Flusaterol

Document: Flusaterol Inhalation powder, pre-dispensed ENG PL change

PackageLeaflet: Information fortheUser

Flusaterol 50microgram/250microgram/dose inhalationpowder, pre- dispensed

Flusaterol 50microgram/500microgram/dose inhalationpowder, pre- dispensed

(Salmeterol/Fluticasonepropionate)

Readall ofthis leafletcarefully beforeyou 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 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.

What is in this leaflet:

1 What Flusaterol is and what it is used for

2 What you need to know before you takeFlusaterol

3 How to useFlusaterol

4 Possible side effects

5 How to storeFlusaterol

6 Contents of the pack and otherinformation

1. WhatFlusaterol is andwhat it is usedfor

Flusaterol 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.

The doctor has prescribed this medicine to help prevent breathing problems such as:

Asthma
Chronic Obstuctive Pulmonary Disease (COPD)

Flusaterol at a dose of 50/500 micrograms, reduces the number of flare ups of COPD.

You must use Flusateroleverydayas directed by your doctor. This willmake sure that itworks properlyin controllingyourasthma or COPD symptoms.

Flusaterol helps to stop breathlessness andwheeziness comingon. It does not work onceyouarebreathless or wheezy.If that happensyou need to use afast acting ‘reliever’medication, such as salbutamol.

2. What you need to know beforeyou useFlusaterol

Do not takeFlusaterolif:

You are allergic to salmeterolxinafoate,fluticasonepropionateor to

the other ingredient lactose monohydrate(a typeof sugar).

Warnings and precautions.

Your doctor will superviseyour treatment morecloselyif you havemedical

conditions such as:

Heart disease, including an irregular or fast heartbeat
Overactive thyroid gland
High blood pressure
Diabetes mellitus (Flusaterol may increase your blood sugar)
Low potassium in your blood
Tuberculosis (TB) now or in the past.

Ifyou haveever had anyof theseconditions, tellyour doctor beforeyou useFlusaterol.

Children and adolescents

Flusaterol should not be used in children and adolescents

Other medicines and Flusaterol

Pleasetell your doctor orpharmacistif you aretakingor have recentlytaken anyother

medicines.This includes medicines for asthma or medicines obtained without prescription. This is because Flusaterolmaynot be suitableto be taken with some other medicines.

Tellyour doctor if you aretaking thefollowingmedicines, beforestartingto use

Flusaterol.

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

Antiviral and antifungal medicines (such as ritonavir, ketoconazole and itraconazole). Some of these medicines may increase the amount of salmeterol or fluticasone salmeterol in your body. This can increase your risk of experiencing side effects with Flusaterol, including irregular heartbeats, or may make side effects worse.
Corticosteroids (by mouth or by injection). If you have had these medicines recently, this might increase the risk of this medicine affecting your adrenal gland.

Pregnancy, breast-feeding and fertility

Ifyou arepregnant or breast feeding, think you may be pregnant or planning to have a baby ask yourdoctor for advice beforetaking this medicine. Your doctor willdecide whetheryou can take Flusaterol during this time.

Driving andusing machines

Flusaterol is not likelyto affectyour abilityto drive or usemachines.

Flusaterol contains lactose(a typeof sugar).

Ifyou havebeen told byyourdoctor thatyou haveintoleranceto some sugars, contact yourdoctor beforetaking this medicinal product.

3. How to use Flusaterol

Use your Flusaterol every day, until your doctor advises you to stop.

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

After use, rinse your mouth with water.

The recommended dose is:

For adults with asthma

Flusaterol 50 microgram/250 microgram/ dose: One inhalation twice a day.

Flusaterol 50 microgram /500 microgram/dose: One inhalation twice a day.

For adults with Chronic Obstructive Pulmonary Disease (COPD)

Flusaterol 50 microgram /500 microgram/ dose: One inhalation twice a day.

Use in children and adolescents

Flusaterol should not be used in children and adolescents.

Your symptoms may become well controlled using <Product name > twice a day. If so, your doctor may decide to reduce your dose to once a day. The dose may change to:

• once at night – if you have night time symptoms

• once in the morning – if you have day time symptoms

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

If you are using Flusaterol for asthma, your doctor will want to regularly check your symptoms.

If your asthma or breathing gets worse tell your doctor straight away. You may find that you feel more wheezy, your chest feels tight more often or you may need to use more of your fast acting ‘reliever’ medicine. If any of these happen, you should continue to take Flusaterol but do not increase the number of puffs you take. Your chest condition may be getting worse and you could become seriously ill. See your doctor as you may need additional treatment.

Instructions for use

Your doctor, nurse or pharmacist should show you how to use your inhaler (Elpenhaler). They should check how you use it from time to time. Not using the Flusaterol properly or as prescribed may mean that it will not help your asthma or COPD as it should.

HANDLING OF THE Elpenhaler

The following are instructions to the patient for the proper inhalation of the two medicines packed in the two blisters of the single dose strips (double-blister strips), which are stored in the Elpenhaler.

DESCRIPTION

The Elpenhaler is a device for inhaling at the same time two medicines which are in the form of powder. The two medicines form in one medicinal combination. Each medicine is packed separately from the other in one of the two blisters of the specially designed double-blister strip.

The double-blister strip contains one (1) dose of the medicinal combination.

The Elpenhaler is comprised of 3 parts:

- The mouthpiece and its protective cover (1).

- The surface (2) on which the double-blister strip is placed

(supporting surface).

- The storage compartment (3) which houses the

double-blister strips.

The three parts are connected to each other and can be

opened separately.

The supporting surface contains:

- An attachment point (2A) where the double-blister strip

is attached.

- Two cavities (2B) which accommodate the two blisters

of the strip.

- Two strip guides (2C) which firmly secure the

double-blister strip in the correct position on the

supporting surface.

USE OF THE Elpenhaler

Α. Preparing the device