Aloflute 25microgram/125microgram per metered dose pressurised inhalation, suspension

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

salmeterol/fluticasone propionate

Available from:

3M Health Care Ltd

ATC code:

R03AK06

INN (International Name):

salmeterol/fluticasone propionate

Dosage:

25microgram/125microgram

Pharmaceutical form:

Pressurised inhalation, suspension

Administration route:

Inhalation

Units in package:

1x120 metered doses inhaler

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

3M Health Care Ltd

Therapeutic group:

Adrenergics and other anti-asthmatics

Therapeutic indications:

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

Authorization status:

Authorised

Authorization date:

2015-05-15

Patient Information leaflet

1 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

ALOFLUTE 

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 Aloflute

is and what it is used for 
2. 
What you need to know before you use Aloflute 
3. 
How to use Aloflute 
4. 
Possible side effects 
5. 
How to store Aloflute 
6. 
Contents of the pack and other information 

1. 
WHAT ALOFLUTE IS AND WHAT IT IS USED FOR 

Aloflute

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. 

ALOFLUTE IS INDICATED FOR USE IN ADULTS 18 YEARS OF AGE AND
OLDER ONLY. 
ALOFLUTE 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 Aloflute every day as directed by your doc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Aloflute 25 microgram/125 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 125
micrograms of 
fluticasone propionate.  This is equivalent to a
delivered dose (ex actuator) of 21 
micrograms of salmeterol and 110 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 mauve dustcaps. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Aloflute 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 
Aloflute is indicated in adults 18 years of age and older only. 
Aloflute 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 Aloflute must be used
daily for optimum benefit, 
even when asymptomatic.  

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