Pholcodine Linctus Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pholcodine Linctus BP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains Pholcodine BP 5 mg
3. PHARMACEUTICAL FORM
Clear orange viscous syrup
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Adults: Cough suppressant for relief of acute non-productive cough associated with upper respiratory tract infection
Children of 6-12 years of age: Cough suppressant for relief of acute non-productive cough associated with upper respiratory tract infection
4.2 Posology and method of administration
Adults: 10 ml up to six times daily.
Dosage should be reduced in elderly or debilitated patients.
Children 6-12 years: 5 ml up to four times daily
Pholcodine is contraindicated in children under the age of 6 years (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 out of the reach and sight of children
4.3 Contraindications
Pholcodine should not be given to subjects in or at risk of developing respiratory failure as the sedative properties of pholcodine may exacerbate the condition.
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).
Patients with hypersensitivity or idiosyncratic response to pholcodine or to any of the excipients.
Patients with liver disease since pholcodine is metabolised in the liver and the drug may accumulate.
Not to be used in children under the age of 6 years.
4.4 Special warnings and precautions for use
1. Should be used with caution by patients with liver or renal impairment
2. Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma, suffering from 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
5. Children and elderly patients should be supervised while taking this medication.
6. Special care should be taken in patients with a history of drug abuse.
Tolerance and dependency may occur with prolonged use.
7. Patients with rare hereditary problems of fructose intolerance should not take this
medicine.
8. Sunset yellow (E110) may cause allergic reactions.
4.5 Interaction with other medicinal products and other forms of interaction
The reduction in blood pressure caused by antihypertensives may accentuate the hypotensive effects of pholcodine. Diuretics may have a similar effect. The sedative effects of central nervous system depressants may be increased by alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).
Hypertensive crisis may be caused by concurrent use of pholcodine with monoamine - oxidase inhibitors therefore not to be used in patients taking MAOIs or within 14 days of stopping treatment.
Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.
4.6 Pregnancy and lactation
Risk - benefit must be considered before using pholcodine during pregnancy or lactation. Opioid analgesics cross the placenta. Regular use during pregnancy may cause physical dependency and respiratory difficulties in the foetus, leading to withdrawal symptoms in the neonate, particularly in the premature neonate. There is a risk of gastric stasis in the mother during labour which may lead to inhalation pneumonia. Teratogenic effects in humans have not been documented but controlled studies have not been done, nor have studies in animals been documented for pholcodine. Although it is known that some opioid analgesics are excreted in breast milk, information on the excretion of pholcodine in breast milk is lacking.
4.7 Effects on ability to drive and use machines
Pholcodine may cause drowsiness. Patients receiving this medication should not drive or operate machinery unless it has been shown not to affect mental or physical ability.
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. Naloxone has been used successfully to reverse central or peripheral opioid effects in children (0.01 mg/kg body weight). Other treatment option is activated charcoal (1 g/kg body weight) if more than 4 mg/kg has been ingested within 1 hour, provided the airway can be protected.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Morphine or codeine derivative. By tradition used mainly as an antitussive. It suppresses the cough reflex by a direct central action, probably in the medulla or pons. It has little or no analgesic or euphorigenic activity. It is metabolised by the liver.
5.2 Pharmacokinetic properties
Usual dosage 10-15mg.
Duration of action 4-5 hours.
5.3 Preclinical safety data
Not applicable.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Citric Acid Monohydrate Saccharin Sodium Propylene Glycol Sodium Benzoate Carboxymethylcellulose 7H3SXF Sunset Yellow E110 Sorbitol Solution 70%
Purified Water (to volume)
6.2. Incompatibilities
None known.
6.3. Shelf life
High Density Polyethylene Bottles: 48 months
Amber Glass Bottles: 48 months
6.4. Special precautions for storage
Do not store above 25°C. Store in the original container.
6.5 Nature and contents of container
2000 ml and 1000 ml
High Density Polyethylene Bottles Pharmaceutical Grade III Amber Glass Bottles
6.6. Instruction for use and handling.
As for all medicines - no special precautions.
7. MARKETING AUTHORISATION HOLDER
Pinewood Laboratories Ltd
Ballymacarbry
Clonmel
Co. Tipperary
Ireland
8. MARKETING AUTHORISATION NUMBER
PL 04917/0002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
20/11/2003
10 DATE OF REVISION OF THE TEXT
08/07/2015