Thursday, October 27, 2016

Merocets Plus





1. Name Of The Medicinal Product



Merocets Plus.


2. Qualitative And Quantitative Composition



Cetylpyridinium Chloride EP 1.4mg; Menthol EP 5.0mg;Eucalyptus Oil 3.0mg.



3. Pharmaceutical Form



Lozenge.



4. Clinical Particulars



4.1 Therapeutic Indications



Symptomatic treatment of sore throat. Symptomatic relief of nasal congestion.



4.2 Posology And Method Of Administration



Oral: Adults and children over 6 years: One lozenge every 3 hours. Allow the lozenge to dissolve slowly in the mouth.



4.3 Contraindications



Known idiosyncrasy to cetylpyridinium chloride and menthol.



4.4 Special Warnings And Precautions For Use



If sore throat persists consult a doctor.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



None known.



4.6 Pregnancy And Lactation



There is no or inadequate evidence of safety of cetylpyridinium chloride in human pregnancy but it has been in wide use for many years without apparent ill consequences. No data are available on the use of Merocets Plus in pregnancy.



4.7 Effects On Ability To Drive And Use Machines



None known.



4.8 Undesirable Effects



Very rare reports of urticaria. Infrequent and transient complaints of a burning sensation of the mouth.



4.9 Overdose



No experience of overdosage but normal procedures of gastric lavage and maintenance of respiration and circulation should apply.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Cetylpyridinium chloride is a surface active quaternary ammonium compound with antibacterial properties.



5.2 Pharmacokinetic Properties



Cetylpyridinium chloride exerts its antimicrobial activity topically in the mouth and throat as it dissolves from the lozenge. Pharmacokinetic data are not available.



5.3 Preclinical Safety Data



None stated.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Sucrose, granular; Glucose Liquid; Ethyl Alcohol; Purified Water



6.2 Incompatibilities



Not applicable.



6.3 Shelf Life



36 months unopened.



6.4 Special Precautions For Storage



Do not store above 25°C



6.5 Nature And Contents Of Container



PVC/PVdC/aluminium foil laminate blister in cardboard cartons. Packs of 24 lozenges.



6.6 Special Precautions For Disposal And Other Handling



None stated.



7. Marketing Authorisation Holder



SSL International PLC. Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA.



8. Marketing Authorisation Number(S)



PL 17905/0069



9. Date Of First Authorisation/Renewal Of The Authorisation



23/03/06



10. Date Of Revision Of The Text



23/03/06




1 comment:

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