Duro-Tuss Dry Cough Liquid Regular

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Pholcodine 1 mg/mL;  ;  ;  

Disponível em:

iNova Pharmaceuticals (New Zealand) Limited

DCI (Denominação Comum Internacional):

Pholcodine 1 mg/mL

Dosagem:

1 mg/mL

Forma farmacêutica:

Oral solution

Composição:

Active: Pholcodine 1 mg/mL       Excipient: Citric acid Disodium edetate dihydrate Hyetellose Purified water Saccharin sodium Sodium benzoate Sodium citrate dihydrate Sorbitol Tutti frutti flavour 051880 A7

Unidades em pacote:

Bottle, plastic, amber PET bottle with ppp tamper evident wadded cap, 100 mL

Classe:

Pharmacy only

Tipo de prescrição:

Restricted

Fabricado por:

Ajinomoto OmniChem SA

Resumo do produto:

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

Data de autorização:

2009-07-15

Características técnicas

NEW ZEALAND DATA SHEET
Page 1 of 4
1 PRODUCT NAME
Duro-Tuss Dry Cough Liquid Regular
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 15 mL of the medicine contains 15 mg pholcodine as the active
ingredient.
Excipients with known effect:
Sodium benzoate, saccharin sodium and sorbitol.
For full list of excipients, see section 6.1
.
3 PHARMACEUTICAL FORM
Oral solution.
A colourless, slightly viscous liquid with fruity odour.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Temporary relief of dry coughs.
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 or any of the excipients listed in
section 6.1
.
•
Patients in, or at risk of developing respiratory failure, (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 section 4.5
).
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 generalized
exanthematous pustulosis
(AGEP), which can be life-threatening or fatal, have been reported in
patients treated with
pholcodine-containing products, most likely in the first week.
Patients should be advised of the signs
and symptoms and monitored closely for skin reactions. If signs and
symptoms suggestive of these
reactions appear, Duro-Tuss Dry Cough Liquid Regular should be
withdrawn immediately.
NEW ZEALAND DATA SHEET
Page