Pholcodine Linctus BP

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

有效成分:

Pholcodine 1 mg/mL;  ;  ;  

可用日期:

AFT Pharmaceuticals Ltd

INN（国际名称）:

Pholcodine 1 mg/mL

剂量:

5 mg/5mL

药物剂型:

Linctus

组成:

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

每包单位数:

Bottle, HDPE, 1 L

类:

Pharmacy only

处方类型:

Restricted

厂商:

PCAS

疗效迹象:

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

產品總結:

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

授权日期:

2003-04-23

产品特点

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