Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Pholcodine 2 mg/mL; ; ;
AFT Pharmaceuticals Ltd
Pholcodine 2 mg/mL
10 mg/5mL
Linctus
Active: Pholcodine 2 mg/mL Excipient: Carmellose sodium Citric acid monohydrate Ethanol Glycerol Maltitol Purified water Raspberry flavour 517503E Saccharin sodium Sodium benzoate
Bottle, HDPE, 1 L
Pharmacy only
Restricted
PCAS
Latest Regulatory Activity
Package - Contents - Shelf Life: Bottle, HDPE - 1 L - 36 months from date of manufacture stored at or below 25°C - Bottle, HDPE - 2 L - 36 months from date of manufacture stored at or below 25°C - Bottle, HDPE - 500 mL - 36 months from date of manufacture stored at or below 25°C - Bottle, glass, Amber - 100 mL - 48 months from date of manufacture stored at or below 25°C - Bottle, glass, Amber - 125 mL - 48 months from date of manufacture stored at or below 25°C - Bottle, glass, Amber - 200 mL - 48 months from date of manufacture stored at or below 25°C - Bottle, glass, Amber - 500 mL - 48 months from date of manufacture stored at or below 25°C
2003-04-23
1 NEW ZEALAND DATASHEET 1 NAME OF THE MEDICINE Strong Pholcodine Linctus BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL contains pholcodine 10 mg. For full list of excipients, see Section 6.1 List of excipients. 3 PHARMCEUTICAL FORM Strong Pholcodine Linctus BP is a clear colourless/ light yellow solution with a raspberry and cola odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS To suppress a dry non-productive cough 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE: FOR ORAL ADMINISTRATION _ADULTS AND CHILDREN OVER 12 YEARS _ 5 mL 3-4 times daily, or as directed by your doctor. _CHILDREN 6 – 12 YEARS _ Pholcodine Linctus BP 5 mg/5 mL should be used in children 6-12 years instead. MUST NOT BE USED IN CHILDREN UNDER 6 YEARS OF AGE. 4.3 CONTRAINDICATIONS Patients in or at risk of developing respiratory failure or during an asthma attack, 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. 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. Patients with ventilatory failure. Children under 6 years of age. 2 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE • Should be used with caution by patients with liver or renal impairment. • 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. • Do not take with any other cough and cold medicine. • Sunset yellow (in Pholcodine Linctus BP) may cause allergic reactions • Use of Pholcodine with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses. • Children and elderly patients should be supervised while takin Read the complete document