FOBUMIX EASYHALER 80 MICROGRAMS / 4.5 MICROGRAMS INHALATION POWDER - patient leaflet, side effects, dosage

Budesonide/formoterol fumarate dihydrate

Read all of this leaflet carefully before you 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. See section 4.

What is in this leaflet

• 1. What Fobumix Easyhaler 80/4.5 is and what it is used for

• 2. What you need to know before you use

Fobumix Easyhaler 80/4.5

• 3. How to use Fobumix Easyhaler 80/4.5

• 4. Possible side effects

• 5. How to store Fobumix Easyhaler 80/4.5

• 6. Contents of the pack and other information

1. what fobumix easyhaler ® 80/4.5 is and what it is used for

Fobumix Easyhaler is an inhaler that is used to treat asthma in adults aged 18 years and older. It contains two different medicines: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called ‘corticosteroids’. It works by reducing and preventing swelling and inflammation in your lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting beta2adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This helps you to breathe more easily.

This medicine is not suitable for people with severe asthma.

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.

2. what you need to know before you use fobumix easyhaler® 80/4.5

Do not use Fobumix 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 Fobumix Easyhaler if you:

• are diabetic
• have a lung infection
• have high blood pressure or you have ever had a heart problem (including an uneven heart beat, a very fast pulse, narrowing of the arteries or heart failure)
• have problems with your thyroid or adrenal glands
• have low levels of potassium in your blood
• have severe liver problems.

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.

Children and adolescents

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

Other medicines and Fobumix Easyhaler

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:

• Beta-blocker medicines (such as atenolol or propranolol for high blood pressure), including eyedrops (such as timolol for glaucoma).
• Medicines for a fast or uneven heart beat (such as quinidine).
• Medicines like digoxin, often used to treat heart failure.
• Diuretics, also known as ‘water tablets’ (such as furosemide). These are used to treat high blood pressure.
• Steroid medicines that you take by mouth (such as prednisolone).
• Xanthine medicines (such as theophylline or aminophylline). These are often used to treat asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic anti-depressants (such as amitriptyline) and the anti-depressant nefazodone.
• Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin and telithromycin).
• Medicines for Parkinson’s disease (such as levo-dopa).
• Medicines for thyroid problems (such as levo-thyroxine).
• Monoamine Oxidase Inhibitors, also known as MAOIs (such as phenelzine).

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.

Pregnancy and breast-feeding

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
• Do not use Fobumix Easyhaler unless your doctor tells you to.
• If you get pregnant while using Fobumix Easyhaler, do not stop using Fobumix Easyhaler but talk to your doctor immediately.

Driving and using machines

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.

3. how to use fobumix easyhaler® 80/4.5

• Each delivered (inhaled) dose contains 80 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate. This dose corresponds to that received from other budesonide/for­moterol combination products which have a metered dose of 100 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate but similar delivered doses to Fobumix Easyhaler.
• Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• It is important to use Fobumix Easyhaler every day, even if you have no asthma symptoms at the time.
• Your doctor will want to regularly check your asthma symptoms.

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 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).

Important information about your asthma symptoms

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:

• your breathing is getting worse or you often wake up at night with asthma.
• your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.

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

ASTHMA

Fobumix Easyhaler 80/4.5 can be prescribed for asthma in two different ways. The amount of Fobumix Easyhaler to use and when to use it depends on how it has been prescribed for you. a) If you have been prescribed Fobumix Easyhaler and a separate reliever inhaler, read the section called ‘A) Using Fobumix Easyhaler and a separate reliever inhaler’.

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

• A) Using Fobumix Easyhaler and a separate reliever inhaler

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

Adults (18 years and above)

• The usual dose is 1 or 2 inhalations, twice a day.
• Your doctor may increase this to 4 inhalations, twice a day.
• If your symptoms are well controlled, your doctor may ask you to take your medicine once a day.

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.

• B) Using Fobumix Easyhaler as your only asthma inhaler Only use Fobumix Easyhaler in this way if your doctor has told you to.

• Use your Fobumix 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 Fobumix Easyhaler 80/4.5 as a ‘reliever inhaler’ to treat asthma symptoms when they happen.

• If you get asthma symptoms, take 1 inhalation and wait a few minutes.
• If you do not feel better, take another inhalation.
• Do not take more than 6 inhalations at a single time.

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

If you use more Fobumix 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 Fobumix Easyhaler 80/4.5 than you should are trembling, headache or a rapid heart beat.

If you forget to use Fobumix Easyhaler

• If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

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.

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 Fobumix Easyhaler and talk to your doctor immediately:

• Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow) or hives together with difficulties to breath (angioedema) and/or sudden feeling of faintness. This may mean that you are having an allergic reaction. This happens rarely, affecting less than 1 in 1,000 people.
• Sudden acute wheezing or shortness of breath immediately after using your inhaler. If either of these symptoms occur, stop using your Fobumix Easyhaler inhaler straightaway and use your ‘reliever’ inhaler. Contact your doctor immediately as you may need to have your treatment changed. This happens very rarely, affecting less than 1 in 10,000 people.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• Palpitations (awareness of your heart beating), trembling or shaking. If these effects occur, they are usually mild and usually disappear as you continue to use Fobumix Easyhaler.
• Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth out with water after using your Fobumix Easyhaler.
• Mild sore throat, coughing and a hoarse voice.
• Headache.

Uncommon (may affect up to 1 in 100 people)

• Feeling restless, nervous or agitated.
• Disturbed sleep.
• Feeling dizzy.
• Nausea (feeling sick).
• Fast heart beat.
• Bruising of the skin.
• Muscle cramps.
• Blurred vision.

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

• Rash, itching.
• Bronchospasm (tightening of the muscles in the airways which causes wheezing). If the wheezing comes on suddenly after using Fobumix Easyhaler stop using Fobumix Easyhaler and talk to your doctor immediately.
• Low levels of potassium in your blood.
• Uneven heart beat.

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

• Depression.
• Changes in behaviour, especially in children.
• Chest pain or tightness in the chest (angina pectoris).
• An increase in the amount of sugar (glucose) in your blood.
• Taste changes, such as an unpleasant taste in the mouth.
• 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:

150269–4

• changes in bone mineral density (thinning of the bones)
• cataract (clouding of the lens in the eye)
• glaucoma (increased pressure in the eye)
• a slowing of the rate of growth of children and adolescents
• an effect on the adrenal gland (a small gland next to the kidney).

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 the Yellow Card Scheme, 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.

5. how to store fobumix easyhaler® 80/4.5

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is stated on the carton, foil bag and label of your inhaler after EXP. The expiry date refers to the last day of that month.
• After opening the foil bag do not store above 25°C and store protected from moisture. It is recommended to keep the Easyhaler in its protective cover.
• If your Fobumix Easyhaler gets damp you need to replace it with a new one.
• Replace Fobumix Easyhaler 4 months after you opened the foil bag. Write down the date you opened the bag to help you remember.
• 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.

• – The other ingredient is lactose monohydrate (which contains milk proteins).

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

Fobumix 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. Fobumix 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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Orion Pharma (UK) Limited, Abbey Gardens, 4 Abbey Street, Reading, RG1 3BA, United Kingdom

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:

6. Contents of the pack and other information

How to use the Easyhaler inhaler

HOW TO USE CORRECTLY

Step 3: INHALE

• Keep holding the inhaler upright
• Breathe out normally
• Place the mouthpiece in your mouth between your teeth and close your lips tightly around the mouthpiece
• Take a strong and deep breath in
• Take the inhaler out of your mouth, then breathe out normally.
• Make sure the whole mouthpiece is well inside your mouth, so that the medication gets into your lungs
• Make sure your lips make a good seal around the mouthpiece
• Do not breathe out into the inhaler. This is important: it could clog up the inhaler. If you breathed out into the inhaler, empty the powder from mouthpiece, see below

If you need to take another inhalation, please repeat the steps 1–3 Shake-Click-Inhale.

After you have used the inhaler:

• Put the dust cap back on the mouthpiece. It stops the inhaler going off by accident.
• After you have taken the dose, rinse your mouth with water, and spit it out.

How to empty the powder from the mouthpiece

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.

• Tap the mouthpiece to empty the powder onto a table top, or the palm of your hand.
• Then start again with steps Shake-Click-Inhale.

Cleaning the Easyhaler

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.

Using the Easyhaler with a protective cover

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:

• Keep the inhaler in the upright position when clicking it
• Replace the dustcap after taking the dose as this stops the inhaler going off by accident.

When to switch to a new Easyhaler

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

• 1. Shake – 2. Click – 3. Inhale.
• After you have taken the dose, rinse your mouth with water and spit it out.
• Do not get your inhaler wet, protect it from moisture.