Wednesday, October 5, 2016

Tixylix Toddler Syrup





1. Name Of The Medicinal Product



Tixylix® Toddler Syrup


2. Qualitative And Quantitative Composition



Active ingredient:



Glycerol 0.75ml per 5 ml



For excipients see section 6.1



3. Pharmaceutical Form



Syrup



A clear viscous liquid



4. Clinical Particulars



4.1 Therapeutic Indications



For the relief of dry tickly coughs



4.2 Posology And Method Of Administration



For oral administration.



Children 3 months to under 1 year: One 5 ml spoonful three to four times a day



Children 1 to 5 years: Two 5 ml spoonfuls three to four times a day



Allow 3 to 4 hours between doses.



Children under 3 months: Not recommended



4.3 Contraindications



Hypersensitivity to any of the ingredients.



4.4 Special Warnings And Precautions For Use



Not recommended for children under 3 months.



If symptoms persist for more than 3 days consult your doctor.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



No known drug interactions exist.



4.6 Pregnancy And Lactation



No data are available for glycerol on exposed pregnancies or use during lactation. Caution should be exercised when prescribing during pregnancy..



4.7 Effects On Ability To Drive And Use Machines



On the basis of the known pharmacodynamic and adverse event profile for glycerol, Tixylix Toddler Syrup has no major influence on the ability to drive and use machinery.



4.8 Undesirable Effects



No adverse effects known.



4.9 Overdose



Overdosage with this product may possibly cause diarrhoea. Treatment should be symptomatic.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Glycerol has demulcent properties and may possibly block sensory cough receptors in the respiratory tract.



5.2 Pharmacokinetic Properties



None stated.



5.3 Preclinical Safety Data



None stated.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Liquid maltitol (Lycasin)



Hydroxyethylcellulose



Sodium Benzoate



Citric Acid Monohydrate



Sodium Citrate



Natural flavours (vanilla, blackcurrant)



Purified Water



6.2 Incompatibilities



None stated.



6.3 Shelf Life



36 months



6.4 Special Precautions For Storage



Keep the container tightly closed



Do not store above 25°C



6.5 Nature And Contents Of Container



Container: Amber-coloured glass bottle



Closure: Child resistant cap



Measuring spoon provided.



Pack size: 100ml, 150ml



Container: Amber-coloured polyethylene teraphthalate bottle



Closure: Child resistant cap



Measuring spoon provided.



Pack size: 150ml



6.6 Special Precautions For Disposal And Other Handling



Not applicable.



Administrative Data


7. Marketing Authorisation Holder



Novartis Consumer Health UK Limited



Wimblehurst Road



Horsham



West Sussex



RH12 5AB



Trading style: Novartis Consumer Health



8. Marketing Authorisation Number(S)



PL 00030/0150



9. Date Of First Authorisation/Renewal Of The Authorisation



18 November 1999



10. Date Of Revision Of The Text



7 July 2009



Legal category: GSL




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