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Drug information

OTC
Read time: 1 mins
Last updated: 06 Oct 2023
...
 

Summary of product characteristics


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


4.1. 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.


5.1. 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.


6.1. 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 and other handling

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

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.

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Disclaimer

The drug SPC information (indications, contra-indications, interactions, etc), has been developed in collaboration with eMC (www.medicines.org.uk/emc/). Medthority offers the whole library of SPC documents from eMC.

Medthority will not be held liable for explicit or implicit errors, or missing data.

Reporting of suspected adverse reactions 

Drug Licencing

Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).