This information is intended for use by health professionals

1. Name of the medicinal product

Lemsip Cough for Chesty Cough 50mg/5ml Oral Solution

2. Qualitative and quantitative composition

Guaifenesin 50mg/5ml

Excipient(s):

Sucrose: 3.965 g per 5ml dose

Sodium: 3.66 mg (0.16mmol) per 5ml dose

For full list of excipients, see section 6.1 .

3. Pharmaceutical form

Oral solution

4. Clinical particulars
4.1 Therapeutic indications

Symptomatic relief of deep chesty coughs and to soothe the throat.

4.2 Posology and method of administration

For oral administration.

Under 12 years: On medical advice only

To be taken three or four times daily.

Glass bottle

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

PETE plastic bottle

Adults and children 12 years and over: 10 ml dose (fill measure cup to 10 ml); 15 ml (one 10 ml measure in cup followed by a 5 ml measure); 20 ml (10 ml taken twice). Rinse the measure cup after use.

4.3 Contraindications

Hypersensitivity to guaifenesin or to any of the excipients.

4.4 Special warnings and precautions for use

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

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

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

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.

4.6 Pregnancy and lactation

Guaifenesin has been linked with an increased risk of neural tube defects in a small number of women with febrile illness in the first trimester of pregnancy. The product should be used in pregnancy only if the benefits outweigh this risk. There is no information on use in lactation.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Guaifenesin has occasionally been reported to cause gastro-intestinal discomfort, nausea and vomiting, particularly in very high doses. Also, hypersensitivity reactions may occur.

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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group:

Expectorants

ATC Code:

R05CA03

Guaifenesin

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

The active ingredient is not known to cause sedation.

5.2 Pharmacokinetic properties

Guaiphenesin

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

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

Glycerol,

Toluflavour solution,

Sodium benzoate,

Citric acid anhydrous granular,

Sodium citrate,

Lemon oil terpeneless,

Isopropyl alcohol,

Purified water

Sodium cyclamate.

6.2 Incompatibilities

None known.

6.3 Shelf life

Glass bottle - Three years.

Transparent blue plastic PETE bottle - Two years.

Transparent green plastic PETE bottle - Two years.

6.4 Special precautions for storage

None

6.5 Nature and contents of container

Amber glass bottles with a polypropylene cap with a child resistant closure with a polyethylene tamper-evident band with expanded polyethylene wad (100ml, 150 ml, 200ml and 300 ml).

Transparent blue plastic PETE bottle (180 ml).

Transparent green plastic PETE bottle (180ml).

Translucent yellow graduated polypropylene measuring cup.

Pack size: 100 ml, 150 ml, 180ml, 200 ml and 300 ml.

6.6 Special precautions for disposal and other handling

To be taken orally at the recommended dose.

7. Marketing authorisation holder

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS

8. Marketing authorisation number(s)

PL 00063/0036

9. Date of first authorisation/renewal of the authorisation

21/01/2004

10. Date of revision of the text

01/12/2017