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Viani Diskus


PACKAGE LEAFLET


Package leaflet: Information for the user


Viani Diskus 50 microgram/100 microgram/dose inhalation powder, pre-dispensed

Viani Diskus 50 microgram/250 microgram/dose inhalation powder, pre-dispensed

Viani Diskus 50 microgram/500 microgram/doseinhalation powder, pre-dispensed

[To be completed nationally]


salmeterol/fluticasone propionate


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


What is in this leaflet:

1. What Viani is and what it is used for

2. What you need to know before you use Viani

3. How to use Viani

4. Possible side effects

How to store Viani

6. Contents of the pack and other information


What Viani is and what it is used for


Viani contains two medicines, salmeterol and fluticasone propionate:



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


You must use Viani every day as directed by your doctor. This will make sure that it works properly in controlling your asthma or COPD.


Viani helps to stop breathlessness and wheeziness coming on. However Viani should not be used to relieve a sudden attack of breathlessness or wheezing. If this happens you need to use a fast-acting ‘reliever’ (‘rescue’) inhaler, such as salbutamol. You should always have your fast-acting 'rescue' inhaler with you.


What you need to know before you use Viani


Do not take Viani:

If you are allergic to salmeterol, fluticasone propionate or to the other ingredient lactose monohydrate.


Warnings and precautions

Talk to your doctor before using Viani if you have:


Other medicines and Viani

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines for asthma or any medicines obtained without a prescription. This is because Viani may not be suitable to be taken with some other medicines.

Tell your doctor if you are taking the following medicines, before starting to use Viani:


Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine


Driving and using machines

Viani is not likely to affect your ability to drive or use machines.


Viani contains lactose

Viani Diskus contains up to 12.5 milligrams of lactose in each dose. The amount of lactose in this medicine does not normally cause problems in people who are lactose intolerant.


How to use Viani


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



For asthma

Adults and adolescents aged 12 years and over


Children 4 to 12 years of age


For adults with Chronic Obstructive Pulmonary Disease (COPD)

Viani 50/500 Diskus - One inhalation twice a day


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

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 Viani 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 Viani 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


Using your inhaler

To open your Diskus, hold the outer case in one hand and put the thumb of your other hand on the thumbgrip. Push your thumb away from you as far as it will go. You will hear a click. This will open a small hole in the mouthpiece.



Hold your Diskus with the mouthpiece towards you. You can hold it in either your right or left hand. Slide the lever away from you as far as it will go. You will hear a click. This places a dose of your medicine in the mouthpiece.



Every time the lever is pulled back a blister is opened inside and the powder made ready for you to inhale. Do not play with the lever as this opens the blisters and wastes medicine.


Hold the Diskus away from your mouth, breathe out as far as is comfortable. Do not breathe into your Diskus.


Put the mouthpiece to your lips; breathe in steadily and deeply through the Diskus, not through your nose.

Remove the Diskus from your mouth.

Hold your breath for about 10 seconds or for as long as is comfortable.

Breathe out slowly.



Afterwards rinse your mouth with water and spit it out, and/or brushing your teeth. This may help to stop you getting thrush and becoming hoarse.


To close the Diskus, slide the thumbgrip back towards you, as far as it will go. You will hear a click.

The lever will return to its original position and is reset.



Your Diskus is now ready for you to use again.


As with all inhalers, caregivers should ensure that children prescribed Viani Diskus use correct inhalation technique, as described above.


Cleaning your inhaler

Wipe the mouthpiece of the Diskus with a dry tissue to clean it.


If you use more Viani than you should

It is important to use the inhaler as instructed. If you accidentally take a larger dose than recommended, talk to your doctor or pharmacist. You may notice your heart beating faster than usual and that you feel shaky. You may also have dizziness, a headache, muscle weakness and aching joints.


If you have used larger doses for a long period of time, you should talk to your doctor or pharmacist for advice. This is because larger doses of Viani may reduce the amount of steroid hormones produced by the adrenal gland.


If you forget to use Viani

Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.


If you stop using Viani

It is very important that you take your Viani every day as directed. Keep taking it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of Viani. This could make your breathing worse.


In addition, if you suddenly stop taking Viani or reduce your dose of Viani this may (very rarely) cause you to have problems with your adrenal gland (adrenal insufficiency) which sometimes causes side effects.


These side effects may include any of the following:


When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and you may have any of the side effects listed above.


If you get any side effects, talk to your doctor or pharmacist. To prevent these symptoms occurring, your doctor may prescribe extra corticosteroids in tablet form (such as prednisolone).


If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them. To reduce the chance of side effects, your doctor will prescribe the lowest dose of Viani to control your asthma or COPD.

Allergic reactions: you may notice your breathing suddenly gets worse immediately after using Viani. You may be very wheezy and cough or be short of breath. You may also notice itching, a rash (hives) and swelling (usually of the face, lips, tongue or throat), or you may suddenly feel that your heart is beating very fast or you feel faint and light headed (which may lead to collapse or loss of consciousness). If you get any of theseeffects or if they happen suddenly after using Viani, stop using Viani and tell your doctor straight away. Allergic reactions to Viani are uncommon (they affect less than 1 person in 100).

Other side effects are listed below:


Very Common (affects more than 1 person in 10)


Common (affects less than 1 person in 10)


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


Uncommon(affects less than 1 person in 100)


Rare (affects less than 1 person in 1000)

Your doctor will check you regularly for any of these side effects and make sure you are taking the lowest dose of Viani to control your asthma.


Frequency not known, but may also occur:

Depression or aggression. These effects are more likely to occur in children.


Reporting of side effects

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

You can also report side effects directly via the national reporting system listed via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Viani



Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


6. Contents of the pack and other information


What Viani contains


What Viani looks like and contents of the pack

The devices are packed in cartons which hold:

1 x Diskus 28 inhalations

or 1, 2, 3 or 10 x Diskus each containing 60 inhalations

Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

[To be completed nationally]


Manufacturer:

Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations),

Priory Street, Ware, Hertfordshire SG12 ODJ, United Kingdom.

Tel: +44 (0)1920 463993; Fax: +44 (0)1920 864000


Glaxo Wellcome Production

Zone Industrielle No.2, 23 Rue Lavoisier, la madeleine, 27000 Evreux, France.

Tel: +33 2 3223 5500; Fax: +33 2 3223 5558


Aspen Bad Oldesloe GmbH

Industriestrasse 32-36, 23843 Bad Oldesloe, Germany


This medicinal product is authorised in the Member States of the EEA under the following names:


Austria Samtoral Diskus

Finland Viani Diskus

Germany Viani Diskus

Ireland Viani Diskus

Italy Aliflus Diskus

Portugal Vesaspir Diskus

Spain Brisair Accuhaler

Sweden Viani Diskus


This leaflet was last revised in 2015-03-18.

[To be completed nationally]

[Detailed information on this medicine is available on the web site of {MA/Agency}]


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