FOBULER 160 MICROGRAMS/4.5 MICROGRAMS Inhalation powder

Зміст інструкції

1. What is Fobuler 80 micrograms/4.5 micrograms and what is it used for
2. What you need to know before using Fobuler 80 micrograms/4.5 micrograms
3. How to use Fobuler 80 micrograms/4.5 micrograms
4. Possible side effects
5. How to store Fobuler 80 micrograms/4.5 micrograms
6. Package Contents and Other Information
7. What is Fobuler 160 mcg/4.5 mcg and what is it used for
8. Possible side effects
9. How to store Fobuler 160 mcg/4,5 mcg
10. Contents of the pack and other information
11. Possible side effects
12. How to store Fobuler 320 mcg/9 mcg
13. Contents of the pack and other information

QR code linking to the URL: www.oeh.fi/bfit
Scan this code or visit www.oeh.fi/bfit to see the instructions on how to use the Easyhaler

Fobuler,80 micrograms/4.5 micrograms/inhalation, powder for inhalation
Budesonide/formoterol fumarate dihydrate

Read this leaflet carefully before you start to take this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may harm them.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Fobuler 80 micrograms/4.5 micrograms is and what it is used for
• 2. What you need to know before you use Fobuler 80 micrograms/4.5 micrograms
• 3. How to use Fobuler 80 micrograms/4.5 micrograms
• 4. Possible side effects
• 5. How to store Fobuler 80 micrograms/4.5 micrograms
• 6. Contents of the pack and other information

1. What is Fobuler 80 micrograms/4.5 micrograms and what is it used for

Fobuler consists of an inhaler used for the treatment of asthma in adults, adolescents and in children over 6 years of age. 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 the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called “long-acting “β - adrenergic receptor agonists” or “bronchodilators”. It works by relaxing the muscles of the airways, making it easier to breathe.

This medicine is not suitable for people with severe asthma. It can be prescribed for asthma in two different ways.

a) Some people are prescribed two asthma inhalers: Fobuler 80 micrograms/4.5 micrograms and a separate “reliever inhaler”.

• They use Fobuler every day to help prevent asthma symptoms from occurring.
• They use the “reliever inhaler” when asthma symptoms occur, to help them breathe more easily.

b) Some people are prescribed Fobuler 80 micrograms/4.5 micrograms as their only asthma inhaler.

• They use Fobuler every day to help prevent asthma symptoms from occurring.
• They also use Fobuler when they need extra doses to relieve asthma symptoms, to help them breathe more easily. They do not need a separate inhaler for this purpose.

2. What you need to know before using Fobuler 80 micrograms/4.5 micrograms

Do not use Fobuler 80 micrograms/4.5 micrograms:

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

Warnings and Precautions
Talk to your doctor or pharmacist before using Fobuler, if:

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

Rinse your mouth after inhaling the dose to avoid a fungal infection in your mouth.
Contact your doctor if you experience blurred vision or other visual disturbances.
For those who engage in sports: the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive doping test.

Other medicines and Fobuler
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.
Some medicines can increase the effects of Fobuler and your doctor will carefully check 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-blockers (such as atenolol or propranolol for high blood pressure), including eye drops (such as timolol for glaucoma).
• Medicines for a fast or irregular heartbeat (such as quinidine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics, also known as “water tablets” (such as furosemide), used to treat high blood pressure.
• Steroid medicines taken by mouth (such as prednisolone).
• Xanthine medicines (such as theophylline or aminophylline), often used to treat asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant 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 levodopa).
• Medicines for thyroid problems (such as levothyroxine).

If you fall into any of the above cases, or if in doubt, consult your doctor or pharmacist before using
Fobuler.
Also inform your doctor or pharmacist if you are going to have a general anaesthetic for surgery or dental
treatment.

Pregnancy and breastfeeding

• If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
• Do not take Fobuler unless directed by your doctor.
• If you become pregnant during treatment with Fobuler, do not stop using Fobuler but consult your doctor immediately.

Driving and using machines
Fobuler has no effect or has a negligible effect on the ability to drive or operate tools or
machinery.

Fobuler contains lactose,which is a type of sugar. If your doctor has told you that you have an intolerance to
certain sugars, consult your doctor before using this medicine. The amount of lactose contained in
this medicine usually does not cause problems in people with lactose intolerance. The lactose excipient
contains small amounts of milk proteins that may cause allergic reactions.

3. How to use Fobuler 80 micrograms/4.5 micrograms

• Always use this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
• It is important to use Fobuler every day, even if you do not have asthma symptoms at the moment.
• If you are using Fobuler for asthma, your doctor will want to periodically check your symptoms.

If you have taken steroid tablets for your asthma, your doctor may reduce the number of tablets you are taking once you have started using Fobuler. If you have taken steroid tablets for a long period, your doctor may request periodic blood tests. Following the reduction of oral steroid tablets, you may experience a general feeling of unwellness, even though your respiratory symptoms may improve. You may experience symptoms such as a blocked or runny nose, weakness or muscle or joint pain, and a skin rash (eczema). If any of these symptoms worry you or if symptoms such as headache, fatigue, nausea (feeling sick) or vomiting (feeling unwell) occur, contact your doctor immediately. You may need to take another medicine if allergic or arthritic symptoms develop. Ask your doctor if you have any doubts about continuing or discontinuing therapy with Fobuler. Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for example, when you have a respiratory infection or before surgery).

Important information about asthma symptoms
If you notice the onset of shortness of breath or wheezing while using Fobuler, you should continue to use it but consult your doctor as soon as possible, as you may need additional treatment.
Contact your doctor immediately if:

• Your breathing gets worse or if you often wake up at night due to asthma.
• You begin to feel tightness in your chest in the morning or if the chest tightness lasts longer than usual. These signs may mean that your asthma is not properly controlled and that you may need different or additional treatment immediately.

ASTHMA
Fobuler 80 micrograms/4.5 micrograms can be prescribed for asthma in two different ways. The amount of Fobuler to use and when to use it depends on your doctor's prescription.
a) If you have been prescribed Fobuler and a separate inhaler, to be used as needed, read the paragraph “A) Using Fobuler and a separate inhaler, to be used as needed”.
b) If you have been prescribed Fobuler as your only inhaler, read the paragraph “B) Using Fobuler as your only inhaler for asthma”.

A) Using Fobuler and a separate inhaler, to be used as needed
Use Fobuler every day.This helps to prevent the onset of asthma symptoms.

Adults (18 years and over)

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

Adolescents (12-17 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 the medicine once a day.

Children (6-11 years)

• The usual dose is 2 inhalations, twice a day.

The use of Fobuler should be avoided in children under 6 years of age.
The doctor (or nurse) will help you manage your asthma and adjust the dose of this medicine to the lowest dose that can control your asthma. However, do not change the dose without first talking to your doctor (or nurse).

Use the separate inhaler, to be used “as needed”, to treat asthma symptoms when they occur.
Always carry your “inhaler to be used as needed” with you, so you can use it when necessary. Do not use Fobuler to treat asthma symptoms, but the inhaler to be used as needed.

B) Using Fobuler as your only inhaler for asthma
Use Fobuler in this way only as directed by your doctor and if you are over 12 years of age.

Use Fobuler 80 micrograms/4.5 microgramsevery day.This helps to prevent the onset of asthma symptoms. You can take:

• 1 inhalation in the morning and1 inhalation in the evening or
• 2 inhalations in the morning or
• 2 inhalations in the evening.

Also use Fobuler 80 micrograms/4.5 microgramsas an “inhaler to be used as needed”, to treat asthma symptoms when they occur.

• If asthma symptoms occur, 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 one time.

Always carry Fobuler with you to use when needed.
Normally, a total daily dose of more than 8 inhalations is not necessary. However, your doctor may allow you to take up to 12 inhalations per day for a limited period.
If you have to use 8 or more inhalations regularly per day, consult your doctor or nurse because it may be necessary to change the treatment.
Do not use more than 12 inhalations in total in 24 hours.
If asthma symptoms occur while you are exercising, use Fobuler as described in this leaflet.
However, do not use Fobuler immediately before exercise to prevent symptoms from occurring.

If you use more Fobuler than you should
Do not exceed the prescribed dose without consulting your trusted doctor.
The most common symptoms that can occur if you use more Fobuler 80 micrograms/4.5 micrograms than you should are: tremor, headache or a rapid heartbeat.

If you forget to use Fobuler

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
• Do nottake a double dose to make up for a missed dose.

If you have any doubts about using this medicine, ask your doctor or pharmacist.

Instructions on how to use the inhaler are at the end of the leaflet.

4. Possible side effects

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

If any of the following occur, stop using Fobuler and contact your doctor immediately:

• Swelling of the face, particularly around the mouth (tongue and/or throat and/or difficulty swallowing) or hives, accompanied by difficulty breathing (angioedema) and/or a sudden feeling of illness. This could indicate the presence of an allergic reaction. This effect occurs rarely, affecting less than 1 in 1,000 people.
• Sudden wheezing or shortness of breath immediately after using the inhaler. If any of these symptoms occur, immediately stop using Fobuler and use your reliever inhaler. Contact your doctor immediately if you need to change your treatment.This occurs 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 heartbeat), tremor or agitation. If these effects occur, they are usually mild and generally disappear with continued treatment with Fobuler.
• Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth with water after using Fobuler.
• Mild sore throat, cough and hoarseness.
• Headache.

Uncommon (may affect up to 1 in 100 people)

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

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

• Skin rash, itching.
• Bronchospasm (tightening of the muscles around the airways causing wheezing). If wheezing occurs, immediately after using Fobuler, stop using Fobuler and contact your doctor immediately.
• Low levels of potassium in the blood.
• Irregular heartbeat.

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

• Depression.
• Changes in behaviour, especially in children.
• Chest pain or feeling of tightness in the chest (angina pectoris).
• Increased amount of sugar (glucose) in the blood.
• Changes in taste, for example, an unpleasant taste in your mouth.
• Changes in blood pressure.

Corticosteroids administered by inhalation can affect the normal production of steroid hormones by the body, particularly if high doses are used for a prolonged period. These 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).
• Slowed growth in children and adolescents.
• Effect on the adrenal gland (a small gland located above the kidney). The occurrence of these effects is very less likely with inhaled corticosteroids than with oral corticosteroids.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine

5. How to store Fobuler 80 micrograms/4.5 micrograms

• Keep this medicine out of the sight and reach of children.
• Do not use the inhaler after the expiry date that is stated on the carton, aluminium pouch or inhaler label, after the wording Exp. The expiry date refers to the last day of that month.
• After opening the aluminium pouch, store at a temperature not exceeding 25  C and protect from moisture. It is recommended to keep Easyhaler in its protective case.
• If Fobuler gets wet, it must be replaced with a new one.
• Replace Fobuler 4 months after opening the aluminium pouch. Note the date of opening the pouch, to help you remember.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Fobuler 80 micrograms/4.5 micrograms contains
The active ingredients are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 80
micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
The excipient is lactose monohydrate (which contains milk proteins).

Description of the appearance of Fobuler 80 micrograms/4.5 micrograms and package contents
Fobuler 80 micrograms/4.5 micrograms consists of an inhaler that contains the medicine. The powder
for inhalation is whitish-yellowish in color. Each inhaler contains 60 or 120 doses and has a white body and
a red top.
Fobuler 80 micrograms/4.5 micrograms is available in packs of 1 or 3 inhalers.
Not all pack sizes may be marketed.
Its packaging may contain a protective case. If you need a protective cap, please contact the Marketing Authorisation Holder (details below).

Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Detailed and up-to-date information on how to use this product is available by scanning
this QR code (also included on the box and inhaler label) with a smartphone. The same
information is also available at the following URL: www.oeh.fi/bfit
QR code linking to the URL: www.oeh.fi/bfit

How to use the Easyhaler inhaler
Information about Easyhaler
Fobuler may be different from inhalers you have used in the past. Therefore, it is very important that you use it
correctly, as incorrect use may result in not receiving the correct amount of
medicine. This can make you very ill or may mean that your asthma is not treated properly.
Your doctor, nurse or pharmacist will show you how to use the inhaler correctly. Make sure you
understand the correct way to use the inhaler. If you have any doubts, contact your doctor, nurse or
pharmacist. As with all inhalers, those caring for children should ensure that children prescribed Fobuler use the correct inhalation technique, as described below. You can also
use the instructional video available at www.oeh.fi/bfit

First use of the Easyhaler
CORRECT USE

The Easyhaler is supplied in an aluminium pouch. Do not open the pouch 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 pouch and mark the date, for example on your calendar. Use the inhaler within 4 months of opening the aluminium pouch.

r m a c o

Step 1: SHAKE Remove the mouthpiece cover Shake the inhaler 3 to 5 times holding it in an upright position

e SHAKE x 3-5 d a n a i

l Important points to remember It is important to keep the inhaler in an upright position If you accidentally press while shaking the inhaler, empty the powder from the mouthpiece as shown below

Step 2: PRESS Continue to hold the inhaler in an upright position between your index and thumb Press down until you hear a click and let the inhaler click again. This releases a dose Press down only once

t I PRESS x 1

Important points to remember The inhaler will not click if the mouthpiece cover is still inserted Press down only once If you accidentally press more than once, empty the powder from the mouthpiece, as shown below Press to release the dose before inhaling, do not press and inhale at the same time Keep the inhaler in an upright position while you press and while you inhale the dose. If you turn it upside down, the powder may escape before being inhaled.

Step 3: INHALE Continue to hold the inhaler in an upright position Exhale normally Put the mouthpiece in your mouth between your teeth and close your lips tightly around the mouthpiece Inhale strongly and deeply Remove the inhaler from your mouth, then exhale normally.

INHALE

o Important points to remember c Make sure the entire mouthpiece is well inserted into the mouth, so that the medicine enters the lungs m Make sure your lips tighten around the mouthpiece r Do not exhale into the inhaler. This is important: it could block the inhaler. If you exhale into the inhaler, empty the powder from the mouthpiece, as shown below

If you need to take another inhalation, repeat steps 1-3 Shake-Press-Inhale.
After using the inhaler:

• Put the mouthpiece cover back on the mouthpiece. This prevents the inhaler from being activated accidentally.
• After taking the dose, rinse your mouth with water and spit it out.

n How to empty the powder from the mouthpiece a If you accidentally press the inhaler, or it has been pressed more than once, or if you have exhaled into it, empty the mouthpiece. i Tap the mouthpiece on the table or the palm of your hand to release the powder. l Then start again with the Shake-Press- Inhale steps. a

Cleaning the Easyhaler
Keep the inhaler dry and clean. If necessary, you can clean the mouthpiece of the 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 case You can use a protective case with the inhaler. This helps to improve the product’s shelf life. When you first insert the inhaler into the protective case, make sure the mouthpiece cover is on the inhaler, as this prevents the inhalation from being activated accidentally. You can use the inhaler without removing it from the protective case. Follow the same instructions as above, 1. Shake - 2. Press - 3. Inhale. Remember to: Keep the inhaler in an upright position when you press Close the mouthpiece cover after taking the dose as this prevents the inhaler from being activated accidentally.

l F a r m a c o

Remember

• 1. Shake - 2. Press - 3. Inhale.
• After taking the dose, rinse your mouth with water and spit it out.
• Do not wet the inhaler, protect it from moisture

If you have any questions about using this medicine, ask your doctor or pharmacist.

d When to switch to a new Easyhaler The dose counter shows the number of doses remaining. The dose counter turns after every 5 actuations. When the dose counter starts to turn red, there are still 20 doses to deliver. If you do not already have a new Easyhaler, contact your doctor for a new prescription. When the dose counter reaches 0 (zero), you need to replace the Easyhaler. If you are using the protective case, keep it and insert the new inhaler into it.

QR code linking to the URL: www.oeh.fi/bfit
Scan this code or visit www.oeh.fi/bfit to see instructions on how to use the Easyhaler

Fobuler,160 micrograms/4.5 micrograms/inhalation, powder for inhalation
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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Fobuler 160 mcg/4.5 mcg and what is it used for

Fobuler consists of an inhaler that is used for the treatment of asthma in adults and adolescents of
age between 12 and 17 years. It is also used for the treatment of symptoms of Chronic Obstructive
Bronchopneumonia (COPD) in adults 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 the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called “long-acting beta-agonists” or “bronchodilators”. It works by relaxing the muscles of the airways, thus making breathing easier.

Asthma
Fobuler 160 mcg/4.5 mcg can be prescribed for asthma in two different ways.

a) Some people are prescribed two asthma inhalers: Fobuler 160 mcg/4.5 mcg and a separate “as needed” inhaler.

• They use Fouler every day. This helps prevent the onset of asthma symptoms.
• They use the “as needed” inhaler when they experience asthma symptoms, to make breathing easier.

b) Some people are prescribed Fobuler 160 mcg/4.5 mcg as a single asthma inhaler.

• They use Fobuler every day. This helps prevent the onset of asthma symptoms.
• They also use Fobuler when they need additional doses to relieve asthma symptoms, to make breathing easier and, if agreed with the doctor, also to prevent the onset of asthma symptoms (for example, during exercise or in case of exposure to allergens). They do not need a separate inhaler for this purpose.

Chronic Obstructive Bronchopneumonia (COPD)
Fobuler 160 mcg/4.5 mcg can also be used to treat the symptoms of COPD in adults. The
COPD is a chronic disease of the pulmonary airways, often caused by cigarette smoking.

2What you need to know before you use Fobuler 160 mcg/4.5 mcg
Do not use Fobuler 160 mcg/4.5 mcg:

• if you are allergic to budesonide, formoterol or any of the other ingredients of this medicine (listed in section 6) which is lactose (containing small amounts of milk proteins).

Warnings and Precautions
Talk to your doctor or pharmacist before using Fobuler if:

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

Contact your doctor if you experience blurred vision or other visual disturbances.
Rinse your mouth after inhaling the dose to avoid a fungal infection in your mouth.

Other medicines and Fobuler
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
Some medicines can increase the effects of Fobuler and your doctor will carefully check 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-blockers (such as atenolol or propranolol for high blood pressure), including eye drops (such as timolol for glaucoma).
• Medicines for a fast or irregular heartbeat (such as quinidine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics, also known as “water tablets” (such as furosemide), used to treat high blood pressure.
• Steroid medicines taken by mouth (such as prednisolone).
• Xanthine medicines (such as theophylline or aminophylline), often used to treat asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant 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 levodopa).
• Medicines for thyroid problems (such as levothyroxine).

If you fall into any of the above cases, or if in doubt, consult your doctor or pharmacist before using
Fobuler.
Tell your doctor or pharmacist also if you have to undergo general anesthesia for a surgical or dental procedure.

Pregnancy and breastfeeding

• If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
• Do not take Fobuler unless directed by your doctor.
• If you become pregnant during treatment with Fobuler, do not stop using Fobuler but consult your doctor immediately.

Driving and using machines
Fobuler has no or negligible effect on the ability to drive or operate tools or
machinery.

Fobuler contains lactose,which is a type of sugar. If your doctor has told you that you have an intolerance to
some sugars, consult your doctor before using this medicine. The amount of lactose contained in
this medicine usually does not cause problems in people intolerant to lactose. The excipient lactose
contains small amounts of milk proteins that may cause allergic reactions.

For athletes
The use of the medicine without therapeutic need constitutes doping and may still result in positive
doping tests.

3How to use Fobuler 160 mcg/4.5 mcg

• Always use this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.
• It is important to use Fobuler every day, even if you do not have symptoms of asthma or COPD at the moment.
• If you use Fobuler for asthma, your doctor will want to check your symptoms periodically.

If you have taken steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets
you are taking once you have started using Fobuler. If you have taken steroid tablets for a long
period, your doctor may request periodic blood tests. When you reduce the
number of oral steroids you may experience a feeling of general malaise despite your respiratory symptoms
may improve. You may experience symptoms such as nasal congestion and runny nose,
weakness or muscle or joint pain and skin rash (eczema). If any of these
symptoms worry you or if you experience symptoms such as headache, fatigue, nausea (feeling unwell)
or vomiting (feeling unwell) contact your doctor immediately. You may need to take another
medicine in case of allergic or arthritic symptoms. Ask your doctor if you have doubts about continuing or
not continuing therapy with Fobuler.
Your doctor may consider adding steroid tablets to your usual treatment during periods of
stress (for example when you have a respiratory infection or before surgery).

Important information about the symptoms of asthma or COPD
If you notice the onset of shortness of breath or wheezing while using Fobuler, you should continue to use it but consult
your doctor as soon as possible as you may need additional treatment.
Contact your doctor immediately if:

• Your breathing gets worse or if you wake up often at night due to asthma.
• You start to feel tightness in your chest in the morning or if the tightness in your chest lasts longer than usual. These signs may mean that your asthma or COPD is not properly controlled and that you may need immediate different or additional treatment.

ASTHMA
Fobuler 160 mcg/4.5 mcg can be prescribed for asthma in two different ways. The amount of Fobuler to
use and when to use it depends on your doctor’s prescription.
c) If you have been prescribed Fobuler and a separate as needed inhaler, read the paragraph “A) Using
Fobuler and a separate as needed inhaler”.
d) If you have been prescribed Fobuler as a single inhaler, read the paragraph “B) Using Fobuler as a single
inhaler for asthma”.

A) Using Fobuler and a separate as needed inhaler
Use Fobuler every day. This helps prevent the onset of asthma symptoms.

Adults (18 years and over)

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

Adolescents (12-17 years)

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

A lower dose of Fobuler is available for children aged 6 to 11 years.
The use of Fobuler is not recommended for children under 6 years of age.
The doctor (or nurse) will help you manage your asthma and adjust the dose of this medicine to
the lowest dose that controls your asthma. However, do not change the dose without first talking to your
doctor (or nurse).

Use the separate “as needed” inhaler to treat asthma symptoms when they occur.
Always carry the “as needed” inhaler with you, so you can use it when needed. Do not use
Fobuler to treat asthma symptoms, but the as needed inhaler.

B) Using Fobuler as a single inhaler for asthma
Use Fobuler in this way only as directed by your doctor and if you are over 12 years of age.

Use Fobuler 160 mcg/4.5 mcg every day.This helps prevent the onset of asthma symptoms. You can
take:

• 1 inhalation in the morning and1 inhalation in the evening or
• 2 inhalations in the morning or
• 2 inhalations in the evening.

The doctor may increase this dose to 2 inhalations twice a day.

Also use Fobuler 160 mcg/4.5 mcg as an “as needed” inhalerto treat asthma symptoms
when they occur and to prevent the onset of asthma symptoms (for example, during exercise
or in case of exposure to allergens). .

• If asthma symptoms occur, 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 one time.

Always carry Fobuler with you, to use it when needed.
Normally, a total daily dose of more than 8 inhalations is not necessary. However, your doctor may
allow you to take up to 12 inhalations a day for a limited period.
If you regularly need 8 or more inhalations a day, consult your doctor or nurse as
it may be necessary to change the treatment.
Do not use more than 12 inhalations in total in 24 hours.
If asthma symptoms occur while you are exercising, use Fobuler as described in this leaflet. It
is important to discuss with your doctor the use of Fobuler to prevent the onset of
asthma symptoms; the treatment you have been prescribed may be affected by how often you exercise or
how often you are exposed to allergens.

COPD (Chronic Obstructive Bronchopneumonia)

• For use in adults (18 years and over) only.
• The usual dose is 1 inhalation twice a day.

The doctor may also prescribe other bronchodilator medicines, for example anticholinergics (such as tiotropium or
ipratropium bromide) for COPD.

If you use more Fobuler than you should
It is important that you take the dose as indicated on the label or as recommended by your doctor.
Do not exceed the prescribed dose without consulting your trusted doctor.
The most common symptoms that can occur if you use more Fobuler 160 mcg/4.5 mcg than you should are:
tremor, headache or rapid heartbeat.

If you forget to use Fobuler

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
• Do nottake a double dose to make up for a missed dose.

If you have any questions about using this medicine, ask your doctor or pharmacist.

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 any of the following happens, stop using Fobuler and contact your doctor immediately:

• Swelling of the face, especially around the mouth (tongue and/or throat and/or difficulty swallowing) or hives accompanied by difficulty breathing (angioedema) and/or sudden feeling of fainting, which could indicate an allergic reaction. This effect is rare and affects up to 1 in 1,000 people.
• Sudden wheezing and shortness of breath immediately after using your inhaler. If any of these symptoms occur, you should stop using Fobuler immediately and use your reliever inhaler. Contact your doctor immediately if you need to change your treatment.This is very rare, affecting up to 1 in 10,000 people. Tell your doctor if you have any of the following symptoms while taking Fobuler, they may be symptoms of a lung infection:
• Fever or chills.
• Increased mucus production, changes in mucus color.
• Increased cough or greater difficulty breathing. Pneumonia (lung infection), in patients with COPD 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)
• Palpitations (awareness of your heartbeat), tremor or agitation. If these effects occur, they are usually mild and disappear with continued treatment with Fobuler.
• Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth with water after using Fobuler.
• Mild sore throat, cough and hoarseness.
• Headache.

Uncommon (may affect up to 1 in 100 people)

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

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

• Skin rash, itching.
• Bronchospasm (tightening of the muscles in the airways causing wheezing). If you experience wheezing breathing immediately after using Fobuler, stop using Fobuler and contact your doctor immediately.
• Low levels of potassium in the blood.
• Irregular heartbeat.

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

• Depression.
• Changes in behaviour, especially in children.
• Chest pain or tightness (angina pectoris).
• Increased amount of sugar (glucose) in the blood.
• Changes in taste, for example unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids can affect the normal production of steroid hormones in the body, particularly if high doses are used for a prolonged period. These 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).
• Slowed growth in children and adolescents.
• Effect on the adrenal gland (a small gland near the kidney). The occurrence of these effects is less likely with inhaled corticosteroids than with corticosteroids in tablet form.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fobuler 160 mcg/4,5 mcg

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton, the aluminium pouch or on the inhaler label after Scad. The expiry date refers to the last day of that month.
• After opening the aluminium pouch, store at a temperature not exceeding 25  C and protect from moisture. It is recommended to keep the Easyhaler in its protective case.
• If your Fobuler gets wet, it must be replaced with a new one.
• Replace Fobuler 4 months after opening the aluminium pouch. Note the date of opening the pouch to help you remember.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fobuler 160 mcg/4,5 mcg contains

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

Description of the appearance of Fobuler 160 mcg/4,5 mcg and contents of the pack
Fobuler 160 mcg/4,5 mcg consists of an easyhaler inhaler containing the medicine. The powder for
inhalation is whitish-yellowish in color. Each inhaler contains 60 doses and has a white body and a red
top.
Fobuler 160 mcg/4,5 mcg is available in packs of 1 or 3 inhalers, 120 doses also in packs of 2
inhalers.
Not all pack sizes may be marketed.
Its pack may contain a protective case. If a protective cap is needed, please contact the marketing authorisation holder (details below).

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Sales concessionaire
Farmaceutici Caber S.r.l
Via del Mare, 36 Pomezia
(RM)

Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Detailed and up-to-date information on how to use this product is available by scanning
this QR code (also included on the box and inhaler label) with a smartphone. The same
information is also available at the following URL: www.oeh.fi/bfit
QR code linking to the URL: www.oeh.fi/bfit

How to use the Easyhaler inhaler
Information about Easyhaler
Fobuler may be different from inhalers you have used in the past. Therefore, it is very important that you use it
correctly, as incorrect use may result in not receiving the correct amount of
medicine. This can make you feel very unwell or may mean that asthma and COPD are not treated
correctly.
Your doctor, nurse or pharmacist will show you how to use the inhaler correctly. Make sure you
understand the correct way to use the inhaler. If you have any doubts, contact your doctor, nurse or
pharmacist. As with all inhalers, those caring for children should ensure that children prescribed Fobuler use the correct inhalation technique, as described below. You can also
use the instructional video available at www.oeh.fi/bfit

First use of the Easyhaler

The Easyhaler is supplied in an aluminium pouch. Do not open the pouch until you are ready to start using the medicine, as this helps to keep the powder dry in the inhaler. When you are ready to start treatment, open the pouch and mark the date, for example on your calendar. Use the inhaler within 4 months of opening the pouch.

a r m a c o

CORRECT USE

Step 1: SHAKE Remove the mouthpiece cover Shake the inhaler 3 to 5 times holding it in a vertical position

e SHAKE x 3-5 d a n a i l

l Important points to remember It is important to keep the inhaler in a vertical position If you accidentally press while shaking the inhaler, empty the powder from the mouthpiece as shown below

Step 2: PRESS a Continue to hold the i inhaler in a vertical position between the index and z thumb n Press down until you hear a e click and let the inhaler click again. This releases a dose A Press down only once

I PRESS x 1

Punti importanti da ricordare The inhaler will not click if the mouthpiece cover is still inserted Press down only once If you accidentally press more than once, empty the powder from the mouthpiece, as shown below Press to release the dose before inhaling, do not press and inhale at the same time Keep the inhaler in a vertical position while pressing and while inhaling the dose. If you turn it over, the powder may leak before being inhaled.

If you need to take another inhalation, repeat steps 1-3 Shake-Press-Inhale.
After using the inhaler:

• Put the mouthpiece cover back on the mouthpiece. This prevents the inhaler from activating accidentally.
• After taking the dose, rinse your mouth with water and spit it out.

Step 3: INHALE Continue to hold the inhaler in a vertical position Exhale normally Put the mouthpiece in your mouth between your teeth and close your lips tightly around the mouthpiece Inhale strongly and deeply Remove the inhaler from your mouth, then exhale normally.

INALARE

o Important points to remember c Make sure the entire mouthpiece is well inserted into the mouth, so that the medicine enters the lungs m Make sure your lips close tightly around the mouthpiece r Do not exhale into the inhaler. This is important: it could clog the inhaler. If you exhale into the inhaler, empty the powder F from the mouthpiece, as shown below

a How to empty the powder from the mouthpiece If you accidentally press the inhaler or it has been pressed more than i once or if you have exhaled into it, empty the mouthpiece. l Tap the mouthpiece on the table or the palm of your hand to release the powder. Then start again with the Shake-Press- Inhale steps. I a i

Cleaning the Easyhaler
Keep the inhaler dry and clean. If necessary, you can clean the mouthpiece of the 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 case You can use a protective case with the inhaler. This helps to improve the product’s durability. When you first insert the inhaler into the protective case, make sure the mouthpiece cover is on the inhaler, as this prevents the inhalation from activating accidentally. You can use the inhaler without removing it from the protective case. Follow the same instructions above, 1. Shake - 2. Press - 3. Inhale. Remember to: Keep the inhaler in a vertical position when pressing Close the mouthpiece cover after taking the dose as this prevents the inhaler from activating accidentally.

l F a r m a c o

Remember

• 1. Shake - 2. Press - 3. Inhale.
• After taking the dose, rinse your mouth with water and spit it out.
• Do not wet the inhaler, protect it from moisture

If you have any doubts about using this medicine, ask your doctor or pharmacist.

When to switch to a new Easyhaler The dose counter shows the number of doses remaining. The dose counter rotates n after every 5 actuations. When the dose counter starts to turn red, there are still 20 doses to deliver. a If you do not already have a new Easyhaler, contact your doctor for a new prescription. When the dose counter reaches 0 i (zero), you need to replace the Easyhaler. l If you are using the protective case, keep it and insert the new a inhaler into it.

QR code linking to the URL: www.oeh.fi/bfit
Scan this code or visit www.oeh.fi/bfit to see instructions on how to use the Easyhaler

Fobuler, 320 micrograms/9 micrograms/inhalation, powder for inhalation
Budesonide/formoterol fumarate dihydrate

Read this leaflet carefully before you start using this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Fobuler 320 mcg/9 mcg is and what it is used for
• 2. What you need to know before you use Fobuler 320 mcg/9 mcg
• 3. How to use Fobuler 320 mcg/9 mcg
• 4. Possible side effects
• 5. How to store Fobuler 320 mcg/9 mcg
• 6. Contents of the pack and other information

1What Fobuler 320 mcg/9 mcg is and what it is used for
Fobuler consists of an inhaler that is used to treat asthma in adults and adolescents
aged 12 to 17 years. It is also used to treat the symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults 18 years of age and over. 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 beta-agonists” or “bronchodilators”. It works by relaxing the muscles in your airways, making it easier to breathe.

Asthma
For asthma, your doctor will prescribe two inhalers: Fobuler 320 mcg/9 mcg and a separate “reliever” inhaler.

• Use Fobuler every day. This will help prevent asthma symptoms from occurring.
• Use the “reliever” inhaler when asthma symptoms occur, to help you breathe more easily.

Do not use Fobuler 320 mcg/9mcg as a reliever inhaler.

Chronic obstructive pulmonary disease (COPD)
Fobuler 320 mcg/9mcg can also be used to treat the symptoms of severe COPD in adults. The
COPD is a chronic disease of the airways in the lungs, often caused by cigarette smoking.

2What you need to know before you use Fobuler 320 mcg/9 mcg
Do not use Fobuler 320 mcg/9 mcg:

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

Warnings and Precautions
Talk to your doctor or pharmacist before using Fobuler if:

• You are diabetic.
• You have a lung infection.
• You have high blood pressure or have ever had heart problems in the past (including irregular heartbeat, very fast pulse, narrowing of the arteries or heart failure).
• You have problems with your thyroid or adrenal glands.
• You have low levels of potassium in your blood.
• You have severe liver problems. Contact your doctor if you experience blurred vision or other visual disturbances. Rinse your mouth after inhaling the dose to avoid a fungal infection in your mouth.

Other medicines and Fobuler
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, even those available without a prescription.
Some medicines can increase the effects of Fobuler and your doctor will carefully check 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 eye drops (such as timolol for glaucoma).
• Medicines for a fast or irregular heartbeat (such as quinidine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics, also known as “water tablets” (such as furosemide), used to treat high blood pressure.
• Steroid medicines taken by mouth (such as prednisolone).
• Xanthine medicines (such as theophylline or aminophylline), often used to treat asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant 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 levodopa).
• Medicines for thyroid problems (such as levothyroxine).

If you fall into any of the above categories, or if in doubt, consult your doctor or pharmacist before
using Fobuler.
Also tell your doctor or pharmacist if you are going to have a general anaesthetic for surgery or dental
treatment.

Pregnancy and breastfeeding

• If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
• Do not take Fobuler unless directed by your doctor.
• If you become pregnant during treatment with Fobuler, do not stop using Fobuler but consult your doctor immediately.

Driving and using machines
Fobuler has no effect or a negligible effect on the ability to drive or operate tools or
machinery.

Fobuler contains lactose,which is a type of sugar. If your doctor has told you that you have an intolerance
to some sugars, consult your doctor before using this medicine. The amount of lactose contained in
this medicine usually does not cause problems in people who are lactose intolerant. The lactose
excipient contains small amounts of milk proteins that may cause allergic reactions.

For athletes
The use of the medicine without therapeutic need constitutes doping and may still result in a positive
doping test.

3How to use Fobuler 320 mcg/9 mcg

• Always use this medicine exactly as your doctor has instructed. If you have any doubts, ask your doctor or pharmacist.
• It is important to use Fobuler every day, even if you do not have symptoms of asthma or COPD at the moment.
• If you are using Fobuler for asthma, your doctor will want to check your symptoms periodically. If you have taken steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets you are taking once you have started using Fobuler. If you have taken steroid tablets for a long period, your doctor may request periodic blood tests. When you reduce the number of oral steroids, you may feel a general sense of discomfort even though your respiratory symptoms may improve. You may experience symptoms such as a stuffy or runny nose, muscle weakness or joint pain, and a skin rash (eczema). If any of these symptoms worry you or if you experience symptoms such as headache, fatigue, nausea (feeling sick) or vomiting (feeling unwell), please contact your doctor immediately. You may need to take another medicine in case of allergic or arthritic symptoms. Ask your doctor if you have any doubts about continuing or stopping Fobuler therapy. Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for example, when you have a respiratory infection or before surgery).

Important information about the symptoms of asthma or COPD
If you notice the onset of shortness of breath or wheezing while using Fobuler, you should continue to use it but consult
your doctor as soon as possible as you may need additional treatment.
Contact your doctor immediately if:

• Your breathing gets worse or if you wake up often at night due to asthma.
• You start to feel tightness in your chest in the morning or if the tightness in your chest lasts longer than usual. These signs may mean that your asthma or COPD is not properly controlled and you may need different or additional treatment immediately.

ASTHMA
Use Fobuler every day.This helps to prevent asthma symptoms from occurring.

Adults (18 years and over)

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

Adolescents (12-17 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 the medicine once a day.
• A lower dose of Fobuler is available for children aged 6 to 11 years.

The use of Fobuler is not recommended for children under 6 years of age.
Your doctor (or nurse) will help you manage your asthma and adjust the dose of this medicine to
the lowest dose that controls your asthma. However, do not change the dose without first talking to your
doctor (or nurse).

Use the separate “reliever inhaler” to treat asthma symptoms when they occur.
Always carry your “reliever inhaler” with you, so you can use it when needed. Do not use
Fobuler to treat asthma symptoms, but the reliever inhaler.

COPD (Chronic Obstructive Pulmonary Disease)

• For use in adults (18 years and over) only.
• The usual dose is 1 inhalation twice a day.

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

If you use more Fobuler than you should
It is important that you take the dose as indicated on the label or as recommended by your doctor.
Do not exceed the prescribed dose without consulting your trusted doctor.
The most common symptoms that can occur if you use more Fobuler 320 mcg/9 mcg than you should are:
tremor, headache or a rapid heartbeat.

If you forget to use Fobuler

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
• Do nottake a double dose to make up for a missed dose.

If you have any questions about using this medicine, ask your doctor or pharmacist.

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 any of the following happen, stop using Fobuler and contact your doctor immediately:

• Swelling of the face, especially around the mouth (tongue and/or throat and/or difficulty swallowing) or hives accompanied by difficulty breathing (angioedema) and/or sudden feeling of fainting, which may indicate an allergic reaction. This effect is rare and affects up to 1 in 1,000 people.
• Sudden wheezing and shortness of breath immediately after using your inhaler. If any of these symptoms occur, you should stop using Fobuler immediately and use your reliever inhaler. Contact your doctor immediately if you need to change your treatment.This is very rare, affecting up to 1 in 10,000 people. Tell your doctor if you have any of the following symptoms while taking Fobuler, they may be symptoms of a lung infection:
• Fever or chills.
• Increased mucus production, changes in mucus color.
• Increased cough or greater difficulty breathing. Pneumonia (lung infection), in patients with COPD 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)
• Palpitations (awareness of your heartbeat), tremor or agitation. If these effects occur, they are usually mild and disappear with continued treatment with Fobuler.
• Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth with water after using Fobuler.
• Mild sore throat, cough and hoarseness.
• Headache.

Uncommon (may affect up to 1 in 100 people)

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

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

• Skin rash, itching.
• Bronchospasm (tightening of the muscles in the airways, causing wheezing). If you experience wheezing immediately after using Fobuler, stop using Fobuler and contact your doctor immediately.
• Low levels of potassium in the blood.
• Irregular heartbeat.

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

• Depression.
• Changes in behaviour, especially in children.
• Chest pain or tightness (angina pectoris).
• Increased amount of sugar (glucose) in the blood.
• Changes in taste, for example, unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids can affect the normal production of steroid hormones in the body, especially if high doses are used for a prolonged period. These effects include:

• Changes in bone mineral density (thinning of the bones).
• Cataracts (clouding of the lens in the eye).
• Glaucoma (increased pressure in the eye).
• Slowed growth in children and adolescents.
• Effect on the adrenal gland (a small gland near the kidney). The occurrence of these effects is much less likely with inhaled corticosteroids than with corticosteroids in tablet form.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fobuler 320 mcg/9 mcg

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is reported on the carton, the aluminium pouch or on the inhaler label after Expiry. The expiry date refers to the last day of that month.
• After opening the aluminium pouch, store at a temperature not exceeding 25  C and protect from humidity. It is recommended to keep the Easyhaler in its protective case.
• If your Fobuler gets wet, it must be replaced with a new one.
• Replace Fobuler 4 months after opening the aluminium pouch. Note the date of opening the pouch to help you remember.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fobuler 320 mcg/9 mcg contains

• The active ingredients are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
• The excipient is lactose monohydrate (which contains milk proteins).

Description of the appearance of Fobuler 320 mcg/9 mcg and contents of the pack
Fobuler 320 mcg/9 mcg consists of an easyhaler inhaler that contains the medicine. The powder for
inhalation is white to pale yellow in colour. Each inhaler contains 60 doses and has a white body and a red
top.
Fobuler 320 mcg/9 mcg is available in packs of 1, 2 or 3 inhalers.
Not all pack sizes may be marketed.
The pack may contain a protective case. If a protective cap is needed, please
contact the marketing authorisation holder (details below).

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Sales concessionaire
Farmaceutici Caber S.r.l
Via del Mare, 36 Pomezia
(RM)

Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Detailed and up-to-date information on how to use this product is available by scanning
this QR code (also included on the carton and inhaler label) with a smartphone. The same
information is also available at the following URL: www.oeh.fi/bfit.
QR code linking to the URL: www.oeh.fi/bfit

How to use the Easyhaler inhaler
Information about Easyhaler
Fobuler may be different from inhalers you have used in the past. Therefore, it is very important that you use it
correctly, as incorrect use may mean you do not receive the correct amount of
medicine. This can make you very unwell or may mean that asthma and COPD are not treated
correctly.
Your doctor, nurse or pharmacist will show you how to use the inhaler correctly. Make sure you
understand how to use the inhaler correctly. If you are unsure, contact your doctor, nurse or
pharmacist. As with all inhalers, anyone caring for children should ensure that children who
are prescribed Fobuler use the correct inhalation technique, as described below. You can also
use the instructional video available at www.oeh.fi/bfit

First use of the Easyhaler

The Easyhaler is supplied in an aluminium pouch. Do not open the aluminium pouch until you are ready to start using the medicine, as this helps to keep the powder dry inside the inhaler. When you are ready to start treatment, open the pouch and mark the date, for example on your calendar. Use the inhaler within 4 months of opening the aluminium pouch.

CORRECT USE

Step 1: SHAKE Remove the mouthpiece cover Shake the inhaler 3 to 5 times holding it in an upright position

SHAKE x 3-5

Important points to remember It is important to keep the inhaler in an upright position If you accidentally press while shaking the inhaler, empty the powder from the mouthpiece as shown below

Step 2: PRESS Continue to hold the inhaler in an upright position between your index and thumb Press down until you hear a click and let the inhaler click again. This releases a dose Press down only once

PRESS x 1

Important points to remember The inhaler will not click if the mouthpiece cover is still inserted Press down only once If you accidentally press more than once, empty the powder from the mouthpiece, as shown below Press to release the dose before inhaling, do not press and inhale at the same time Keep the inhaler in an upright position while you press and while you inhale the dose. If you turn it upside down, the powder may escape before being inhaled.

Step 3: INHALE Continue to hold the inhaler in an upright position Exhale normally Put the mouthpiece in your mouth between your teeth and close your lips tightly around the mouthpiece Inhale strongly and deeply Remove the inhaler from your mouth, then exhale normally.

INHALE

Important points to remember Make sure the entire mouthpiece is well inserted into your mouth, so that the medicine enters your lungs Make sure your lips seal tightly around the mouthpiece Do not exhale into the inhaler. This is important: it could block the inhaler. If you exhale into the inhaler, empty the powder from the mouthpiece, as shown below

If you need to take another inhalation, repeat steps 1-3 Shake-Press-Inhale.
After using the inhaler:

• Put the mouthpiece cover back on the mouthpiece. This prevents the inhaler from being activated accidentally.
• After taking the dose, rinse your mouth with water and spit it out.

Cleaning the Easyhaler
Keep the inhaler dry and clean. If necessary, you can clean the mouthpiece of the inhaler with a dry cloth
or tissue. Do not use water: the powder in the Easyhaler is sensitive to moisture.

How to empty the powder from the mouthpiece If you accidentally press the inhaler or it has been pressed more than once or if you have exhaled into it, empty the mouthpiece. Tap the mouthpiece on the table or on the palm of your hand to dislodge the powder. Then start again with the Shake-Press- Inhale steps.

Using the Easyhaler with a protective case You can use a protective case with the inhaler. This helps to improve the product's durability. When you first insert the inhaler into the protective case, make sure the mouthpiece cover is on the inhaler, as this prevents the inhalation from being activated accidentally. You can use the inhaler without removing it from the protective case. Follow the same instructions as above, 1. Shake - 2. Press - 3. Inhale. Remember to: Keep the inhaler in an upright position when you press Close the mouthpiece cover after taking the dose as this prevents the inhaler from being activated accidentally.

When to switch to a new Easyhaler The dose counter shows the number of doses remaining. The dose counter rotates after every 5 actuations. When the dose counter starts to turn red, there are still 20 doses to deliver. If you do not already have a new Easyhaler, contact your doctor for a new prescription. When the dose counter reaches 0 (zero), you need to replace the Easyhaler. If you are using the protective case, keep it and insert the new inhaler into it.

Remember

• 1. Shake - 2. Press - 3. Inhale.
• After taking the dose, rinse your mouth with water and spit it out.
• Do not wet the inhaler, protect it from moisture

If you have any questions about using this medicine, ask your doctor or pharmacist.