GLYCERIN & BLACKCURRANT LINCTUS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Glycerin and Blackcurrant Linctus

2 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)

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 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.

5.1 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

6.1

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

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.