Thursday, October 27, 2016

Calcough Children's Soothing Syrup





1. Name Of The Medicinal Product



Glycerin and Blackcurrant Soothing Cough Syrup or Glycerin and Blackcurrant Linctus or Benylin Dry Coughs Blackcurrant or CalCough Children's Soothing Syrup or Benylin Children's Blackcurrant Flavour Cough Syrup


2. Qualitative And Quantitative Composition






Active Ingredient



Glycerin Ph. Eur.



Liquid sugar



(Equivalent to sucrose B.P.




Quantity per 5ml



0.75ml



1.93ml



1.7g)



3. Pharmaceutical Form



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



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.



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 content 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



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



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. Pharmaceutical Particulars



6.1 List Of Excipients



Citric acid monohydrate gran



Sodium benzoate



Anthocyanin



Blackcurrant Flavour 1740.7107 IFF



Blackcurrant Juice 1740.1436 IFF



Liquid Glucose BPC 1963



Purified Water



6.2 Incompatibilities



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 LDPE 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 And Other Handling



Not applicable.



7. Marketing Authorisation Holder



The Boots Company PLC



1 Thane Road West



Nottingham NG2 3AA



Trading as: BCM



8. Marketing Authorisation Number(S)



PL 00014/0307



9. Date Of First Authorisation/Renewal Of The Authorisation






Date of First Authorisation:



Date of Last Renewal:




14 March 1984



25 July 2000



10. Date Of Revision Of The Text



April 2010




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