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STRONG PHOLCODINE LINCTUS B.P.

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Strong Pholcodine Linctus B.P.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Pholcodine 10.0 mg/5 ml
For excipients, see 6.1.

3.

PHARMACEUTICAL FORM
Oral solution

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
For the symptomatic relief of unproductive cough.

4.2.

Posology and method of administration
Adults and the elderly
5 ml three or four times daily.
Children
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
age.
Method of administration
For oral use.

4.3

Contraindications
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
year.
Pholcodine should be avoided in patients being treated with monoamine
oxidase inhibitors or within 2 weeks of cessation of their use.

4.4

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
advice.
The sugar content may destabilise diabetes and encourage dental caries.
Keep all medicines out of the reach of children.

4.5.

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.

4.6.

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.

4.7.

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.

4.8

Undesirable effects
Nausea, dizziness, drowsiness and constipation are occasionally met. Immune
system disorders: hypersensitivity reactions and anaphylaxis.

4.9

Overdose
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.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
Pholcodine is a cough suppressant used for the relief of an unproductive
cough.
It is a mild sedative but has little analgesic activity.

5.2.

Pharmacokinetic properties
Pholcodine is well absorbed from the gastrointestinal tract
pharmacokinetics is independent of the dose in the dose range 15-60 mg.

and

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.

5.3.

Pre-clinical Safety Data
No relevant data.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients
Citric Acid Monohydrate
Ethanol 96% v/v
Chloroform
Amaranth (E123)
Sunset Yellow (E110)
Potable Water
Glycerol
Syrup

6.2.

Incompatibilities
No major incompatibilities are known.

6.3.

Shelf life
Three years.

6.4.

Special precautions for storage
Store in a cool place.

6.5.

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.

6.6.

Instructions for use/handling
No special instructions.

7.

MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Ltd
Hani Wells Business Park
Unit 7, Hardicker Street,
Manchester,
M19 2RB
United Kingdom

8.

MARKETING AUTHORISATION NUMBER(S)
PL 18374/0026

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
09/03/2005

10

DATE OF REVISION OF THE TEXT
30/11/2007

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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