Sirdupla 25microgram/250microgram per metered dose pressurised inhalation, suspension

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: myHealthbox

Aktif bileşen:

salmeterol/fluticasone propionate

Mevcut itibaren:

Generics (UK) Ltd t/a Mylan

ATC kodu:

R03AK06

INN (International Adı):

salmeterol/fluticasone propionate

Doz:

25microgram/250microgram

Farmasötik formu:

Pressurised inhalation, suspension

Uygulama yolu:

Inhalation

Paketteki üniteler:

1x120 metered doses inhaler

Reçete türü:

POM - Prescription Only Medicine

Tarafından üretildi:

3M Health Care Ltd

Terapötik grubu:

Adrenergics and other anti-asthmatics

Terapötik endikasyonlar:

iT is indicated in the regular treatment of asthma where use of a combination product (long-acting β2 agonist and inhaled corticosteroid) is appropriate

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2015-05-15

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
SIRDUPLA
25 MICROGRAM/125 MICROGRAM PER METERED DOSE
pressurised inhalation, suspension
25 MICROGRAM/250 MICROGRAM PER METERED DOSE 
pressurised inhalation, suspension
salmeterol/fluticasone propionate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or 
 pharmacist.
- This medicine has been prescribed for you only. Do not pass 
  it on to others. It may harm them, even if their symptoms 
  and signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. 
  This includes any possible side effects not listed in this 
  leaflet. See section 4.
IN THIS LEAFLET
1. What Sirdupla is and what it is used for
2. What you need to know before you use Sirdupla
3. How to use Sirdupla
4. Possible side effects
5. How to store Sirdupla
6. Contents of the pack and other information

1.  WHAT SIRDUPLA IS AND WHAT IT IS USED FOR
Sirdupla contains two medicines, salmeterol and fluticasone 
propionate.
• Salmeterol is a long-acting bronchodilator. Bronchodilators 
  help the airways in the lungs to stay open. This makes it 
  easier for air to get in and out. The effects last for at least 
  12 hours. 
• Fluticasone propionate is a corticosteroid which reduces 
  swelling and irritation in the lungs.
SIRDUPLA IS INDICATED FOR USE IN ADULTS 18 YEARS OF AGE 
AND OLDER ONLY.
SIRDUPLA IS NOT INDICATED FOR USE IN CHILDREN 12 YEARS OF 
AGE AND YOUNGER OR ADOLESCENTS 13 TO 17 YEARS OF AGE.
The doctor has prescribed this medicine to help prevent 
breathing problems such as asthma. 
You must use Sirdupla every day as directed by your doctor. 
This will make sure that it works properly in controlling your 
asthma. 
SIRDUPLA HELPS TO STOP BREATHLESSNESS AND WHEEZINESS 
COMING ON. HOWEVER SIRDUPLA SHOULD NOT BE USED TO 

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Sirdupla 25 microgram/250 microgram per metered dose
pressurised inhalation, 
suspension 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each metered dose (ex valve) contains:  

25 micrograms of salmeterol (as salmeterol xinafoate) and 
250
 micrograms of 
fluticasone propionate.  This is equivalent to a
delivered dose (ex actuator) of 21 
micrograms of salmeterol and 220 micrograms of fluticasone
propionate.  

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Pressurised inhalation, suspension. 
The canister contains a white to off white suspension. 
The canisters are fitted
into white plastic actuators incorporating an
atomising orifice 
and fitted with burgundy dustcaps. 

4 CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 
Sirdupla is indicated in the regular treatment of asthma where
use of a combination 
product (long-acting 
β
2 
agonist and inhaled corticosteroid) is appropriate:  

-

patients not adequately controlled with inhaled corticosteroids and
'as needed' 
inhaled short-acting 
β
2 
agonist  

or  

-

patients already adequately controlled on both
inhaled corticosteroid and 
long-acting 
β
2 
agonist 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Sirdupla is indicated in adults 18 years of age and older only. 
Sirdupla is not indicated for use in children, 12 years of age
and younger or 
adolescents, 13 to 17 years of age. 

Posology 

Route of administration: Inhalation use. 

Patients should be made aware that Sirdupla must be used
daily for optimum benefit, 
even when asymptomatic.  

Patients should be regularly reassessed by a doctor,
so that the strength of Sirdupla 
they are receiving remains optimal and is only changed on
medical advice.  THE DOSE 
SHOULD BE TITRATED TO THE LOWEST DOSE AT WHICH