Strepsils Sore Throat & Blocked Nose Lozenges - Summary of Product Characteristics (SPC)

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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: 31/08/2011

SPC	Strepsils Sore Throat & Blocked Nose Lozenges

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Strepsils Sore Throat & Blocked Nose Lozenges

Amylmetacresol 0.6mg

2,4-Dichlorobenzyl Alcohol 1.2mg

Levomenthol 8.0mg

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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 Children

One 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 25°C

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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

Reckitt Benckiser Ireland Ltd

7 Riverwalk

Citywest Business Campus,

Dublin 24

Ireland

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8. MARKETING AUTHORISATION NUMBER(S)

PA 979/60/1

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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30^th January 1991 / 30^th January 2006

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10. DATE OF REVISION OF THE TEXT

August 2011

Link to this document from your website:
http://www.medicines.ie/medicine/12401/SPC/Strepsils+Sore+Throat+%26+Blocked+Nose+Lozenges/

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Active Ingredients

Levomenthol

Amylmetacresol

Dichlorobenzyl alcohol

Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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Reckitt Benckiser Ireland Limited

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Active Ingredients