Pholcodine Linctus Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strong Pholcodine Linctus BP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains Pholcodine BP 10mg
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
Adults: 5ml spoonful 3-4 times daily
Children: Not recommended.
4.3. Contra-Indications
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
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
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 antidepressants.
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.
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
Restlessness, excitement and ataxia may occur after large doses. A toxic dose in children is reported to be about 200mg.
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.
PHARMACOLOGICAL PROPERTIES
5.
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.
5.2. Pharmacokinetic Properties
Metabolised in the liver.
5.3. Pre-clinical Safety Data
Not stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Citric Acid BP
Sodium Carboxymethylcellulose 7HOF BP
Glycerol BP
Sodium Benzoate BP
Saccharin Sodium BP
Maltitol liquid (E965)
Ethanol 96% BP Raspberry/Cola flavour Purified Water BP to volume
6.2. Incompatibilities
None known.
6.4.
6.5.
7.
Amber glass bottles - 2 years
High density polyethylene bottles - 2 years
Nature and content of container
Amber Grade III glass bottle with pilfer proof screw cap, 100ml, 125ml, 200ml and 500ml. Virgin HDPE bottle with tamper evident screw cap, 500ml, 1 Litre and 2 Litres.
MARKETING AUTHORISATION HOLDER
Pinewood Laboratories Ltd.,
Ballymacarbry,
Clonmel,
Co. Tipperary,
Ireland
DATE OF REVISION OF THE TEXT
10
27/07/2015