Tixylix Baby Syrup
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tixylix Baby Syrup
Tixylix Toddler Syrup
Tixylix Blackcurrant Flavour 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.
One 5 ml spoonful three to four times a day Two 5 ml spoonfuls three to four times a day
Children 3 months to under 1 year:
Children 1 to 5 years:
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 Interactions 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 Baby 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.
5.1 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
Not applicable.
7. MARKETING AUTHORISATION HOLDER
Novartis Consumer Health UK Limited Park View,
Riverside Way,
Watchmoor Park,
Camberley,
Surrey,
GU15 3YL
Trading as: Novartis Consumer Health
8. MARKETING AUTHORISATION NUMBER
PL 00030/0150
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/05/2008
10 DATE OF REVISION OF THE TEXT
25/07/2013