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MORRISONS PHOLCODINE LINCTUS ORAL SOLUTION

Active substance(s): PHOLCODINE / PHOLCODINE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Pholcodine Linctus Bell’s Healthcare 5mg per 5ml Oral Solution
Manordine Cough Linctus
Superdrug Pholcodine Linctus BP
Morrisons Pholcodine Linctus Oral Solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Pholcodine 5 mg per 5ml
Excipient(s) of known effect:
Each 10ml of solution contains Sucrose 8g
Each 10ml of solution contains 6.6% vol% Ethanol (alcohol)
Amaranth E123, Sodium methylhydroxybenzoate E219, Sunset yellow E110
For a full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM
Oral Solution

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
Oral
Adults and Elderly:
Children: 6 - 12 years

1 - 2 teaspoonful (5-10 ml)
½ - 1 teaspoonful (2.5-5 ml)

These doses may be repeated 3 - 4 times a day
This medicinal product 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 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 6 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).



Pholcodine should not be given to subjects with 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.



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.



Consult a doctor before use if you have a history of drug abuse.



This medicinal product contains small amounts of ethanol (alcohol)



Keep out of the sight and reach of children



Do not exceed the stated dose



Do not take with other cough medicines



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, barbiturates, hypnotics, narcotic analgesics,
sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).
Pholcodine may
metoclopramide.

be

antagonistic

to

cisapride,

domperidone

and

Pholcodine may cause delayed absorption of mexiletine.

4.6 Fertility, pregnancy and lactation
Use with caution only where benefit exceeds risk. Opioids may depress
neonatal respiration, cause withdrawal effects in neonates of depended
mothers, and be associated with gastric stasis and risk of inhalation pneumonia
in mother during labour.
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 that already included in other sections.

6.1 List of excipients
Sucrose
Ethanol 96% w/v
Glycerol
Citric acid
Amaranth solution

Sodium methyl hydroxybenzoate
Quinoline Yellow (E104)
Sunset Yellow (E110)
Purified Water

6.2

Incompatibilities
Not known

6.3

Shelf life
Three years.

6.4 Special precautions for storage
Do not store above 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.
30 ml CE marked polypropylene measuring cup with 2.5 ml, 3.3 ml, 4 ml, 5
ml,
7.5 ml, 10 ml, 15 ml, 20 ml and 25 ml graduations.
(May not be included in all marketed products)

Not all pack sizes may be marketed.

6.6

Special precautions for disposal
None.

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 03105/0059

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
25/01/2007

10

DATE OF REVISION OF THE TEXT
28/07/2016

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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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