Benylin Tickly Coughs Non-Drowsy

Oral liquid

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 mlChildren 1 – 5 years: 5 mlThe 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.

5.1 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.

6.1 List of excipients Citric acid monohydrateSodium benzoate (E211)Cough syrup 513277 flavour (containing anise oil, liquorice, propylene glycol,ethanol (alcohol)Black treacleLiquid glucosePurified water6.2 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.orAn amber glass bottle with an aluminium roll-on pilfer proof cap with a triseal (LDPE/EPE/LDPE) liner.Pack size: 125ml and 150mlOrAn 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