Duro-Tuss Dry Cough

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Cetylpyridinium chloride monohydrate 1.33mg; Pholcodine 5.5mg;  ;  ;  ; Cetylpyridinium chloride monohydrate 1.33mg; Pholcodine 5.5mg

Mevcut itibaren:

iNova Pharmaceuticals (New Zealand) Limited

INN (International Adı):

Cetylpyridinium chloride monohydrate 1.33 mg

Farmasötik formu:

Lozenge

Kompozisyon:

Active: Cetylpyridinium chloride monohydrate 1.33mg Pholcodine 5.5mg       Excipient: Citric acid Isomalt Menthol Orange flavour 051239A Saccharin sodium Sunset yellow FCF Active: Cetylpyridinium chloride monohydrate 1.33mg Pholcodine 5.5mg Excipient: Citric acid Isomalt Menthol Orange flavour 051239A Sucralose Sunset yellow FCF

Paketteki üniteler:

Blister pack, Sample, PVC/PVDC blister, 2 lozenges

Sınıf:

Pharmacy only

Reçete türü:

Restricted

Tarafından üretildi:

Vertellus Health & Specialty Products LLC

Terapötik endikasyonlar:

Relives dry cough and associated sore throats

Ürün özeti:

Package - Contents - Shelf Life: Blister pack, Sample, PVC/PVDC blister - 2 lozenges - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC blister - 4 lozenges - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC blisters - 24 lozenges - 36 months from date of manufacture stored at or below 30°C

Yetkilendirme tarihi:

1995-05-08

Bilgilendirme broşürü

Duro-Tuss Dry Cough Lozenge_May 2010 final_NZ.doc 

Page 1 of 3 pages 

DURO-TUSS 
TM
 DRY COUGH LOZENGES 

_PHOLCODINE AND CETYLPYRIDINIUM CHLORIDE _

CONSUMER 
MEDICINE 
INFORMATION 
     _ _
WHAT IS IN THIS LEAFLET 

This leaflet answers some common 
questions about Duro-Tuss Dry Cough 
Lozenges. It does not contain all the 
available information.  It does not take 
the place of talking to your pharmacist 
or doctor. 

All medicines have risks and benefits.  
Your pharmacist or doctor has weighed 
the risks of you taking Duro-Tuss Dry 
Cough Lozenges against the benefits 
they expect it will have for you. 

IF YOU HAVE ANY CONCERNS ABOUT 
TAKING THIS MEDICINE, ASK YOUR DOCTOR 
OR PHARMACIST. 

KEEP THIS LEAFLET.  
You may need to read it again. 
WHAT DURO-TUSS DRY 
COUGH LOZENGES ARE 
USED FOR 

Pholcodine and Cetylpyridinium 
chloride are used to relieve dry coughs 
and associated sore throat. 

Pholcodine works on the cough centre 
in the brain to control and help stop 
coughing.  

Cetylpyridinium chloride has antiseptic 
activities and is used for the treatment 
of infections of the mouth and throat. 

ASK YOUR PHARMACIST OR DOCTOR IF 
YOU HAVE ANY QUESTIONS ABOUT THIS 
MEDICINE. 
Your pharmacist or doctor may have 
given it for another reason. 

BEFORE YOU TAKE DURO-
TUSS DRY COUGH 
LOZENGES 

_WHEN YOU MUST NOT TAKE IT _

DO NOT TAKE THIS MEDICINE IF YOU HAVE 
AN ALLERGY TO: 
•  any medicine containing 
Pholcodine or Cetylpyridinium 
chloride 
•  any of the ingredients listed at the 
end of this leaflet. 

Some of the symptoms of an allergic 
reaction may include: 

•  shortness of breath_ _
•  wheezing or difficulty breathing_ _
•  swelling of the face, lips, tongue or 
other parts of the body_ _
•  rash, itching or hives on the skin.  

DO NOT TAKE THIS MEDICINE IF YOU 
H

Ürün özellikleri

NEW ZEALAND DATA SHEET
Duro-Tuss Dry Cough Lozenge (Lemon and Orange)
Page 1 of 5
1
PRODUCT NAME
Duro-Tuss Dry Cough Lozenge (Lemon and Orange).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains pholcodine 5.5 mg and cetylpyridinium chloride
1.33 mg.
Excipients with known effects: Sucralose and isomalt.
For the full list of excipients (see section 6.1).
3
PHARMACEUTICAL FORM
Lemon flavour: Round, flat bevelled lozenges, 19mm diameter. Firm,
smooth surfaces. Lozenges not adhering to
each other. Colour: yellow.
Orange flavour: Round, flat bevelled lozenges, 19mm diameter. Firm,
smooth surfaces. Lozenges not adhering
to each other. Colour: orange.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Relives dry cough and associated sore throats.
4.2
Dose and method of administration
Dosage
_Adults and children aged 12 years & over_: Two lozenges. Every 3
hours as required (maximum of 12 lozenges
per day).
_Children aged 6-11 years_: One lozenge. Every 3 hours as required
(maximum of 6 lozenges per day).
_Children under 6 years_: Do not use.
Method of administration
For oropharyngeal use. Slowly dissolve lozenge in mouth, one at a
time. Do not swallow.
4.3
Contraindications
•
Children under 6 years of age
•
Hypersensitivity to the pholcodine, cetylpyridinium chloride, or to
any of the excipients listed in section 6.1
•
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 section 4.5).
4.4
Special warnings and precautions for use
Use with caution in patients with:
•
Liver or renal disease
•
Chronic or persistent cough, or where cough is accompanied by
excessive secretions
•
Asthma, including an acute asthma attack or where cough is accompanied
by excessive secretions.
Severe c