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