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BENYLIN CHILDRENS BLACKCURRANT FLAVOUR COUGH SYRUP

Active substance(s): GLYCERIN / LIQUID SUGAR

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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 Children’s Cough & Sore Throat Syrup

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QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient

Quantity per 5ml

Glycerin Ph. Eur.

0.75ml

Liquid sugar

1.93ml

(Equivalent to sucrose B.P.

1.7g)

PHARMACEUTICAL FORM
Syrup

4

CLINICAL PARTICULARS

4.1

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.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk
balance of the medicinal product. Healthcare professionals are asked to report
any suspected adverse reactions via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.

4.9

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

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PHARMACOLOGICAL PROPERTIES

5.1

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.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Citric acid monohydrate granular
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 EPE 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.

7

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
4th June 2015

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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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