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Reckitt Benckiser Ireland Limited

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: 23/06/2011
SPC Strepsils Honey and Lemon

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 Honey and Lemon Lozenges

Amylmetacresol 0.6mg

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 1.2mg

Excipients: Contains 1.441g sucrose, 976mg glucose

For a full list of excipients, see section 6.1


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3. PHARMACEUTICAL FORM

Lozenge

A yellow circular lozenge with a taste of honey and lemon, 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.


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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.

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 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 Honey and Lemon 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

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.


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5.2 Pharmacokinetic properties

None available.


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5.3 Preclinical safety data

None available.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Honey

Tartaric Acid

Peppermint Oil

Terpeneless Lemon Oil

Quinoline yellow (E104)

Sucrose

Glucose Syrup


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

3 years for 24 lozenge pack and 8 lozenge pack.

18 months for 2 lozenge pack.

3 years for lozenges packed in polypropylene tube, with an in use shelf-life of 'use within 3 months of opening.


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6.4 Special precautions for storage

Blister pack - Do not store above 25°C.

Polypropylene tube, do not store above 25°C. Keep the tube tightly closed in order to protect from moisture.


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6.5 Nature and contents of container

A blister push-through pack consisting of hard temper aluminium foil heat sealed to a PVC/PVDC blister.

Each blister contains 12 lozenges. Two trays are packed in a carton or for two lozenge sample two blisters are attached to a stencilled card.

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

An injection moulded white pigmented polypropylene tube fitted with a plastic spring with an injection moulded white polyethylene cap (containing white silica gel that is sealed with a white cardboard disc).

The tube contains 10 lozenges.

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 Ireland Ltd

7 Riverwalk

Citywest Business Campus

Dublin 24


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8. MARKETING AUTHORISATION NUMBER(S)

PA 979/38/2


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

16th October 1986 / 16th October 2006


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10. DATE OF REVISION OF THE TEXT

June 2011



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Active Ingredients

 
   Amylmetacresol
   Dichlorobenzyl alcohol

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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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