Summary of Product Characteristics (SmPC) - Tixylix Childrens dry & Tickly Cough 15%v/v syrup
1 NAME OF THE MEDICINAL PRODUCT
Tixylix Children’s Dry & Tickly Cough 15%v/v Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient:
Glycerol 0.75ml per 5 ml
Excipient(s) with known effect:
Liquid maltitol (Lycasin) 2.06g/5ml dose.
Sodium benzoate (E 211) 10mg per 5ml dose.
Propylene glycol (E 1520) 4.7mg per 5ml dose.
Lemon flavour (contains propylene glycol E1520)
Honey flavour (contains propylene glycol E1520)
For the full list of 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.
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 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Glycerol has demulcent properties and may possibly block sensory cough receptors in the respiratory tract. ATC code: R05DB
5.2 Pharmacokinetic properties
None stated.
5.3 Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
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 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 sirop bottle Closure: Tamper evident cap with Tri-seal liner. Measuring spoon provided.
Pack size: 100ml
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd.
Linthwaite,
Huddersfield,
HD7 5QH, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00240/0583
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
03/10/2023
10 DATE OF REVISION OF THE TEXT
03/10/2023