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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: 29/11/2011
SPC Strepsils Strawberry Sugar Free Lozenges



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1. NAME OF THE MEDICINAL PRODUCT

Strepsils Strawberry Sugar Free Lozenges

Amylmetacresol 600 micrograms

2,4-Dichlorobenzyl alcohol 1.2mg


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each Lozenge contains amylmetacresol 600 micrograms and 2,4-Dichlorobenzyl alcohol 1.2 mg.

Excipients: also includes Ponceau 4R (E124) 0.01mg per lozenge, and maltitol syrup 457.6mg per lozenge.

For a full list of excipients, see section 6.1


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3. PHARMACEUTICAL FORM

Lozenge.

Pink, circular lozenge with a characteristic strawberry taste, embossed on both sides with Strepsils brand icon.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Strepsils Sugar Free are indicated for the symptomatic relief of mouth and throat infections including sore throat.


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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

Strepsils Strawberry Sugar Free Lozenges are contraindicated in persons who have previously shown hypersensitivity. Patients with rare hereditary problems of fructose intolerance should not take this medicine.


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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

Not applicable.


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4.6 Pregnancy and lactation

The safety of Strepsils Sugar Free during pregnancy and lactation 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

In view of the nature and presentation of Strepsils Sugar Free Lozenges, accidental or deliberate overdosage is highly unlikely.

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.


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5.2 Pharmacokinetic properties

No data available.


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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

Strawberry Flavour 052312B

Ponceau 4R (CI 16255 E124)

Sodium Saccharin

Tartaric Acid

Isomalt

Maltitol Syrup


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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 30°C.


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6.5 Nature and contents of container

A blister push-through pack consisting of a hard temper aluminium foil heat sealed to a PVC/PVDC blister. Each blister contains 6, 8, 10, 12, 16, 20 or 24 lozenges. Two trays are packed in a carton or for two lozenge sample two blisters are attached to a stencilled card.

Not all pack sizes may be marketed.


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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

7 Riverwalk

Citywest Business Campus

Dublin 24


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8. MARKETING AUTHORISATION NUMBER(S)

PA 979/38/3


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 02 May 1997

Date of last renewal: 02 May 2007


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10. DATE OF REVISION OF THE TEXT

April 2008



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Active Ingredients

 
  Amylmetacresol
  2,4-Dichlorobenzyl alcohol