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The product code(s) for this leaflet is: PL27925/0092.
Fobumix Easyhaler 320/9 inhalation powder
QR code to www.oeh.fi/bfgb
Scan this code or visit www.oeh.fi/bfgb to see instructions on how to use Easyhaler
Fobumix Easyhaler 320 micrograms/ 9 micrograms, Inhalation Powder
Budesonide/formoterol fumarate dihydrate
1. What Fobumix Easyhaler 320/9 is and what it is used for
2. What you need to know before you use Fobumix Easyhaler 320/9
3. How to use Fobumix Easyhaler 320/9
4. Possible side effects
5. How to store Fobumix Easyhaler 320/9
6. Contents of the pack and other information
Fobumix 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.
Fobumix Easyhaler is indicated for use in adults 18 years of age and older only.
Fobumix Easyhaler is NOT indicated for use in children 12 years of age and younger or adolescents 13 to 17 years of age.
Talk to your doctor or pharmacist before using Fobumix Easyhaler if you:
Contact your doctor if you experience blurred vision or other visual disturbances.
Rinse your mouth after inhaling your dose in order to avoid fungal infection in the mouth.
This medicine should not be used in children or adolescents under the age of 18 years.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Fobumix Easyhaler and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
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 Fobumix Easyhaler.
Also tell your doctor or pharmacist if you are going to have a general anaesthetic for an operation or for dental work.
Fobumix Easyhaler has no or negligible effect on your ability to drive or to use tools or machines.
Fobumix 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.
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 Fobumix 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 Fobumix 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).
If you feel you are getting breathless or wheezy while using Fobumix Easyhaler, you should continue to use Fobumix 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.
Use your Fobumix 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 Fobumix Easyhaler to treat asthma symptoms - use your reliever inhaler.
Your doctor may also prescribe other bronchodilator drugs, for example anticholinergics (such as tiotropium or ipratropium bromide) for your COPD disease.
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 Fobumix Easyhaler 320/9 than you should are trembling, headache or a rapid heart beat.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
The instructions on how to use the inhaler are at the end of the leaflet.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor if you have any of the following while taking Fobumix 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).
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)
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.
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 Yellow Card Scheme, www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
Fobumix Easyhaler 320/9 is an inhaler containing your medicine. The inhalation powder is white to yellowish in colour. Each inhaler contains 60 doses and has a white body with red upper part.
Fobumix Easyhaler 320/9 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).
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in November 2021
Detailed and updated information on how to use this product is available by scanning this QR code (included also on the outer carton and inhaler label) with a smartphone. The same information is also available on the following URL: www.oeh.fi/bfgb
QR code to www.oeh.fi/bfgb
About your Easyhaler
Fobumix Easyhaler may be different to inhalers you have used in the past. Therefore it is very important that you use it properly as using incorrectly can lead to you not receiving the right amount of medicine. This could make you very unwell or could lead to your asthma and COPD not being treated as it should.
Your doctor, nurse or pharmacist will show you how to use your inhaler properly. Make sure you understand the correct way to use the inhaler. If you are unsure contact your doctor, nurse or pharmacist. As with all inhalers, caregivers should ensure that children prescribed Fobumix Easyhaler use correct inhalation technique, as described below. You can also use the instruction video at www.oeh.fi/bfgb
The Easyhaler comes in a foil bag. Do not open the foil bag until you are ready to start using the medicine as it helps to keep the powder dry in the inhaler.
When you are ready to start treatment open the bag and record the date e.g., in your calendar.
Use the inhaler within 4 months of removing from the foil bag.
Step 1: SHAKE
SHAKE x 3-5
Important points to remember
Step 2: CLICK
CLICK x 1
Important points to remember
Step 3: INHALE
INHALE
Important points to remember
If you need to take another inhalation, please repeat the steps 1-3 Shake-Click-Inhale.
If you click the inhaler by accident, or if you might have clicked it more than once, or if you breathe out into it, empty the mouthpiece.
Keep your inhaler dry and clean. If necessary you may wipe the mouthpiece of your inhaler with a dry cloth or tissue. Do not use water: the powder in the Easyhaler is sensitive to moisture.
You may use a protective cover with your inhaler.This helps to improve durability of the product. When you first insert your inhaler in the protective cover make sure the dustcap is on the inhaler as this stops it going off by accident. You can use the inhaler without removing it from the protective cover.
Follow the same instructions as above, 1. Shake – 2. Click – 3. Inhale.
Remember to:
The dose counter shows the number of remaining doses. The counter turns after every 5th click. When the dose counter starts turning red, there are 20 doses left.
If you do not already have a new Easyhaler, contact your doctor for a new prescription. When the counter reaches 0 (zero), you need to replace the Easyhaler.
If you use the protective cover, you can keep it and insert your new inhaler into it.
Remember
If you have any further questions on the use of this product, ask your doctor or pharmacist.