Strepsils Orange with Vitamin C 100mg 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: 22/11/2011

SPC	Strepsils Orange with Vitamin C 100mg 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 Orange with Vitamin C Lozenges

Vitamin C 100mg

2,4-Dichlorobenzyl alcohol 1.2mg

Amylmetacresol 0.6mg

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredients	mg/lozenge
2, 4-Dichlorobenzyl alcohol	1.2 mg
Amylmetacresol BP	0.6 mg
Vitamin C as Ascorbic acid And Sodium Ascorbate Equivalent to	100 mg

Excipients: each lozenge also contains 968.5mg glucose, 1437.9mg sucrose, 0.162mg sunset yellow FCF (E110) and 0.016mg Ponceau 4R (E124).

For a full list of excipients, see section 6.1

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3. PHARMACEUTICAL FORM

Lozenge

An orange flavoured and coloured circular lozenge. 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 infection.

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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. 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.

The colours Sunset yellow FCF and Ponceau 4R may cause allergic reactions.

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4.5 Interaction with other medicinal products and other forms of interaction

Interactions

No clinically significant interactions are known.

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4.6 Pregnancy and lactation

The safety of Strepsils Orange with Vitamin C Lozenges has not been established, but 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

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. Ascorbic acid and sodium ascorbate provide a source of Vitamin C, which may be beneficial during infection when Vitamin C levels are believed to fall.

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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

Levomenthol

Tartaric Acid

Flavour Givaudan Bloodorange 78300-34

Propylene glycol

Sunset yellow FCF (E110)

Ponceau 4R (E124)

Liquid Glucose

Liquid Sucrose

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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 consisting of PVC/PVDC laminate heat-sealed to aluminium foil. Each blister tray contains 12 lozenges. Two trays are packed in a carton providing a pack size of 24 lozenges.

2 lozenge sample pack.

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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 979/39/1

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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

24^th September 1985 / 24^th September 2010

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10. DATE OF REVISION OF THE TEXT

October 2011

Link to this document from your website:
http://www.medicines.ie/medicine/10931/SPC/Strepsils+Orange+with+Vitamin+C+100mg+Lozenges/

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Active Ingredients

Vitamin C

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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