Pholcodine Linctus
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pholcodine Linctus BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient %w/v
Pholcodine Ph. Eur. 0.1
3 PHARMACEUTICAL FORM
Oral solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the symptomatic relief of unproductive coughs For oral administration
4.2 Posology and method of administration
Adults and children over 12 years: Two 5ml spoonfuls.
Elderly: The normal adult dose is still appropriate in the elderly.
Children 6 to 12 years: One 5ml spoonful.
The dose may be taken, if necessary, 3 to 4 times daily.
This medicine is contraindicated in children under 6 years of age (See section 4.3).
Children of 6-12 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 all medicines out of the sight and reach of children.
4.3 Contraindications
Hypersensitivity to the active substance or any of the excipients.
Pholcodine should not be given to subjects in, or at risk of developing respiratory failure (may depress respiration).
Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum retention.
Patients with renal or hepatic failure.
Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (see also section 4.5).
Not to be used in children under the age of 6 years.
4.4 Special warnings and precautions for use
Should be used with caution by patients with liver or renal disease.
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.
Do not take with any other cough and cold medicine.
Use of pholcodine with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.
If symptoms persist consult your doctor.
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 in 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
The safety of pholcodine during pregnancy has not been established, but it’s use in pregnancy has not revealed any direct evidence or teratogenicity. There is no information available as to whether the drug is excreted in breast milk, but it is unlikely to be harmful to the infant. However, it’s use should be carefully assessed by consideration of small benefits versus potential risks to the foetus or neonate.
4.7 Effects on ability to drive and use machines
The product may cause drowsiness and patients should be warned not to drive or operate machinery.
This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine affects you
• It is an offence to drive while under the influence of this medicine
• However, you would not be committing an offence (called a ‘statutory defence’) if:
-The medicine has been prescribed to treat a medical or dental problem and -You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and -It was not affecting your ability to drive safely
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.
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.
4.9 Overdose
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. In cases of severe poisoning the specific narcotic antagonist naloxone may be used.
Information regarding children:
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 mild sedative but little analgesic activity.
5.2 Pharmacokinetic properties
Maximum plasma concentrations are attained at 4 to 8 hours after an oral dose. The elimination half life ranges from 32 to 43 hours and volume of distribution is 36-49L/kg. Pholcodine is protein bound to the extent of 23.5%. Pholcodine is metabolised in the liver but undergoes little conjugation.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6 Pharmaceutical Particulars
6.1 List of excipients
Glycerin
Citric acid monohydrate Sodium benzoate Purified water Liquid sugar Domiphen bromide
6.2 Incompatibilities
None stated
6.3 Shelf life
18 Months
6.4 Special precautions for storage
Do not store above 25oC
6.5 Nature and contents of container
Amber coloured glass bottle fitted with a child resistant polypropylene cap with a LDPE liner.
All packs are in the following sizes: 100, 200, 2000ml.
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
Trading as: BCM Almus
8 MARKETING AUTHORISATION NUMBER
PL 00014/5718R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08/07/1988 / 17/02/2004
10 DATE OF REVISION OF THE TEXT
26/05/2016