Glycerol Blackcurrant Flavour Cough Syrup
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glycerol Blackcurrant Flavour Cough Syrup
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Quantity per 5 ml 0.75ml 1.93ml 17g)
Active Ingredient Glycerol Liquid sugar (Equivalent to sucrose
Excipient with known effect:
Liquid Glucose to 5ml
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
A dark red, blackcurrant flavoured 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: 10ml
Children 1 - 5 years: 5ml
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 content of this product.
Patients with rare glucose-galactose malabsorption should not take this medicine
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 Fertility, 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 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 Sodium benzoate Anthocyanin
Blackcurrant Flavour 1740.7107 IFF Blackcurrant Juice 1740.1436 IFF Liquid Glucose 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 00014/0862
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10 DATE OF REVISION OF THE TEXT