Pholcodine Linctus BP

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pholcodine 1 mg/mL;  ;  ;  

Available from:

AFT Pharmaceuticals Ltd

INN (International Name):

Pholcodine 1 mg/mL

Dosage:

5 mg/5mL

Pharmaceutical form:

Linctus

Composition:

Active: Pholcodine 1 mg/mL       Excipient: Carmellose Citric acid monohydrate Propylene glycol Purified water Saccharin sodium Sodium benzoate Sorbitol Sunset yellow FCF

Units in package:

Bottle, HDPE, 1 L

Class:

Pharmacy only

Prescription type:

Restricted

Manufactured by:

PCAS

Therapeutic indications:

Pholcodine Linctus BP: For relief of a dry, non-productive cough.

Product summary:

Package - Contents - Shelf Life: Bottle, HDPE - 1 L - 48 months from date of manufacture stored at or below 25°C - Bottle, HDPE - 2 L - 48 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 (hospital pack) - 200 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

Authorization date:

2003-04-23

Summary of Product characteristics

1
NEW ZEALAND DATASHEET
1
NAME OF THE MEDICINE
Pholcodine Linctus BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL contains pholcodine 5 mg.
For full list of excipients, see Section 6.1 List of excipients.
3
PHARMCEUTICAL FORM
Pholcodine Linctus BP is a clear colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For relief of a dry, non-productive cough
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE: FOR ORAL ADMINISTRATION
_ADULTS AND CHILDREN OVER 12 YEARS _
10 mL up to six times daily. Dosage should be reduced in elderly or
weak patients.
_CHILDREN 6 – 12 YEARS _
5 mL up to four times daily. For children 6-12 years, it is
recommended to seek advice
from a healthcare professional before use.
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