STRONG PHOLCODINE LINCTUS B.P.
NAME OF THE MEDICINAL PRODUCT
Strong Pholcodine Linctus B.P.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pholcodine 10.0 mg/5 ml
For excipients, see 6.1.
For the symptomatic relief of unproductive cough.
Posology and method of administration
Adults and the elderly
5 ml three or four times daily.
Not recommended. Patients should be referred to Pholcodine Linctus B.P.
The use of cough suppressants containing narcotic analgesics is not generally
recommended in children and should be avoided in those under one year of
Method of administration
For oral use.
Hypersensitivity to pholcodine or to any of the other ingredients.
Pholcodine should not be taken by patients suffering from liver disease. It
should not be administered to patients in or at risk of developing respiratory
failure or during an attack of asthma. It should be avoided in children under 1
Pholcodine should be avoided in patients being treated with monoamine
oxidase inhibitors or within 2 weeks of cessation of their use.
Special warnings and precautions for use
Pholcodine should be used with caution in patients with renal impairment or a
history of asthma.
It is not advised for persistent or productive coughs and in chronic bronchitis
or bronchiectasis because of the risks of sputum retention.
Its use should not be continued for longer than a few days without medical
The sugar content may destabilise diabetes and encourage dental caries.
Keep all medicines out of the reach of children.
Interactions with other medicinal products and other forms of interaction
When taken with alcohol, the effects of CNS depression may be potentiated.
It may cause delayed absorption of mexiletine and potentiation of the effects
of hypnotics and anxiolytics. When used with monoamine-oxidase inhibitors,
it may cause CNS excitation and hypertension and these effects can occur up
to 2 weeks after stopping such treatment. Domperidone and metoclopramide
have the opposing effects on gastrointestinal activity to pholcodine.
Pregnancy and lactation
As the safety of pholcodine linctus in pregnancy and breast feeding has not
been established, as with all drugs, it should be avoided if possible, especially
during the first trimester of pregnancy.
Effects on ability to drive and use machines
At the recommended dose, pholcodine is not considered to be a hazard.
However, as pholcodine may cause sedation, nausea and dizziness, anyone so
affected should be advised not to drive or operate machinery.
Nausea, dizziness, drowsiness and constipation are occasionally met. Immune
system disorders: hypersensitivity reactions and anaphylaxis.
Restlessness, excitement, ataxia, nausea, drowsiness and respiratory
depression may occur after large doses. A toxic dose in children is said to be
about 200 mg.
Activated charcoal has been reported to have beneficial effects when used
within an hour of pholcodine ingestion. Treatment of acute severe poisoning
should include a trial of naloxone in patients with depressed respiration. This
should not be repeated unless there is a clinically effective response.
Otherwise treatment should be symptomatic and supportive.
Pholcodine is a cough suppressant used for the relief of an unproductive
It is a mild sedative but has little analgesic activity.
Pholcodine is well absorbed from the gastrointestinal tract
pharmacokinetics is independent of the dose in the dose range 15-60 mg.
Following 15 mg pholcodine orally, Cmax is 9 ng/ml, Tmax is 4.8 hours,
AUC is 47 ng.h/ml and the elimination half-life is 37 hours.
The main metabolic pathway is by conjugation. Metabolism by o-dealkylation to morphine is a relatively minor pathway in man.
Pre-clinical Safety Data
No relevant data.
List of excipients
Citric Acid Monohydrate
Ethanol 96% v/v
Sunset Yellow (E110)
No major incompatibilities are known.
Special precautions for storage
Store in a cool place.
Nature and contents of container
500 ml white polythene bottle with a white wadless plastic cap.
2 litre white polythene bottle with a white plastic screw cap with an EPE liner
faced with aluminium.
100 ml and 200 ml amber glass bottles with white Jaycaps.
Not all pack sizes may be marketed.
Instructions for use/handling
No special instructions.
MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Ltd
Hani Wells Business Park
Unit 7, Hardicker Street,
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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