Wednesday, September 21, 2016

Kamillosan Ointment (Chefaro UK Ltd)





1. Name Of The Medicinal Product



Kamillosan Chamomile Ointment


2. Qualitative And Quantitative Composition



Each tube or sachet of Kamillosan Ointment contains 10.5% extracts of chamomile standardised to give 0.01% L- a-bisabolol active ingredient.



3. Pharmaceutical Form



Light brown ointment with Characteristic odour.



4. Clinical Particulars



4.1 Therapeutic Indications



For prophylaxis and treatment of uncomplicated inflammation of the skin including sore nipples, nappy chafe, nappy rash and chapped hands.



4.2 Posology And Method Of Administration



Kamillosan ointment is for topical application as follows:



Sore nipples in nursing mothers: after breast feeding.



Nappy chafe and nappy rash: at change of nappy.



Other conditions: twice daily as necessary.



4.3 Contraindications



None known.



4.4 Special Warnings And Precautions For Use



None known.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



None known.



4.6 Pregnancy And Lactation



Kamillosan may be used during pregnancy and lactation.



4.7 Effects On Ability To Drive And Use Machines



None.



4.8 Undesirable Effects



None known.



4.9 Overdose



There are no known symptoms of overdosage.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



The chamomile extract possesses topical anti-inflammatory properties due to the presence of the natural anti-inflammatory substance L-a-bisabolol.



5.2 Pharmacokinetic Properties



Not applicable.



5.3 Preclinical Safety Data



There is none applicable.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Beeswax BP



Emulsifying wax BP



Anhydrous lanolin BP



Yellow soft paraffin BP



Maize oil



Mixed esters of p-hydroxybenzoic acid (preservative)



6.2 Incompatibilities



None known.



6.3 Shelf Life



2 years.



6.4 Special Precautions For Storage



Store in a dry place below 25°C.



6.5 Nature And Contents Of Container



Aluminium tubes containing 5, 20, 24, 30, 50, 100 and 125g of ointment. Sachets containing 1 and 1.5g of ointment.



6.6 Special Precautions For Disposal And Other Handling



None.



7. Marketing Authorisation Holder



Chefaro UK Ltd,



4th Floor, Hamilton House,



Mabledon Place, Bloomsbury,



LONDON, WC1H 9BB



United Kingdom



8. Marketing Authorisation Number(S)



PL 02855/0035



9. Date Of First Authorisation/Renewal Of The Authorisation



1st October 1999



10. Date Of Revision Of The Text



December 2009




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