Lemsip Chesty Cough 50 mg/5 ml Oral Solution - 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: 22/05/2012

SPC	Lemsip Chesty Cough 50 mg/5 ml Oral Solution

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 excipient(s)
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

Lemsip Chesty Cough 50 mg/5 ml Oral Solution

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml oral solution contains 50 mg Guaifenesin

Each 5 ml of oral solution contains 4 g of sucrose.

For Excipients see 6.1.

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3. PHARMACEUTICAL FORM

Oral solution.

Pale Yellow or colourless solution, with characteristic lemon odour.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Symptomatic relief of deep chesty coughs.

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4.2 Posology and method of administration

For oral administration.

To be taken three or four times daily.

Adults and children over 12: Two to four 5 ml spoonfuls.

Do not exceed the stated dose. Do not take with any other cough and cold medicine.

Not recommended for children under 12 years.

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4.3 Contraindications

Contraindicated in children under 12 years of age.

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4.4 Special warnings and precautions for use

Do not exceed the stated dose. Do not take with any other cough and cold medicine.

Not recommended for children under 12 years.

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

None known.

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4.6 Pregnancy and lactation

May be used.

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4.7 Effects on ability to drive and use machines

None.

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4.8 Undesirable effects

Gastrointestinal discomfort has been reported.

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4.9 Overdose

Very large doses may cause nausea and vomiting. The drug is, however, rapidly metabolised and excreted in the urine. Patients should be kept under observation and treated symptomatically.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Guaifenesin

Guaifenesin is reported to reduce the viscosity of tenacious sputum and is used as an expectorant.

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5.2 Pharmacokinetic properties

Guaifenesin

Guaifenesin is absorbed from the gastrointestinal tract. It is metabolised and excreted in the urine.

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5.3 Preclinical safety data

No preclinical findings of relevance to the prescriber have been reported.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Sucrose (extra fine sugar)

Glycerol

Tolu flavour solution

Sodium benzoate

Citric acid anhydrous granular

Sodium citrate

Lemon oil terpeneless

Isopropanol

Sodium cyclamate

Water, purified

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6.2 Incompatibilities

Not applicable.

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6.3 Shelf life

Three years.

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6.4 Special precautions for storage

This medicinal product does not require any special storage precautions.

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6.5 Nature and contents of container

Amber glass bottles with a polypropylene cap with a polyethylene tamper-evident band with expanded polyethylene wad. Pack sizes: 100 ml, 150 ml, 200 ml and 300 ml.

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 Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

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8. MARKETING AUTHORISATION NUMBER(S)

PA 979/26/1.

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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of First Authorisation: 7th April, 2006

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10. DATE OF REVISION OF THE TEXT

May 2012

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http://www.medicines.ie/medicine/12403/SPC/Lemsip+Chesty+Cough+50+mg+5+ml+Oral+Solution/

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Active Ingredients

Guaifenesin

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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