Document: Salmeson inhalation powder pre-dispensed ENG PL change

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

---

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

tightly around the mouthpiece.

- Breathe in slowly and deeply from your mouth (and not

from your nose) until your lungs are full.

- Hold in your breath approximately 5 seconds or as long as

you comfortably can and at the same time remove the

device from your mouth.

- Exhale and continue to breathe normally.

. Inhalation of the dose

- Open the mouthpiece. You will notice that you have inhaled all the powder and that the blisters of the strip are empty.

- Remove the empty strip, and proceed to step C.

C. Cleaning the device

- Following each use, wipe the mouthpiece and the supporting surface with a dry cloth or dry paper tissue. Do not use water to clean the device.

- Close the mouthpiece and place the protective cover around it.

If youusemoreSalmesonthanyou should

It is important to usethe inhaler as instructed.Ifyouaccidentallytakea largerdose than recommended, talk toyourdoctor orpharmacist.You maynoticeyour heart beating fasterthan usual and thatyou feel shaky. You mayalso havea headache,muscle weaknessand achingjoints.

Ifyou haveused larger doses fora longperiod oftime,you should talk toyour doctor or pharmacistforadvice.This is because larger doses of Salmesonmayreduce the amountof steroid hormones produced bythe adrenalgland.

If youforget to use Salmeson

Do not take adouble doseto make up for a forgotten dose.

If youstop using Salmeson

It is veryimportant thatyou takeyour Salmesoneverydayas directed.

Keep takingit untilyourdoctor tellsyou to stop.Do not stop or suddenlyreduceyour doseof Salmeson. This could make your breathingproblem worseand very rarelyside effects could occur. Theseinclude:

• stomach pain

• tiredness and loss of appetite

• sickness and diarrhoea

• weight loss

• headache or drowsiness

• low levels of potassium in your blood

• low blood pressure and seizures.

Veryrarely, if youget aninfection or at times of extreme stress (such as after a serious accident or if youhavesurgery),you mayget similarside effects.

To prevent thesesymptoms occurring,your doctor mayprescribeextracorticosteroids

(like prednisolone).

Ifyou haveanyfurther questions on the use of this medicine, askyourdoctor orpharmacist.

4. Possible sideeffects

Likeallmedicines, this medicine cancause sideeffects, although not everybody gets them.

The followingside effects havebeenreported bypeople takingthe combination of salmeterol and fluticasonepropionate.

Allergic reactions: you may noticeyourbreathing suddenly gets worseafter using Salmeson. You maybeverywheezyand cough. You mayalso notice itchingand swelling(usuallyof the face, lips, tongueor throat).If youget these effects or ifthey happensuddenly afterusingSalmeson, tellyourdoctor straight away.Allergicreactions to Salmeson areuncommon (theyaffect less than 1 person in 100).

Other sideeffects arelisted below:

Very common(affects morethan 1 person in 10):

• Headache – this usually gets better as treatment continues.

• Increased number ofcolds hasbeen reported in patients with COPD

Common (affects less than 1 person in 10):

• Thrush (sore, creamy-yellow, raised patches) in the mouth and throat. Also sore tongue, throat and hoarse voice. Rinsing your mouth out with water and spitting it out immediately after taking each dose may help. Your doctor may prescribe an antifungal medication to treat the thrush.

• Aching, swollen joints and muscle pain.

The following side effects have also been reported in patients with Chronic Obstructive Pulmonary Disease (COPD):

• Pneumonia and bronchitis (lung infection). Tell your doctor if you notice any of the following: increasd sputum production, change in sputum colour, fever, chills, increased cough, increased breathing problems.

• Bruising and fractures.

• Inflammation of sinuses (a feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes with a throbbing ache).

• A reduction in amount of potassium in the blood (you may get an uneven heartbeat, muscle weakness, cramp).

Uncommon (affects less than 1 person in 100):

• Very fast heartbeat (tachycardia).

• Feeling shaky and fast or uneven heartbeat (palpitations) – these are usually harmless and get less as treatment continues

• Muscle cramps

• Feeling worried (this effect mainly occurs in children)

• Throat irritation. Rinsing your mouth with water and spitting it out immediately after taking each puff may help.

• Chest pain

Rare side effects (affects less than 1 patient in 1,000)

• Breathing difficulties or wheezing that get worse straight after taking Salmeson. If this happens stop using your Salmeson inhaler. Use your fast-acting ‘reliever’ inhaler to help your breathing and tell your doctor straight away.

• Salmeson may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time, the effects includes:

- Slowing of growth in children and adolescents

- Thinning of the bones

- Cataract and glaucoma affecting the eyes

- Weight gain

- Rounded (moon shaped) face (Cushing’s Syndrome)

.

• Increases in the amount of sugar (glucose) in your blood (hyperglycaemia). If you have diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be required.

• Disturbed sleep and behavioural changes, such as being unusually active and irritable (these effects mainly occur in children).

• Uneven heartbeat or heart gives an extra beat (arrhythmias). Tell your doctor, but do not stop taking Salmeson unless they tell you to stop.

• Rash

Frequency not known but may also occur:

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. How to storeSalmeson

Keep this medicine out of the sight and reach of children.

Storebelow 25 °C.

Do not use this medicine after the expirydatewhich is stated on the label and carton after EXP. The expirydaterefers to the last dayof that month.

Do not throw away any medicines via wastewater or household waste. Askyour pharmacisthow to throw awaymedicines if you no longeruse. Thesemeasureswill help to protect theenvironment.

6. Contents of the pack and otherinformation

WhatSalmesoncontains

The activesubstances are salmeterol xinafoate and fluticasone propionate.

Each pre-dispensed dose of Salmeson contains:

50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate

or

50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate.

The otheringredient is lactose monohydrate.

WhatSalmesonlooks likeandcontents of thepack

Salmeson contains salmeterol and fluticasone propionate packed in the blisters of the single dose foil strips (double-blister strips), which are stored in the inhalation device Elpenhaler.

The foil protects the powder for inhalation from the effects of the atmosphere.

Each dose is pre-dispensed in one double-blisterstrip.

Each carton box contains one inhalation device Elpenhalerwith 60 double blister strips. Pack size: 60 doses

Each carton box contains one inhalation device Elpenhalerwith 30 alu-alu double blister strips and one spare storage compartment with 30 additional alu-alu double blister strips. Pack size: 60 doses.

Each carton box contains one inhalation device Elpenhaler with 30 alu-alu double blister strips. Pack size: 30 doses (sample pack).

Each carton box contains three inhalation devices Elpenhaler with 60 alu-alu double blister strips each. Pack size: 180 doses.

Not all pack sizes may be marketed

Marketing AuthorisationHolder:

<To becompleted nationally>

Manufacturer

ELPEN PharmaceuticalCo.Inc95, Marathonos Ave.,GR-19009 Pikermi, Attica

Greece

This leafletwas last revised in date2013-03-13