Tixylix chesty cough

Tixylix chesty cough Medicine

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.

Shelf life

36 months.

Contraindications

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

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

Incompatibilities

None.

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

Pharmaceutical form

Linctus

A clear, colourless or straw coloured solution

Undesirable effects

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

Gastro-intestinal Disorders: nausea, vomiting

Immune System Disorders: hypersensitivity reactions

Preclinical safety data

None.

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.

Pharmacodynamic properties

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

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.

Date of revision of the text

25 July 2013

Name of the medicinal product

Tixylix® Chesty Cough

Marketing authorisation holder

Novartis Consumer Health UK Limited

Park View,

Riverside Way,

Watchmoor Park,

Camberley,

Surrey,

GU15 3YL

Trading as: Novartis Consumer Health

Special precautions for storage

Store below 25°C.

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 or 150ml.

Marketing authorisation number(s)

PL 00030/0082

Qualitative and quantitative composition

Each 5ml contains Guaifenesin 50mg

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.

Effects on ability to drive and use machines

None.

Dosage (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.

Special precautions for disposal and other handling

Keep all medicines out of the reach of children.

Date of first authorisation/renewal of the authorisation

Granted: 1 August 1997