SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Benylin Dry Coughs Non-Drowsy Blackcurrant Flavour Syrup Benylin Children’s Dry Cough & Sore Throat Syrup CalCough Children’s Syrup

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient Glycerol Sucrose

Excipient with known effect:

Liquid Glucose

For the 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

Posology

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.

Method of Administration For oral administration.

4.3    Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

4.4    Special warnings and precautions for    use

Diabetics should take note of the carbohydrate content of this product.

Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Do not give to children under one year.

Keep out of the sight and 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

Not relevant.

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

Management:

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

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Cough suppressants and mucolytics, ATC code: R05FB01

Glycerol 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

Glycerol 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.

6.1 List of excipients

Citric acid monohydrate Sodium benzoate E211 Anthocyanin

Blackcurrant Flavour 1740.7107 IFF Blackcurrant Juice 1740.1436 IFF Liquid Glucose Purified Water

6.2 Incompatibilities

Not applicable.

6.3    Shelf life

2 years.

6.4    Special precautions for storage

This medicinal product does not require any special storage conditions.

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.

Not all pack sizes may be marketed.

Special precautions for disposal