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BUTTERCUP BLACKCURRANT FLAVOUR COUGH SYRUP

Active substance(s): IPECACUANHA LIQUID EXTRACT / LEVOMENTHOL / LIQUID GLUCOSE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Buttercup Blackcurrant Flavour Cough Syrup

2

3

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

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.

4.3

Contraindications
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

5.2

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.

Pharmacokinetic properties
Not applicable.

5.3

Preclinical safety data
None.

6

PHARMACEUTICAL PARTICULARS

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

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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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