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BUTTERCUP SYRUP HONEY & LEMON FLAVOUR

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

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Buttercup Syrup Honey & Lemon Flavour

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ipecacuanha Liquid Extract
Liquid Glucose
Levomenthol
Honey

3.

13.9 mg/5 ml
5.08 g/5 ml
1.32 mg/5ml
0.33 g/5 ml

PHARMACEUTICAL FORM
Oral Liquid

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 every 2-3 hours.
Children 2-12 years of age: one 5 ml spoonful, three to four times a day.
Not recommended for children under 2 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.
The label will state “Keep all medicines out of the reach and sight of children.”
4.5. Interactions 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 and honey are demulcents, which when applied locally to irritated
tissues tend 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
Sodium Citrate
Sodium Benzoate (E211)
Sodium Metabisulphite (E223)
Ethanol (96%)
Lemon Juice Concentrate JD 1420
Lemon Oil Terpeneless
Caramel (E150)
Purified water

6.2.

Incompatibilities

None known.

6.3.

Shelf life
36 months

6.4.

Special precautions for storage
Do not store above 25°C

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.

6.6

7.

Special precautions for disposal
None.

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

8.

MARKETING AUTHORISATION NUMBER(S)
PL 02855/0025

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17th January 2005

10

DATE OF REVISION OF THE TEXT
30/09/2014

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Further information

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