Buttercup Blackcurrant Flavour Cough Syrup
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Buttercup Blackcurrant Flavour Cough Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ipecacuanha Liquid Extract 13.9 mg/5 ml
Liquid Glucose 5.5 g/5 ml
Levomenthol 1.2 mg/5 ml
3 PHARMACEUTICAL FORM
Syrup
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of chesty, bronchial and dry or tickly coughs, because it soothes sore and irritated throat membranes that are often the cause of these coughs, while easing and relieving congestion.
4.2 Posology and method of administration
Adults: two 5 ml spoonfuls, three to four times a day.
Not more than 4 doses should be taken in any 24 hours. Do not exceed the stated dose.
Not recommended for children under 12 years of age.
Route of administration: oral.
Contraindications
4.3
None known.
4.4 Special warnings and precautions for use
Not more than four doses should be given in any 24 hours. Do not exceed the stated dose.
Do not take with any other cough and cold medicine.
Consult a pharmacist or other healthcare professional before use in children under 6 years.
If symptoms persist, consult your doctor.
Keep all medicines out of the reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
There are no restrictions on the use of this product during pregnancy.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
In small doses, ipecacuanha is an expectorant, but large doses can produce vomiting and diarrhoea. However, at the recommended dosage there are no known toxic or side effects associated with the product.
4.9 Overdose
Symptoms following overdosage are rare and it is felt that at the worst this could cause vomiting and diarrhoea. However, in the event of overdosage, medical advice should be sought immediately.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
a) Ipecacuanha, the active ingredient of this product, is a naturally occurring traditionally used expectorant and is often used in proprietary cough medicines.
b) Liquid glucose is a demulcent, which when applied locally to irritated tissues tends to coat the surface and by mechanical means protect the underlying cells from stimuli that result from contact with air or irritants in the environment.
c) Menthol is used for relief of congestion and is often an ingredient in proprietary cough medicines.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
None.
PHARMACEUTICAL PARTICULARS
6
6.1 List of excipients
Citric acid monohydrate Sodium Benzoate Sodium Metabisulphite Ethanol (96%)
Blackcurrant Concentrate 07023511 Blackcurrant Flavour 17403985 Blackcurrant Flavour 52 227a Purified water
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months
6.4 Special precautions for storage
None
6.5 Nature and contents of container
75 ml glass bottle: R.O.P.P.
150 ml glass bottle: R.O.P.P.
All sizes are in clear flat bottles, with straight sides. Caps are twist off.
100 ml glass bottle: R.O.P.P. Clear glass round bottle, cap is twist off. A 5ml green polystyrene measuring spoon is included in the carton.
6.6 Special precautions for disposal
None
7. MARKETING AUTHORISATION HOLDER
Omega Pharma Ltd. 1st Floor 32 Vauxhall Bridge Road LONDON, SW1V 2SA United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 02855/0022
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30th November 2004
10 DATE OF REVISION OF THE TEXT
30/09/2014