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CHILDRENS BLACKCURRANT COUGH SYRUP

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Children’s Blackcurrant Cough Syrup

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Syrup containing Ipecacunha Tincture 6% w/w
Squill Elixir 9% v/v
Squill Vinegar 6%

3

PHARMACEUTICAL FORM
Syrup

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For coughs in children aged 2 to 12 years.

4.2

Posology and method of administration
Not recommended for children under 2 years old.
For children aged 2 to 6 years:
One 5ml spoonful to be taken every four hours
Not more than 4 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

For children aged 6 to 12 years:
Two 5ml spoonfuls to be taken every four hours

4.3

Contraindications
Squill should not be given in patients with impaired renal function or cardiac
disorders. Ipecacunha should not be used as an emetic in patients suffering
from shock or in a coma or in patients who have ingested corrosive substances.
Hypersensitivity to any of the ingredients is a contra-indication to use.

4.4

Special warnings and precautions for use
Store out of reach of children.

4.5

Interaction with other medicinal products and other forms of interaction
None.

4.6

Fertility, pregnancy and lactation
Not applicable.

4.7

Effects on ability to drive and use machines
Not applicable

4.8

Undesirable effects
For squill these may include nausea and vomiting. Violent purging has also
been reported and it may have digitalis effects on the heart. Ipecacunha can
have an irritant effect on the gastro-intestinal tract in large doses.

4.9

Overdose
None.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Squill has an irritant effect on the gastric muscosa and it is used for its reflex
expectorant action. Ipecacunha acts as an expectorant in small doses. It acts as
an emulsion when given in a syrup/tincture form.

5.2

Pharmacokinetic properties
Both squill and ipecacunha have an irritant effect on the gastric mucosa.
Glycerine coats the throat therefore easing it.

5.3

Preclinical safety data
There are no pre-clinical data of clinical concern.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Tolu syrup (prepared in situ)
Anise oil.
Blackcurrant syrup (which contains sulphate dioxide).
Glycerine
Sucrose
Ethanol
Sodium methyl hydroxy benzoate
Potable water

6.2

Incompatibilities
None.

6.3

Shelf life
36 months.

6.4

Special precautions for storage
Store out of reach of children.

6.5

Nature and contents of container
Nature:
Amber glass bottle.

6.6

Contents:
100ml and 200ml

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,
P.C. 1060
Nicosia.
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 28444/0048

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23/12/2011

10

DATE OF REVISION OF THE TEXT
23/12/2011

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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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