Budesonide and formoterol Sandoz

Package leaflet: Information for the user

Budesonide and Formoterol Sandoz 160 micrograms/4.5 micrograms/inhalation, powder for

inhalation in
single-dose container
Budesonide/formoterol fumarate dihydrate
Generic medicine
Read this entire leaflet carefully before 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 give it to other people, even if their symptoms
are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What Budesonide and Formoterol Sandoz is and what it is used for
2. What you need to know before using Budesonide and Formoterol Sandoz
3. How to use Budesonide and Formoterol Sandoz
4. Possible side effects
5. How to store Budesonide and Formoterol Sandoz
6. Contents of the pack and other information

1. What Budesonide and Formoterol Sandoz is and what it is used for

Budesonide and Formoterol Sandoz is an inhaler used to treat:
asthma in adults and adolescents aged 12 to 17 years.
the symptoms of chronic obstructive pulmonary disease (COPD) in adults aged 18 years and older.
It contains two different medicines: budesonide and formoterol fumarate dihydrate.
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 β-adrenoceptor agonists” or “bronchodilators”. It works by relaxing the muscles in the airways, helping you breathe more easily.
Asthma
Budesonide and Formoterol Sandoz may be prescribed for asthma in two different ways.
a) Some people are prescribed two inhalers for asthma: Budesonide and Formoterol Sandoz and a separate “rescue inhaler”.
They use Budesonide and Formoterol Sandoz every day. This helps prevent asthma symptoms from occurring.
They use the “rescue inhaler” when asthma symptoms occur, to help restore normal breathing.
b) Some people are prescribed Budesonide and Formoterol Sandoz as their only asthma inhaler.
They use Budesonide and Formoterol Sandoz every day. This helps prevent asthma symptoms from occurring.
They also use Budesonide and Formoterol Sandoz when they need extra doses to relieve asthma symptoms, to help restore normal breathing. They do not require a separate inhaler for this purpose.
Chronic obstructive pulmonary disease (COPD)
Budesonide and Formoterol Sandoz can also be used to treat the symptoms of COPD in adults.
COPD is a long-term disease characterized by ongoing breathing difficulties caused by narrowing of the airways in the lungs, often accompanied by cough and mucus production. It is often caused by cigarette smoking.

2. What you need to know before using Budesonide and Formoterolo Sandoz

Do not use Budesonide and Formoterolo Sandoz if:
you are allergic to budesonide, formoterol, or any of the other ingredients of this medicine, namely lactose
(which contains small amounts of milk proteins).

Warnings and precautions
Talk to your doctor or pharmacist before using Budesonide and Formoterolo Sandoz if:
you have diabetes.
you have a lung infection.
you have high blood pressure or have previously had heart problems (including irregular heartbeat, very rapid pulse, narrowed arteries, or heart failure).
you have thyroid or adrenal gland problems.
you have low potassium levels in the blood.
you have severe liver problems.
Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and Budesonide and Formoterolo Sandoz
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other
medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:
Beta-blockers (such as atenolol or propranolol for hypertension), including eye drops
(such as timolol for glaucoma).
Medicines for rapid or irregular heartbeat (such as quinidine, disopyramide,
procainamide).
Medicines for allergies, also known as antihistamines, such as terfenadine.
Oxytocin, a medicine used to assist childbirth.
Procarbazine, a medicine used to treat cancer.
Medicines such as digoxin, often used to treat heart failure.
Diuretics, also known as “water tablets” (such as furosemide). These are used for
the treatment of hypertension.
Corticosteroids (such as prednisolone). These are used to treat inflammation or
to prevent organ transplant rejection.
Xanthines (such as theophylline or aminophylline), often used to treat asthma.
Other medicines to dilate the airways, also called bronchodilators (such as
salbutamol).
Medicines used to treat depression, also known as tricyclic antidepressants (such as
amitriptyline) and the antidepressant nefazodone.
Medicines used to treat mental disorders, nausea or vomiting, called phenothiazines (such as
chlorpromazine and prochlorperazine).
Medicines to treat fungal infections (such as ketoconazole, itraconazole, voriconazole,
posaconazole) and bacterial infections (such as clarithromycin, telithromycin, furazolidone).
Medicines for Parkinson’s disease (such as levodopa).
Medicines for thyroid problems (such as levothyroxine).
Ritonavir, cobicistat (medicines used to treat HIV infection). The effects of
Budesonide and Formoterolo Sandoz may be increased, and your doctor may need to monitor you closely.
If you fall into any of the above categories, or if you are in doubt, consult your doctor or pharmacist before
using Budesonide and Formoterolo Sandoz.
Also inform your doctor or pharmacist if you are due to undergo general anaesthesia for a surgical or
dental procedure.

Pregnancy, breastfeeding and fertility
If you are pregnant, or planning to become pregnant, consult your doctor before using
Budesonide and Formoterolo Sandoz – do not use Budesonide and Formoterolo Sandoz unless
specifically instructed by your doctor.
If you become pregnant while being treated with Budesonide and Formoterolo Sandoz, do not
stop using Budesonide and Formoterolo Sandoz but consult your doctor immediately.
If you are breastfeeding, inform your doctor before using Budesonide and Formoterolo Sandoz.

Driving and using machines
Budesonide and Formoterolo Sandoz has no effect or negligible effects on the ability to drive
vehicles or to operate
tools or machinery.

Budesonide and Formoterolo Sandoz contains lactose
Budesonide and Formoterolo Sandoz contains lactose, which is a type of sugar. If your doctor has informed 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 excipient lactose contains small amounts of milk proteins which may cause allergic
reactions.

For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use Budesonide and Formoterol Sandoz

Use Budesonide and Formoterol Sandoz exactly as prescribed by your doctor.
If you have any doubts,
consult your doctor or pharmacist.
It is important to use Budesonide and Formoterol Sandoz every day, even if you currently have no symptoms of
asthma or COPD.
If you are using Budesonide and Formoterol Sandoz for asthma, your doctor will want to monitor your symptoms periodically.
If you have been taking corticosteroid tablets for your asthma or COPD, your doctor may reduce the number of
tablets you are taking once you have started using Budesonide and Formoterol Sandoz. If you have taken
corticosteroid tablets for a long period, your doctor may require you to have periodic blood tests. When reducing the amount of oral corticosteroids, you may feel generally unwell, even though your respiratory symptoms may improve. You might experience symptoms such as nasal congestion or rhinorrhea, weakness, or muscle or joint pain, and skin rash (eczema). If any of these symptoms concern you, or if you experience symptoms such as headache, fatigue, nausea, or vomiting, please contact your doctor immediately. You may need to take another medicine to treat allergic or arthritic symptoms. Ask your doctor if you have any doubts about continuing or discontinuing treatment with Budesonide and Formoterol Sandoz.
Your doctor may consider adding corticosteroid tablets to your usual treatment during periods of stress (for example, when you have a respiratory infection or before undergoing surgery).

Important information about asthma or COPD symptoms
If you notice the onset of breathlessness or wheezing while using Budesonide and Formoterol Sandoz, you should
continue using Budesonide and Formoterol Sandoz but consult your doctor as soon as possible, as additional treatment may be needed.
Contact your doctor immediately if:
Your breathing worsens or if you wake up frequently at night due to asthma.
You begin to experience chest tightness in the morning or if chest tightness lasts longer than usual.
These signs may indicate that your asthma or COPD is not adequately controlled and that you may need different or additional treatment immediately.

Asthma
Budesonide and Formoterol Sandoz may be prescribed for asthma in two different ways. The amount of Budesonide and Formoterol Sandoz to use and when to use it depends on your doctor's prescription.
a) If you have been prescribed Budesonide and Formoterol Sandoz and a separate reliever inhaler, read section “a) Use of Budesonide and Formoterol Sandoz and a separate reliever inhaler”.
b) If you have been prescribed Budesonide and Formoterol Sandoz as your only inhaler, read section “b) Use of Budesonide and Formoterol Sandoz as the only inhaler for asthma”.

a) Use of Budesonide and Formoterol Sandoz and a separate reliever inhaler
Use Budesonide and Formoterol Sandoz every day. This helps prevent the onset of asthma symptoms.
Adults (18 years of age and over)
The usual dose is 1 or 2 inhalations twice daily.
Your doctor may increase this dose to 4 inhalations twice daily.
If your symptoms are well controlled, your doctor may instruct you to take the medicine once daily.
Adolescents (12–17 years)
The usual dose is 1 or 2 inhalations twice daily.
If your symptoms are well controlled, your doctor may instruct you to take the medicine once daily.
The use of Budesonide and Formoterol Sandoz is not recommended for children under 12 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 discussing it with your doctor (or nurse).
Use the separate “reliever inhaler” to treat asthma symptoms.
Always carry your “reliever inhaler” with you to use when needed. Do not use Budesonide and Formoterol Sandoz to treat asthma symptoms; use the reliever inhaler instead.

b) Use of Budesonide and Formoterol Sandoz as the only inhaler for asthma
Use Budesonide and Formoterol Sandoz in this way only if instructed by your doctor and if you are 12 years of age or older.
Use Budesonide and Formoterol Sandoz every day. This helps prevent the onset of asthma symptoms. You may take:
1 inhalation in the morning and 1 inhalation in the evening.
or
2 inhalations in the morning
or
2 inhalations in the evening.
Your doctor may increase this dose to 2 inhalations twice daily.
Also use Budesonide and Formoterol Sandoz as a “reliever inhaler” 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 Budesonide and Formoterol Sandoz with you to use when needed.
Normally, a total daily dose exceeding 8 inhalations is not required. However, your doctor may allow you to take up to 12 inhalations per day for a limited period.
If you regularly need to use 8 or more inhalations per day, consult your doctor or nurse, as your treatment may need to be adjusted.
Do not use more than 12 inhalations in total within 24 hours.
If asthma symptoms occur during physical exercise, use Budesonide and Formoterol Sandoz as described in this
leaflet. However, do not use Budesonide and Formoterol Sandoz immediately before exercise to prevent the onset of symptoms.

Chronic obstructive pulmonary disease (COPD)
This medicine is intended for use in adults only (18 years of age and over).
The usual dose is 2 inhalations twice daily.
Your doctor may also prescribe other medicines to open the airways, known as bronchodilators (such as tiotropium bromide or ipratropium bromide) for the treatment of COPD.

Instructions for use

Your doctor, nurse, or pharmacist will show you how to use the inhaler and will periodically check
that you are using it correctly.
The inhaler contains 60 doses of medicine in powder form within an aluminium strip wound in a spiral.
The inhaler has a dose counter that shows how many doses remain, counting down from
60 to 0. When only the last 10 doses remain, the numbers will appear on a red background.
The inhaler is not reusable – discard the inhaler when it is empty and replace it with a new one.

Before using the inhaler

• Open the transparent door of the side compartment.
• Remove the aluminium strip from the side compartment by carefully tearing it along its entire length against the "teeth" of the side compartment, as shown in the figure below. Do not pull or tear the strip.

• Close the door of the side compartment and dispose of the used strip.

Important:
During use of the inhaler, the used strip will gradually fill the side compartment.
The aluminium strips with black bars do not contain medicine. Eventually, the numbered sections
of the strip will appear in the side compartment.
Do not allow more than 2 sections of aluminium strip to accumulate in the side compartment,
as the inhaler may jam. Carefully remove the strip as described above and
dispose of it safely.
Using the inhaler
Hold the inhaler in your hands, as shown in the figures.

1. Opening

• Open the protective cap by pulling downwards to expose the mouthpiece.
• Check the dose counter to see how many doses remain.

2. Dose Preparation

• Lift the edge of the white lever. Make sure the side compartment is closed.

Remember: Lift the white lever only when you are ready to inhale a dose of the medicine. If
you "play" with the white lever, you will waste doses of medication.

• Opening: Pull the white lever fully until it stops and until you hear a click. This action positions a new dose with the number facing upwards.

• Closing: Then close the white lever completely until it returns to its original position, producing a click. The inhaler is now ready to be used immediately.

3. Inhalation

• Breathe out fully, keeping away from the mouthpiece of the inhaler. Never breathe directly into the inhaler, as this may affect the dose.
• Hold the inhaler horizontally with the protective cap facing downwards.
• Close lips firmly around the mouthpiece.
• Inhale as deeply and forcefully as possible through the inhaler, not through the nose.

• Remove the inhaler from the mouth and hold your breath for 5–10 seconds, or as long as comfortable.
• Then, breathe out slowly, but not into the inhaler.
• Close the protective cap over the mouthpiece.
• Rinse your mouth with water and spit it out. This may help prevent the development of fungal infections in the mouth and hoarseness.

Cleaning

• Clean the outside of the mouthpiece with a clean, dry cloth if necessary.
• Do not attempt to disassemble the inhaler for cleaning or for any other purpose!
• Do not use water or wet wipes to clean any parts of the inhaler, as moisture may affect the dose!
• Never insert pins or other sharp objects into the mouthpiece or any other part of the inhaler, as this may damage the inhaler!

If you use more Budesonide and Formoterolo Sandoz than you should
It is important that you take the dose as indicated in the leaflet or as advised by your doctor.
Do not exceed the prescribed dose without consulting your doctor.
The most common symptoms that may occur if you use more Budesonide and Formoterolo Sandoz than you should are: tremor, headache, or a fast or irregular heartbeat.

If you forget to use Budesonide and Formoterolo Sandoz

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

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following, stop using Budesonide and Formoterol Sandoz 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 sudden fainting. This could indicate an allergic reaction. This side effect is rare (may affect up to 1 in 1,000 people).
• Sudden wheezing or sudden breathlessness immediately after using the inhaler. If you experience any of these symptoms, you must stop using Budesonide and Formoterol Sandoz immediately and use your "reliever" inhaler. Contact your doctor immediately, as your treatment may need to be changed. This occurs very rarely (may affect up to 1 in 10,000 people).

Other possible side effects:

Common (may affect up to 1 in 10 people)

• Palpitations (awareness of heartbeat), tremor or shivering. If these effects occur, they are usually mild and disappear with continued use of Budesonide and Formoterol Sandoz.
• Oral thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth with water after using Budesonide and Formoterol Sandoz.
• Mild sore throat, cough, and hoarseness.
• Headache.
• Pneumonia (lung infection) in patients with COPD.

Inform your doctor if you experience any of the following symptoms while taking Budesonide and Formoterol Sandoz, as they may be signs of a lung infection:

• Fever or chills.
• Increased mucus production, changes in mucus colour.
• Worsening cough or increased breathlessness.

Uncommon (may affect up to 1 in 100 people)

• Feeling restless, nervousness, or agitation.
• Disturbed sleep.
• Dizziness.
• Blurred vision.
• Nausea (feeling unwell).
• Fast heartbeat.
• Skin bruising.
• Muscle cramps.
• Aggression.
• Anxiety.

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

• Skin rash, itching.
• Bronchospasm (narrowing of the muscles in the airways, causing wheezing). If wheezing occurs immediately after using Budesonide and Formoterol Sandoz, stop using the medicine 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, particularly in children.
• Chest pain or tightness (angina pectoris).
• Increased blood sugar (glucose) levels.
• Taste disturbances, for example unpleasant taste in the mouth.
• Changes in blood pressure.
• Weight gain, moon-shaped face, weakness, abdominal obesity (Cushing's syndrome).

Inhaled corticosteroids may 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).
• Cushingoid features.
• Increased susceptibility to infections, and there may also be impaired ability to respond to stress. These effects are much less likely with inhaled corticosteroids than with oral corticosteroid tablets.

Reporting of side effects

If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Budesonide and Formoterol Sandoz

Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the box and label of the inhaler after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Budesonide and Formoterolo Sandoz contains

• The active substances are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate, corresponding to a delivered dose (from the single-dose container in the blister) of 194.7 micrograms of budesonide and 6.1 micrograms of formoterol fumarate dihydrate.
• The other ingredient is lactose monohydrate (which contains milk proteins).

Description of the appearance of Budesonide and Formoterolo Sandoz and contents of the pack
Budesonide and Formoterolo Sandoz consists of a red/white plastic inhaler containing the medicinal product.
Each inhaler contains an OPA/Al/PVC-Al blister with 60 doses of powder for inhalation in single-dose containers. The powder for inhalation is white, pale white, or slightly yellowish, with no aggregates.
Budesonide and Formoterolo Sandoz is available in packs containing 1, 2, or 6 inhalers, each containing 60 doses.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturer
Aeropharm GmbH
François-Mitterrand-Allee 1
07407 Rudolstadt
Germany
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
Sachsen-Anhalt, 39179 Barleben
Germany

This medicinal product is authorized in the European Economic Area Member States under the following names:
Belgium Budesonide e Formoterolo Sandoz 160 microgram/ 4.5 microgram/inhalatie, inhalatiepoeder, voorverdeeld
Denmark Budesonide e Formoterolo Sandoz
Finland AEROCOMP Forspiro 160 mikrog/4.5 mikrog/annos, inhalaatiojauhe, annosteltu
France Budesonide e Formoterolo Sandoz 160 microgrammes/4.5 microgrammes/dose, poudre pour inhalation en récipient unidose
Ireland Budesonide e Formoterolo Sandoz 160 microgram/4.5 microgram/dose inhalation powder, pre-dispensed
Italy Budesonide e Formoterolo Sandoz
Norway Budesonide e Formoterolo Sandoz
Portugal Budesonide e Formoterolo Sandoz
Spain Budesonide e Formoterolo Sandoz 160 microgramos/4.5 microgramos/inhalación polvo para inhalación (unidosis)
Sweden Budesonide e Formoterolo Sandoz 160 mikrog/4.5 mikrog/dos, inhalationspulver, avdelad dos

Package leaflet: Information for the user

Budesonide and Formoterol Sandoz 320 micrograms/9 micrograms/inhalation, powder for

inhalation, pre-dosed
budesonide/formoterol fumarate dihydrate
Generic medicine
Please read this leaflet carefully before 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 give it to other people, even if their symptoms
are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What Budesonide and Formoterol Sandoz is and what it is used for
2. What you need to know before using Budesonide and Formoterolo Sandoz
3. How to use Budesonide and Formoterol Sandoz
4. Possible side effects
5. How to store Budesonide and Formoterol Sandoz
6. Contents of the pack and other information

1. What Budesonide and Formoterol Sandoz is and what it is used for

Budesonide and Formoterol Sandoz is an inhaler used to treat asthma in adults and adolescents aged 12 to 17 years. It is also used to treat symptoms of chronic obstructive pulmonary disease (COPD) in adults aged 18 years and older. It contains two different medicines: budesonide/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 "β-adrenergic receptor agonists with long duration of action" or "bronchodilators". It works by relaxing the muscles in the airways, helping you to breathe more easily.
Asthma
For asthma, your doctor will prescribe two different inhalers: Budesonide and Formoterol Sandoz and a "reliever inhaler".
Use Budesonide and Formoterol Sandoz every day. This helps prevent asthma symptoms from occurring.
Use the "reliever inhaler" when asthma symptoms occur, to help you breathe more easily. Do not use Budesonide and Formoterol Sandoz as a "reliever inhaler".
Chronic obstructive pulmonary disease (COPD)
Budesonide and Formoterol Sandoz may also be used to treat symptoms of COPD in adults. COPD is a long-term disease of the airways in the lungs. It is often caused by cigarette smoking.

2. What you need to know before using Budesonide and Formoterol Sandoz

Do not use Budesonide and Formoterol Sandoz:
if you are allergic to budesonide, formoterol, or any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Budesonide and Formoterol Sandoz if:
you have diabetes.
you have a lung infection.
you have high blood pressure or have previously had heart problems (including irregular heartbeat, very rapid pulse, narrowing of the arteries, or heart failure).
you have thyroid or adrenal gland problems.
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.

Other medicines and Budesonide and Formoterol Sandoz
Tell your doctor or pharmacist if you are currently taking, have recently taken, or might take any other
medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:
Beta-blockers (such as atenolol or propranolol for hypertension), including eye drops
(such as timolol for glaucoma).
Medicines for rapid or irregular heartbeat (such as quinidine, disopyramide,
procainamide).
Medicines for allergies, also called antihistamines, such as terfenadine.
Oxytocin, a medicine used to assist childbirth.
Procarbazine, a medicine used to treat cancer.
Medicines such as digoxin, often used to treat heart failure.
Diuretics, also known as "water tablets" (such as furosemide). These are used to
treat hypertension.
Corticosteroids (such as prednisolone). These are used to treat inflammation or
to prevent organ transplant rejection.
Xanthines (such as theophylline or aminophylline), often used to treat asthma.
Other medicines for widening the airways, also called bronchodilators (such as
salbutamol).
Medicines used to treat depression, also called tricyclic antidepressants (such as
amitriptyline) and the antidepressant nefazodone.
Medicines used to treat mental disorders, nausea, or vomiting, called phenothiazines (such as
chlorpromazine and prochlorperazine).
Medicines used to treat fungal infections (such as ketoconazole, itraconazole, voriconazole,
posaconazole) and bacterial infections (such as clarithromycin, telithromycin, furazolidone).
Medicines used for Parkinson's disease (such as levodopa).
Medicines used for thyroid problems (such as levothyroxine).
Medicines called "HIV protease inhibitors" (such as ritonavir, cobicistat) used to treat HIV
infection. The effects of Budesonide and Formoterol Sandoz may be increased, and your doctor may
need to monitor you closely.
If you are in any of the above situations, or if you are unsure, consult your doctor or pharmacist before using
Budesonide and Formoterol Sandoz.
Also inform your doctor or pharmacist if you are due to undergo general anaesthesia for a surgical or
dental procedure.

Pregnancy, breastfeeding, and fertility
If you are pregnant, or planning to become pregnant, consult your doctor before using
Budesonide and Formoterol Sandoz – do not use Budesonide and Formoterol Sandoz unless
specifically instructed by your doctor.
If you become pregnant while being treated with Budesonide and Formoterol Sandoz, do not
stop using Budesonide and Formoterol Sandoz but contact your doctor immediately.
If you are breastfeeding, inform your doctor before using Budesonide and Formoterol Sandoz.

Driving and using machines
Budesonide and Formoterol Sandoz has no effect or negligible effects on the ability to drive
vehicles or operate tools or machinery.

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

For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to use Budesonide and Formoterol Sandoz

Use Budesonide and Formoterol Sandoz exactly as directed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
It is important to use Budesonide and Formoterol Sandoz every day, even if you do not currently have symptoms of asthma or COPD.
If you are using Budesonide and Formoterol Sandoz for asthma, your doctor will want to monitor your symptoms periodically.
If you have been taking oral corticosteroid tablets for your asthma or COPD, your doctor may reduce the number of tablets you are taking once you have started using Budesonide and Formoterol Sandoz. If you have taken oral corticosteroids for a long period, your doctor may require you to have periodic blood tests. When reducing the amount of oral corticosteroids, you may feel generally unwell, even though your respiratory symptoms may improve. You might experience symptoms such as nasal congestion or rhinorrhea, weakness or muscle or joint pain, or skin rash (eczema). If any of these symptoms concern you, or if you develop symptoms such as headache, fatigue, nausea, or vomiting, please contact your doctor immediately. You may need to take another medicine to treat allergic or arthritic symptoms. Ask your doctor if you have any doubts about continuing treatment with Budesonide and Formoterol Sandoz.
Your doctor may consider adding oral corticosteroids to your usual treatment during periods of stress (for example, when you have a respiratory infection or before undergoing surgery).

Important information about asthma or COPD symptoms
If you notice the onset of breathlessness or wheezing while using Budesonide and Formoterol Sandoz, continue using Budesonide and Formoterol Sandoz but consult your doctor as soon as possible, as additional treatment may be needed.
Contact your doctor immediately if:
Your breathing worsens or if you wake up frequently at night due to asthma.
You begin to experience chest tightness in the morning or if chest tightness lasts longer than usual. These signs may indicate that your asthma or COPD is not adequately controlled and that you may need different or additional treatment immediately.

Asthma
Use Budesonide and Formoterol Sandoz every day. This helps prevent the occurrence of asthma symptoms.

Adults (18 years of age and older)
The usual dose is 1 inhalation twice daily.
Your doctor may increase this dose to 2 inhalations twice daily.
If your symptoms are well controlled, your doctor may instruct you to take the medicine once daily.

Adolescents (12–17 years of age)
The usual dose is 1 inhalation twice daily.
If your symptoms are well controlled, your doctor may instruct you to take the medicine once daily.
The use of Budesonide and Formoterol Sandoz is not recommended for children under 12 years of age.
Your doctor (or nurse) will help 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 discussing it with your doctor (or nurse).
Use a separate "reliever inhaler" to treat asthma symptoms. Always carry your "reliever inhaler" with you to use when needed. Do not use Budesonide and Formoterol Sandoz to treat asthma symptoms—use the reliever inhaler instead.

Chronic obstructive pulmonary disease (COPD)
This medicine is intended for use in adults only (18 years of age and older).
The usual dose is 1 inhalation twice daily.
Your doctor may also prescribe other medicines to open your airways, known as bronchodilators (such as tiotropium bromide or ipratropium bromide), for the treatment of COPD.

Instructions for use
Your doctor, nurse, or pharmacist will show you how to use the inhaler and will periodically check that you are using it correctly.
The inhaler contains 60 doses of medicine in the form of powder within a strip wound in a spiral. The inhaler has a dose counter that shows how many doses remain, counting down from 60 to 0. When only the last 10 doses remain, the numbers will appear against a red background.
The inhaler is not reusable—discard the inhaler when empty and replace it with a new one.

Before using the inhaler

• Open the transparent door of the side compartment.
• Remove the aluminium strip from the side compartment by carefully tearing it along its entire length against the "teeth" of the side compartment, as shown in the figure below. Do not pull or tear the strip.

• Close the door of the side compartment and discard the used strip.

Important:
During use of the inhaler, the used strip will gradually fill the side compartment. The aluminium strips with black bars do not contain medicine. Eventually, the numbered sections of the strip will appear in the side compartment.
Do not allow more than 2 sections of aluminium strip to accumulate in the side compartment, as the inhaler may jam. Carefully remove the used strip as described above and dispose of it safely.

Using the inhaler
Hold the inhaler in your hands as shown in the figures.

1. Opening

• Open the protective cap by pulling downwards to expose the mouthpiece.
• Check the dose counter to see how many doses remain.

2. Dose preparation

• Lift the edge of the white lever. Make sure the side compartment is closed.

Remember: lift the white lever only when you are ready to inhale a dose of the medicine. If
you "play" with the white lever, you will waste doses of medicine.

• Opening: Pull the white lever fully until it stops and until you hear a click. This action brings a new dose into position, with the number facing upwards.

• Closing: then close the white lever completely until it returns to its original position, producing a click. The inhaler is now ready to be used immediately.

3. Inhalation

• Breathe out fully, keeping away from the mouthpiece of the inhaler. Never breathe directly into the inhaler, as this may affect the dose.
• Hold the inhaler horizontally with the protective cap facing downwards.
• Close your lips firmly around the mouthpiece.
• Breathe in steadily and deeply through the inhaler, not through your nose.

• Remove the inhaler from your mouth and hold your breath for 5–10 seconds, or as long as comfortable.
• Then breathe out slowly, but not into the inhaler.
• Close the protective cap over the mouthpiece.
• Rinse your mouth with water and spit it out. This may help prevent the development of fungal infections in the mouth and hoarseness.

Cleaning

• Clean the outside of the mouthpiece with a clean, dry cloth if necessary.
• Do not attempt to disassemble the inhaler for cleaning or for any other purpose!
• Do not use water or wet wipes to clean any parts of the inhaler, as moisture may affect the dose!
• Never insert pins or other sharp objects into the mouthpiece or any other part of the inhaler, as this may damage the device!

If you use more Budesonide and Formoterolo Sandoz than you should
It is important that you take the dose as indicated on the leaflet or as advised by your doctor.
Do not exceed the prescribed dose without consulting your doctor.
The most common symptoms that may occur if you use more Budesonide and Formoterolo Sandoz than you should are: tremor, headache, or a fast or irregular heartbeat.

If you forget to use Budesonide and Formoterolo Sandoz

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
  If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any of the following occur, stop using Budesonide and Formoterol Sandoz 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 sudden fainting. This could indicate an allergic reaction. This side effect is rare (may affect up to 1 in 1,000 people).
• Sudden wheezing or sudden breathlessness immediately after using the inhaler. If you experience any of these symptoms, you must stop using Budesonide and Formoterol Sandoz immediately and use your "rescue" inhaler. Contact your doctor immediately, as your treatment may need to be changed. This occurs very rarely (may affect up to 1 in 10,000 people).

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

• Palpitations (awareness of heartbeat), tremor, or shivering. If these effects occur, they are usually mild and tend to disappear with continued use of Budesonide and Formoterol Sandoz.
• Oral thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth with water after using Budesonide and Formoterol Sandoz.
• Mild sore throat, cough, and hoarseness.
• Headache.
• Pneumonia (lung infection) in patients with COPD.

Inform your doctor if you experience any of the following symptoms while taking Budesonide and Formoterol Sandoz, as they could be signs of a lung infection:

• Fever or chills.
• Increased mucus production, changes in mucus color.
• Worsening cough or increased difficulty breathing.

Uncommon (may affect up to 1 in 100 people)

• Aggression
• Anxiety
• Feeling restless, nervous, or agitated.
• Disturbed sleep.
• Dizziness.
• Nausea (feeling unwell).
• Fast heartbeat.
• Skin bruising.
• Muscle cramps.
• Blurred vision.

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

• Skin rash, itching.
• Bronchospasm (narrowing of the muscles in the airways, causing wheezing). If wheezing occurs immediately after using Budesonide and Formoterol Sandoz, stop using the medicine 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, particularly in children.
• Chest pain or tightness (angina pectoris).
• Increased levels of sugar (glucose) in the blood.
• Taste disturbances, such as unpleasant taste in the mouth.
• Changes in blood pressure.
• Weight gain, moon-shaped face, weakness, abdominal obesity (Cushing's syndrome).

Inhaled corticosteroids may affect the normal production of steroid hormones in the body, particularly if high doses are used for prolonged periods. 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.
• Effects on the adrenal gland (a small gland near the kidney).
• Cushingoid features.
• Increased susceptibility to infections, and impaired ability to respond to stress may also occur.

These effects are much less likely to occur with inhaled corticosteroids than with oral corticosteroid tablets.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via 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 Budesonide and Formoterol Sandoz

Keep this medicine out of the sight and reach of children.
Do not store above 30 °C.
Do not use this medicine after the expiry date stated on the carton and on the label of the inhaler after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via 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 Budesonide and Formoterolo Sandoz contains

• The active substances are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate, corresponding to a delivered dose (from the single-dose container within the blister) of 346.3 micrograms of budesonide and 10.8 micrograms of formoterol fumarate dihydrate.
• The other component is lactose monohydrate (which contains milk proteins).

Description of the appearance of Budesonide and Formoterolo Sandoz and the contents of the pack
Budesonide and Formoterolo Sandoz consists of a red/white plastic inhaler containing the medicinal product.
Each inhaler contains an OPA/Al/PVC-Al blister with 60 pre-measured doses of inhalation powder. The inhalation powder is white or pale white or slightly yellowish, without any aggregates.
Budesonide and Formoterolo Sandoz is available in packs containing 1, 2, 3 or 6 inhalers, each containing 60 doses.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturer
Aeropharm GmbH
François-Mitterrand-Allee 1
07407 Rudolstadt
Germany
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
Sachsen-Anhalt, 39179 Barleben
Germany

This medicinal product is authorized in the European Economic Area Member States under the following names:
Belgium Budesonide e Formoterolo Sandoz 320 microgram/ 9 microgram/inhalatie, inhalatiepoeder, voorverdeeld
Denmark Budesonide e Formoterolo Sandoz
Finland AEROCOMP Forspiro 320 mikrog/9 mikrog/annos, inhalaatiojauhe, annosteltu
France BUDESONIDE/FUMARATE DE FORMOTEROL SANDOZ 320 microgrammes/9 microgrammes/dose, poudre pour inhalation en récipient unidose
Ireland Budesonide e Formoterolo Sandoz 320 microgram/9 microgram/dose inhalation powder, pre-dispensed
Italy Budesonide e Formoterolo Sandoz
Malta Budesonide/Formoterol fumarate, 320 mcg/ 9 mcg Sandoz
Norway Budesonide e Formoterolo Sandoz
Portugal Budesonide e Formoterolo Sandoz
Spain Budesonide e Formoterolo Sandoz 320 microgramos/9 microgramos/inhalación polvo para inhalación (unidosis)
Sweden Budesonide e Formoterolo Sandoz 320 mikrog/9 mikrog/dos, inhalationspulver, avdelad dos