This information is intended for use by health professionals
Strong Pholcodine Linctus BP
Each 5ml contains Pholcodine BP 10mg
Oral solution: Clear, colourless, raspberry and cola flavoured syrup.
Suppression of non-productive cough.
5 ml spoonful 3-4 times in any 24 hours.
Liver disease, ventilatory failure, asthma, bronchitis, bronchiectasis. Use in patients with hypersensitivity or idiosyncratic response to the active ingredient, use in children.
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 If signs and symptoms suggestive of these reactions appear, this medicine should be withdrawn immediately.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.
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.
This product should not be used during pregnancy or lactation unless it is considered essential by the physician.
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.
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)
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.
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.
Metabolised in the liver.
Citric Acid BP
Sodium Carboxymethylcellulose 7HOF BP
Sodium Benzoate BP
Saccharin Sodium BP
Lycasin 80/55 HSE
Ethanol 96% BP
Purified Water BP to volume
Amber glass bottles – 2 years
High density polyethylene bottles – 2 years
Store below 20°C. Protect from light.
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.
As for all medicines – no special requirements.
Pinewood Laboratories Ltd.,
Co. Tipperary, Ireland
15 August 1991