Package leaflet: Information for the user

Salfluae Forspiro, 50 microgram/500 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 Salfluae Forspiro is and what it is used for

2. What you need to know before you use Salfluae Forspiro

3. How to use Salfluae Forspiro

4. Possible side effects

5. How to store Salfluae Forspiro

6. Contents of the pack and other information

1What Salfluae Forspiro is and what it is used for

The name of your medicine is Salfluae Forspiro. Salfluae Forspiro is an inhaler that contains two active ingredients, 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.

The doctor has prescribed this medicine to help to prevent breathing problems associated with chronic obstructive pulmonary disease (COPD).

Salfluae Forspiroreduces the number of flare ups of symptoms related to COPD.

YoumustuseSalfluae Forspiro everyday,asprescribedbyyourdoctor.Thiswillensurethat themedicineworksproperlyincontrollingthesesymptoms.

Salfluae Forspiro helpstostopbreathlessnessandwheezinesscomingon.However,Salfluae Forspiro shouldnot beusedtorelieveasuddenattackofbreathlessnessofwheezing.Ifthishappensyouneedto useafast-acting“reliever”(“rescue”)inhaler,suchassalbutamol.Youshouldalwayshave yourfast-acting“rescue”inhalerwithyou.

Salfluae ForspiroisintendedforuseinadultswithCOPD18yearsofageandolderonly.

Notforuseinasthma.

2What you need to know before you use Salfluae Forspiro

Do not use Salfluae Forspiro

Warnings and precautions

Your doctor will supervise your treatment more closely if you have or ever had:

• heart disease, including irregular or fast heartbeat

• overactive thyroid gland

• high blood pressure

• diabetes mellitus (Salfluae Forspiro may increase your blood sugar)

• low potassium in your blood

• tuberculosis (TB) now or in the past or other lung infections

TalktoyourdoctorbeforeusingSalfluae Forspiro ifanyoftheaboveappliestoyou.

Children and adolescents

Donotgivethismedicinetochildrenandadolescentslessthan18yearsofage.Salfluae Forspiro isintendedforuseinadults18yearsofageandolderonly.

Other medicines and Salfluae Forspiro

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, before you start using Salfluae Forspiro. This includes other medicines for COPD, other inhalers or any medicines obtained without a prescription. This is because Salfluae Forspiro may not be suitable to be taken with some other medicines..

In particular tell your doctor if you are taking any of the following:

• .Beta-blockers (such as atenolol, propranolol, sotalol). Beta blockers are mostly used for high blood pressure and heart conditions.

• Medicines to treat infections caused by viruses and fungi (such as ritonavir, ketoconazole, itraconazole and erythromycin). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body, which can increase your risk of experiencing side effects, including irregular heartbeats, or may make side effects worse.

• Corticosteroids (taken by mouth or by injection). If you have used these medicines recently, this might increase the risk of Salfluae Forspiro affecting the function of your adrenal gland

• 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, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will assess whether you can take this medicine or not.

Driving and using machines

Salfluae Forspiro is unlikely to affect your ability to drive or use machines.

Salfluae Forspiro contains lactose

Salfluae Forspiro contains 11.95 mg lactose in each dose.

The amount of lactose in this medicine does not normally cause problems in people who are lactose intolerant.

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

3How to use Salfluae Forspiro

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

Inhalation use.

• Use Salfluae Forspiro every day, until your doctor advises you to stop.

• Do not take more than the recommended dose.

• Do not stop taking Salfluae Forspiro or reduce the dose of Salfluae Forspiro without talking to your doctor first.

• Salfluae Forspiro should be inhaled through the mouth into the lungs.

Adults

The recommended dose is:

One inhalation twice a day

It is very important to follow your doctor’s instructions on how many inhalations to take and how often to take your medicine.

Use in children and adolescents

This medicine is notfor use in children and adolescents less than 18 years of age.

Method of use

If your breathing gets worse or is not well controlled even if Salfluae Forspiro is used regularly as prescribed by your doctor, tell your doctor straight away. You may feel more wheezy, your chest feels tight more often or you may need more of your fast-acting ‘reliever’ medicine. If any of these happen, you should continue to take Salfluae Forspiro but do not increase the number of inhalations you take. Your chest condition could be getting worse and you could become seriously ill. See your doctor straight away as you may need additional treatment.

Instructions for use

Your doctor, nurse or pharmacist should show you how to use your inhaler. They should check on how you use it from time to time. If you do not use the inhaler properly or as prescribed, the medicine might not help your COPD and your symptoms as it should.

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.