This information is intended for use by health professionals

1. Name of the medicinal product

Benylin Tickly Coughs Non-Drowsy

2. Qualitative and quantitative composition

Active ingredient

per 5 ml

Glycerol

0.75 ml

Sucrose

1.707g

For excipients see 6.1.

3. Pharmaceutical form

Oral liquid

4. Clinical particulars
4.1 Therapeutic indications

For the relief of irritating, tickly dry coughs and sore throats.

4.2 Posology and method of administration

For oral administration.

Adults 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.

Elderly: There is no need for dosage reduction in the elderly.

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.

Do not give to children under one year.

Keep all medicines out of the reach of children.

Information relating specifically to excipients in the formulation.

This medicine contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose.

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

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 product 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 applicable.

4.8 Undesirable effects

No adverse effects would be anticipated.

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

Glycerol and sucrose have demulcent properties and will soothe irritated sore throats and possibly block sensory cough receptors withing 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 intenstine by the enzyme sucrose to glucose and frucrose 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 (E211)

Cough syrup 513277 flavour (containing anise oil, liquorice, propylene glycol,

ethanol (alcohol)

Black treacle

Liquid glucose

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

No special precautions for storage.

6.5 Nature and contents of container

A white flint glass bottle with an aluminium roll-on pilfer proof cap with a flowed in liner, or a triseal (LDPE/EPE/LDPE) liner.

Alternative cap: A wadless polypropylene tamper evident cap.

Pack size: 200ml.

or

An amber glass bottle with an aluminium roll-on pilfer proof cap with a triseal (LDPE/EPE/LDPE) liner.

Pack size: 125ml and 150ml

Or

An amber PET bottle with a child resistant polypropylene cap fitted with an expanded polyethylene liner.

Pack size: 150ml or 300ml.

6.6 Special precautions for disposal and other handling

Not applicable.

Administrative data
7. Marketing authorisation holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

8. Marketing authorisation number(s)

PL 15513/0142

9. Date of first authorisation/renewal of the authorisation

11th January 2005

10. Date of revision of the text

6 February 2015