Duro-Tuss Phenylephrine PE Dry Cough + Nasal Decongestant

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Phenylephrine hydrochloride 0.667 mg/mL;  ; Pholcodine 1 mg/mL;  ;  ;  

Available from:

iNova Pharmaceuticals (New Zealand) Limited

INN (International Name):

Phenylephrine hydrochloride 0.667 mg/mL

Pharmaceutical form:

Oral solution

Composition:

Active: Phenylephrine hydrochloride 0.667 mg/mL   Pholcodine 1 mg/mL       Excipient: Amaranth Citric acid Custard flavour 052940 A Glycerol Hyetellose Methyl hydroxybenzoate Propyl hydroxybenzoate Purified water Raspberry flavour 580004 A Saccharin sodium Sorbitol

Units in package:

Bottle, plastic, PET with polypropylene tamper-evident wadded cap, 30 mL

Class:

Pharmacy only

Prescription type:

Restricted

Manufactured by:

Siegfried PharmaChemikalien Minden GmbH

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, PET with polypropylene tamper-evident wadded cap - 30 mL - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, PET with polypropylene tamper-evident wadded cap - 100 mL - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, PET with polypropylene tamper-evident wadded cap - 200 mL - 24 months from date of manufacture stored at or below 30°C

Authorization date:

2007-11-19

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 7
1 PRODUCT NAME
Duro-Tuss Phenylephrine PE Dry Cough + Nasal Decongestant
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 15 mL of the medicine contains 15 mg pholcodine and 10 mg
phenylephrine hydrochloride as
active ingredients.
Excipients with known effect:
Methyl hydroxybenzoate, propyl hydroxybenzoate, saccharin sodium and
sorbitol.
For full list of excipients, see section 6.1 List of excipients
.
3 PHARMACEUTICAL FORM
Oral solution.
Clear red, slightly viscous liquid with odour of raspberry and
custard.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Temporary relief of a dry cough and clearing a blocked or runny nose.
4.2
Dose and method of administration
For oral administration.
AGE
DOSAGE
HOW OFTEN
Adults & children 12 years & over
10 – 15 mL
Every 6 hours as required
(Maximum 4 times a day)
Children 6 – 11 years
5 – 10 mL
Children under 6 years
Do not use
4.3
Contraindications
•
Children under the age of 6 years.
•
Hypersensitivity to pholcodine, phenylephrine hydrochloride or any of
the excipients listed
in section 6.1 List of excipients
.
•
Patients in, or at risk of developing respiratory failure or during
acute asthma attacks, as it
may depress respiration.
•
Patients with chronic bronchitis, COPD, bronchiolitis or
bronchiectasis due to sputum
retention.
•
Patients with renal or hepatic failure.
•
Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days
of stopping such
treatment (see also see 4.5 Interaction with other medicines and other
forms of interaction
).
4.4
Special warnings and precautions for use
Use with caution in patients with liver or renal disease.
Pholcodine should be used with caution in patients with chronic or
persistent cough, asthma,
including an acute asthma attack, or where cough is accompanied by
excessive secretions.
Severe cutaneous adverse reactions (SCARs) including acute generalised
exanthematous pustulosis
(AGEP), which can be life-threatening or fatal, have been reported in
patients treated with
NEW