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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.

• 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 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.

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:

This medicine contains two active substances.

• Salmeterol: a long-acting substance that widens the airways

• Fluticasone: a corticosteroid which reduces swelling and inflammation in the lungs

2What you need to know before you use Setirenol

Do not use Setirenol

Warnings and precautions

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

• heart disease, including an irregular or fast heartbeat

• overactive thyroid gland

• high blood pressure

• diabetes mellitus

• low potassium in your blood

• tuberculosis now or in the past, or other lung infections

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:

• you feel more wheezy

• your chest feels tight more often

• you need to use more of your fast acting airway widening inhaler

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:

• medicines to treat high blood pressure, heart or other illnesses, with active substance names ending with “olol” (beta-blockers), such as atenolol, propranolol and sotalol

• medicines to treat viruses, such as ritonavir

• medicines to treat infections, such as ketoconazole,itraconazole and erythromycin

• corticosteroids taken by the mouth or injected: medicines to treat inflammation or prevent organ transplant rejection

• diuretics, also known as ‘water tablets’ used to treat high blood pressure

• other bronchodilators (such as salbutamol)

• xanthine medicines. These are often used to treat asthma.

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.

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:

• once at night if you have night-time symptoms

• once in the morning if you have daytime symptoms

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

• Open the transparent side chamber door.

• Remove the foil strip from the side chamber by carefully tearing away the full length of strip against the ‘teeth’ of the side chamber as shown below. Do not pull or tug on the strip.