Strepsils Original 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: 10/09/2009

SPC	Strepsils Original 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 Original Lozenges

Amylmetacresol 0.6mg

2, 4-Dichlorobenzyl Alcohol 1.2mg

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each lozenge contains:

2, 4-Dichlorobenzyl alcohol	1.2 mg
Amylmetacresol	0.6mg

Also contains glucose 1g, sucrose 1.5g, ponceau 4R (E124) & carmoisine (E122)

For a full list of excipients, see section 6.1

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3. PHARMACEUTICAL FORM

Lozenge

A circular, biplanar red lozenge with an aniseed odour, embossed on both sides with strepsils brand icon.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For mouth and throat infections

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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 or as directed by a physician.

Elderly: There is no need for dosage reduction in the elderly.

For oral administration.

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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 reach of children.

Consult your doctor if symptoms persist or if anything unusual happens

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine

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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 during pregnancy and lactation has not been established, but it is not considered to constitute a hazard during these periods.

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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

Occasionally 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 amymetacresol have antiseptic properties.

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5.2 Pharmacokinetic properties

None stated.

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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

Anise Oil

Peppermint Oil

Levomenthol

Tartaric Acid

Ponceau 4R Edicol (E124)

Carmoisine Edicol (E122)

Solids from Liquid sugar and from

Liquid Glucose

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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 blister push-through tray of PVC/PVDC laminate heat-sealed to aluminium foil.

24 lozenges (each blister tray contains 12 lozenges packed in a carton).

8 lozenges (one tray contains 8 lozenges in a wrap around cardboard carton with tamper-evident seal).

2 lozenges pack.

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6.6 Special precautions for disposal and other handling

Not 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 979/57/1

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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first Authorisation: 24^th July

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10. DATE OF REVISION OF THE TEXT

August 2009

Link to this document from your website:
http://www.medicines.ie/medicine/10978/SPC/Strepsils+Original+Lozenges/

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Active Ingredients

Amylmetacresol

2,4-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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