Lemsip (guaifenesin)

Lemsip (guaifenesin) Medicine

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.

Shelf life

Glass bottle - Three years.

Transparent blue plastic PETE bottle - Two years.

Transparent green plastic PETE bottle - Two years.

Contraindications

Hypersensitivity to guaifenesin or to any of the excipients.

Incompatibilities

None known.

List of excipients

Sucrose

Glycerol,

Toluflavour solution,

Sodium benzoate,

Citric acid anhydrous granular,

Sodium citrate,

Lemon oil terpeneless,

Isopropyl alcohol,

Purified water

Sodium cyclamate.

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.

Preclinical safety data

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

Therapeutic indications

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

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.

Pharmacokinetic properties

Guaiphenesin

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

Date of revision of the text

01/12/2017

Name of the medicinal product

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

Marketing authorisation holder

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS

Special precautions for storage

None

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.

Marketing authorisation number(s)

PL 00063/0036

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

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.

Effects on ability to drive and use machines

None.

Dosage (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.

Special precautions for disposal and other handling

To be taken orally at the recommended dose.

Date of first authorisation/renewal of the authorisation

21/01/2004