Tixylix Dry Cough

1. Name Of The Medicinal Product

Tixylix® Dry Cough

2. Qualitative And Quantitative Composition

Each 5 ml contains Pholcodine Ph Eur 4 mg

3. Pharmaceutical Form

Linctus

4. Clinical Particulars

4.1 Therapeutic Indications

Cough Suppressant for relief of acute non-productive cough associated with upper respiratory tract infection.

Route of administration: Oral

4.2 Posology And Method Of Administration

The following doses are to be given 6 hourly as required. Do not exceed 4 doses in 24 hours.

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

6 - 10 years : 5 ml to 10 ml

Children of 6 -10 years of age: not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical attention 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 pholcodine or to any of the excipients.

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

Pholcodine should not be given to specific patients where suppression of the cough reflex is inadvisable.

Pholcodine should not be given to subjects in, or at risk of developing respiratory failure.

Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum retention.

Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (see also section 4.5).

4.4 Special Warnings And Precautions For Use

1. Should be used with caution by patients with liver or renal disease.

2. Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma, or are suffering from an acute asthma attack or where cough is accompanied by excessive secretions.

3. Do not take with any other cough and cold medicine.

4. Use of pholcodine with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.

Appearing on the Label or in the Leaflet (should one be provided)

If symptoms persist for more than 5 days consult your doctor.

If your child is taking other medicines consult your doctor or pharmacist.

Warning : Do not exceed the stated dose (in a rectangle).

Keep all medicines out of the reach and sight of children.

Do not exceed the stated dose.

Do not take with any other cough and cold medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not to be used in patients taking MAOIs or within 14 days of stopping treatment.

Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.

The reduction of blood pressure caused by antihypertensives may accentuate the hypotensive effects of pholcodine. Diuretics may have the same effect.

Pholcodine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).

4.6 Pregnancy And Lactation

Not applicable

4.7 Effects On Ability To Drive And Use Machines

Not applicable

4.8 Undesirable Effects

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

Occasional drowsiness, dizziness, excitation, confusion, sputum retention, vomiting, gastrointestinal disturbances (nausea and constipation) and skin reactions including rash.

Immune system disorders have been noted including hypersensitivity reactions and anaphylaxis.

4.9 Overdose

Restlessness, ataxia and excitement may occur. Treatment should be directed to elimination of ingested material by gastric lavage. General supportive measures should be followed. There may be respiratory depression and pin-point pupils : Naloxone 0.01 - 0.1 mg/kg should reverse this. If initial response is not maintained this dose may be repeated.

It is thought to be of low toxicity, but the effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms: These include nausea, drowsiness, restlessness, excitement, ataxia and respiratory depression.

Management: Treatment of overdose should be symptomatic and supportive. Gastric lavage may be of use. Naloxone has been used successfully to reverse central or peripheral opioid effects in children (0.01mg/kg body weight). Other treatment option is activated charcoal (1g/kg body weight) if more than 4mg/kg has been ingested within 1 hour, provided the airway can be protected.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pholcodine is a cough suppressant with little analgesic and sedative action. Its effects on depression of respiration are less than those of morphine.

5.2 Pharmacokinetic Properties

The duration of action is 4 - 5 hours.

Biotransformation to morphine is not apparent.

5.3 Preclinical Safety Data

None

6. Pharmaceutical Particulars

6.1 List Of Excipients

Liquid maltitol, glycerol, hydroxyethylcellulose, citric acid, sodium benzoate, acesulfame potassium, blackcurrant flavour (containing propylene glycol), vanilla flavour (containing propylene glycol) and purified water.

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Amber glass bottle with wadded aluminium ROPP closure, or wadded, polypropylene or polypropylene/HDPE, child resistant tamper evident closure.

Pack sizes: 100 ml, 1000 ml.

6.6 Special Precautions For Disposal And Other Handling

None

Administrative Data

7. Marketing Authorisation Holder

Novartis Consumer Health UK Limited

Wimblehurst Road,

Horsham,

West Sussex,

RH12 5AB,

United Kingdom.

Trading as Novartis Consumer Health

8. Marketing Authorisation Number(S)

PL 00030/0090

9. Date Of First Authorisation/Renewal Of The Authorisation

1 August 1997

10. Date Of Revision Of The Text

03 June 2009

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