Tixylix Chesty Cough

1. Name Of The Medicinal Product

Tixylix® Chesty Cough

2. Qualitative And Quantitative Composition

Each 5ml contains Guaifenesin 50mg

For excipients see section 6.1

3. Pharmaceutical Form

Linctus

A clear, colourless or straw coloured solution

4. Clinical Particulars

4.1 Therapeutic Indications

Expectorant for the symptomatic relief of acute productive (chesty) cough.

The linctus is for the lubrication and relief of the sore throat and hoarseness, which may be associated with the cough.

4.2 Posology And Method Of Administration

The following dose is taken 4 hourly. Do not exceed 6 doses in 24 hours.

Tixylix Chesty Cough is contra-indicated in children under 6 years of age.

6 – 10 years 5 to 10ml

Not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical advice if the child's condition deteriorates during treatment.

Do not exceed the stated dose.

Keep out of the sight and reach of children.

4.3 Contraindications

Hypersensitivity to the active ingredients or to any of the excipients.

Not to be used in children under 6 years of age.

4.4 Special Warnings And Precautions For Use

Consult a doctor before use if suffering from an acute asthma attack, a chronic cough or are asthmatic.

Stop use and consult a healthcare professional if the cough persists for longer than 5 days.

Stop use and consult a healthcare professional if the cough is accompanied by a fever, rash or persistent headache or is recurrent.

If symptoms persist, consult a doctor.

Keep out of the sight and reach of children.

Do not exceed the stated dose.

Do not take with any other cough and cold medicine, including cough suppressants.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Should not be taken with a cough suppressant.

If urine is collected within 24 hours of a dose of Tixylix Chesty Cough a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

4.6 Pregnancy And Lactation

No special warnings or precautions.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

The following side effects may be associated with the use of guaifenesin:

Gastro-intestinal Disorders: nausea, vomiting

Immune System Disorders: hypersensitivity reactions

4.9 Overdose

Symptoms of very large overdosage are nausea and vomiting. Guaifenesin is, however, rapidly metabolised and excreted in the urine. Patients should be kept under observation and treated symptomatically.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Guaifenesin is reported to reduce the viscosity of tenacious sputum and is used as an expectorant.

5.2 Pharmacokinetic Properties

Guaifenesin is readily absorbed from the gastrointestinal tract. It is readily metabolised and excreted in the urine. It has a plasma half life of 1 hour.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium benzoate

Sodium saccharin

Glycerol

Sorbital solution (70%) (Non-cryst)

Citric acid monohydrate or anhydrous citric acid

Blackcurrant flavour DA13624

Vanilla flavour NN21166

Acesulfame Potassium

Hydroxyethylcellulose

Purified water

6.2 Incompatibilities

None.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 25ºC.

6.5 Nature And Contents Of Container

Container: Amber glass bottles

Closure: Wadded, aluminium roll-on pilfer-proof closure (ROPP)

or

Wadded, polypropylene or polypropylene/HDPE child resistant tamper evident closure

Wad: PVdC-coated. Board or EPE

Each bottle contains 100 ml.

6.6 Special Precautions For Disposal And Other Handling

Keep all medicines out of the reach of children.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

Trading as Novartis Consumer Health

8. Marketing Authorisation Number(S)

PL 00030/0082

9. Date Of First Authorisation/Renewal Of The Authorisation

Granted: 1 August 1997

10. Date Of Revision Of The Text

04 June 2009

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