Tixylix Childrens Dry and Tickly Cough Syrup

Syrup A clear viscous liquid

4.1 Therapeutic indications For the relief of dry tickly coughs4.2 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. **Important information about some of the ingredients**: This medicine contains: • Sodium benzoate (E211), 10mg per 5ml dose. • Maltitol may have a mild laxative effect. Calorific value 2.3Kcal/g. If you have been told by your doctor that your child is intolerant to some sugars, contact your doctor before taking this medicinal product. Patients with rare hereditary problems of fructose intolerance should not take this medicine. • This medicine contains 4.7mg propylene glycol (E1520) in each 5ml dose. • Less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially “sodium-free”.4.5 Interaction with other medicinal products and other forms of interaction No known drug interactions exist.4.6 Fertility, 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, this medicine has no major influence on the ability to drive and use machinery.4.8 Undesirable effects No adverse effects known. **Reporting of suspected adverse reactions** Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for 'MHRA Yellow Card' in the Google Play or Apple App Store.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. ATC code: R05DB5.2 Pharmacokinetic properties None stated.5.3 Preclinical safety data None stated.

6.1 List of excipients Liquid maltitol (Lycasin) (E965) Hydroxyethyl cellulose (E1525) Sodium Benzoate (E211) Citric Acid Monohydrate (E330) Sodium Citrate (E331) Lemon flavour (contains propylene glycol E1520) Honey flavour (contains propylene glycol E1520) Purified Water6.2 Incompatibilities None stated.6.3 Shelf life 36 months6.4 Special precautions for storage Keep the container tightly closed Do not store above 25°C6.5 Nature and contents of container Container: Amber-coloured glass sirop bottle Closure: Tamper evident cap with Tri-seal liner. Measuring spoon provided. Pack size: 100ml6.6 Special precautions for disposal and other handling Not applicable.