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CALCOUGH CHILDRENS SOOTHING SYRUP

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Glycerin and Blackcurrant Soothing Cough Syrup Glycerin and Blackcurrant Linctus Benylin Dry Coughs Blackcurrant CalCough Children's Soothing Syrup Benylin Children's Blackcurrant Flavour Cough Syrup Benylin Childrens Cough & Sore Throat Syrup

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient Glycerin Ph. Eur. Liquid sugar (Equivalent to sucrose B.P. Quantity per 5ml 0.75ml 1.93ml 1.7g)

3

PHARMACEUTICAL FORM
Syrup

4
4.1

CLINICAL PARTICULARS
Therapeutic indications For the relief of irritating, tickling dry coughs and sore throats.

4.2

Posology and method of administration Adults, elderly and children over 5 years: 10 ml Children 1 - 5 years: 5 ml The dose may be repeated three or four times a day.

Children under one year: Not to be given to children under 1 year. For oral administration.

4.3

Contraindications Hypersensitivity or intolerance to any of the ingredients.

4.4

Special warnings and precautions for use Diabetics should take note of the carbohydrate contents of this product. Do not give to children under one year. Keep all medicines out of the reach of children.

4.5

Interaction with other medicinal products and other forms of interaction No clinically significant interactions known

4.6

Pregnancy and lactation The safety of this medicine during pregnancy and lactation has not been established, but is not considered to constitute a hazard during these periods.

4.7

Effects on ability to drive and use machines None stated.

4.8

Undesirable effects
Immune system disorder: hypersensitivity reactions, including anaphylaxis.

4.9

Overdose Overdosage would not be expected to cause any problems and treatment would be merely symptomatic and supportive.

5
5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Glycerin and sucrose have demulcent properties and will soothe irritated sore throats and possibly block sensory cough receptors within the respiratory tract.

5.2

Pharmacokinetic properties Glycerin is readily absorbed from the gastrointestinal tract and undergoes extensive metabolism principally in the liver. It may be used in the synthesis of lipids, and is metabolised to glucose or glycogen or oxidised to carbon dioxide and water. It may also be excreted in the urine unchanged. Sucrose is hydrolysed in the small intestine by the enzyme sucrase to glucose and fructose which are then absorbed.

5.3

Preclinical safety data There are no preclinical data of relevance to the prescriber which are additional to that already included.

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients Citric acid monohydrate gran Sodium benzoate

Anthocyanin Blackcurrant Flavour 1740.7107 IFF Blackcurrant Juice 1740.1436 IFF Liquid Glucose BPC 1963 Purified Water

6.2

Incompatibilities Not applicable.

6.3

Shelf life 24 months

6.4

Special precautions for storage None stated.

6.5

Nature and contents of container 125ml, 150ml or 200ml white flint glass or amber glass bottle with an aluminium roll-on pilfer-proof cap with a flowed in liner, or a triseal (LDPE/EPE/LDPE) liner. Alternative caps: A wadless polypropylene tamper evident cap or a child resistant polypropylene cap with a LDPE liner. A double ended measuring spoon of 2.5ml and 5.0ml capacity may optionally be provided with the product.

6.6

Special precautions for disposal Not applicable.

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MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA Trading as: BCM

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MARKETING AUTHORISATION NUMBER(S)
PL 00014/0307

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14/03/1984 / 23/09/2005

10

DATE OF REVISION OF THE TEXT
20/12/2012

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