Glycerin & Blackcurrant Linctus
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
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Quantity per 5ml
0.75ml
1.93ml
1.7g)
Active Ingredient Glycerin Ph. Eur.
Liquid sugar
(Equivalent to sucrose B.P.
3 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.
5 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
8 MARKETING AUTHORISATION NUMBER(S)
PL 00014/0307
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14/03/1984 / 23/09/2005
10 DATE OF REVISION OF THE TEXT
4th June 2015