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Bufoler Easyhaler

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Package leaflet: Information for the patient


Bufoler Easyhaler, 160 micrograms/4.5 micrograms/inhalation, Inhalation Powder Budesonide/formoterol fumarate dihydrate


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 Bufoler Easyhaler 160/4.5 is and what it is used for

2. What you need to know before you use Bufoler Easyhaler 160/4.5

3. How to use Bufoler Easyhaler 160/4.5

4. Possible side effects

How to store Bufoler Easyhaler 160/4.5

6. Contents of the pack and other information


What Bufoler Easyhaler 160/4.5 is and what it is used for


Bufoler Easyhaler is an inhaler that is used to treat asthma in adults aged 18 years and older. It is also used to treat the symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 years and older. It contains two different medicines: budesonide and formoterol fumarate dihydrate.


What you need to know before you use Bufoler Easyhaler 160/4.5


Do not use Bufoler Easyhaler 160/4.5:

if you are allergic to budesonide, formoterol or to the other ingredient of this medicine (listed in section 6) which is lactose (which contains small amounts of milk protein).


Warnings and precautions

Talk to your doctor or pharmacist before using Bufoler Easyhaler if you:


Rinse your mouth after inhaling your dose in order to avoid fungal infection in the mouth.


Children and adolescents

This medicine should not be used in children or adolescents under the age of 18 years.


Other medicines and Bufoler Easyhaler

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:


If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Bufoler Easyhaler.


Also tell your doctor or pharmacist if you are going to have a general anaesthetic for an operation or for dental work.


Pregnancy and breast-feeding


Driving and using machines

Bufoler Easyhaler has no or negligible effect on your ability to drive or to use tools or machines.


Bufoler Easyhaler contains lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine. The amount of lactose in this medicine does not normally cause problems in people who are lactose intolerant.

The excipient lactose contains small amounts of milk proteins, which may cause allergic reaction.


How to use Bufoler Easyhaler 160/4.5



If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets that you take, once you start to use Bufoler Easyhaler. If you have been taking oral steroid tablets for a long time, your doctor may want you to have blood tests from time to time. When reducing oral steroid tablets, you may feel generally unwell even though your chest symptoms may be improving. You might experience symptoms such as a stuffy or runny nose, weakness or joint or muscle pain and rash (eczema). If any of these symptoms bother you, or if symptoms such as headache, tiredness, nausea (feeling sick) or vomiting (being sick) occur, please contact your doctor immediately. You may need to take other medication if you develop allergic or arthritic symptoms. Speak to your doctor if you are concerned as to whether you should continue to use Bufoler Easyhaler.


Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for example, when you have a chest infection or before an operation).


Important information about your asthma or COPD symptoms

If you feel you are getting breathless or wheezy while using Bufoler Easyhaler, you should continue to use Bufoler Easyhaler but go to see your doctor as soon as possible, as you may need additional treatment.


Contact your doctor immediately if:

These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.


ASTHMA

Bufoler Easyhaler 160/4.5 can be prescribed for asthma in two different ways. The amount of Bufoler Easyhaler to use and when to use it depends on how it has been prescribed for you.

If you have been prescribed Bufoler Easyhaler and a separate reliever inhaler, read the section called ‘A) Using Bufoler Easyhaler and a separate reliever inhaler’.

If you have been prescribed Bufoler Easyhaler as your only inhaler, read the section called ‘B) Using Bufoler Easyhaler as your only asthma inhaler’.


A) Using Bufoler Easyhaler and a separate reliever inhaler

Use your Bufoler Easyhaler every day. This helps to prevent asthma symptoms from happening.


Adults (18 years and above)

Your doctor (or asthma nurse) will help you to manage your asthma. They will adjust the dose of this medicine to the lowest dose that controls your asthma. However, do not adjust the dose without talking to your doctor (or asthma nurse) first.


Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen. Always keep your ‘reliever inhaler’ with you to use when you need it. Do not use Bufoler Easyhaler to treat asthma symptoms - use your reliever inhaler.


B) Using Bufoler Easyhaler as your only asthma inhaler

Only use Bufoler Easyhaler in this way if your doctor has told you to.


Use your Bufoler Easyhaler 160/4.5 every day. This helps to prevent asthma symptoms from happening. You can take:

1 inhalation in the morning and 1 inhalation in the evening

or

2 inhalations in the morning

or

2 inhalations in the evening.


Your doctor may increase this to 2 inhalations twice a day.


Also use Bufoler Easyhaler 160/4.5 as a ‘reliever inhaler’ to treat asthma symptoms when they happen.


Always keep your Bufoler Easyhaler with you, so you can use it when you need it.


A total daily dose of more than 8 inhalations is not normally needed. However, your doctor may allow you to take up to 12 inhalations a day for a limited period.


If you regularly need to use 8 or more inhalations a day, make an appointment to see your doctor or nurse. They may need to change your treatment.


Do not use more than 12 inhalations in total in 24 hours.


If you are doing exercise and you get asthma symptoms, use Bufoler Easyhaler as described here. However, do not use Bufoler Easyhaler just before exercise to stop asthma symptoms from happening.


COPD (Chronic Obstructive Pulmonary Disease)


Your doctor may also prescribe other bronchodilator drugs, for example anticholinergics (such as tiotropium or ipratropium bromide) for your COPD disease.


Preparing your new Bufoler Easyhaler

Bufoler Easyhaler is easy to use. Read through these instructions first: they tell you what you should do and what to look out for.


UNPACK THE INHALER

Take the inhaler out of its packaging. It comes in a laminate bag to keep the powder dry. Only take it out of the bag when you are ready to start using it.

Make sure you have all the parts (Figure 1):

If you don’t use a protective cover move on to section “To take a dose from Bufoler Easyhaler”.




Fit the inhaler into its protective cover:
Open up the protective cover (Figure 2). Make sure the dust cap covers the mouthpiece of the inhaler (this stops the inhaler going off by accident). Insert the inhaler into the protective cover to improve durability of the product. If you are not using the device immediately, close the protective cover.


TO TAKE A DOSE FROM BUFOLER EASYHALER

If you use a protective cover with your Bufoler Easyhaler, open it.

Remove the dust cap.


A. Shake

Shake the device vigorously up and down three to five times (Figure 3a or 3b).
This is to make sure the powder flows properly and gives the correct dose.


Make sure…

B. Click


Make sure…

you keep the inhaler upright as you click it and inhale the dose.

C. Inhale

In the sitting or standing position

Breathe out normally


Make sure…



If you have problems using the inhaler

Don’t rush things. It’s important to breathe normally. Practice a few times, in front of the mirror if this helps.

If you click the inhaler by accident, or if you might have clicked it more than once, or if you breathe out into it, tap the mouthpiece to empty the powder onto a table top,or the palm of your hand (Figure 6a or 6b). This ensures proper dosing. Then start again with steps A, B and C.


If you’re to take a second inhalation

Start again with steps A, B and C (Note that you need to shake the device again).


After you’ve used the inhaler



Cleaning the Easyhaler

Clean the Easyhaler’s mouthpiece at least once a week with a dry cloth. Do not use water: the powder in the Easyhaler is sensitive to moisture.


If you use a protective cover, you can take the Easyhaler out of it to wipe it. When you are putting it back into its protective cover, put the dust cap on the mouthpiece to stop it going off accidentally.


Getting a new Easyhaler

The inhaler has a dose counter which shows how many doses are left (Figure 7a or 7b). The counter turns after every fifth actuation. When the dose counter starts turning red, there are 20 doses left.
If you don’t already have a new Easyhaler, contact your doctor for a new prescription. When the counter reaches 0, you need to replace the Easyhaler even though you can still observe the powder in the clear window on the back of the inhaler.

Now you can use the new inhaler as usual. See section 3 for more details.


If you use more Bufoler Easyhaler than you should

It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor. You should not exceed your prescribed dose without seeking medical advice.


The most common symptoms that may occur after if you use more Bufoler Easyhaler 160/4.5 than you should are trembling, headache or a rapid heart beat.


If you forget to use Bufoler Easyhaler


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


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.

If either of the following happen to you, stop using Bufoler Easyhaler and talk to your doctor immediately:


Tell your doctor if you have any of the following while taking Bufoler Easyhaler they could be symptoms of a lung infection:

Pneumonia (infection of the lung) in COPD patients is a common side effect (may affect up to 1 in 10 people).


Other possible side effects:


Common (may affect up to 1 in 10 people)


Uncommon (may affect up to 1 in 100 people)


Rare (may affect up to 1 in 1,000 people)


Very rare (may affect up to 1 in 10,000 people)

Changes in your blood pressure.


Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. The effects include:


These effects are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.


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 [to be completed nationally]. By reporting side effects, you can help provide more information on the safety of this medicine.



5. How to store Bufoler Easyhaler 160/4.5



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 to protect the environment.


6. Contents of the pack and other information


What Bufoler Easyhaler 160/4.5 contains


What Bufoler Easyhaler 160/4.5 looks like and contents of the pack

Bufoler Easyhaler 160/4.5 is an inhaler containing your medicine. The inhalation powder is white to yellowish in colour. Each inhaler contains 60 or 120 doses and has a white body with red upper part.

Bufoler Easyhaler 160/4.5 is available in packs of 1 or 3 inhaler(s).

Not all pack sizes may be marketed.

Your pack may contain a protective cover. If you need a protective cover, please contact the Marketing Authorisation Holder (details given below).


Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland


Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland



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


Name of the Member State

Name of the medicinal product

Sweden

Bufoler Easyhaler, 160 micrograms/4.5 micrograms/inhalation

Netherlands

Bufoler Easyhaler, 160 micrograms/4.5 micrograms/inhalation


This leaflet was last revised in 7 November 2016

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