Galloways Bronchial Cough Care
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