Fobumix Easyhaler 160/4.5 inhalation powder

• 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.

1. What Fobumix Easyhaler 160/4.5 is and what it is used for
2. What you need to know before you use Fobumix Easyhaler 160/4.5
3. How to use Fobumix Easyhaler 160/4.5
4. Possible side effects
5. How to store Fobumix Easyhaler 160/4.5
6. Contents of the pack and other information

Fobumix Easyhaler 160/4.5 can be prescribed for asthma in three different ways.

a) Some people are prescribed two asthma inhalers: Fobumix Easyhaler 160/4.5 and a separate ‘reliever inhaler’.

• They use Fobumix Easyhaler every day. This helps to prevent asthma symptoms from happening.
• They use their ‘reliever inhaler’ when they get asthma symptoms, to make it easier to breathe again.

b) Some people are prescribed Fobumix Easyhaler 160/4.5 as their only asthma inhaler.

• They use Fobumix Easyhaler every day. This helps to prevent asthma symptoms from happening.
• They also use Fobumix Easyhaler when they need extra doses for relief of asthma symptoms, to make it easier to breathe again and if agreed with the doctor also to prevent asthma symptoms from happening (for example, when exercising or on exposure to allergens). They do not need a separate inhaler for this.

c) Some people are prescribed Fobumix Easyhaler 160/4.5 only when required for relief of asthma symptoms

• They use Fobumix Easyhaler, when they get asthma symptoms, to make it easier to breathe again. They do not need a separate inhaler.
• If agreed with the doctor, they can also use Fobumix Easyhaler to prevent asthma symptoms from happening, for example, when exercising or on exposure to allergens.

Fobumix Easyhaler 160/4.5 can also be used to treat the symptoms of COPD in adults. COPD is a long-term disease of the airways in the lungs, which is often caused by cigarette smoking.

• 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).

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.

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.

• 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.

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 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 or COPD is not being properly controlled and you may need different or additional treatment immediately.

ASTHMA

Fobumix Easyhaler 160/4.5 can be prescribed for asthma in 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 every day and also when required’ and ‘C) Using Fobumix Easyhaler only when required to relieve asthma symptoms’.

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.

Adolescents (12 to 17 years)

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

A lower strength of Fobumix Easyhaler is available for children aged from 6 to 11 years.

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

B) Using Fobumix Easyhaler as your only asthma inhaler every day and also when required (maintenance and reliever therapy)

Only use Fobumix Easyhaler in this way if your doctor has told you to and if you are aged 12 or above.

Use your Fobumix 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 Fobumix Easyhaler 160/4.5 as a ‘reliever inhaler’ to treat asthma symptoms when they happen and to prevent asthma symptoms from happening (for example, when exercising or on exposure to allergens).

• 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.

It is important that you discuss with your doctor the use of Fobumix Easyhaler to prevent asthma symptoms from happening; how often you exercise or how often you are exposed to allergens could impact the treatment that it is prescribed to you.

C) Using Fobumix Easyhaler only when required to relieve asthma symptoms (reliever therapy in mild asthma)

Only use Fobumix Easyhaler in this way if your doctor has told you to and if you are aged 12 or above.

Use Fobumix Easyhaler as your reliever inhaler to treat asthma symptoms when they happen and, if agreed with your doctor, to prevent asthma symptoms from happening (for example, when exercising or on exposure to allergens).

• 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 as your reliever inhaler when you need it.

Seek urgent medical advice if Fobumix Easyhaler does not relieve your asthma symptoms or if your asthma symptoms worsen despite treatment with Fobumix Easyhaler.

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.

COPD (Chronic Obstructive Pulmonary Disease)

• Only to be used by adults (aged 18 years and above).
• The usual dose is 2 inhalations twice a day.

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 160/4.5 than you should are trembling, headache or a rapid heart beat.

• 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.

• 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, may affect up to 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, may affect up to 1 in 10 000 people.

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

• fever or chills,
• increased mucus production, change in mucus colour,
• increased cough or increased breathing difficulties.

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)

• 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:

• 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.

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.

• The active substances are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
• The other ingredient is lactose monohydrate (which contains milk proteins).

Fobumix 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. Fobumix 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 that is available depending on the country. 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:

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

• Remove the dustcap
• Shake the inhaler 3 to 5 times holding it in the upright position

Important points to remember

• It is important to keep the inhaler in the upright position
• If you accidentally click while you shake the inhaler, empty the powder from the mouthpiece as shown below

Step 2: CLICK

• Keep holding the inhaler upright between your forefinger and thumb
• Press down until you hear a click, and let the inhaler click back again. This releases a dose
• Only click down once

Important points to remember

• The inhaler will not click if the dustcap is still on
• Only click down once
• If you accidentally click more than once, empty the powder from the mouthpiece, see below
• Click to release dose before you inhale, not at the same time
• Keep the inhaler upright when you click it and when you inhale the dose. If you tip it, the powder could fall out before you are able to inhale it

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.

Important points to remember

• 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.

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.

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 Easyhaler. This may help 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.

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.

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