This information is intended for use by health professionals

1. Name of the medicinal product

Adult Meltus Chesty Coughs Sugar & Colour Free

Lemsip Cough for Mucus Cough & Catarrh 100mg/2.5mg/5ml Oral Solution

2. Qualitative and quantitative composition

Adult Cough Linctus Sugar & Colour Free contains per 5 ml dose:

Guaiphenesin 100 mg

Cetylpyridinium chloride 2.5 mg

Also contains Liquid Sorbitol (E420), Glycerol and Ethanol.

For full list of excipients, see section 6.1.

3. Pharmaceutical form

Oral Solution

Clear, pale straw coloured liquid

4. Clinical particulars
4.1 Therapeutic indications

For the symptomatic relief of acute chesty coughs and catarrh associated with influenza, colds and mild throat infections.

4.2 Posology and method of administration

Oral

Not recommended for children under 12 years of age.

Glass bottle - Adults and children 12 years and over:

One or two 5 ml spoonfuls to be taken and swallowed slowly every three or four hours.

PETE plastic bottle - Adults and children 12 years and over:

5 ml (fill the measure cup to 5 ml) or 10 ml (fill measure cup to 10 ml). To be taken 3 or 4 times daily. Rinse the measure cup after use.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients

4.4 Special warnings and precautions for use

Ask your doctor before use if you suffer from a chronic cough, if you have asthma or are suffering from an acute asthma attack.

Stop use and ask a healthcare professional if your cough lasts for more than 5 days, comes back, or is accompanied by a fever, rash, or persistent headache.

Do not take with a cough suppressant.

Not suitable for children under 12 years of age.

This medicinal product contains 9.0% v/v of ethanol i.e. each 5ml dose contains up to 0.364 mg of alcohol, equivalent to 9ml of beer, or 3.75ml of wine. This can be harmful for those suffering from alcoholism. This should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

4.5 Interaction with other medicinal products and other forms of interaction

Can cause transient abnormality in platelet aggregation patterns determined one hour after ingestion.

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).

4.6 Fertility, pregnancy and lactation

No known contraindications.

There is limited amount of data from the use of Guaifenesin in pregnant women.

There is no information on use in lactation.

Therefore, it should not be used during pregnancy or breastfeeding unless advised by a doctor or a pharmacist.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

The following side effects may be associated with the use of Guaifenesin:

Gastro-intestinal disorders: Nausea and vomiting.

Immune system disorders: Hypersensitivity reactions

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

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

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Cough and cold preparations, Expectorants;

ATC Code: R05CA10

A cough linctus containing an expectorant and an oral antiseptic in a sugar and colour free base. The expectorant, guaifenesin, is employed to produce a thinning of mucous secretions increasing the volume of mucus that can be expelled by mucociliary action due to a reduction in the adhesiveness and viscosity of tenacious sputum. Thus providing relief to bronchial catarrh.

The antiseptic, cetylpyridinium chloride, is used for the treatment of superficial mouth infections and has an antibacterial activity on Gram-positive bacteria.

5.2 Pharmacokinetic properties

Guaifenesin is readily absorbed from the gastrointestinal tract after oral administration and rapidly metabolised by oxidation to beta-(2-methoxyphenoxy)-lactic acid. Within 3 hours, approximately 40% of a single dose is excreted in the urine as this metabolite. The half-life in plasma is approximately 1 hour.

Guaifenesin may increase the absorption rate of paracetamol, however the clinical relevance of this is unknown

No pharmacokinetic data are available for cetylpyridinium chloride.

5.3 Preclinical safety data

There are no preclinical safety data of relevance to the consumer.

6. Pharmaceutical particulars
6.1 List of excipients

Glycerol

Ethanol 96%

Levomenthol

Liquid Sorbitol Non-Crystallising (E420)

Saccharin Sodium

Sodium Cyclamate

Povidone

Custard Flavour

Raspberry Flavour

Blackberry Flavour

Purified Water

6.2 Incompatibilities

None stated.

6.3 Shelf life

Glass bottle - Five years unopened.

Transparent blue plastic PETE bottle – Two years unopened.

Transparent green plastic PETE bottle – Two years unopened.

6.4 Special precautions for storage

Do not store above 25°C.

Do not refrigerate or freeze.

6.5 Nature and contents of container

Amber glass sirop bottle fitted with tamper evident polypropylene cap with expanded polyethylene liner, packed in printed cartons containing 100ml of linctus.

Transparent blue plastic PETE bottle (180 ml).

Transparent green plastic PETE bottle (180 ml)

Translucent yellow graduated polypropylene measuring cup.

6.6 Special precautions for disposal and other handling

None stated.

7. Marketing authorisation holder

Ultra Chemical Limited

103-105 Bath Road,

Slough,

Berkshire,

SL1 3UH,

UK

8. Marketing authorisation number(s)

PL 14236/0007

9. Date of first authorisation/renewal of the authorisation

25/10/1995 / 14/09/2001

10. Date of revision of the text

May 2017