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IPECAC & SQUILL LINCTUS PAEDIATRIC B.P.C.

Active substance(s): IPECACUANHA TINCTURE / SQUILL TINCTURE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Ipecacuanha and Squill Linctus Paediatric BPC or Childrens Cough
Expectorant
Asda Children’s Chesty Cough Syrup

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ipecacuanha Tincture BP 2.0% v/v
Squill Tincture BP 3.0% v/v

3

PHARMACEUTICAL FORM
Oral liquid

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
As an expectorant.

4.2

Posology and method of administration
Children

5 ml to be taken three times daily.
Route of administration
Oral.

4.3

Contraindications
Impaired renal function, impaired hepatic function, cardiac disorders,
moderate to severe respiratory insufficiency, alcoholism and raised
intracranial pressure or if hypersensitive to any ingredient.

4.4

Special warnings and precautions for use
Use with caution in hypokalaemia.

4.5

Interaction with other medicinal products and other forms of interaction
Cardiac glycosides may be present in squill. Serum levels of cardiac
glycosides (e.g. digoxin) may be increased by the concurrent
administration of certain antibiotics (such as erythromycin and
tetracycline) captopril, quinidine, and other drugs acting on the heart.

4.6

Fertility, pregnancy and lactation
As with other medicines, the product should not be taken during
pregnancy or lactation unless the benefits are considered to outweigh the
risks.

4.7

Effects on ability to drive and use machines
No significant effects have been reported.

4.8

Undesirable effects
Large doses may cause nausea, vomiting and diarrhoea.

4.9

Overdose
Symptoms
Overdosage is unlikely in view of the emetic action of ipecacuanha.
However, if it does occur, cardiotoxicity may result from the absorption
of emetine or the cardiac glycosides in squill. Vasomotor collapse
followed by death could occur.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Ipecacuanha and squill have been used traditionally as expectorants.
Their reflex expectorant action is thought to occur as a result of an
irritant action on the respiratory tract producing cough.

5.2

Pharmacokinetic properties
No detailed information is available for ipecacuanha. The principal
alkaloid, emetine, is rapidly absorbed after oral administration and is
concentrated in liver, kidneys, lungs and spleen. It is excreted very
slowly with up to 35% being retained at 35 days. Its metabolic fate is
unknown.
No Pharmacokinetic data are available for squill.

5.3

Preclinical safety data
No relevant data.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Nipasept sodium
Compound orange spirit
Citric acid monohydrate
Syrup
Powdered blackcurrant flavour
Blackcurrant colour
Potable wate

6.2

Incompatibilities
No major incompatibilities have been reported.

6.3

Shelf life
36 months.
6 months once opened

6.4

Special precautions for storage
Store below 25°C.

6.5

Nature and contents of container
Dispensing packs
2000 ml white polythene bottle with white plastic screw cap with an
aluminium faced
EPE liner.
500 ml white polythene bottle with white plastic wadless screw cap.
Patient packs or OTC packs as appropriate
100 ml and 200 ml amber glass bottles with plastic Jay cap closures.

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Ltd
Hani Wells Business Park,
Unit 7, Hardicker Street,
Manchester,

M19 2RB
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 18374/0024

9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23/09/2005

10

DATE OF REVISION OF THE TEXT
23/09/2005

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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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