

2,4-Dichlorobenzyl alcohol and amylmetacresol have antiseptic properties. Lignocaine is a local anaesthetic of the amide type.


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5.2 Pharmacokinetic properties

Lignocaine is readily absorbed from mucous membranes. The plasma elimination half-life is about 2 hours. Lignocaine undergoes significantly first-pass metabolism in the liver and is rapidly de-ethylated to the active metabolite monoethylglycine-xylidide and then hydrolysed to various metabolites including glycinexylidide. Less than 10% is excreted unchanged by the kidneys. The metabolites are also excreted in the urine.

No data are available for amylmetacresol or 2,4-Dichlorobenzyl alcohol.


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5.3 Preclinical safety data

Not applicable.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Ethanol (96 per cent)

Citric acid monhydrate

Glycerol (E422)

Liquid Sorbitol (non crystallising) (E420)

Saccharin

Levomenthol

Peppermint flavour

Aniseed flavour

Carmoisine Edicol (E122)

Purified water

Sodium hydroxide (for pH-adjustment)

Concentrated Hydrochloric acid. (for pH-adjustment)


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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 25°C.


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6.5 Nature and contents of container

A clear glass bottle fitted with a polyethylene spray pump and nozzle containing 20 ml of product packed in a 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

Reckitt Benckiser Ireland Ltd

7 Riverwalk

Citywest Business Campus

Dublin 24


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8. MARKETING AUTHORISATION NUMBER(S)

PA 979/40/2


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

25th July 1996/25th July 2006


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10. DATE OF REVISION OF THE TEXT

June 2011



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Active Ingredients

 
  Lignocaine
  Amylmetacresol
  2,4-Dichlorobenzyl alcohol