MIFLONIDE 200 MCG Inhalation powder, hard capsule

Зміст інструкції

1. Miflonide Breezhaler 200 micrograms powder for inhalation, hard capsule
   1. What is Miflonide Breezhaler and what is it used for
   2. What you need to know before you use Miflonide Breezhaler
   3. How to use Miflonide Breezhaler
   4. Possible side effects
   5. How to store Miflonide Breezhaler
   6. Package Contents and Other Information
2. Miflonide Breezhaler 400 micrograms powder for inhalation, hard capsule
   1. What is Miflonide Breezhaler and what it is used for
   2. What you need to know before using Miflonide Breezhaler
   3. How to use Miflonide Breezhaler
   4. Possible side effects
   5. How to store Miflonide Breezhaler
   6. Contents of the pack and other information

Miflonide Breezhaler 200 micrograms powder for inhalation, hard capsule

Budesonide

Read this leaflet carefully before you start to use this medicine as 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 because 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 Miflonide Breezhaler is and what it is used for
• 2. What you need to know before you use Miflonide Breezhaler
• 3. How to use Miflonide Breezhaler
• 4. Possible side effects
• 5. How to store Miflonide Breezhaler
• 6. Contents of the pack and other information
• 7. How to use Miflonide Breezhaler with the Miflonide Breezhaler inhaler

1. What is Miflonide Breezhaler and what is it used for

What is Miflonide Breezhaler
Miflonide Breezhaler consists of a capsule to be inserted into an inhaler called Miflonide Breezhaler.
The inhaler opens the capsule and releases a dry powder that is sent to the lungs through
inhalation.
Miflonide Breezhaler contains a substance called budesonide, which belongs to a group of
substances called “corticosteroids”. Some people call them “steroids” or “preventative medicines”.

What is Miflonide Breezhaler used for
Miflonide Breezhaler is used to prevent asthma attacks and relieve breathing difficulties
in adults and children 6 years of age and older. This medicine should be used
regularly, every day, even if you feel better because it helps prevent future breathing problems.
It should not be used to treat a sudden asthma attack when you have one. To treat
this type of attack you will need to use a different inhalation medicine (“for immediate relief”),
such as albuterol or salbutamol.

How does Miflonide Breezhaler work
Asthma is caused by inflammation of the small airways in your lungs, which become thickened and
make it difficult to breathe.
Miflonide Breezhaler reduces and prevents inflammation and helps keep your airways open
to reduce asthma symptoms, allowing you to breathe more easily.

2. What you need to know before you use Miflonide Breezhaler

Do not use Miflonide Breezhaler

• if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6);
• if you have or have had a lung disease called pulmonary tuberculosis (TB);
• in children under 6 years of age.

If any of the above applies to you, do not use Miflonide Breezhaler. If you have any
doubts, ask your doctor or pharmacist before using Miflonide Breezhaler.

Warnings and precautions
Talk to your doctor before taking Miflonide Breezhaler:

• if you have had tuberculosis
• if you have fungal or viral infections of the airways;
• if you have any other lung or respiratory problem that may increase the risk of a fungal infection;
• if you have liver disease or suffer from jaundice. The doctor will prescribe the most suitable dose for you.

If any of the above applies to you (or if you have any doubts), tell your doctor before
taking Miflonide Breezhaler.
Tell your doctor immediately

• if you have difficulty breathing, with wheezing or coughing, after taking the medicine. If this happens, stop taking this medicine immediately. The doctor will give you another medicine to use instead;
• if you develop skin rashes, itching, hives, swelling of the face or throat, difficulty breathing or swallowing, or feel dizzy when using Miflonide Breezhaler. You may be having a serious allergic reaction to the medicine;
• if you feel extremely weak, lose weight, feel unwell (nausea) and have frequent diarrhea while using Miflonide Breezhaler. These may be symptoms of an adrenal gland that is not working properly;
• if you experience weight gain, a rounded face, weakness and/or fat around the abdomen while using Miflonide Breezhaler. These may be symptoms of a hormonal disorder called Cushing's syndrome;
• if you have blurred vision or changes in vision while using Miflonide Breezhaler,
• if you experience sleep disturbances or depression or feel restless, agitated, nervous, overexcited or irritable during treatment with Miflonide Breezhaler;
• if you develop fungal infections in your mouth during use of Miflonide Breezhaler.

If any of the above applies to you, tell your doctor immediately.
The doctor may occasionally request tests relating to the kidneys (tests of adrenal gland function).
If this medicine is used for a long time by a child, the doctor will regularly check
the child's height.
Do not swallow the capsules – they must be used only with the Miflonide Breezhaler inhaler

Other medicines and Miflonide Breezhaler
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor if you are using:

• medicines used to treat infections, such as itraconazole, ketoconazole, clarithromycin, telithromycin, erythromycin or rifampicin;
• medicines used to treat HIV infection, such as ritonavir, saquinavir or nelfinavir;
• medicines used to treat heart problems (cardiac arrhythmias), such as amiodarone.

If any of the above applies to you, or if you have any doubts, tell your doctor
immediately.

If you are taking steroid tablets
If you have been taking steroid tablets for a long time to control your asthma, the doctor may
slowly reduce the amount, after you have started taking Miflonide Breezhaler for about
10 days. Do not stop taking the steroid tablets suddenly.
Sometimes, when you reduce the amount of tablets taken, you may experience symptoms such as:

• a stuffy or runny nose, muscle or joint pain;
• skin rash (eczema);
• tiredness, feeling unwell (nausea) or sickness (vomiting).

If you experience any of these symptoms, tell your doctor immediately.

Pregnancy
If you are pregnant, if you suspect you may be pregnant or are planning to become pregnant, ask your doctor
or pharmacist for advice before taking this medicine. During pregnancy, you should not use this
medicine unless it is clearly necessary and, in this case, only following your doctor's instructions.

Breastfeeding
If you are breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine. The doctor will discuss with you the potential risks of using Miflonide Breezhaler during
breastfeeding. Ask your doctor for advice before taking any medicine.

Driving and using machines
It is unlikely that Miflonide Breezhaler will affect your ability to drive or operate machinery.

Miflonide Breezhaler contains lactose monohydrate
This medicine contains lactose (24.77 mg per capsule). If you have been diagnosed with
lactose intolerance, contact your doctor before taking this medicine

3. How to use Miflonide Breezhaler

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

How much Miflonide Breezhaler to take

• Your doctor will adjust the dose so that you use the minimum amount of medicine that is effective for you.
• It is important to use the inhaler every day, even if you feel better, because this medicine will help prevent future breathing problems.
• If you notice that wheezing or shortness of breath worsen, tell your doctor immediately. You may feel if your medicine is not working as well as it should.
• If you or your child need to take less than 200 micrograms per day, you cannot

use this medicine.

Children under 6 years of age
Miflonide Breezhaler should not be used in children under 6 years of age.

Children 6 years of age and over

• The usual dose is between 200 and 400 micrograms of medicine each day. Normally this dose is inhaled twice a day, half dose at a time. This means inhaling one capsule twice a day.
• Your doctor may ask you to take a different number of capsules or to use the inhaler only once a day.
• If your child has severe asthma, your doctor may ask you to use up to 800 micrograms per day. This means inhaling two capsules twice a day.

Adults

• The usual dose is between 200 and 1600 micrograms of medicine per day. Normally this dose is inhaled twice a day, half dose at a time. This means inhaling one to four capsules twice a day.
• Your doctor may ask you to take a different number of capsules or to use the inhaler only once a day.

If you have any doubts about how many capsules to use, ask your doctor or pharmacist for advice before taking
Miflonide Breezhaler.

How to use Miflonide Breezhaler with the Breezhaler inhaler

• Use Miflonide Breezhaler capsules only with the inhaler supplied with the pack. The capsules must remain in the blister until you are ready to use them.
• Do not swallow the capsules. The powder contained in the capsules must be used only for inhalation.
• To avoid getting an infection in your mouth called “thrush”, rinse your mouth well with water after using the inhaler.
• Read section 7 carefully for further information on how to use Miflonide Breezhaler capsules with the Miflonide Breezhaler inhaler.

If you use more Miflonide Breezhaler than you should
It is important that you take the dose that has been recommended by your doctor. Do not increase or
decrease the dose without asking your doctor for advice.
If you use more medicine than you should, or if others use your capsules, contact your doctor
immediately or go to the nearest emergency room. Take the medicine pack with you.

If you forget to take Miflonide Breezhaler
If you forget to inhale a dose, inhale the next dose at the usual time.
Do not inhale a double dose to make up for a missed inhalation.

If you stop taking Miflonide Breezhaler
Stopping treatment with Miflonide Breezhaler may increase the possibility of worsening
asthma. Do not suddenly stop using Miflonide Breezhaler unless your doctor tells you to do so.
If you have any doubts about using this medicine, contact your doctor or pharmacist.

4. Possible side effects

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

Some rare side effects can be serious.
Tell your doctor immediately

• If you have difficulty breathing, with wheezing or coughing, after using the medicine. If this happens, stop taking this medicine immediately. Your doctor may give you another medicine to use instead.
• If you get skin rashes, itching, hives, swelling of the face and throat, difficulty breathing or swallowing or feel dizzy while using Miflonide Breezhaler. You may have a severe allergic reaction to this medicine.
• If you become extremely weak, lose weight, feel sick (nausea) and have frequent diarrhoea while using Miflonide Breezhaler. These can be symptoms of an insufficiently active adrenal gland.
• If you gain weight, develop a full moon face, become weak and/or obese around the abdomen while using Miflonide Breezhaler. These can be symptoms of a hormonal disorder called Cushing's syndrome or hyperadrenocorticism.
• If you have blurred vision or changes in vision while using Miflonide Breezhaler.

If any of the above occur, tell your doctor immediately.

Other side effects can include:
Common(may affect up to 1 in 10 people)

• Fungal infections in the mouth or throat. To avoid getting a fungal infection called “thrush”, rinse your mouth well with water after using the inhaler.
• Hoarseness and sore throat. These effects may disappear when you stop using the inhaler, use fewer capsules or rest your voice.

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

• Slowed growth in children and adolescents
• Thinning of the bones
• Feeling hyperactive or restless
• Behavioural problems, including depression, especially in children
• Cough
• Itchy skin rashes
• Bruising

Not known(frequency cannot be estimated from available data)

• Sleep disturbances
• Feeling frightened, nervous, overexcited or irritable. These effects are more likely to occur in children.

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 through the Italian Medicines Agency, website: http:// www.agenziafarmaco.gov.it/it/responsabili .By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Miflonide Breezhaler

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after SCAD. The expiry
date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
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. Package Contents and Other Information

What Miflonide Breezhaler Contains

• The active ingredient is budesonide. Each capsule contains 230 micrograms of budesonide and releases 200 micrograms of budesonide when used with the Miflonide Breezhaler inhaler.
• The excipient is lactose monohydrate. The capsules are made of food gelatin.

Description of the Appearance of Miflonide Breezhaler and Package Contents
Miflonide Breezhaler is a powder that is inhaled using the Miflonide Breezhaler inhaler. The
powder is contained in a capsule.

• The 200 microgram capsule is half light pink and half transparent, colorless, with the inscription “BUDE 200”.
• The following packs are available: Single pack containing 2x10 or 6x10 hard capsules and 1 inhaler. Multipack (consisting of 2 single packs of 6x10) containing 120 hard capsules and 2 inhalers. Multipack (consisting of 3 single packs of 6x10) containing 180 hard capsules and 3 inhalers.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio VA
Italy

Manufacturer
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata NA
Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria: MIFLONIDE
Belgium: MIFLONIDE
Bulgaria: MIFLONIDE
Croatia: MIFLONIDE
Cyprus: MIFLONIDE
Czech Republic: MIFLONID
Denmark: MIFLONIDE
Estonia: MIFLONIDE
Finland: MIFLONIDE
France: MIFLONIL
Germany: MIFLONIDE
Greece: MIFLONIDE
Hungary: MIFLONIDE
Ireland: MIFLONIDE
Italy: MIFLONIDE BREEZHALER
Latvia: MIFLONIDE
Lithuania: MIFLONIDE
Luxembourg: MIFLONIDE
Malta: MIFLONIDE
Netherlands: MIFLONIDE
Poland: MIFLONIDE
Portugal: MIFLONIDE
United Kingdom: MIFLONIDE
Romania: MIFLONIDE
Slovakia: MIFLONID
Slovenia: MIFLONIDE
Spain: MIFLONIDE
Sweden: MIFLONIDE

Instructions for Use of Miflonide Breezhaler
To understand how to use the Miflonide Breezhaler capsules with the Miflonide Breezhaler inhaler, read
the following instructions carefully.
Use the Miflonide Breezhaler capsules only with the Miflonide Breezhaler inhaler supplied with the
pack.

• Do not use a different type of inhaler.
• Do not swallow the capsules. The powder contained in the capsules must be inhaled. Remember that Miflonide Breezhaler must only be used to prevent asthma attacks. Use your “rescue” inhaler to treat an asthma attack.

Your Miflonide Breezhaler pack:

Cap

Inhaler with
cap
Base

Blister containing
the capsules
Blister
Mouthpiece
Filter

Base
of the inhaler
Side button
Capsule housing
Each Miflonide Breezhaler pack contains:

• a Miflonide Breezhaler inhaler;
• one or more blisters containing the Miflonide Breezhaler capsules for use with the inhaler. The Miflonide Breezhaler inhaler allows you to inhale the medicine contained in the Miflonide Breezhaler capsule. How to use the Miflonide Breezhaler inhaler

Remove the cap

Open the inhaler
Holding the base of the inhaler firmly, tilt the mouthpiece. This
opens the inhaler.

Prepare the capsule
Immediately before use,with dry hands, remove a capsule from
the blister.
Do not swallow the capsule.

Insert the capsule
Insert the capsule into the capsule housing.

Never insert the capsule directly into the mouthpiece.

Close the inhaler
Close the inhaler until you hear a “click”.

Pierce the capsule

• Hold the inhaler in a vertical position, with the mouthpiece pointing upwards.
• Pierce the capsule by firmly pressing both side buttons towards each other simultaneously. Do this only once.
• When the capsule is pierced, you should hear a “click”.

Release the side buttons completely

Exhale
Before bringing the mouthpiece to your mouth, exhale completely.

Do not blow into the mouthpiece.

Inhale the medicine
To inhale the medicine deeply into your airways:

• hold the inhaler as shown in the figure. The side buttons should be on the right and left. Do not press the side buttons;
• bring the mouthpiece to your mouth and close your lips tightly around the mouthpiece;
• inhale rapidly but steadily and as deeply as possible.

Note
When you inhale through the inhaler, the capsule rotates on itself in its
housing and you should hear a buzzing sound. While the medicine reaches your
lungs, you may smell a sweet aroma.

Further information
Small pieces of capsule may sometimes pass through the filter and enter your
mouth. If this happens, you may feel the presence of these pieces on your
tongue. It is not harmful to swallow or inhale these pieces. The possibility of the
capsule breaking increases if the capsule is accidentally pierced more
than once (point 6).

If you do not hear the buzzing of the capsule
The capsule may be stuck in the housing. If this happens:

• open the inhaler and gently dislodge the capsule by tapping on the base of the inhaler. Do not press the side buttons.
• close the inhaler and inhale the medicine again, repeating steps 8 and 9.

Hold your breath
After inhaling the medicine:

• hold your breath for at least 5-10 seconds or as long as possible without difficulty, removing the inhaler from your mouth;
• then breathe freely;
• open the inhaler to check if any powder remains in the capsule.

If powder remains in the capsule:

• close the inhaler;
• repeat steps 8, 9, 10 and 11. Most people are able to empty the capsule with one or two inhalations.

Further information
If the capsule is empty, you have taken enough medicine.

• Open the mouthpiece again and remove the empty capsule by turning it out of the housing. Dispose of the empty capsule in household waste.

If the prescription requires you to take more than one capsule, repeat steps 3–12
as needed.

After you have finished taking the medicine

• Close the inhaler and replace the cap. Rinse your mouth with water after taking the medicine. Spit out the rinsing water. This reduces the risk of developing fungal infections (thrush) in the mouth. Do not store the capsules inside the Miflonide Breezhaler inhaler.

How to clean the inhaler
Never wash the inhaler with water. If you want to clean the inhaler, wipe the inside and outside of the
mouthpiece with a clean, dry, lint-free cloth to remove any dust residue. Keep the inhaler dry.

Remember:

• Do not swallow Miflonide Breezhaler capsules.
• Use only the Miflonide Breezhaler inhaler contained in this pack.
• The capsules must always be stored in the blister and removed only immediately before use.
• Never put Miflonide Breezhaler capsules directly into the mouthpiece of the Miflonide Breezhaler inhaler.
• Do not press the side buttons more than once.
• Never blow into the mouthpiece of the Miflonide Breezhaler inhaler.
• Always release the side buttons before inhaling.
• Never wash the Miflonide Breezhaler inhaler with water. Keep it dry. Read “How to clean the inhaler”.
• Never disassemble the Miflonide Breezhaler inhaler.
• Always use the new Miflonide Breezhaler inhaler contained in each new Miflonide Breezhaler pack. When the pack is finished, discard the inhaler.
• Do not store the capsules in the Miflonide Breezhaler inhaler.
• Always store the Miflonide Breezhaler inhaler and Miflonide Breezhaler capsules in a dry place.

Miflonide Breezhaler 400 micrograms powder for inhalation, hard capsule

Budesonide

Read this leaflet carefully before you start using this medicine as 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 they have the same symptoms as you, as it may 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 Miflonide Breezhaler is and what it is used for
• 2. What you need to know before you use Miflonide Breezhaler
• 3. How to use Miflonide Breezhaler
• 4. Possible side effects
• 5. How to store Miflonide Breezhaler
• 6. Contents of the pack and other information
• 7. How to use Miflonide Breezhaler with the Miflonide Breezhaler inhaler

1. What is Miflonide Breezhaler and what it is used for

What is Miflonide Breezhaler
Miflonide Breezhaler consists of a capsule to be inserted into an inhaler called Miflonide Breezhaler.
The inhaler opens the capsule and releases a dry powder that is sent to the lungs through
inhalation.
Miflonide Breezhaler contains a substance called budesonide, which belongs to a group of
substances called “corticosteroids”. Some people call them “steroids” or “preventative medicines”.

What is Miflonide Breezhaler used for
Miflonide Breezhaler is used to prevent asthma attacks and relieve breathing difficulties
in adults and children 6 years of age and older. This medicine should be used
regularly, every day, even if you feel better because it helps prevent future breathing problems.
It should not be used to treat a sudden asthma attack when you have one. To treat
this type of attack you should use a different inhalation medicine (“for immediate relief”),
such as albuterol or salbutamol.

How Miflonide Breezhaler works
Asthma is caused by inflammation of the small airways in your lungs, which become thickened and
make it difficult to breathe.
Miflonide Breezhaler reduces and prevents inflammation and helps keep the airways open
to reduce asthma symptoms, allowing you to breathe more easily.

2. What you need to know before using Miflonide Breezhaler

Do not use Miflonide Breezhaler

• if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6);
• if you have or have had a lung disease called pulmonary tuberculosis (TB);
• in children under 6 years of age.

If any of the above applies to you, do not use Miflonide Breezhaler. If you have any
doubts, ask your doctor or pharmacist before using Miflonide Breezhaler.

Warnings and precautions
Talk to your doctor before taking Miflonide Breezhaler:

• if you have had tuberculosis;
• if you have fungal or viral infections of the airways;
• if you have any other lung or respiratory problem that may increase the risk of a fungal infection;
• if you have liver disease or suffer from jaundice. The doctor will prescribe the most suitable dose for you.

If any of the above applies to you (or if you have any doubts), tell your doctor before
taking Miflonide Breezhaler.
Tell your doctor immediately

• if you have difficulty breathing, with wheezing or coughing, after taking the medicine. If this happens, stop taking this medicine immediately. The doctor will give you another medicine to use instead;
• if you develop skin rashes, itching, hives, swelling of the face or throat, difficulty breathing or swallowing, or feel dizzy when using Miflonide Breezhaler. You may have a severe allergic reaction to the medicine;
• if you feel extremely weak, lose weight, feel unwell (nausea) and have frequent diarrhoea while using Miflonide Breezhaler. These may be symptoms of an insufficiently active adrenal gland;
• if you experience weight gain, a full moon face, weakness and/or obesity around the abdomen while using Miflonide Breezhaler. These may be symptoms of a hormonal disorder called Cushing's syndrome;
• if you have blurred vision or changes in vision while using Miflonide Breezhaler;
• if you experience sleep disturbances or depression or feel restless, agitated, nervous, overexcited or irritable during treatment with Miflonide Breezhaler;
• if you develop fungal infections in your mouth while using Miflonide Breezhaler.

If any of the above applies to you, tell your doctor immediately.
The doctor may occasionally request tests concerning the kidneys (tests of adrenal gland function).
If this medicine is used for a long time by a child, the doctor will regularly check
the child's height.
Do not swallow the capsules – they must be used only with the Miflonide Breezhaler inhaler

Other medicines and Miflonide Breezhaler
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor if you are using:

• medicines used to treat infections, such as itraconazole, ketoconazole, clarithromycin, telithromycin, erythromycin or rifampicin;
• medicines used to treat HIV infection, such as ritonavir, saquinavir or nelfinavir;
• medicines used to treat heart problems (cardiac arrhythmias), such as amiodarone.

If any of the above applies to you, or if you have any doubts, tell your doctor
immediately.

If you are taking steroids in tablet form
If you have been taking steroids in tablet form for a long time to control your asthma, the doctor may
slowly reduce the amount, after you have started taking Miflonide Breezhaler for about
10 days. Do not stop taking the steroid tablets suddenly.
Sometimes, when the amount of tablets taken is reduced, you may experience symptoms such as:
a stuffy or runny nose, muscle or joint pain;
skin rash (eczema);
fatigue, feeling unwell (nausea) or feeling sick (vomiting).
If you experience any of these symptoms, tell your doctor immediately.

Pregnancy
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor
or pharmacist for advice before taking this medicine. During pregnancy, you should not use this
medicine unless it is clearly necessary and, in this case, only following the doctor's instructions.

Breast-feeding
If you are breast-feeding, ask your doctor or pharmacist for advice before taking this
medicine. The doctor will discuss with you the potential risks of using Miflonide Breezhaler during
breast-feeding. Ask your doctor for advice before taking any medicine.

Driving and using machines
It is unlikely that Miflonide Breezhaler will affect your ability to drive or use machines.

Miflonide Breezhaler contains lactose monohydrate
This medicine contains lactose (24.54 mg per capsule). If you have been diagnosed with
lactose intolerance, contact your doctor before taking this medicine

3. How to use Miflonide Breezhaler

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

How much Miflonide Breezhaler to take

• Your doctor will adjust the dose so that you use the minimum amount of medicine that is effective for you.
• It is important to use the inhaler every day, even if you feel better, because this medicine will help prevent future breathing problems.
• If you notice that wheezing or shortness of breath worsen, inform your doctor immediately. You may feel if your medicine is not working as well as it should.
• If you or your child need to take less than 400 micrograms a day, you cannot

use this medicine.

Children under 6 years of age
Miflonide Breezhaler should not be used in children under 6 years of age.

Children 6 years of age and older

• The usual dose is between 200 and 400 micrograms of medicine each day. Usually this dose is inhaled twice a day, half dose at a time.
• Your doctor may ask you to use the inhaler only once a day.
• If your child has severe asthma, your doctor may ask you to use up to 800 micrograms a day. This means inhaling one capsule twice a day.

Adults

• The usual dose is between 200 and 1600 micrograms of medicine per day. Usually this dose is inhaled twice a day, half dose at a time. This means inhaling one to two capsules twice a day.
• Your doctor may ask you to take a different number of capsules or to use the inhaler only once a day.

If you have any doubts about how many capsules to use, ask your doctor or pharmacist for advice before taking
Miflonide Breezhaler.

How to use Miflonide Breezhaler with the Breezhaler inhaler

• Use Miflonide Breezhaler capsules only with the inhaler supplied with the package. The capsules must remain in the blister until you use them.
• Do not swallow the capsules. The powder contained in the capsules must only be used for inhalation
• To avoid getting an infection in the mouth called “thrush”, rinse your mouth well with water after using the inhaler.
• Read section 7 carefully for further information on how to use Miflonide Breezhaler capsules with the Miflonide Breezhaler inhaler.

If you use more Miflonide Breezhaler than you should
It is important that you take the dose recommended by your doctor. You should not increase or
decrease the dose without asking your doctor for advice.
If you use more medicine than you should, or if others use your capsules, contact your doctor
immediately or go to the nearest emergency room. Bring the medicine package with you.

If you forget to take Miflonide Breezhaler
If you forget to inhale a dose, inhale the next dose at the usual time.
Do not inhale a double dose to make up for a missed inhalation.

If you stop taking Miflonide Breezhaler
Stopping treatment with Miflonide Breezhaler may increase the possibility of worsening
asthma. Do not suddenly stop using Miflonide Breezhaler unless your doctor asks you to do so.
If you have any doubts about using this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Some rare side effects can be serious.
Tell your doctor immediately

• If you have difficulty breathing, with wheezing or coughing, after using the medicine. If this happens, stop taking this medicine immediately. Your doctor may give you another medicine to use instead.
• If you get skin rashes, itching, hives, swelling of the face and throat, difficulty breathing or swallowing or feel dizzy while using Miflonide Breezhaler. You may have a serious allergic reaction to this medicine.
• If you become extremely weak, lose weight, feel unwell (nausea) and have frequent diarrhea while using Miflonide Breezhaler. These can be symptoms of an insufficiently active adrenal gland.
• If you gain weight, develop a full moon face, become weak and/or obese around the abdomen while using Miflonide Breezhaler. These can be symptoms of a hormonal disorder called Cushing's syndrome or hyperadrenocorticism.
• If you have blurred vision or your vision changes while using Miflonide Breezhaler.

If any of the above occur, tell your doctor immediately.

Other side effects may include:
Common(may affect up to 1 in 10 people)

• Fungal infections in the mouth or throat. To avoid getting a fungal infection called “thrush”, rinse your mouth well with water after using the inhaler.
• Hoarseness and sore throat. These effects may disappear when you stop using the inhaler, use fewer capsules or rest your voice.

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

• Slowed growth in children and adolescents
• Thinning of the bones
• Feeling hyperactive or restless
• Behavioral problems, including depression, especially in children
• Cough
• Itchy skin rashes
• Bruising

Not known(frequency cannot be estimated from available data)

• Sleep disturbances
• Feeling frightened, nervous, overexcited or irritable. These effects are more likely to occur in children.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the Italian Medicines Agency,
website: http:// www.agenziafarmaco.gov.it/it/responsabili .By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Miflonide Breezhaler

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry
date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
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 Miflonide Breezhaler contains

• The active ingredient is budesonide. Each capsule contains 460 micrograms of budesonide and releases 400 micrograms of budesonide when used with the Miflonide Breezhaler inhaler.
• The excipient is lactose monohydrate. The capsules are made of food gelatin.

Description of the appearance of Miflonide Breezhaler and contents of the pack
Miflonide Breezhaler is a powder that is inhaled using the Miflonide Breezhaler inhaler. The
powder is contained in a capsule.

• The 400 microgram capsule is half opaque pink and half transparent, colorless, with the inscription “BUDE 400”.
• The following packs are available Single pack containing 2x10 or 6x10 hard capsules and 1 inhaler. Multipack (consisting of 2 single packs of 6x10) containing 120 hard capsules and 2 inhalers. Multipack (consisting of 3 single packs of 6x10) containing 180 hard capsules and 3 inhalers.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio VA
Italy

Manufacturer
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata NA
Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria: MIFLONIDE
Belgium: MIFLONIDE
Bulgaria: MIFLONIDE
Croatia: MIFLONIDE
Cyprus: MIFLONIDE
Czech Republic: MIFLONID
Denmark: MIFLONIDE
Estonia: MIFLONIDE
Finland: MIFLONIDE
France: MIFLONIL
Germany: MIFLONIDE
Greece: MIFLONIDE
Hungary: MIFLONIDE
Ireland: MIFLONIDE
Italy: MIFLONIDE BREEZHALER
Latvia: MIFLONIDE
Lithuania: MIFLONIDE
Luxembourg MIFLONIDE
Malta: MIFLONIDE
Netherlands: MIFLONIDE
Poland: MIFLONIDE
Portugal: MIFLONIDE
United Kingdom: MIFLONIDE
Romania: MIFLONIDE
Slovakia: MIFLONID
Slovenia: MIFLONIDE
Spain: MIFLONIDE
Sweden: MIFLONIDE

Instructions for use of Miflonide Breezhaler
To understand how to use the Miflonide Breezhaler capsules with the Miflonide Breezhaler inhaler, read
the following instructions carefully.
Use the Miflonide Breezhaler capsules only with the Miflonide Breezhaler inhaler supplied with the
pack.

• Do not use a different type of inhaler.
• Do not swallow the capsules. The powder contained in the capsules must be inhaled.
• Remember that Miflonide Breezhaler must only be used to prevent asthma attacks. Use your “rescue” inhaler to treat an asthma attack.

Your Miflonide Breezhaler pack:

Cap

Inhaler with
cap
Base

Blister containing
the capsules
Blister
Mouthpiece
Filter Base
of the inhaler
Side button
Capsule housing
Each Miflonide Breezhaler pack contains:

• a Miflonide Breezhaler inhaler;
• one or more blisters containing Miflonide Breezhaler capsules for use with the inhaler. The Miflonide Breezhaler inhaler allows you to inhale the medicine contained in the Miflonide Breezhaler capsule.

How to use the Miflonide Breezhaler inhaler

Remove the cap

Open the inhaler
Hold the base of the inhaler firmly and tilt the mouthpiece. This
opens the inhaler.

Prepare the capsule
Immediately before use,with dry hands, remove a capsule from the
blister.
Do not swallow the capsule.

Insert the capsule
Insert the capsule into the capsule housing.

Do not insert the capsule directly into the mouthpiece.

Close the inhaler
Close the inhaler until you hear a “click”.

Puncture the capsule

• Hold the inhaler in a vertical position, with the mouthpiece facing upwards.
• Puncture the capsule by firmly pressing both side buttons towards each other simultaneously. Perform this operation only once.
• When the capsule is punctured, you should hear a “click”.

Release the side buttons completely

Exhale
Before bringing the mouthpiece to your mouth, exhale completely.

Do not blow into the mouthpiece.

Inhale the medicine
To inhale the medicine deeply into your airways:

• hold the inhaler as shown in the figure. The side buttons must be on the right and left. Do not press the side buttons;
• bring the mouthpiece to your mouth and close your lips firmly around the mouthpiece;
• inhale quickly but steadily and as deeply as possible.

Note
When you inhale through the inhaler, the capsule rotates on itself in its
housing and you should hear a buzzing sound. While the medicine reaches your
lungs, you may smell a sweet aroma.

Further information
Small pieces of capsule may sometimes pass through the filter and enter your
mouth. If this happens, you may feel the presence of these pieces on your
tongue. It is not harmful to swallow or inhale these pieces. The possibility of the
capsule breaking increases if the capsule is accidentally punctured more
than once (point 6).

If you do not hear the capsule buzzing
The capsule may be stuck in the housing. If this happens:

• open the inhaler and gently shake the capsule by tapping on the base of the inhaler. Do not press the side buttons.
• close the inhaler and inhale the medicine again, repeating steps 8 and 9.

Hold your breath
After inhaling the medicine:

• hold your breath for at least 5-10 seconds, or as long as possible without difficulty, removing the inhaler from your mouth;
• then breathe freely;
• open the inhaler to check if any powder remains in the capsule.

If powder remains in the capsule:

• close the inhaler;
• repeat steps 8, 9, 10 and 11. Most people are able to empty the capsule with one or two inhalations.

Further information
If the capsule is empty, you have taken enough medicine.

• Open the mouthpiece again and remove the empty capsule by turning it out of the housing. Dispose of the empty capsule in household waste.

If the prescription requires taking more than one capsule, repeat steps 3–12
as needed.

After you have finished taking the medicine

• Close the inhaler and replace the cap. Rinse your mouth with water after taking the medicine. Spit out the rinsing water. This reduces the risk of developing fungal infections (thrush) in your mouth. Do not store the capsules inside the Miflonide Breezhaler inhaler.

How to clean the inhaler
Never wash the inhaler with water. If you want to clean the inhaler, wipe the inside and outside of the
mouthpiece with a clean, dry, lint-free cloth to remove any dust residue. Keep the inhaler dry.

Remember

• Do not swallow Miflonide Breezhaler capsules.
• Use only the Miflonide Breezhaler inhaler contained in this pack.
• The capsules must always be stored in the blister and removed only immediately before use.
• Never put Miflonide Breezhaler capsules directly into the mouthpiece of the Miflonide Breezhaler inhaler.
• Do not press the side buttons more than once.
• Never blow into the mouthpiece of the Miflonide Breezhaler inhaler.
• Always release the side buttons before inhaling.
• Never wash the Miflonide Breezhaler inhaler with water. Keep it dry. Read “How to clean the inhaler”.
• Never disassemble the Miflonide Breezhaler inhaler
• Always use the new Miflonide Breezhaler inhaler contained in each new Miflonide Breezhaler pack. When the pack is finished, dispose of the inhaler.
• Do not store the capsules in the Miflonide Breezhaler inhaler.
• Always store the Miflonide Breezhaler inhaler and Miflonide Breezhaler capsules in a dry place.