Duro-Tuss Dry Cough Liquid Forte

Страна: Нова Зеландія

мова: англійська

Джерело: Medsafe (Medicines Safety Authority)

Активний інгредієнт:

Pholcodine 3 mg/mL;  ;  ;  ; Pholcodine 3 mg/mL

Доступна з:

iNova Pharmaceuticals (New Zealand) Limited

ІПН (Міжнародна Ім'я):

Pholcodine 3 mg/mL

Дозування:

3 mg/mL

Фармацевтична форма:

Oral solution

Склад:

Active: Pholcodine 3 mg/mL       Excipient: Apricot flavour 012500 Citric acid Hyetellose Methyl hydroxybenzoate Purified water Saccharin sodium Sorbitol Sunset yellow FCF Active: Pholcodine 3 mg/mL Excipient: Apricot flavour 012500 Citric acid Disodium edetate Hyetellose Purified water Saccharin sodium Sodium benzoate Sodium citrate Sorbitol Sunset yellow FCF

Одиниць в упаковці:

Bottle, plastic, PET sample, with pp CRC tamper evident wadded cap, 30 mL

Клас:

Pharmacy only

Тип рецепту:

Restricted

Виробник:

PCAS

Огляд продуктів:

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

Дата Авторизація:

1994-11-14

інформаційний буклет

Duro-Tuss Dry Cough Forte_Sep 2010 final_NZ.doc 
Page 1 of 3 pages 

DURO-TUSS
 TM
 DRY COUGH LIQUID FORTE 

_PHOLCODINE _

CONSUMER 
MEDICINE 
INFORMATION 
     _ _
WHAT IS IN THIS LEAFLET 

This leaflet answers some common 
questions about these medicines. 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 these medicines 
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 LIQUID FORTE IS 
USED FOR 

Pholcodine is used to relieve dry 
coughs. 

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

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 LIQUID 
FORTE 

_WHEN YOU MUST NOT TAKE IT _

DO NOT TAKE THIS MEDICINE IF YOU HAVE 
AN ALLERGY TO: 
•  any medicine containing 
Pholcodine  
•  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 
HAVE: 
•  severe asthma, bronchitis or other 
serious respiratory conditions 

DO NOT TAKE THIS MEDICINE AFTER THE 
EXPIRY DATE PRINTED ON THE PACK OR IF 
THE PACKAGING IS DAMAGED OR SHOWS 
SIGNS OF TAMPERING. 

If it has expired or is damaged, return it 

Характеристики продукта

NEW ZEALAND DATA SHEET
Page 1 of 5
1 PRODUCT NAME
Duro-Tuss Dry Cough Liquid Forte
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL of the medicine contains 15 mg pholcodine.
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 clear yellow-orange, slightly viscous solution with an odour of
apricot.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Temporary relief of stubborn dry coughs.
4.2
Dose and method of administration
For oral administration.
AGE
DOSAGE
HOW OFTEN
Adults & children 12 years & over
5 mL
Every 6 hours as required
(Maximum 4 times a day)
Children under 12 years
Do not use
4.3
Contraindications
•
Children under the age of 12 years.
•
Hypersensitivity to pholcodine or any of the excipients listed in
section 6.1
.
•
Patients in, or at risk of, developing respiratory failure or during
acute asthma attacks (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 generalised
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 Forte should be withdrawn
immediately.
NEW ZEALAND DATA SHEET
Page 2 of 5
C