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Setirenol

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Package leaflet: Information for the user


Setirenol, 50 microgram/250 microgram/dose, inhalation powder, predispensed


salmeterol/fluticasone propionate


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


What is in this leaflet

1. What Setirenol is and what it is used for

2. What you need to know before you use Setirenol

3. How to use Setirenol

4. Possible side effects

5. How to store Setirenol

6. Contents of the pack and other information


1What Setirenol is and what it is used for


Setirenol is used to treat:

asthma


This medicine contains two active substances.


2What you need to know before you use Setirenol


Do not use Setirenol

if you are allergic to salmeterol, fluticasone or to the other ingredient of this medicine (listed in section 6).


Warnings and precautions

Talk to your doctor or pharmacist before using Setirenol if you have:


Setirenolprevents the onset of breathlessness and wheezing. Please note that it does not work when you are already breathless or wheezy.

If such a breathlessness attackoccurs, you need to use a medicine which quickly widens the airways, such as salbutamol.


Inform your doctor immediately if your asthma or breathing gets worse. You may find that:

Continue to use Setirenol if any of these happen, but do not increase the number of inhalations. Your chest condition may be getting worse and you could become seriously ill. Talk to your doctor as you may need additional treatment.


Children and adolescents

Setirenol should not be used in children under the age of 12 years.


Other medicines and Setirenol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The following medicines can influence or be influenced by Setirenol:


Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will assess whether you can take Setirenolduring this time.


Driving and using machines

Setirenol is unlikely to impair your ability to drive or operate machinery.


Setirenol contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Theamountof lactosein thismedicinedoesnotnormallycause problemsin peoplewhoarelactoseintolerant.


3How to use Setirenol

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.


Asthma

The recommended dose for adults and children from 12 years is:


One inhalation twice daily


Your doctor will want to regularly check your asthma symptoms.


If your symptoms become controlled using Setirenoltwice daily, your doctor may reduce your dose to once daily:


Method of use

Use Setirenol every day as prescribed by your doctor, preferably right before mealtime in the morning and/or in the evening.

After use, rinse your mouth with water.


Not using Setirenol properly or as prescribed may worsen your breathing difficulties.For optimal therapy, you must use Setirenol daily, even if you don’t have any symptoms.


Instructions for use

Your doctor, nurse or pharmacist should demonstrate how to use the inhaler and should check your use regularly.

The inhaler contains 60 doses of powder medication in a coiled strip of foil. It has a dose counter which shows you how many doses you have remaining counting down from 60 to 0. When you have reached the last 10 doses the numbers will be on a red background.

The inhaler is not refillable – please dispose of the inhaler when it is empty and replace it with a new one.



Before using the inhaler