This information is intended for use by health professionals

1. Name of the medicinal product

Pholcodine Linctus BP

2. Qualitative and quantitative composition

Each 5 ml contains Pholcodine BP 5 mg

For a full list of excipients, see section 6.1

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 in any 24 hours.

Dosage should be reduced in elderly or debilitated patients.

Children 6-12 years: 5 ml up to four times in any 24 hours.

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. Caution is needed in patients with a history of drug abuse. Pholcodine is an opioid and addiction is observed with opioids as a class.

7. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

8. Sunset yellow (E110) may cause allergic reactions.

9. Severe cutaneous adverse reactions (SCARs) including acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in patients treated with pholcodine, most likely in the first week. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, this medicine should be withdrawn immediately.

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.

Skin and subcutaneous tissue disorders

Unknown: Acute generalized exanthematous pustulosis (see section 4.4)

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 derivatives. 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 in the liver.

5.2 Pharmacokinetic properties

Usual dosage 10 – 15 mg.

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

High Density Polyethylene Bottles

2000 ml and 1000 ml

Pharmaceutical Grade III Amber Glass Bottles with polypropylene tamper evident child resistant closure

200 ml, 125 ml and 100 ml

6.6 Special precautions for disposal and other handling

As for all medicines – no special precautions.

7. Marketing authorisation holder

Pinewood Laboratories Ltd.,

Ballymacarbry,

Clonmel,

Co. Tipperary,

Ireland

8. Marketing authorisation number(s)

PL 04917/0002

9. Date of first authorisation/renewal of the authorisation

Date of First Authorisation: 30 August 1988

Date of Renewal of Authorisation: 30 August 2003

10. Date of revision of the text

15/06/2020