Document: Salmeson inhalation powder pre-dispensed ENG PL change

• Salmeson inhalation powder, pre-dispensed PL
• Salmeson inhalation powder pre-dispensed ENG PL

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PackageLeaflet: Information fortheUser

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

Salmeson 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 Salmeson is and what it is used for

2 What you need to know before you takeSalmeson

3 How to useSalmeson

4 Possible side effects

5 How to storeSalmeson

6 Contents of the pack and otherinformation

1. WhatSalmeson is andwhat it is usedfor

Salmeson contains two medicines, salmeterol and fluticasone propionate:

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

• Asthma

• Chronic Obstuctive Pulmonary Disease (COPD)

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

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

Salmeson 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 useSalmeson

Do not takeSalmesonif:

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 (Salmeson 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 useSalmeson

Children and adolescents

Salmeson should not be used in children and adolescents

Other medicines and Salmeson

Pleasetell your doctor orpharmacistif you aretakingor have recentlytaken anyother

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

Tellyour doctor if you aretaking thefollowingmedicines, beforestartingto use

Salmeson.

• 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 Salmeson, 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 Salmeson during this time.

Driving andusing machines

Salmeson is not likelyto affectyour abilityto drive or usemachines.

Salmeson contains lactose(a typeof sugar).

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

3. How to use Salmeson

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

Always use Salmeson 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

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

Or

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

For adults with Chronic Obstructive Pulmonary Disease (COPD)

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

Use in children and adolescents

Salmeson 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 Salmeson 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 Salmeson 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

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

- Uncover the mouthpiece completely from its protective cover.

- Unlock and push the mouthpiece backwards as to reveal the supporting surface.

- Hold the double-blister strip with its shiny surface upwards.

- Place the strip on the attachment point of the supporting surface. By applying light pressure make sure the strip is securely attached on the attachment point.

- The two blisters of the strip will fit in the cavities of the supporting surface, and the guides will secure the strip in

the correct position.

- Close the mouthpiece, and pull away the protruding end of the strip. The dose is now ready to be inhaled. Pulling away the protruding end of the strip should only be done immediately before inhalation.

Β

Hold the device away from your mouth.

- Exhale completely. Be careful not to exhale on the

mouthpiece of the device.

- Bring the Elpenhaler to your mouth and place your lips<