Pholcodine Linctus
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pholcodine Linctus
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pholcodine 5.0mg/5ml.
Each 5ml of syrup contains 4g of sucrose
Each 5ml of syrup contains 3.3 vol% of ethanol (alcohol)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
A deep orange/ red viscous liquid with a characteristic odour.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Cough suppressant for the relief of acute non-productive cough associated with upper respiratory tract infections.
4.2 Posology and method of administration
Oral use
Recommended Doses
Adults and children over 12 years: 5-10ml.
The elderly: Adult dose is appropriate.
Dosage Schedule
The dosage may be repeated after 4 hours if required but not more than 4 doses in any 24 hours.
4.3 Contraindications
Contraindicated in patients with hypersensitivity to the active substance or to any of the excipients; and in cases of liver failure.
It should not be administered to patients in or at risk of developing respiratory failure or during an attack of asthma.
Patients with chronic bronchitis, chronic obstructive pulmonary disease (COPD), bronchiolitis or bronchiectasis due to sputum retention.
Pholcodine should be avoided in patients being treated with monoamine oxidase inhibitors or within 2 weeks of cessation of their use (see section 4.5).
Children under 12 years of age.
4.4 Special warnings and precautions for use
Pholcodine Linctus should be used with caution in patients with renal, hepatic or respiratory disease, including a history of asthma.
Pholcodine Linctus 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, are suffering from an acute asthma attack or where cough is accompanied by excessive secretions.
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 6.6 vol % ethanol (alcohol), i.e. up to 520 mg per 10 ml dose, equivalent to 13 ml beer, 6 ml wine per dose.
Harmful for those suffering from alcoholism. To be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
It contains 4g of sucrose per 5ml. To be taken into account in people with diabetes. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
It also contains amaranth (E123) and sunset yellow (E110) which may cause allergic reactions.
Do not take with any other cough and cold medicine.
Keep out of the sight and reach of children.
Do not exceed the stated dose.
If symptoms persist consult your doctor.
Do not give to children under 12 years.
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 (see Section 4.3).
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
Safety of this product in pregnancy has not been established. All drugs should be avoided if possible during pregnancy, especially during the first trimester. Pholcodine Linctus 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, pholocodine linctus is not considered to be 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.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 of overdose include restlessness, excitement, ataxia, nausea, drowsiness, and respiratory depression may occur after large doses. A toxic dose in children is said to be about 200mg.
Treatment consists of emptying the stomach by aspiration and lavage. Otherwise treatment should be symptomatic and supportive. Treatment of acute poisoning should include a trial of naloxone. It should not be repeated unless there is a clinically effective response. 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
R05D A08 - Cough suppressants, excl. combinations with expectorants -opium alkaloids and derivatives.
Pholcodine is a cough suppressant with mild sedative but little analgesic action. Its depressant effects on the respiration are less than those of morphine. It has been suggested that it produces its major effect on the patient’s subjective reactions to the cough, rather than on the frequency and intensity of coughing. Opioids act as agonists, interacting with stereospecific and saturable binding sites or receptors in the brain and other tissues.
5.2 Pharmacokinetic properties
Opioids are readily absorbed from the gastro-intestinal tract. Pholcodine may relieve local irritation of the respiratory tract for about 4 - 5 hours after oral administration.
Pathways of metabolism include hydrolysis followed by conjugation, as well as the more common N-dealkylation.
5.3 Preclinical safety data
No data of relevance to the prescriber, which is additional to that included in other sections of the SPC.
6
PHARMACEUTICAL PARTICULARS
List of excipients
6.1
Ethanol (96%)
Citric acid monohydrate Purified water Sodium benzoate Amaranth (E123)
Quinoline yellow (E104)
Yellow dye sunset (E110)
Sucrose
6.2 Incompatibilities
No major incompatibilities known.
6.3 Shelf life
200ml: 24 months unopened.
6.4 Special precautions for storage
Store below 25 °C.
6.5 Nature and contents of container
200ml: Glass bottle with plastic cap or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.
6.6 Instructions for use, handling and disposal
None.
7. MARKETING AUTHORISATION HOLDER
L.C.M. Ltd.
Linthwaite Laboratories
Huddersfield
HD7 5QH
8. MARKETING AUTHORISATION NUMBER(S)
PL 12965/0030
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/10/1993