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LEMSIP COUGH FOR CHESTY COUGH 50MG/5ML ORAL SOLUTION

Active substance(s): GUAIPHENESIN / GUAIPHENESIN / GUAIPHENESIN

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SUMMARY OF PRODUCT CHARACTERISTICS

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, glucosegalactose 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.
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).
Translucent yellow graduated polypropylene measuring cup.
Pack size: 100 ml, 150 ml, 180ml, 200 ml and 300 ml.

6.6

Special precautions for disposal
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
12/09/2016

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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