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Chefaro UK Ltd

4th Floor, Hamilton House, Mabledon Place, Bloomsbury, London, WC1H 9BB, UK
Telephone: +44 (0)207 554 8791
Medical Information e-mail: enquiries@chefaro.co.uk
Customer Care direct line: +44 (0)1748 828 860

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Summary of Product Characteristics last updated on the eMC: 15/02/2011
SPC Buttercup Blackcurrant Flavoured Cough Syrup


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1. NAME OF THE MEDICINAL PRODUCT

Buttercup Blackcurrant Flavoured Cough Syrup


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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


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3. PHARMACEUTICAL FORM

Syrup


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4. CLINICAL PARTICULARS

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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.


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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.


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4.3 Contraindications

None known.


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4.4 Special warnings and precautions for use

If symptoms persist, consult your doctor. Keep all medicines out of the reach of children


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4.5 Interaction with other medicinal products and other forms of interaction

None known.


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4.6 Pregnancy and lactation

There are no restrictions on the use of this product during pregnancy.


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4.7 Effects on ability to drive and use machines

None known.


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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.


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4.9 Overdose

Symptoms following over dosage are rare and it is felt that at the worst this could cause vomiting and diarrhoea. However, in the event of over dosage, medical advice should be sought immediately.


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5. PHARMACOLOGICAL PROPERTIES

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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.


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5.2 Pharmacokinetic properties

Not applicable.


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5.3 Preclinical safety data

None.


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6. PHARMACEUTICAL PARTICULARS

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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


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6.2 Incompatibilities

None known.


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6.3 Shelf life

36 months


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6.4 Special precautions for storage

None


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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.


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6.6 Special precautions for disposal and other handling

None


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7. MARKETING AUTHORISATION HOLDER

Chefaro UK Limited

4th Floor

Hamilton House

Mabledon Place

Bloomsbury

LONDON

WC1H 9BB

United Kingdom


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8. MARKETING AUTHORISATION NUMBER(S)

PL 02855/0022


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30th November 2004


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10. DATE OF REVISION OF THE TEXT

15th November 2010



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/16038/SPC/


Active Ingredients/Generics

 
   levomenthol
   ipecacuanha liquid extract
   liquid glucose