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GALLOWAYS BRONCHIAL COUGH CARE

Active substance(s): EPHEDRINE HYDROCHLORIDE / GUAIFENESIN

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Galloway’s Bronchial Cough Care

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10ml of syrup contains Ephedrine hydrochloride 15mg and Guaifenesin
100mg.
For excipients see 6.1.

3.

PHARMACEUTICAL FORM
Syrup for oral administration.

4

CLINICAL PARTICULARS

4.1.

Therapeutic indications
For the relief of chesty coughs. Helps to loosen mucus to make breathing
easier.

4.2.

Posology and method of administration
Route of administration: Oral.
Adults: 10ml up to four times a day.
Children (7-12 years): 5ml up to four times a day.
Children under 7 years: Not suitable.

4.3.

Contraindications

Galloway’s Bronchial Cough Care is contraindicated in individuals with
known hypersensitivity to the product, or any of its components.
As the product contains ephedrine, it is contraindicated in patients with
coronary thrombosis, hypertension and thyrotoxicosis.

4.4.

Special warnings and precautions for use
Do not exceed the stated dose.
Asthmatics should consult their doctor before using this product.
It should be used with caution in patients with peripheral vascular disease.

4.5.

Interactions with other medicinal products and other forms of interaction
Ephedrine should not be given in conjunction with monoamine oxidase
inhibitors or within 14 days of cessation of such treatment.
Ephedrine should be administered with caution in patients receiving
chloroform, cyclopropane, halothane, or other halogenated anaesthetics.

4.6.

Pregnancy and lactation
Treatment during pregnancy should be avoided unless considered essential by
the physician.

4.7.

Effects on ability to drive and use machines
None known.

4.8.

Undesirable effects
None known.

4.9.

Overdose

In the case of extreme overdose, this may result in CNS effects such as
paranoid psychosis and hallucinations, cardiomyopathy and coma. Treatment
should consist of symptomatic and supportive therapy including gastric lavage,
administration of intravenous fluids and maintenance of blood pressure, body
temperature and adequate respiratory exchange.

5

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
Ephedrine is a sympathomimetic agent with direct and indirect effects on
adrenergic receptors. It has bronchiodilation effects.
Guaifenesin is used widely as an expectorant in cough products and has been
for many years.

5.2.

Pharmacokinetic properties
Ephedrine hydrochloride is readily and completely absorbed from the
gastrointestinal tract, peak plasma levels being achieved approximately one
hour after oral administration. The plasma half-life is reported to be 3-6 hours
depending on urinary pH.
Guaifenesin is absorbed from the gastrointestinal tract. It is metabolised and
excreted into the urine.

5.3.

Preclinical safety data
No data presented.

6

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients
Sorbitol
Chloroform
Anise apricot flavour GB20311
Menthol

Stronger Tincture of Capsicum
Ethanol 96%
Saccharin sodium
Sodium benzoate
Citric acid monohydrate
Caramel 15712
Filtered water

6.2.

Incompatibilities
None known

6.3.

Shelf life
24 months

6.4.

Special precautions for storage
Do not refrigerate

6.5

Nature and contents of container
125ml round amber glass bottle fitted with a ROPP cap

6.6.

Instructions for use, handling, (and disposal)
None

7.

MARKETING AUTHORISATION HOLDER
Omega Pharma
Ltd. 1st Floor
32 Vauxhall Bridge Road
LONDON, SW1V 2SA
United Kingdom

8.

MARKETING AUTHORISATION NUMBER

PL 02855/0026

9.
DATE OF FIRST AUTHORISATION / RENEWAL OF THE
AUTHORISATION
16th November 2004

10

DATE OF REVISION OF THE TEXT
30/09/2014

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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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