It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.

Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

Summary of Product Characteristics last updated on medicines.ie: 31/8/2016

Lemsip Chesty Cough 50 mg/5 ml Oral Solution

1. NAME OF THE MEDICINAL PRODUCT

Lemsip Chesty Cough 50 mg/5 ml Oral Solution

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 the full list of excipients see section 6.1.

3. PHARMACEUTICAL FORM

Oral solution.

Pale yellow or colourless solution, with characteristic lemon odour.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

An expectorant for the symptomatic relief of deep chesty coughs.

Lemsip Chesty Cough 50mg/5ml Oral Solution is indicated in adults and children over 12 years of age.

4.2 Posology and method of administration

Duration of treatment should be limited to a maximum of 5 days. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 5 days

Posology

Adults and children over 12: Two to four 5ml spoonfuls. Dose may be repeated every 4-6 hours up to a maximum of 4 doses in any 24 hour period.

Paediatric population:

When simple measures have failed to provide adequate relief.

Contraindicated for children under 12 years (see section 4.3).

Elderly Population:

No dosage adjustment is considered necessary in the elderly.

Method of administration

For oral administration.

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

4.3 Contraindications

Contraindicated in children under 12 years of age.

Hypersensitivity to guaifenesin or to any of the excipients listed in section 6.1.

Do not take if suffering from porphyria.

4.4 Special warnings and precautions for use

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

Seek medical advice if suffering from chronic cough or asthma.

Use with caution in patients with renal impairment.

Not recommended for concomitant use with a cough suppressant.

Do not take if you are pregnant or breast feeding unless recommended by a health care professional (see section 4.6).

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

This medicinal product contains 0.16mmol (or 3.66mg) sodium per 5ml dose. To be taken into consideration by patients on a controlled sodium diet.

Contains 3.965 g of sucrose per 5ml dose. This should be taken into account in patients with diabetes mellitus.

Paediatric population

Contraindicated for children under 12 years (see section 4.3).

4.5 Interaction with other medicinal products and other forms of interaction

If urine is collected within 24 hours of a dose of the medicinal product, a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

Guaifenesin may increase the rate of absorption of paracetamol.

Paediatric population

Interaction studies have only been performed in adults

4.6 Fertility, pregnancy and lactation

Pregnancy:

The product should not be used during pregnancy unless recommended by a healthcare professional.

There are limited data on the use of guaifenesin in pregnant women.

Breastfeeding:

The product should be avoided during lactation unless recommended by a healthcare professional.

There is insufficient information on the excretion of guaifenesin /metabolites in human milk.

Fertility:

No known effects.

4.7 Effects on ability to drive and use machines

The product has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Adverse events which have been associated with guaifenesin are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

The list of the following adverse effects relates to those experienced with guaifenesin at OTC doses (maximum 800mg per day), in shortterm use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

System Organ Class

Frequency

Adverse Events

Immune System Disorders

Not known

Hypersensitivity

Gastrointestinal Disorders

Not known

Abdominal discomfort, nausea, vomiting

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

4.9 Overdose

Symptoms

Overdose with guaifenesin is unlikely to produce toxic effects since its toxicity is low.

Symptoms associated with guaifenesin overdose include headache, dizziness, nausea and vomiting. Extremely high doses may depress the central nervous system and act as a muscle relaxant. Prolonged use of guaifenesin may result in urolithiasis. The drug is, however, rapidly metabolised and excreted in the urine.

Management

Patients should be kept under observation and treated symptomatically.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Respiratory system, Cough and cold preparations, Expectorants

ATC Code: R05CA03

Guaifenesin is an expectorant which increases the volume of mucous that can be expelled or cleared by mucocilliary action due to reduction in the adhesiveness and viscosity of tenacious sputum.

The active ingredients are not known to cause sedation.

5.2 Pharmacokinetic properties

Guaifenesin is readily absorbed from the gastrointestinal tract after oral administration and rapidly metabolised by oxidation to β-(2-methoxyphenoxy)-lactic acid. Approximately 40% of a dose is excreted as this metabolite in the urine within three hours. The half-life in plasma is approximately one hour.

5.3 Preclinical safety data

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

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose (extra fine sugar)

Glycerol

Tolu flavour solution

Sodium benzoate

Citric acid anhydrous granular

Sodium citrate

Lemon oil terpeneless

Isopropanol

Sodium cyclamate

Water, purified

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage precautions.

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.

6.6 Special precautions for disposal and other handling

No special requirements.

7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

8. MARKETING AUTHORISATION NUMBER(S)

PA 979/26/1.

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of First Authorisation: 7th April, 2006

Date of latest renewal: 7th April 2011

10. DATE OF REVISION OF THE TEXT

August 2016

It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.