1. Name Of The Medicinal Product
Benylin Tickly Coughs Non-Drowsy
2. Qualitative And Quantitative Composition
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For excipients see 6.1.
3. Pharmaceutical Form
Oral liquid
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
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.
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 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. 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
6th August 2010
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