SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Adult Meltus for Chesty Coughs and Catarrh.

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

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Guaifenesin    100mg/5ml

Cetylpyridinium chloride    2.5mg/5ml

Purified honey    0.5g/5ml

Also contains sucrose, glucose and ethanol. For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Oral solution

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

FOR ADULTS AND CHILDREN OVER 12 YEARS

One or two 5m1 spoonsful to be taken and swallowed slowly every three or four hours.

Not recommended for children under 12 years.

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

Patients with rare glucose-galactose malabsorption should not take this medicine.

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    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

None known.

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

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

A cough linctus containing an expectorant and an oral antiseptic in a honey and syrup demulcent base. The expectorant, guaiphenesin, is employed to produce a thinning of mucous secretions and thus gives relief in bronchial catarrh. The antiseptic, cetylpyridinium chloride, is used for the treatment of superficial mouth and throat infections.

5.2 Pharmacokinetic properties

None stated

5.3 Preclinical safety data

None stated

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glycerol

Sucrose Ethanol 96% Star anise oil Levomenthol Chloroform Caramel (E150) Glucose Liquid Purified Water

6.2    Incompatibilities

None known

6.3    Shelf life

Five years

6.4    Special precautions for storage

Store below 25°C

6.5    Nature and contents of container

Glass amber sirop bottle with tamper evident cap with fitted polycone liner in an individual carton, containing 100ml, 150ml or 200ml of product. Pack contains 5ml CE marked polystyrene measuring spoon.

6.6    Instructions for use/handling

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Cupal Ltd.

Venus

1 Old Park Lane Trafford Park

8. MARKETING AUTHORISATION NUMBER

PL 0338/5026R

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14/9/90 / 7/9/99

10 DATE OF REVISION OF THE TEXT

25/03/2013