This information is intended for use by health professionals

1. Name of the medicinal product

Strong Pholcodine Linctus BP

2. Qualitative and quantitative composition

Each 5ml contains Pholcodine BP 10mg

Excipients with known effect:

Ethanol

Maltitol liquid

Sodium benzoate (E211)

Sodium

59.21 mg/5 ml

1000 mg/5 ml,

6 mg/5 ml

2.94 mg/5 ml

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Oral solution: Clear, colourless, raspberry and cola flavoured syrup.

4. Clinical particulars
4.1 Therapeutic indications

Suppression of non-productive cough.

4.2 Posology and method of administration

Posology

Adults: 5 ml spoonful 3-4 times in any 24 hours.

Children: Not recommended.

Method of administration

For oral administration

4.3 Contraindications

Liver disease, ventilatory failure, asthma, bronchitis, bronchiectasis. Use in patients with hypersensitivity or idiosyncratic response to the active ingredient, use in children.

4.4 Special warnings and precautions for use

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 If signs and symptoms suggestive of these reactions appear, this medicine should be withdrawn immediately.

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

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

Cross-reactivity leading to serious allergic reactions (anaphylaxis) have been reported between pholcodine and NMBAs (Neuromuscular Blocking Agents). A precise at-risk period of time between the exposures of pholcodine and NMBAs has not been determined. Clinicians should be aware of this potential in case of future anaesthetic procedures involving NMBAs.

Excipients: Ethanol, Maltitol, Sodium benzoate and Sodium.

Ethanol

This medicine contains less than 59.21 mg of alcohol (ethanol) in each 5 ml which is equivalent to 1.464% v/v. The amount in 5 ml of this medicine is equivalent to less than 1.5 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.

Maltitol

This medicinal product contains Maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Sodium benzoate

This medicine contains 6.0 mg sodium benzoate in each 5 ml which is equivalent to 1.2 mg/ml.

Sodium

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

4.5 Interaction with other medicinal products and other forms of interaction

Depressant effects may occur with concurrent alcohol ingestion; concurrent (or within 2 weeks) use of MAOIs may lead to excitation; the depressant effects might be increased by phenothiazines, MAOIs and tricyclic anti-depressants.

4.6 Pregnancy and lactation

This product should not be used during pregnancy or lactation unless it is considered essential by the physician.

4.7 Effects on ability to drive and use machines

Pholcodine may induce 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

Constipation, nausea and drowsiness occasionally occur.

Immune system disorders: hypersensitivity reactions, 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Restlessness, excitement and ataxia may occur after large doses. A toxic dose in children is reported to be about 200 mg.

Treatment: Gastric lavage with supportive and symptomatic measures. In severe cases, and where respiratory depression occurs an opioid antagonist such as Naloxone – should be considered.

5. Pharmacological properties
5.1 Pharmacodynamic properties

ATC Code – R05DA08

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.

5.2 Pharmacokinetic properties

Metabolised in the liver.

5.3 Preclinical safety data

Not stated

6. Pharmaceutical particulars
6.1 List of excipients

Citric Acid BP

Sodium Carboxymethylcellulose 7HOF BP

Glycerol BP

Sodium Benzoate BP (E211)

Saccharin Sodium BP

Maltitol liquid (E965)

Ethanol 96% BP

Raspberry/Cola flavour

Purified Water BP to volume

6.2 Incompatibilities

None known

6.3 Shelf life

Amber glass bottles – 2 years

High density polyethylene bottles – 2 years

6.4 Special precautions for storage

Do not store above 25°C Protect from light.

6.5 Nature and contents of container

Amber Grade III glass bottle with pilfer proof screw cap, 100 ml, 125 ml, 200 ml and 500 ml.

Virgin HDPE bottle with tamper evident screw cap, 500 ml, 1 Litre, 2 Litres.

6.6 Special precautions for disposal and other handling

No special requirements

Administrative Data

7. Marketing authorisation holder

Pinewood Laboratories Ltd.,

Ballymacarbry, Clonmel,

Co. Tipperary, Ireland

8. Marketing authorisation number(s)

PL 04917/0005

9. Date of first authorisation/renewal of the authorisation

15 August 1991

10. Date of revision of the text

22/06/2022