Thursday, October 20, 2016

Glycerin Honey and Lemon Linctus with Ipecacuanha / Boots Sore Throat and Cough Linctus 2 Years Plus





1. Name Of The Medicinal Product



Glycerin Honey and Lemon Linctus with Ipecacuanha or Boots Sore Throat & Cough Linctus 2 Years +


2. Qualitative And Quantitative Composition














Active Ingredient




Per 5ml



 




Honey mfg




1.11g




Glycerin Ph Eur




0.75ml




Liquid Sugar Demin




2.2ml




Ipecacuanha Liquid Extract




0.015ml



3. Pharmaceutical Form



Linctus



4. Clinical Particulars



4.1 Therapeutic Indications



For the relief of coughs and sore throats.



For oral administration.



4.2 Posology And Method Of Administration



Adults and children over 12 years: 10ml



Children 6 to 12 years: 5ml



Children 2 to 5 years: 2.5ml



This dose may be taken up to three or four times a day if needed.



Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose.



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



Consult a pharmacist or other healthcare professional before use in children under 6 years.



Do not give with any other cough and cold medicine.



If symptoms persist consult your doctor.



Keep all medicines out of the reach of children.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



No clinically significant drug interactions known.



4.6 Pregnancy And Lactation



The safety of this product during pregnancy and lactation has not been established, and its use during these periods should be avoided.



4.7 Effects On Ability To Drive And Use Machines



No known adverse effects.



4.8 Undesirable Effects



No adverse effects would be anticipated.



4.9 Overdose



Overdosage may have an irritant effect on the gastrointestinal tract and persistent bloody vomiting or diarrhoea may occur. In severe cases may give rise to adverse effects on the heart such as conduction abnormalities or myocardial infarction. These combined with dehydration due to vomiting and diarrhoea, may cause circulatory collapse.



Initial treatment of severe overdosage involves the administration of activated charcoal to delay absorption, followed by gastric lavage. Prolonged vomiting may be controlled by intramuscular injection of antiemetics. Fluid and electrolyte balance should be corrected, as should any cardiac defects.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Glycerin, syrup and honey have demulcent properties and will soothe irritated sore throats.



Ipecacuanha has expectorant properties.



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.



No detailed pharmacokinetic data is available for Ipecacuanha.



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



Lemon oil



Citric acid monohydrate



Terpeneless lemon oil



Benzoic acid



Distilled lime oil



Purified water



6.2 Incompatibilities



Not applicable.



6.3 Shelf Life



36 months.



6.4 Special Precautions For Storage



None.



6.5 Nature And Contents Of Container



A white flint glass bottle with an unlined or LDPE/EPE/LDPE lined polypropylene cap.



Alternative cap: A roll-on pilfer-proof cap with a flowed-in liner or a triseal (LDPE/EPE/LDPE) liner.



Pack size: 100, 125, 200 ml



6.6 Special Precautions For Disposal And Other Handling



None stated.



7. Marketing Authorisation Holder



The Boots Company PLC



1 Thane Road West



Nottingham NG2 3AA



8. Marketing Authorisation Number(S)



PL00014/5152R



9. Date Of First Authorisation/Renewal Of The Authorisation



First Authorisation: 8 February 1989



Date of Last Renewal: 12 July 1999



10. Date Of Revision Of The Text



March 2008





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