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Bufomix Easyhaler

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Document: Bufomix Easyhaler 80 microgram per 4.5 microgram per inhalation Inhalation powder ENG PL change


PACKAGE LEAFLET

Package leaflet: Information for the patient


Bufomix Easyhaler, 80 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 Bufomix Easyhaler 80/4.5 is and what it is used for

2. What you need to know before you use Bufomix Easyhaler 80/4.5

3. How to use Bufomix Easyhaler 80/4.5

4. Possible side effects

How to store Bufomix Easyhaler 80/4.5

6. Contents of the pack and other information


What Bufomix Easyhaler 80/4.5 is and what it is used for


Bufomix Easyhaler is an inhaler that is used to treat asthma in adults, adolescents and children aged 6 years and older. It contains two different medicines: budesonide and formoterol fumarate dihydrate.


This medicine is not suitable for people with severe asthma.


What you need to know before you use Bufomix Easyhaler 80/4.5


Do not use Bufomix Easyhaler 80/4.5:

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 Bufomix Easyhaler if you:


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


Other medicines and Bufomix 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 Bufomix Easyhaler.


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


Pregnancy andbreast-feeding


Driving and using machines

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


Bufomix Easyhaler contains lactosewhich 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 Bufomix Easyhaler 80/4.5



If you have been taking steroid tablets for your asthma , your doctor may reduce the number of tablets that you take, once you start to use Bufomix 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 Bufomix 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 symptoms

If you feel you are getting breathless or wheezy while using Bufomix Easyhaler, you should continue to use Bufomix 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 is not being properly controlled and you may need different or additional treatment immediately.


ASTHMA

Bufomix Easyhaler 80/4.5 can be prescribed for asthma in two different ways. The amount of Bufomix Easyhaler to use and when to use it depends on how it has been prescribed for you.

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

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


A) Using Bufomix Easyhaler and a separate reliever inhaler


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


Adults (18 years and above)

Adolescents (12 to 17 years)


Children (6 to 11 years)

The usual dose is 2 inhalations, twice a day.


Bufomix Easyhaler 80/4.5 is not recommended to be used in children who are younger than 6 years.


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 Bufomix Easyhaler to treat asthma symptoms - use your reliever inhaler.


B) Using Bufomix Easyhaler as your only asthma inhaler


Only use Bufomix Easyhaler in this way if your doctor has told you to and if you are aged 18 or above.


Use your Bufomix Easyhaler 80/4.5 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.


Also use Bufomix Easyhaler 80/4.5 as a ‘reliever inhaler’ to treat asthma symptoms when they happen.


Always keep your Bufomix 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 Bufomix Easyhaler as described here. However, do not use Bufomix Easyhaler just before exercise to stop asthma symptoms from happening.


Preparing your new Bufomix Easyhaler

B ufomix 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 Bufomix 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 BUFOMIX EASYHALER

If you use a protective cover with your Bufomix 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


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


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.


G etting 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 Bufomix 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 Bufomix Easyhaler 80/4.5 than you should are trembling, headache or a rapid heart beat.


If you forget to use Bufomix 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 Bufomix Easyhaler and talk to your doctor immediately:


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 Bufomix Easyhaler 80/4.5



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 Bufomix Easyhaler 80/4.5 contains


What Bufomix Easyhaler 80/4.5 looks like and contents of the pack

Bufomix Easyhaler 80/4.5 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.

Bufomix Easyhaler 80/4.5 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 leaflet was last revised in 2016-02-11


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