Pholcodine Linctus
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strong Pholcodine Linctus BP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Name of the active substance: Pholcodine Ph Eur 0.2% w/v Excipient(s) of known effect:
Each 5ml of solution contains Sucrose 3.2g
Each 5ml of solution contains 13.6% vol% Ethanol (alcohol)
Amaranth E123, Methylhydroxybenzoate E218, Sunset yellow E110
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Linctus - Oral use
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Cough suppressant for relief of acute non-productive cough associated with upper respiratory tract infection.
4.2 Posology and method of administration
Route of administration - Oral
Adults: 1 x 5 ml spoonful
The dose may be repeated 3 to 4 times daily
This medicinal product is contraindicated in children under the age of 12 years (see section 4.3).
Do not exceed the stated dose.
Keep out of sight and the reach of children.
4.3 Contraindications
• Hypersensitivity to the active substance or to any of the excipients.
• Not to be used in children under the age of 12 years.
Pholcodine should not be given to subjects in, or at risk of developing respiratory failure or during an attack of asthma.
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).
Liver failure.
4.4 Special warnings and precautions for use
• Should be used with caution by patients with renal, hepatic or respiratory disease, including history of asthma.
• Strong Pholcodine Linctus BP and other cough suppressants may cause sputum retention and this may be harmful in patients with chronic bronchitis and bronchiectasis.
• Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma, 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.
• This medicinal product contains small amounts of ethanol (alcohol)
• Keep out of the sight and reach of children
• Do not exceed the stated dose
• If symptoms persist consult your doctor
• Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this 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 effects of central nervous system depressants including alcohol, anxiolytics, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).
Pholcodine is antagonistic to metoclopramide and may cause delayed absorption of antiarrhythmic drugs.
4.6 Fertility, pregnancy and lactation
Pholcodine should only be used in pregnancy if considered necessary by the physician and should be avoided during the first trimester. Pholcodine has been detected in human milk but in amounts unlikely to affect the suckling infant.
4.7 Effects on ability to drive and use machines
Using the dose recommended, it is not considered a hazard, however, the use of pholcodine may cause sedation, dizziness and nausea. If affected, driving or operation of machinery would not be advised.
4.8 Undesirable effects
The following side effects may be associated with the use of pholcodine: (Frequencies not known: cannot be estimated from the available data)
Immune system disorders:
Hypersensitivity reactions and anaphylaxis, skin reactions including rash.
Psychiatric disorders:
Excitation, confusion.
Nervous system disorders:
Occasional drowsiness, dizziness.
Respiratory, thoracic and mediastinal disorders:
Sputum retention, respiratory depression (in overdose).
Gastrointestinal disorders:
Vomiting, gastrointestinal disturbances (nausea and constipation).
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.yellowcard.mhra.gov.uk.
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. Respiratory distress should be treated by supportive means. Airways protected gastric lavage may be of use. In severe cases a narcotic antagonist such as naloxone may be considered. 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
Pharmacotherapeutic group: Cough and cold preparations ATC code: R05DA08
Pholcodine relieves local irritation of the respiratory tract. Its depressant effects on respiration are less than those of morphine.
5.2 Pharmacokinetic properties
Pholcodine is rapidly absorbed following oral dosage and is effective for up to 4-5 hours.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections.
6.1 List of excipients
Sucrose Glycerol Citric acid Ethanol 96% w/v Methyl hydroxybenzoate Amaranth Solution Quinoline Yellow (E104) Sunset Yellow (E110) Purified Water
6.2 Incompatibilities
None
6.3 Shelf life
Two years.
6.4 Special precautions for storage
Store below 25°C.
Protect from light.
6.5 Nature and contents of container
Bottle: Amber (Type III) glass
Closures: Child resistant closure (CRC) fitted with low density polyethylene EPE/AL/PET liner
OR
Roll on pilfer proof (ROPP) screw cap fitted with low density polyethylene EPE/AL/PET liner
Sizes: 100ml, 200 ml, 500ml, 2000ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Bell, Sons and Co (Druggists) Ltd [Trading Style - Bell’s Healthcare]
Gifford House,
Slaidburn Crescent Southport Merseyside PR9 9AL
8 MARKETING AUTHORISATION NUMBER(S)
PL 03105/0060
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/01/2007
10 DATE OF REVISION OF THE TEXT
28/07/2016