This information is intended for use by health professionals

1. Name of the medicinal product

Pholcodine Linctus

2. Qualitative and quantitative composition

Pholcodine monohydrate 5.0mg/5ml.

Excipients of known effect

This medicine contains, per 5ml dose:

4g Sucrose

270mg Ethanol

0.0525mg Amaranth Dye

0.0525mg Sunset Yellow Dye

For the 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 monohydrate 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.

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

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 monohydrate with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.

Ingredients with specified warnings

This medicine contains 270mg of alcohol (ethanol) in each 5ml dose. The amount in 5ml of this medicine is equivalent to less than 7ml of beer or 3ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects.

It contains 4g of sucrose per 5ml dose. To be taken into account in people with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

It also contains amaranth (E123) and sunset yellow (E110) which may cause allergic reactions.

It also contains 2.5mg sodium benzoate per 5ml dose.

It also contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially 'sodium-free'.

Do not take with any other cough and cold medicine.

Keep out of the sight and reach of children.

Warning: Do not take more medicine than the label tells you to.

If symptoms persist consult your doctor.

Do not give to children under 12 years.

Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs:

Concomitant use of pholcodine and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe this medicine concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).

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 monohydrate. Diuretics may have the same effect.

Pholcodine monohydrate may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).

Sedative medicines such as benzodiazepines or related drugs:

The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration of concomitant use should be limited (see section 4.4).

4.6 Fertility, 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 monohydrate 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 monohydrate 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 monohydrate:

(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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 monohydrate 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 monohydrate 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
6.1 List of excipients

Ethanol (96%)

Citric acid monohydrate (E330)

Purified water

Sodium benzoate (E211)

Amaranth (E123)

Quinoline yellow (E104)

Yellow dye sunset (E110)

Syrup (contains 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 Special precautions for disposal and other handling

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

10. Date of revision of the text

17/04/2020