Tixylix Dry Cough
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tixylix Dry Cough
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains Pholcodine 4 mg For excipients, see 6.1.
3. PHARMACEUTICAL FORM Linctus
The product is a clear, colourless syrup with a sweet blackcurrant odour and taste.
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. Parent 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. Contra-indications
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) Purified water
6.2 Incompatibilities
Not applicable.
Shelf life
6.3
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 Instruction for use/handling
None.
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
PL 00030/0090
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/10/2004
10
DATE OF REVISION OF THE TEXT
03/06/2009