Formodual

Package leaflet:

Patient information
FORMODUAL 100/6 micrograms per dose pressurised inhalation solution
1. What Formodual is and what it is used for
2. What you need to know before using Formodual
Do not take Formodual
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Formodual:

0.20 mg/kg

3. How to use Formodual

.

4. Possible side effects

5. How to store Formodual
6. Contents of the pack and other information

Package leaflet:

Information for the user
FORMODUAL 100/6 micrograms per dose pressurised solution for inhalation
1. What Formodual is and what it is used for
2. What you need to know before using Formodual
Do not take Formodual
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Formodual:

3. How to take Formodual

.

4. Possible side effects

5. How to store Formodual
6. Contents of the pack and other information

Patient Information Leaflet

FORMODUAL 100 micrograms/6 micrograms per inhalation powder

for inhalation
For use in adults only
beclometasone dipropionate anhydrous/formoterol fumarate dihydrate
Please read this leaflet carefully before 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, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, nurse or pharmacist.

Contents of this leaflet:

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

1. What FORMODUAL is and what it is used for

FORMODUAL is a powder that is inhaled through the mouth and delivered directly into the lungs. It contains two active substances: anhydrous beclometasone dipropionate and formoterol fumarate dihydrate.

• Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which have an anti-inflammatory effect, reducing swelling and irritation in the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators, which relax and widen the muscles of the airways, making it easier to breathe in and out.

These two active substances make breathing easier, providing relief from symptoms such as shortness of breath, wheezing and coughing in patients with asthma or COPD, and also help prevent asthma symptoms.

Asthma
FORMODUAL is used for the treatment of asthma in adults.
If FORMODUAL has been prescribed for you, it is likely that:

• your asthma is not adequately controlled using inhaled corticosteroids and short-acting bronchodilators “as needed”, or
• your asthma responds well to treatment with both corticosteroids and long-acting bronchodilators.

COPD
FORMODUAL may also be used to treat symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic airway disease of the lungs, mainly caused by cigarette smoking.

2. What you need to know before using FORMODUAL

Do not use FORMODUAL
If you are allergic to anhydrous beclometasone dipropionate or formoterol fumarate dihydrate, or to
any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor before using FORMODUAL if you have any of the following
conditions:

• heart problems, including any known heart disease and/or cardiac function disorders
• heart rhythm disorders, such as increased or irregular heartbeat, rapid pulse, or palpitations, or if you have been told that your electrocardiogram (ECG) is abnormal
• high blood pressure
• narrowing of the arteries (also known as arteriosclerosis), or if you know you have an aneurysm (an abnormal dilation of blood vessel walls)
• overactive thyroid gland
• low levels of potassium in the blood
• any liver or kidney disorders
• diabetes. If you inhale high doses of formoterol, your blood glucose levels may increase, and therefore additional tests may be needed to monitor blood sugar levels both when you start using this inhaler and periodically throughout treatment.
• tumour of the adrenal gland (called phaeochromocytoma)
• if you are due to undergo anaesthesia. Depending on the type of anaesthesia, you may need to stop treatment with FORMODUAL at least 12 hours before the anaesthesia.
• if you are currently taking, or have recently taken, medicines to treat tuberculosis (TB), or if you have known viral or fungal chest infections.

If you fall into any of the above categories, always inform your doctor before using
FORMODUAL.
If you are unsure whether you can use FORMODUAL, consult your doctor, an asthma nurse
specialist, or pharmacist before using the inhaler.
Your doctor may decide to periodically check your blood potassium levels,
especially if you have severe asthma. Like many bronchodilators, FORMODUAL
may cause a sudden drop in serum potassium levels (hypokalaemia). This occurs because reduced oxygen levels in the blood, associated with certain other treatments taken together with FORMODUAL, may worsen the reduction in potassium levels.
If you have used high doses of inhaled corticosteroids for long periods of time,
you may require additional corticosteroids during periods of stress. Stressful situations may include hospitalization following an accident, severe injuries, or the period before surgery. In such cases, your doctor will decide whether or not to increase your corticosteroid dose and may prescribe steroid tablets or injectable steroids.
If you need to be admitted to hospital,
remember to bring all your medicines and inhalers with you, including FORMODUAL, and any over-the-counter medicines or tablets, preferably in their original packaging.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
This medicine must not be administered to children and adolescents under 18 years of age.

Other medicines and FORMODUAL
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines. This is necessary because FORMODUAL may
affect the action of other medicines. In addition, other medicines may affect the activity of FORMODUAL.
In particular, consult your doctor or pharmacist if you are taking any of the following medicines:

• Some medicines may increase the effects of FORMODUAL, and your doctor may wish to monitor you closely if you are taking these (including certain HIV treatments: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines used to treat various conditions, including heart problems, high blood pressure, or glaucoma (increased pressure in the eyes). If you use beta-blockers (including eye drops), the effect of formoterol may be reduced or blocked.
• Beta-adrenergic drugs (medicines with activity similar to formoterol) may increase the effects of formoterol.
• Medicines used to treat heart rhythm disorders (quinidine, disopyramide, procainamide).
• Medicines used to treat allergic reactions (antihistamines, such as terfenadine).
• Medicines used to treat depression or mental disorders such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazide), or tricyclic antidepressants (e.g. amitriptyline and imipramine), or phenothiazines.
• Medicines used to treat Parkinson's disease (L-dopa).
• Medicines used to treat an underactive thyroid (L-thyroxine).
• Medicines containing oxytocin (which causes uterine contractions).
• Medicines used to treat mental disorders such as monoamine oxidase inhibitors (MAOIs), including drugs with similar properties to furazolidone and procarbazine.
• Medicines used to treat heart disease (digoxin).
• Other medicines used to treat asthma (theophylline, aminophylline, or steroids).
• Diuretics ("water pills" or tablets for urination).

Also inform your doctor or pharmacist if you intend to use a general anaesthetic
for surgery or dental procedures.

Pregnancy and breastfeeding
There are no clinical data available on the use of FORMODUAL during pregnancy.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor before using this medicine.
FORMODUAL should only be used during pregnancy if your doctor advises you to do so.
Your doctor will decide whether you should stop using FORMODUAL during
breastfeeding or whether you should continue using FORMODUAL but stop breastfeeding.
Always follow your doctor’s advice carefully.

Driving and using machines
It is unlikely that FORMODUAL will affect your ability to drive or operate machinery. However, if you experience side effects such as dizziness and/or tremor, your ability to drive or use machinery may be impaired.

FORMODUAL contains monohydrate lactose
Lactose contains small amounts of milk proteins, which may cause reactions in patients who are allergic. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

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

3. How to use FORMODUAL

Use this medicine exactly as directed by your doctor, nurse, or pharmacist. If you have any doubts, consult your doctor or pharmacist.
FORMODUAL delivers an extrafine powder, allowing a greater proportion of the drug contained in the dose to reach the lungs. Therefore, your doctor may prescribe a lower dose of this inhaled medicine compared to the doses you previously used with other inhalers.

Asthma
Your doctor will monitor you regularly to ensure you are taking the correct dose of FORMODUAL. Once your asthma is well controlled, your doctor may consider it appropriate to gradually reduce the dose of FORMODUAL. Do not under any circumstances change the dose without first consulting your doctor.

Formodual may be prescribed by your doctor in two different treatment regimens:
a) Daily use of Formodual for asthma treatment together with a separate "reliever" inhaler to treat sudden worsening of asthma symptoms, such as breathlessness, wheezing, and coughing
b) Daily use of Formodual for asthma treatment and additional use of Formodual as needed to treat sudden worsening of asthma symptoms, such as breathlessness, wheezing, and coughing

a) Use of Formodual together with another "reliever" medicine:
Adults and elderly:
The recommended dose is 1 or 2 inhalations twice daily.
The maximum daily dose is 4 inhalations.
Remember: You must always carry your fast-acting "reliever" inhaler with you to treat worsening asthma symptoms or sudden asthma attacks.

b) Use of Formodual as the only inhaler for asthma:
Adults and elderly:
The recommended dose is one inhalation in the morning and one inhalation in the evening.
You should also use Formodual as a "reliever" inhaler to treat sudden asthma symptoms.
If you experience asthma symptoms, take one inhalation and wait a few minutes.
If you do not feel better, take another inhalation.
No more than 6 "reliever" inhalations should be taken per day.
The maximum daily dose of Formodual is 8 inhalations.
If you feel you need more inhalations per day to control your asthma symptoms, consult your doctor. Your treatment may need to be changed.
Do not increase the dose.
If you think the medicine is not effective, always consult your doctor before increasing the dose.

Chronic obstructive pulmonary disease (COPD)
Adults and elderly:
The recommended dose is 2 inhalations in the morning and 2 inhalations in the evening.

How to use FORMODUAL:
FORMODUAL is for inhalation use only.
If possible, stand or sit upright when taking your inhalation.

If you use more FORMODUAL than you should

• Contact your doctor or the nearest hospital emergency department immediately for advice. Take the medicine with you so that healthcare professionals can see what you have taken.
• Side effects may occur. Inform your doctor if you notice any unusual symptoms, as further investigations or necessary therapeutic measures may be required.

If you forget to use FORMODUAL
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at the correct time. Do not take a double dose.

If you stop using FORMODUAL:
Even if you feel better, do not stop using FORMODUAL or reduce your dose without talking to your doctor. It is very important that FORMODUAL is used every day as prescribed by your doctor, even when you have no symptoms.

If your breathing does not improve:
If your symptoms do not improve after inhaling FORMODUAL, you may be using the device incorrectly. Therefore, review the instructions for correct use of the device provided below and/or contact your doctor or nurse to ensure you are using it properly.

If asthma worsens:
If your symptoms worsen or are difficult to control (for example, if you are using another "reliever" inhaler or Formodual as a reliever more frequently), or if your "reliever" inhaler or Formodual does not improve your symptoms, continue using FORMODUAL but contact your doctor as soon as possible. Your doctor may decide to change your dose of FORMODUAL or prescribe additional or alternative treatment.

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

INSTRUCTIONS FOR USE OF THE NEXTHALER INHALER

A. Contents of the Package
For information on the contents of the package, see section 6. If the contents of the package do not match what is stated above, return the inhaler to the person who supplied it (e.g. pharmacist or doctor) and obtain a new one.

B. Warnings and General Precautions

• Do not remove the inhaler from its pouch unless you intend to use it immediately.
• Use the inhaler only as directed.
• Keep the inhaler cap closed until it is time to take your dose.
• When not in use, store the inhaler in a clean, dry place.
• Do not attempt to disassemble the Nexthaler inhaler for any reason.

C. Main features of the Nexthaler inhaler

Air intake
Taking a dose from the Nexthaler inhaler requires only three simple steps: Opening, Inhaling, Closing.

D. Before using a new Nexthaler inhaler

1. Open the pouch and remove the inhaler.
   • Do not use the inhaler if the pouch is not sealed or is damaged – return it to your supplier and obtain a new one.
   • Use the adhesive label on the package to write down the date when the pouch was first opened.
2. Check the inhaler.
   • If the inhaler appears broken or damaged, return it to your supplier and obtain a new one.
3. Check the dose counter window. If the inhaler is new, the number “120” should appear in the dose counter window.
   • Do not use a new inhaler if the number shown is less than “120” – return it to your supplier and obtain a new one.

E. How to use the Nexthaler inhaler

1. If you are unsure whether you are receiving the dose correctly, contact your pharmacist or doctor.
2. If you are unsure whether the number shown on the dose counter has decreased by one after inhalation, wait until your next scheduled dose and take it as normal. Do not take a double dose.

E.1 Opening
1. Hold the inhaler firmly in an upright position.
2. Check the number of doses remaining: any number between “1” and “120” indicates that doses are still available.

• If the dose counter window shows “0”, this means no doses are left – the inhaler must be disposed of and a new one obtained.

3. Fully open the cap.

4. Before inhaling, breathe out as much as possible.

o Do not breathe through the inhaler.
E.2 Inhalation
Whenever possible, remain standing or sit upright during inhalation.

1. Lift the inhaler, bring it to the level of your mouth and close your lips around

the mouthpiece.
o Do not cover the air inlet while holding the inhaler.
o Do not inhale through the air inlet.

2. Breathe in quickly and deeply through the mouth.

o You may notice a taste in your mouth while taking the dose.
o You may hear or feel a "click" while taking the dose.
o Do not breathe through your nose.
o Do not remove your lips from the inhaler during inhalation.

3. Remove the inhaler from your mouth.
4. Hold your breath for 5 or 10 seconds, or for as long as is comfortable.
5. Breathe out slowly.
o Do not breathe out through the inhaler.
E.3 Closing
1. Place the inhaler upright and fully close the cap.
2. Check that the dose counter has decreased by one number.

3. If you need to take another dose, repeat the steps from point E.1 to

point E.3.
F. Cleaning

• It is normally not necessary to clean the inhaler.
• If needed, you can keep the inhaler clean after use by wiping the device with a dry cloth or dry tissue paper.
• Do not clean the inhaler with water or other liquids. Always keep the device dry.

G. Storage and disposal
For information on storage conditions and disposal instructions,
see section 5.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
As with other inhaled treatments, there is a risk of worsening breathlessness, cough, or wheezing immediately after using FORMODUAL, a condition known as paradoxical bronchospasm. If this occurs, you must STOP using FORMODUAL immediately and use your rapid-acting "rescue" inhaler as soon as possible to treat the symptoms. You must contact your doctor immediately.
Inform your doctor immediately if you experience any allergic reactions, including skin allergies, skin itching, skin rash, skin redness, or swelling of the skin or mucous membranes, particularly affecting the eyes, face, lips, and throat.

The following are additional possible side effects of FORMODUAL, listed in order of frequency.

Common (may affect up to 1 in 10 people):

• tremor
• pneumonia (lung infection) in patients with COPD

Inform your doctor if you experience any of the following symptoms while taking FORMODUAL, as they may indicate a lung infection:

• fever or chills
• increased mucus production or changes in mucus color
• increased coughing or worsening breathing difficulties

Uncommon (may affect up to 1 in 100 people):

• cold-like symptoms, sore throat
• fungal infections (of the mouth and throat). Rinsing the mouth or gargling with water and brushing teeth immediately after inhalation may help prevent these side effects.
• worsening asthma symptoms, breathing difficulties
• hoarseness
• cough
• unusually fast heartbeat
• unusually slow heartbeat
• tightness or pressure in the chest
• headache
• feeling unwell
• feeling tired or nervous
• changes in electrocardiogram (ECG)
• low cortisol levels in urine or blood
• high potassium levels in blood
• high blood glucose levels
• high blood lipid levels

Not known (frequency cannot be estimated from available data):

• blurred vision

Side effects observed with similar inhaled medicines containing beclometasone dipropionate and/or formoterol include:

• palpitations
• irregular heartbeat
• taste disturbances or altered taste
• muscle pain and muscle cramps
• restlessness, dizziness
• feeling anxious
• sleep disorders
• decreased potassium levels in blood
• increased/decreased blood pressure

Long-term and high-dose use of inhaled corticosteroids may lead to systemic effects, including:

• adrenal gland function disorders (adrenal suppression)
• thinning of the bones
• growth retardation in children and adolescents
• increased intraocular pressure (glaucoma), cataracts
• rapid weight gain, particularly in the face and trunk
• sleep disturbances, depression, or feelings of worry, agitation, nervousness, overexcitement, or irritability. These effects are more likely to occur in children.
• abnormal behaviour

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
http://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 FORMODUAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, the pouch, and the label after Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. Remove the inhaler from its protective pouch only immediately before first use.

Before first opening of the pouch:
This medicine does not require any special storage temperature.

After first opening of the pouch:
Do not store at temperatures above 25°C.
After first opening of the pouch, the medicine must be used within 6 months.
Use the label on the carton to write down the date when the pouch was opened.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What FORMODUAL contains
The active substances are: beclometasone dipropionate anhydrous and formoterol fumarate dihydrate.
Each metered dose contains 100 micrograms of anhydrous beclometasone dipropionate
and 6 micrograms of formoterol fumarate dihydrate. This corresponds to an inhaled dose,
delivered through the mouthpiece, of 81.9 micrograms of anhydrous beclometasone dipropionate and
5 micrograms of formoterol fumarate dihydrate.
The other components are: monohydrate lactose (which contains small amounts of milk proteins) and magnesium stearate.
Description of the appearance of FORMODUAL and contents of the pack
This medicinal product is a white or almost white powder for inhalation contained in a plastic inhaler called Nexthaler.
Each pack contains one, two or three inhalers, each providing 120 inhalations.
Each inhaler is packaged in a protective thermoformed aluminium foil pouch (blister pack).
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder
PROMEDICA S.r.l.
Via Palermo 26/A
43122 Parma
Italy
Manufacturers
Chiesi Farmaceutici S.p.A.
Via San Leonardo 96
43122 Parma - Italy
Chiesi S.A.S.
2 rue des Docteurs Alberto et Paolo Chiesi
41260 La Chaussée Saint Victor - France
This medicinal product is authorised in the European Economic Area countries under the following names:

Updated and detailed information about this product is available by scanning with a smartphone or other device the QR code included in the Package Leaflet and on the outer packaging.

The same information is also available at the following URL: https://qrco.de/Nexthaler100-6-120 .

Patient information leaflet

FORMODUAL 100 micrograms/6 micrograms for inhalation powder

for inhalation
For use in adults only
anhydrous beclometasone dipropionate/formoterol fumarate dihydrate
Please read this entire leaflet carefully before 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, consult your doctor, nurse, or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor, nurse, or pharmacist.

Contents of this leaflet:

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

1. What FORMODUAL is and what it is used for

FORMODUAL is a powder that is inhaled through the mouth and delivered directly into the lungs. It contains two active substances: beclometasone dipropionate anhydrous and formoterol fumarate dihydrate.

• Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which have an anti-inflammatory action, reducing swelling and irritation in the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators, which relax and widen the airway muscles, thereby making it easier to breathe in and out.

These two active substances help breathing by providing relief from symptoms such as shortness of breath, wheezing and cough in patients with asthma or chronic obstructive pulmonary disease (COPD), and also help prevent asthma symptoms.

Asthma
FORMODUAL is used for the treatment of asthma in adults.
If FORMODUAL has been prescribed for you, it is likely that:

• your asthma is not adequately controlled using inhaled corticosteroids and short-acting "as-needed" bronchodilators, or
• your asthma responds well to treatment with both corticosteroids and long-acting bronchodilators.

COPD
FORMODUAL may also be used to treat symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic lung airway disease primarily caused by cigarette smoking.

2. What you need to know before using FORMODUAL

Do not use FORMODUAL
If you are allergic to anhydrous beclometasone dipropionate or to formoterol fumarate dihydrate or to
any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor before using FORMODUAL if you have any of the following
conditions:

• heart problems, including any known heart disease and/or cardiac function disorders
• heart rhythm disorders, such as increased or irregular heartbeat, rapid pulse or palpitations, or if you have been informed that your electrocardiogram (ECG) is abnormal
• high blood pressure
• narrowing of the arteries (also known as arteriosclerosis), or if you know you have an aneurysm (an abnormal dilation of blood vessel walls)
• overactive thyroid gland
• low levels of potassium in the blood
• any liver or kidney disorder
• diabetes. If you inhale high doses of formoterol, blood glucose levels may increase and therefore additional tests may be needed to monitor blood sugar levels both when starting treatment with this inhaler and periodically throughout the treatment.
• tumour of the adrenal gland (called phaeochromocytoma)
• if you need to undergo anaesthesia. Depending on the type of anaesthesia, you may need to stop treatment with FORMODUAL at least 12 hours before anaesthesia.
• If you are taking, or have recently taken, medicines to treat tuberculosis (TB), or if you have known viral infections or fungal infections in the chest.

If you fall into any of the above categories, always inform your doctor before using
FORMODUAL.
If you are unsure whether you can use FORMODUAL, consult your doctor, an asthma nurse
specialist, or pharmacist before using the inhaler.
Your doctor may decide to periodically check your blood potassium levels,
especially if your asthma is severe. Like many bronchodilators, FORMODUAL
may cause a sudden drop in serum potassium levels (hypokalaemia). This occurs because
reduced oxygen levels in the blood, associated with certain other treatments taken together with
FORMODUAL, may worsen the reduction in potassium levels.
If you have used high doses of inhaled corticosteroids for long periods of time,
you may require additional corticosteroids during periods of stress. Stressful situations
may include hospitalization following an accident, severe injuries, or the period before surgery. In such cases, your doctor will decide whether or not to increase your corticosteroid dose and may prescribe steroid tablets or injectable steroids.
If hospitalization is required,
remember to bring all your medicines and inhalers with you, including FORMODUAL, and any over-the-counter medicines or tablets, preferably in their original packaging.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
This medicine must not be administered to children and adolescents under 18 years of age.

Other medicines and FORMODUAL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is necessary because
FORMODUAL may
affect the action of other medicines. In addition, other medicines may affect the activity of FORMODUAL.
In particular, consult your doctor or pharmacist if you are taking any of the following
medicines:

• Some medicines may increase the effects of FORMODUAL, and your doctor may wish to monitor you closely if you are taking these (including certain HIV treatments: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines used to treat various conditions, including heart problems, high blood pressure, or glaucoma (increased pressure in the eyes). If you use beta-blockers (including eye drops), the effect of formoterol may be reduced or blocked.
• Beta-adrenergic drugs (medicines with activity similar to formoterol) may increase the effects of formoterol.
• Medicines used to treat heart rhythm disorders (quinidine, disopyramide, procainamide).
• Medicines used to treat allergic reactions (antihistamines, such as terfenadine).
• Medicines used to treat depression or mental disorders such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazide), or tricyclic antidepressants (e.g. amitriptyline and imipramine), or phenothiazines.
• Medicines used to treat Parkinson’s disease (L-dopa).
• Medicines used to treat an underactive thyroid (L-thyroxine).
• Medicines containing oxytocin (which causes uterine contractions).
• Medicines used to treat mental disorders such as monoamine oxidase inhibitors (MAOIs), including drugs with similar properties to furazolidone and procarbazine.
• Medicines used to treat heart disease (digoxin).
• Other medicines used to treat asthma (theophylline, aminophylline, or steroids).
• Diuretics (water tablets).

Also inform your doctor or pharmacist if you intend to use a general anaesthetic
for surgery or dental procedures.

Pregnancy and breastfeeding
There are no clinical data available on the use of FORMODUAL during pregnancy.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding,
seek medical advice before using this medicine.
FORMODUAL should only be used during pregnancy if your doctor advises you to do so.
Your doctor will decide whether you should stop taking FORMODUAL during
breastfeeding or whether you should continue taking FORMODUAL but stop breastfeeding.
Always follow your doctor’s advice carefully.

Driving and using machines
It is unlikely that FORMODUAL will affect your ability to drive or operate
machinery. However, if you experience side effects such as dizziness and/or tremor, your
ability to drive or use machinery may be impaired.

FORMODUAL contains lactose monohydrate
Lactose contains small amounts of milk proteins, which may cause reactions in
patients who are allergic. If your doctor has diagnosed you with an intolerance to certain sugars,
contact him or her before taking this medicine.

For athletes:
Using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to use FORMODUAL

Use this medicine exactly as directed by your doctor, nurse, or pharmacist. If you have any doubts, consult your doctor or pharmacist.

FORMODUAL delivers an extrafine powder, allowing a greater amount of the drug contained in the dose to reach the lungs. Therefore, your doctor may prescribe you a lower dose of this inhaled medicine compared to what you previously used with other inhalers.

Asthma

Your doctor will monitor you regularly to ensure you are taking the correct dose of FORMODUAL. Once your asthma is well controlled, your doctor may consider gradually reducing the dose of FORMODUAL. Do not under any circumstances change the dose without first consulting your doctor.

Formodual may be prescribed by your doctor in two different treatment regimens:

a) Daily use of Formodual for asthma treatment, together with a separate "reliever" inhaler to treat sudden worsening of asthma symptoms such as breathlessness, wheezing, and coughing

b) Daily use of Formodual for asthma treatment, plus additional use of Formodual itself as needed to treat sudden worsening of asthma symptoms such as breathlessness, wheezing, and coughing

a) Use of Formodual together with another "reliever" medicine:

Adults and elderly:

The recommended dose is 1 or 2 inhalations twice daily.

The maximum daily dosage is 4 inhalations.

Remember: You must always carry your fast-acting "reliever" inhaler with you to treat worsening asthma symptoms or sudden asthma attacks.

b) Use of Formodual as the only inhaler for asthma:

Adults and elderly:

The recommended dose is one inhalation in the morning and one inhalation in the evening.

You should also use Formodual as a "reliever" inhaler to treat sudden asthma symptoms.

If you experience asthma symptoms, take one inhalation and wait a few minutes.

If you do not feel better, take another inhalation.

No more than 6 "reliever" inhalations should be taken per day.

The maximum daily dose of Formodual is 8 inhalations.

If you feel you need more inhalations per day to control your asthma symptoms, consult your doctor. Your treatment may need to be changed.

Do not increase the dose.

If you feel the medicine is not effective, always consult your doctor before increasing the dose.

Chronic Obstructive Pulmonary Disease (COPD)

Adults and elderly:

The recommended dose is 2 inhalations in the morning and 2 inhalations in the evening.

How to use FORMODUAL:

FORMODUAL is for inhalation use only.

If possible, stand or sit upright when taking your inhalation.

If you use more FORMODUAL than you should

• Contact your doctor or the nearest hospital emergency department immediately for advice. Take the medicine with you so that healthcare professionals can see what you have taken.
• Side effects may occur. Inform your doctor if you notice any unusual symptoms, as further investigations or necessary therapeutic measures may be required.

If you forget to use FORMODUAL

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at the correct time. Do not take a double dose.

If you stop using FORMODUAL:

Even if you feel better, do not stop using FORMODUAL or reduce your dose without first talking to your doctor. It is very important that FORMODUAL is used every day as prescribed by your doctor, even when you have no symptoms.

If your breathing does not improve:

If your symptoms do not improve after inhaling FORMODUAL, you may be using the device incorrectly. Therefore, check the instructions for correct use of the device provided below and/or contact your doctor or nurse to have them explain the proper technique.

If asthma worsens:

If your symptoms worsen or are difficult to control (for example, if you are using your "reliever" inhaler or Formodual as a "reliever" more frequently), or if your "reliever" inhaler or Formodual does not relieve your symptoms, continue using FORMODUAL but contact your doctor as soon as possible. Your doctor may decide to change your dose of FORMODUAL or prescribe additional or alternative treatment.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

INSTRUCTIONS FOR USE OF THE NEXTHALER INHALER

A. Contents of the Package

For information on the package contents, see section 6. If the contents do not match what is described above, return the inhaler to the person who supplied it (e.g. pharmacist or doctor) and obtain a new one.

B. General Warnings and Precautions

• Do not remove the inhaler from its pouch unless you intend to use it immediately.
• Use the inhaler only as directed.
• Keep the inhaler cap closed until it is time to take your dose.
• When not in use, store the inhaler in a clean, dry place.
• Do not attempt to disassemble the Nexthaler inhaler for any reason.

C. Main Features of the Nexthaler Inhaler

Air intake
Taking a dose from the Nexthaler inhaler requires only three simple steps: Opening, Inhaling, Closing.

D. Before using a new Nexthaler inhaler

1. Open the pouch and remove the inhaler.
   • Do not use the inhaler if the pouch is not sealed or is damaged – return it to your supplier and obtain a new one.
   • Use the adhesive label on the packaging to write the date when the pouch was first opened.
2. Check the inhaler.
   • If the inhaler appears broken or damaged, return it to your supplier and obtain a new one.
3. Check the dose counter window. If the inhaler is new, the number “180” should appear in the dose counter window.
   • Do not use a new inhaler if the number shown is less than “180” – return it to your supplier and obtain a new one.

E. How to use the Nexthaler inhaler

1. If you are unsure whether you are receiving the dose correctly, contact your pharmacist or doctor.
2. If you are unsure whether the dose counter has decreased by one unit after inhalation, wait until your next scheduled dose and take it as usual. Do not take a double dose.

E.1 Opening

1. Hold the inhaler firmly in an upright position.
2. Check the number of doses remaining: any number between “1” and “180” indicates that doses are still available.

• If the dose counter window shows “0”, this means no doses remain – the inhaler must be disposed of and a new one obtained.

3. Fully open the cap.

4. Before inhaling, breathe out as much as possible.

o Do not breathe through the inhaler.
E.2 Inhalation
Whenever possible, remain standing or sit in an upright position during
inhalation.

1. Lift the inhaler, bring it to mouth level, and close lips around

the mouthpiece.
o Do not cover the air intake while holding the inhaler.
o Do not inhale through the air intake.

2. Breathe in quickly and deeply through your mouth.

o You may notice a taste in your mouth while inhaling the dose.
o You may hear or feel a "click" while inhaling the dose.
o Do not breathe through your nose.
o Do not remove your lips from the inhaler during inhalation.

3. Remove the inhaler from your mouth.
4. Hold your breath for 5 or 10 seconds, or for as long as is comfortable.
5. Breathe out slowly.
o Do not breathe out through the inhaler.

E.3 CLOSING
1. Place the inhaler upright and fully close the cap.
2. Check that the dose counter has decreased by one number.

3. If you need to take another dose, repeat the steps from point E.1 to

point E.3.
F. Cleaning

• Cleaning the inhaler is normally not necessary.
• If needed, you can keep the inhaler clean after use by wiping it with a dry cloth or dry paper tissue.
• Do not clean the inhaler with water or other liquids. Always keep the device dry.

G. Storage and disposal
For information on storage conditions and disposal instructions,
see section 5.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
As with other inhaled treatments, there is a risk of worsening breathlessness, coughing, or wheezing immediately after using FORMODUAL, and this event is known as paradoxical bronchospasm. If this occurs, you must STOP using FORMODUAL IMMEDIATELY and use your fast-acting “rescue” inhaler as soon as possible to treat the symptoms. You must contact your doctor immediately.
Inform your doctor immediately if you experience any allergic reactions, including skin allergies, skin itching, skin rash, skin redness, or swelling of the skin or mucous membranes, especially in the eyes, face, lips, and throat.

The following are additional possible side effects of FORMODUAL, listed in order of frequency.

Common (may affect up to 1 in 10 people):

• tremor
• pneumonia (lung infection) in patients with COPD

Inform your doctor if you develop any of the following symptoms while taking FORMODUAL, 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):

• cold-like symptoms, sore throat
• fungal infections (of the mouth and throat). Rinsing your mouth or gargling with water and brushing your teeth immediately after inhalation may help prevent these side effects.
• worsening asthma symptoms, breathing difficulties
• hoarseness
• cough
• unusually rapid heartbeat
• unusually slow heartbeat
• tightness in the chest
• headache
• feeling unwell
• feeling of fatigue or nervousness
• changes in the electrocardiogram (ECG)
• low level of cortisol in urine or blood
• high level of potassium in blood
• high level of glucose in blood
• high level of fats in blood

Not known (frequency cannot be estimated from the available data):

• blurred vision

Side effects observed with similar inhaled medicines containing beclometasone dipropionate and/or formoterol include:

• palpitations
• irregular heartbeat
• taste abnormalities or altered taste
• muscle pain and muscle cramps
• restlessness, dizziness
• feeling of anxiety
• sleep disorders
• decrease in potassium levels in the blood
• increase/decrease in blood pressure

Long-term and high-dose use of inhaled corticosteroids may lead to systemic effects, including:

• adrenal gland function disorders (adrenal suppression)
• thinning of the bones
• growth retardation in children and adolescents
• increased eye pressure (glaucoma), cataract
• rapid weight gain, particularly in the face and trunk
• sleep disturbances, depression or feelings of worry, agitation, nervousness, overexcitement, or irritability. These effects are more likely to occur in children.
• Abnormal behaviour.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
http://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 FORMODUAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box, on the pouch, and on the label after Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. Remove the inhaler from its protective pouch only immediately before first use.
Before first opening of the pouch:
This medicine requires no special storage temperature.
After first opening of the pouch:
Do not store above 25°C.
After first opening of the pouch, the medicine must be used within 6 months.
Use the label on the box to record the date the pouch was opened.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What FORMODUAL contains
The active substances are: beclometasone dipropionate anhydrous and formoterol fumarate dihydrate.
Each metered dose contains 100 micrograms of anhydrous beclometasone dipropionate
and 6 micrograms of formoterol fumarate dihydrate. This corresponds to an inhaled dose,
delivered through the mouthpiece, of 81.9 micrograms of anhydrous beclometasone dipropionate and
5 micrograms of formoterol fumarate dihydrate.
The other components are: lactose monohydrate (which contains small amounts of milk proteins) and magnesium stearate.

Description of the appearance of FORMODUAL and contents of the pack
This medicine is a white or almost white inhalation powder contained in a plastic inhaler called Nexthaler.
Each pack contains one, two, or three inhalers, each providing 180 inhalations.
Each inhaler is packaged in a sealed protective thermoformed pouch (aluminum foil pack).
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
PROMEDICA S.r.l.
Via Palermo 26/A
43122 Parma
Italy

Manufacturers
Chiesi Farmaceutici S.p.A.
Via San Leonardo 96
43122 Parma - Italy
Chiesi S.A.S.
2 rue des Docteurs Alberto et Paolo Chiesi
41260 La Chaussée Saint Victor - France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Updated and detailed information about this product is available by scanning with a smartphone or other device the QR code included in the Package Leaflet and on the outer packaging.

The same information is also available at the following URL:
https://qrco.de/Nexthaler100-6-180.

Patient Information Leaflet: Information for the user

FORMODUAL 200/6 micrograms per dose pressurized inhalation solution

For use in adults only
beclometasone dipropionate/formoterol fumarate dihydrate
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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What FORMODUAL is and what it is used for
2. What you need to know before using FORMODUAL
3. How to use FORMODUAL
4. Possible side effects
5. How to store FORMODUAL
6. Package contents and other information

1. What FORMODUAL is and what it is used for

FORMODUAL is a pressurized solution for inhalation containing two active substances which
are inhaled through the mouth and released directly into the lungs.
The two active substances are:
Beclometasone dipropionate, which belongs to a group of medicines called corticosteroids,
has an anti-inflammatory action that reduces swelling and irritation in the lungs.
Formoterol fumarate dihydrate, which belongs to a group of medicines called long-acting bronchodilators,
relaxes the muscles of the airways, thus making breathing easier.
These two active substances together make breathing easier; they also help prevent asthma symptoms
such as shortness of breath, wheezing and coughing.
FORMODUAL is used for the treatment of asthma in adults.
If FORMODUAL has been prescribed for you, it is likely that:

• your asthma is not adequately controlled using inhaled corticosteroids and short-acting bronchodilators “as needed”, or
• your asthma responds well to treatment with both corticosteroids and long-acting bronchodilators

2. What you must know before using FORMODUAL

Do not use FORMODUAL:

• if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor, pharmacist, or nurse before using FORMODUAL if you experience
any of the following conditions:

• heart problems, such as angina (chest pain), heart failure, narrowed arteries, heart valve disorders, or other known heart abnormalities
• high blood pressure or if you know you have an aneurysm (an abnormal widening of blood vessel walls)
• heart rhythm disorders such as rapid or irregular heartbeat, increased pulse rate, or palpitations, or if you have been told that your electrocardiogram (ECG) is abnormal
• overactivity of the thyroid gland
• low levels of potassium in the blood
• any liver or kidney disorders
• diabetes (if you inhale high doses of formoterol, blood glucose levels may rise. Additional blood tests to monitor blood sugar levels may therefore be needed when you start using this medicine and periodically during treatment)
• tumour of the adrenal gland (called phaeochromocytoma)
• if you are due to undergo anaesthesia. Depending on the type of anaesthetic, it may be necessary to stop treatment with FORMODUAL at least 12 hours before anaesthesia
• if you are taking, or have recently taken, medicines to treat tuberculosis (TB), or if you have known viral or fungal infections in the chest
• if you need to avoid alcohol for any reason

If you fall into any of the above categories, always inform your doctor before using FORMODUAL.
If you have or have had any medical conditions or allergies, or if you are unsure whether you can use
FORMODUAL, consult your doctor, asthma specialist nurse, or pharmacist before using this medicine.
Your doctor may decide to periodically check your blood potassium levels,
especially if you have severe asthma. Like many bronchodilators, FORMODUAL may
cause a sudden drop in serum potassium levels (hypokalaemia). This may occur because reduced
oxygen levels in the blood, associated with certain other treatments taken alongside FORMODUAL,
can worsen the reduction in potassium levels.
If you are taking high doses of inhaled corticosteroids for long periods of time, you may
require additional corticosteroids during periods of stress. Stressful situations may include hospitalisation
due to an accident, severe injuries, or the period before surgery. In such cases, your doctor may decide
whether or not to increase your corticosteroid dose and may prescribe steroid tablets or injectable
steroids.
If you need to be admitted to hospital, remember to bring all your medicines and inhalers with you, including FORMODUAL and any over-the-counter medicines or tablets, preferably in their original packaging.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
FORMODUAL must not be used in children and adolescents under 18 years of age.
Other medicines and FORMODUAL
Inform your doctor, pharmacist, or nurse if you are taking, or have recently taken, any other
medicines, including those obtained without a prescription. This is important because
FORMODUAL may alter the effect of other medicines. In addition, other medicines may affect
the action of FORMODUAL.
In particular, consult your doctor or pharmacist if you are taking any of the following medicines:

• Some medicines may increase the effects of FORMODUAL, and your doctor may wish to monitor you closely if you are taking these (including certain HIV treatments: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines used to treat various conditions, including heart problems, high blood pressure, or glaucoma (increased pressure in the eyes). If you use beta-blockers (including eye drops), the effect of formoterol may be reduced or blocked.
• Beta-adrenergic drugs (medicines with activity similar to formoterol) may increase the effects of formoterol.
• Medicines used to treat heart rhythm disorders (quinidine, disopyramide, procainamide).
• Medicines used to treat allergic reactions (antihistamines).
• Medicines used to treat symptoms of depression or mental disorders, such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazide), tricyclic antidepressants (e.g. amitriptiline and imipramine), phenothiazines.
• Medicines used to treat Parkinson’s disease (L-dopa).
• Medicines used to treat an underactive thyroid (L-thyroxine).
• Medicines containing oxytocin (which causes uterine contractions).
• Medicines used to treat mental disorders such as monoamine oxidase inhibitors (MAOIs), including drugs with similar properties such as furazolidone and procarbazine.
• Medicines used to treat heart disease (digoxin).
• Other medicines used to treat asthma (theophylline, aminophylline, or steroids).
• Diuretics ("water pills").

Also inform your doctor or pharmacist if you are planning to use a general anaesthetic for surgery or a dental procedure.
Pregnancy, breastfeeding and fertility
There are no clinical data available on the use of FORMODUAL during pregnancy.
FORMODUAL must not be used if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, unless your doctor has specifically advised you that you may do so.
Driving and using machines
It is unlikely that FORMODUAL will affect your ability to drive or operate machinery.
FORMODUAL contains alcohol
FORMODUAL contains 9 mg of alcohol (ethanol) per dose, which is equivalent to 0.25 mg/kg for a two-dose administration. The amount of alcohol in two doses of this medicine is less than that found in 1 ml of wine or beer. The small amount of alcohol in this medicine will not have noticeable effects.
For athletes:
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test;

3. How to use FORMODUAL

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will regularly monitor you to ensure you are taking the optimal dose
of FORMODUAL. Your doctor will prescribe the lowest dose that provides optimal
control of your symptoms.
Dosage:
Adults and elderly
The recommended dose is 2 inhalations twice daily.
The maximum daily dose is 4 inhalations.
Remember: You must always carry your "reliever" fast-acting inhaler with you to treat
any worsening of asthma symptoms or sudden asthma attacks.
Patients at risk:
Dose adjustment is not required if you are elderly. There is no available information on the use of
FORMODUAL in patients with liver or kidney problems.
Use in children and adolescents under 18 years of age
Children and adolescents under 18 years of age MUST NOT take this medicine.
FORMODUAL is effective in the treatment of asthma with a beclometasone dipropionate dosage
that may be lower than that of other inhaled products containing this substance. If you have pre-
viously used a different inhaled medicine containing beclometasone dipropionate, your doctor
will prescribe the exact dose of FORMODUAL needed to treat your asthma.
Do not increase the dose
If you feel the medicine is not very effective, always consult your doctor before increasing the dosage.
If asthma worsens
If your symptoms worsen or are difficult to control (for example, if you are using your "reliever"
inhaler more frequently), or if your "reliever" inhaler fails to improve symptoms, contact your doctor
immediately. Your asthma may be worsening, and your doctor may decide to change your dose of
FORMODUAL 200/6 micrograms per dose pressurized inhalation solution or prescribe an alternative
treatment.
Method of administration
FORMODUAL is for inhalation use only
This medicine is contained in a pressurized canister inserted into a plastic inhaler device with a mouthpiece. On the back of the inhaler there is a dose counter indicating the number of doses remaining. Each time the canister is pressed, a dose of medicine is released and the counter decreases by one. Be careful not to drop the inhaler, as this may reduce the number of doses displayed by the counter.
Checking the inhaler is working
Before using the inhaler for the first time, or if it has not been used for 14 days or more, you must check that the inhaler is working properly.

• Remove the protective cap from the mouthpiece
• Hold the inhaler upright with the mouthpiece pointing downwards
• Move the mouthpiece away and press firmly on the canister to release one dose
• Check the dose counter. If using the inhaler for the first time, the number 120 should appear in the counter window.

How to use the inhaler
Whenever possible, remain standing or sit upright while inhaling.
Before inhaling, check the dose counter window: any number between "1" and "120" indicates that doses remain. If the dose counter window shows "0", no doses remain – the inhaler must be disposed of and a new one obtained.

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust, dirt, or any foreign object.
2. Breathe out as slowly and deeply as possible.
3. Hold the canister vertically, with the body of the inhaler upright, then place the mouthpiece between your lips, sealing your lips tightly around it. Do not bite the mouthpiece.
4. Breathe in slowly and deeply through your mouth, and immediately after starting to inhale, press firmly on the top of the inhaler to release a dose. If you have a weak grip, it may be easier to hold the inhaler with both hands: place your index fingers on the top of the inhaler and both thumbs on the base.
5. Hold your breath as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not breathe out into the inhaler.

If another dose is needed, keep the inhaler in an upright position for about half a minute and repeat steps 2 to 5.
Important: Do not perform steps 2 to 5 too quickly.
After use, replace the protective cap and check the dose counter.
To reduce the risk of developing a fungal infection in the mouth or throat, rinse your mouth or gargle
with water or brush your teeth after each use of the inhaler.
You must obtain a new pack of medicine when the dose counter shows the number 20. Stop using
the inhaler when the dose counter shows 0, as the amount of medicine remaining in the device may
not be sufficient to deliver a complete dose.
If you see a "mist" escaping from the inhaler or from the sides of your mouth, this means Formodual has not reached your lungs as intended. Release another dose, following the instructions and repeating steps from point 2.
If you feel the effect of FORMODUAL is too strong or not strong enough, consult your doctor or pharmacist.
If you find it difficult to press the inhaler while starting to inhale, you may use the AeroChamber Plus spacer device. Ask your doctor, pharmacist, or nurse for information about this device.
It is important that you read the instruction leaflet provided with your AeroChamber Plus spacer device and carefully follow the instructions on how to use and clean it.
Cleaning
The inhaler should be cleaned once a week.
During cleaning, do not remove the canister from the inhaler and do not use water or other liquids
to clean the inhaler.
To clean the inhaler:

1. Remove the protective cap from the mouthpiece by pulling it away from the inhaler.
2. Clean the inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or tissue.
3. Replace the protective cap on the mouthpiece.

If you use more FORMODUAL than you should

• Taking more formoterol than you should may cause the following effects: feeling nauseous, nausea, rapid heartbeat, palpitations, heart rhythm disturbances, changes in the electrocardiogram (ECG), headache, tremor, drowsiness, excess acid in the blood, low potassium levels in the blood, high blood glucose levels. Your doctor may perform blood tests to monitor your potassium and glucose levels.
• Taking too much beclometasone dipropionate may cause temporary disturbances of the adrenal glands. These problems will resolve spontaneously within a few days, but your doctor may decide to monitor your serum cortisol levels.

Contact your doctor if you experience any of these symptoms.
If you forget to use FORMODUAL
Take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose, but take the next dose at the correct time. Do not take a double dose to make up for a forgotten dose.
If you stop using FORMODUAL
Even if you feel better, do not stop using FORMODUAL or reduce your dose. If you intend to do so, discuss it with your doctor. It is very important that FORMODUAL is used regularly, even when you have no symptoms.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
As with other inhaled treatments, there is a risk of worsening breathlessness and wheezing immediately after using FORMODUAL, an event known as paradoxical bronchospasm. If this occurs, you must IMMEDIATELY STOP
using FORMODUAL and use your "rescue" fast-acting inhaler as soon as possible to treat symptoms of breathlessness and wheezing. You must contact your doctor immediately.
Inform your doctor immediately if signs of hypersensitivity reactions occur, such as skin allergies, itching, rash, skin redness, or swelling of the skin or mucous membranes, particularly of the eyes, face, lips, and throat.

The following are other possible side effects listed in order of frequency.

Common (may affect up to 1 in 10 people):

• fungal infections (of the mouth and throat)
• headache
• hoarseness
• sore throat

Uncommon (may affect up to 1 in 100 people):

• palpitations, unusually rapid heartbeat, and heart rhythm disturbances
• changes in electrocardiogram (ECG)
• increased blood pressure
• flu-like symptoms
• sinusitis
• rhinitis
• ear inflammation
• throat irritation
• cough and productive cough
• asthma attack
• vaginal fungal infections
• nausea
• taste disturbances or altered taste
• lip burning
• dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhea
• muscle pain and cramps
• facial and throat flushing
• increased blood flow to certain body tissues
• excessive sweating
• tremor
• restlessness
• dizziness
• urticaria (hives)
• changes in certain blood components: reduced white blood cell count, increased platelet count, reduced potassium levels in the blood, increased blood sugar levels, increased insulin levels, free fatty acids, and ketones in the blood

The following side effects have been reported with "uncommon" frequency in patients with chronic obstructive pulmonary disease (COPD):

• lung infection; inform your doctor if you notice any of the following symptoms: increased sputum (phlegm) production, change in sputum colour, fever, increased coughing, worsening breathing problems
• reduced cortisol levels in the blood: caused by the effect of corticosteroids on the adrenal gland
• irregular heartbeat

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

• chest tightness
• absence of heartbeat (caused by premature ventricular contractions)
• decreased blood pressure
• kidney inflammation
• persistent swelling of the skin and mucous membranes lasting for several days

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

• shortness of breath
• worsening of asthma
• decreased platelet count in the blood
• swelling of the hands and feet

Long-term, high-dose inhaled corticosteroid use may very rarely lead to systemic effects, including:

• adrenal gland function disorders (adrenal suppression)
• reduced bone mineral density (bone thinning)
• growth retardation in children and adolescents
• increased intraocular pressure (glaucoma)
• cataract

Not known (frequency cannot be estimated from available data):

• sleep disorders
• depression or anxiety
• nervousness
• feeling of hyperexcitability or irritability
• blurred vision
  These events are more likely in children, but their frequency is unknown.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 FORMODUAL

Keep this medicine out of the sight and reach of children.
For pharmacists:
Store in the refrigerator (2 °C – 8 °C) for up to 18 months.
For patients:
Do not use this medicine for more than 3 months after the date of purchase from the pharmacy and never use it after the expiry date stated on the carton and label after EXP. The expiry date refers to the last day of that month.
Do not store the inhaler at temperatures above 25°C.
If the inhaler has been exposed to very low temperatures, warm it with your hands for a few minutes before use. Never heat it using artificial methods.
Warning: The container contains pressurised liquid. Do not expose to temperatures above 50°C. Do not pierce the container.
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 FORMODUAL contains:
The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate.
Each actuation from the metering valve contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to an inhaled dose from the mouthpiece of 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate.
The other components are: norflurane (HFC-134a), anhydrous ethanol, hydrochloric acid.
This medicinal product contains fluorinated greenhouse gases. Each inhaler contains 10.356 g of norflurane (HFC-134a), equivalent to 0.015 tonnes of CO2 (global warming potential = 1430).

Description of the appearance of FORMODUAL and contents of the pack
FORMODUAL is a pressurized solution for inhalation contained in an aluminum canister coated internally, equipped with a metering valve, inserted into a plastic inhaler incorporating either a dose counter (120 actuations) or a dose indicator (180 actuations), with a plastic protective cap.

Each pack contains:
1 pressurized container (providing 120 inhalations)
2 pressurized containers (each providing 120 inhalations)
1 pressurized container (providing 180 inhalations)

Not all pack sizes may be marketed.

Marketing Authorization Holder
Promedica S.r.l.
Via Palermo 26/A
43122 Parma - Italy

Manufacturer responsible for batch release
Chiesi Farmaceutici S.p.A.
Via San Leonardo, 96
43122 Parma - Italy

Alternative manufacturers responsible for batch release
Chiesi Pharmaceuticals GmbH
Gonzagagasse 16/16
1010 Vienna - Austria
Chiesi S.A.S
2 rue des Docteurs Alberto et Paolo CHIESI, La Chaussée Saint Victor
41260 - France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package leaflet: information for the user

FORMODUAL 200/6 micrograms per dose pressurized inhalation solution

For use in adults only
beclometasone dipropionate/formoterol fumarate dihydrate
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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What FORMODUAL is and what it is used for

FORMODUAL is a pressurized solution for inhalation containing two active substances which
are inhaled through the mouth and delivered directly into the lungs.
The two active substances are:
Beclometasone dipropionate, which belongs to a group of medicines called corticosteroids,
has an anti-inflammatory action that reduces swelling and irritation in the lungs.
Formoterol fumarate dihydrate, which belongs to a group of medicines called long-acting bronchodilators,
relaxes the muscles of the airways, thus making breathing easier.
These two active substances together help you breathe more easily; they also help prevent asthma symptoms
such as shortness of breath, wheezing and coughing.
FORMODUAL is used for the treatment of asthma in adults.
If FORMODUAL has been prescribed for you, it is likely that:

• your asthma is not adequately controlled using inhaled corticosteroids and short-acting bronchodilators “as needed”, or
• your asthma responds well to treatment with both corticosteroids and long-acting bronchodilators

2. What you need to know before using FORMODUAL

Do not use FORMODUAL:

• if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Contact your doctor, pharmacist, or nurse before using FORMODUAL if you have
any of the following conditions:

• heart problems, such as angina (chest pain), heart failure, narrowed arteries, heart valve disorders, or other known heart abnormalities
• high blood pressure or if you know you have an aneurysm (an abnormal widening of blood vessel walls)
• heart rhythm disorders such as rapid or irregular heartbeat, increased pulse rate, or palpitations, or if you have been told that your electrocardiogram (ECG) is abnormal
• overactive thyroid gland
• low levels of potassium in the blood
• any liver or kidney problems
• diabetes (if you inhale high doses of formoterol, blood glucose levels may rise. Additional blood tests to monitor blood sugar levels may therefore be necessary when you start using this medicine and periodically throughout treatment)
• a tumor of the adrenal gland (called a pheochromocytoma)
• if you are due to undergo anesthesia. Depending on the type of anesthetic, you may need to stop treatment with FORMODUAL at least 12 hours before anesthesia
• if you are taking, or have recently taken, medicines to treat tuberculosis (TB), or if you have known viral or fungal chest infections
• if you need to avoid alcohol for any reason

If you fall into any of the above categories, always inform your doctor before using FORMODUAL.
If you have or have had any medical conditions or allergies, or if you are unsure whether you can use
FORMODUAL, consult your doctor, asthma nurse specialist, or pharmacist before using this medicine.
Your doctor may decide to periodically monitor your blood potassium levels,
especially if you have severe asthma. Like many bronchodilators, FORMODUAL may
cause a sudden drop in serum potassium levels (hypokalaemia). This occurs because reduced
oxygen levels in the blood, associated with certain other treatments taken alongside FORMODUAL,
can worsen the reduction in potassium levels.
If you take high doses of inhaled corticosteroids for long periods of time, you may
require additional corticosteroids during times of stress. Stressful situations may include hospitalization
following an accident, severe injuries, or the period before surgery. In such cases, your doctor may
decide whether or not to increase your corticosteroid dose and may prescribe steroid tablets or
injectable steroids.
If you need to be hospitalized, remember to bring all your medicines and inhalers with you, including
FORMODUAL and any over-the-counter medicines or tablets, preferably in their original packaging.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
FORMODUAL must not be used in children and adolescents under 18 years of age.
Other medicines and FORMODUAL
Inform your doctor, pharmacist, or nurse if you are taking, or have recently taken, any
other medicines, including those obtained without a prescription. This is necessary because
FORMODUAL may alter the effect of other medicines. In addition, other medicines may affect
the activity of FORMODUAL.
In particular, consult your doctor, pharmacist, or nurse if you are taking any of the
following medicines:

• Some medicines can increase the effects of FORMODUAL, and your doctor may wish to monitor you closely if you are taking these (including some HIV treatments: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines used to treat various conditions, including heart problems, high blood pressure, or glaucoma (increased pressure in the eyes). If you use beta-blockers (including eye drops), the effect of formoterol may be reduced or blocked.
• Beta-adrenergic drugs (medicines with effects similar to formoterol) may increase the effects of formoterol.
• Medicines used to treat heart rhythm disorders (quinidine, disopyramide, procainamide).
• Medicines used to treat allergic reactions (antihistamines).
• Medicines used to treat symptoms of depression or mental disorders, such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazide), tricyclic antidepressants (e.g. amitriptyline and imipramine), phenothiazines.
• Medicines used to treat Parkinson’s disease (L-dopa).
• Medicines used to treat an underactive thyroid (L-thyroxine).
• Medicines containing oxytocin (which causes uterine contractions).
• Medicines used to treat mental disorders such as monoamine oxidase inhibitors (MAOIs), including drugs with similar properties such as furazolidone and procarbazine. Medicines used to treat heart conditions (digoxin).
• Other medicines used to treat asthma (theophylline, aminophylline, or steroids).
• Diuretics ("water pills").

Also inform your doctor or pharmacist if you plan to use a general anesthetic for surgery or a dental
procedure.
Pregnancy, breastfeeding, and fertility
There are no clinical data available on the use of FORMODUAL during pregnancy.
FORMODUAL must not be used if you are pregnant, suspect you may be pregnant, are planning a
pregnancy, or are breastfeeding, unless your doctor has specifically advised you to do so.
Driving and using machines
It is unlikely that FORMODUAL will affect your ability to drive or operate machinery.
FORMODUAL contains alcohol
FORMODUAL contains 9 mg of alcohol (ethanol) per dose, equivalent to 0,25 mg/kg for a two-dose
inhalation. The amount of alcohol in two doses of this medicine is less than that found in 1 ml of wine or
beer. The small amount of alcohol in this medicine will not have noticeable effects.
For individuals engaged in sports:
Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping
test.

3. How to use FORMODUAL

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will monitor you regularly to ensure you are taking the optimal
dose of FORMODUAL. Your doctor will prescribe the lowest dose that provides optimal control of
your symptoms.
Dosage:
Adults and elderly
The recommended dose is 2 inhalations twice daily.
The maximum daily dose is 4 inhalations.
Remember: You must always carry your rapid-acting “reliever” inhaler with you to treat
worsening asthma symptoms or sudden asthma attacks.
Patients at risk:
Dose adjustment is not required if you are elderly. There is no available information on the use of
FORMODUAL in patients with liver or kidney problems.
Use in children and adolescents under 18 years of age
Children and adolescents under 18 years of age MUST NOT take this medicine.
FORMODUAL is effective in the treatment of asthma with a beclometasone dipropionate dosage
that may be lower than that of other inhaled products containing this substance. If you have pre-
viously used a different inhaled medicine containing beclometasone dipropionate, your doctor will
prescribe the exact dose of FORMODUAL to treat your asthma.
Do not increase the dose
If you feel the medicine is not very effective, always consult your doctor before increasing the dosage.
If asthma worsens
If your symptoms worsen or are difficult to control (for example, if you are using your “reliever”
inhaler more frequently), or if your “reliever” inhaler does not improve your symptoms, contact your
doctor immediately. Your asthma may be worsening, and your doctor may decide to change your
dose of FORMODUAL 200/6 micrograms per dose pressurized inhalation solution or prescribe an
alternative treatment.
Method of administration
FORMODUAL is for inhalation use only
This medicine is contained in a pressurized canister inserted into a plastic inhaler with a mouthpiece.
On the back of the inhaler there is a dose indicator showing the number of doses remaining. Each
time the canister is pressed, the dose indicator decreases by a small amount. The number of remaining
doses is displayed at intervals of 20.
Be careful not to drop the inhaler, as this may cause the counter to display an incorrect number of
remaining doses.
Checking the inhaler is working
Before using the inhaler for the first time, or if the inhaler has not been used for 14 days or more,
you must check that the inhaler is working properly.

• Remove the protective cap from the mouthpiece
• Hold the inhaler upright with the mouthpiece pointing downwards
• Move the mouthpiece away and press firmly on the canister to release one dose
• Check the dose indicator. If you are using the inhaler for the first time, the number 180 should appear in the dose indicator window.

How to use the inhaler
Whenever possible, remain standing or sitting upright while inhaling.
Before inhaling, check the dose counter window: any number between “1” and “180” indicates that
doses remain. If the dose counter window shows “0”, no doses remain – the inhaler must be disposed
of and a new one obtained.

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust, dirt, or any foreign objects.
2. Breathe out as slowly and deeply as possible.
3. Hold the canister vertically, with the body of the inhaler facing upwards, and place the mouthpiece between your lips, sealing your lips firmly around it. Do not bite the mouthpiece.
4. Breathe in slowly and deeply through your mouth, and immediately after starting to inhale, press firmly on the top of the inhaler to release a dose. If you have a weak grip, it may be easier to hold the inhaler with both hands: place your index fingers on the top of the inhaler and both thumbs on the base.
5. Hold your breath as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not breathe out into the inhaler.

If another dose is required, keep the inhaler in an upright position for about half a minute and repeat steps 2 to 5.
Important: Do not perform steps 2 to 5 too quickly.
After use, replace the protective cap and check the dose indicator.
To reduce the risk of developing a fungal infection in the mouth or throat, rinse your mouth or
gargle with water, or brush your teeth after each inhalation.
You must obtain a new medicine pack when the dose indicator shows the number 20. Stop using
the inhaler when the dose indicator shows 0, as the amount of medicine remaining in the device
may not be sufficient to deliver a complete dose.
If after inhalation you see a “mist” escaping from the inhaler or from the sides of your mouth, this
means Formodual did not reach your lungs as intended. Administer another dose by following the
instructions and repeating steps 2 to 5.
If you feel the effect of FORMODUAL is too strong or not strong enough, consult your doctor or
pharmacist.
If you find it difficult to activate the inhaler while starting to inhale, you may use the AeroChamber Plus spacer device. Ask your doctor, pharmacist, or nurse for information about this device.
It is important that you read the instruction leaflet provided with your AeroChamber Plus spacer device and carefully follow the instructions on how to use and clean it.
Cleaning
The inhaler should be cleaned once a week.
During cleaning, do not remove the canister from the inhaler and do not use water or other liquids
to clean the inhaler.
To clean the inhaler:

1. Remove the protective cap from the mouthpiece by pulling it away from the inhaler.
2. Wipe the inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or tissue.
3. Replace the protective cap on the mouthpiece.

If you use more FORMODUAL than you should

• Taking more formoterol than prescribed may cause the following effects: feeling sick, nausea, rapid heartbeat, palpitations, heart rhythm disturbances, changes in the electrocardiogram (ECG), headache, tremor, drowsiness, excess acid in the blood, low potassium levels in the blood, high blood glucose levels. Your doctor may perform blood tests to monitor your potassium and glucose levels.
• Taking excessive amounts of beclometasone dipropionate may cause temporary disturbances of the adrenal glands. These problems will resolve spontaneously within a few days, but your doctor may decide to monitor your serum cortisol levels.

Contact your doctor if you experience any of these symptoms.
If you forget to use FORMODUAL
Take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose,
but take the next dose at the correct time. Do not take a double dose to make up for a forgotten dose.
If you stop using FORMODUAL
Even if you feel better, do not stop using FORMODUAL or reduce the dose. If you intend to do so, discuss it with your doctor. It is very important that FORMODUAL is used regularly, even when symptoms are absent.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other inhaled treatments, there is a risk of worsening breathlessness and wheezing immediately after using FORMODUAL, and this occurrence is known as paradoxical bronchospasm. If this happens, you must STOP using FORMODUAL IMMEDIATELY and use your "as-needed" fast-acting inhaler as soon as possible to treat symptoms of breathlessness and wheezing. You must contact your doctor immediately.
Inform your doctor immediately if you experience hypersensitivity reactions, such as skin allergies, itching, rash, skin redness, or swelling of the skin or mucous membranes, especially of the eyes, face, lips, and throat.

Below are other possible side effects listed in order of frequency.

Common (may affect up to 1 in 10 people):

• fungal infections (of the mouth and throat)
• headache
• hoarseness
• sore throat

Uncommon (may affect up to 1 in 100 people):

• palpitations, abnormally rapid heartbeat, and heart rhythm disturbances
• changes in electrocardiogram (ECG)
• increased blood pressure
• flu-like symptoms
• sinus inflammation
• rhinitis
• ear inflammation
• throat irritation
• cough and productive cough
• asthma attack
• vaginal fungal infections
• nausea
• taste abnormalities or altered taste
• lip burning
• dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhoea
• muscle pain and cramps
• facial and throat redness
• increased blood flow to certain body tissues
• excessive sweating
• tremor
• restlessness
• dizziness
• urticaria (hives)
• changes in certain blood components: either reduced white blood cell count, or increased platelet count, or reduced potassium levels in blood, or increased blood sugar levels, or increased insulin, free fatty acids, and ketones in blood

The following side effects have been reported with "uncommon" frequency in patients with chronic obstructive pulmonary disease (COPD):

• lung infection; inform your doctor if you notice any of the following symptoms: increased sputum (phlegm) production, change in sputum colour, fever, increased coughing, worsening breathing problems
• reduced cortisol levels in blood: caused by the effect of corticosteroids on the adrenal gland
• irregular heartbeat

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

• chest tightness
• absence of heartbeat (caused by premature ventricular contractions)
• decreased blood pressure
• kidney inflammation
• persistent swelling of the skin and mucous membranes lasting for several days

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

• shortness of breath
• worsening of asthma
• reduced platelet count in blood
• swelling of hands and feet

Long-term, high-dose inhaled corticosteroid use may very rarely lead to systemic effects, including:

• adrenal gland function disorders (adrenal suppression)
• reduced bone mineral density (bone thinning)
• growth retardation in children and adolescents
• increased pressure inside the eyes (glaucoma)
• cataract

Not known (frequency cannot be estimated from available data):

• sleep disorders
• depression or anxiety
• nervousness
• feeling of hyperexcitability or irritability
• blurred vision
  These events are more likely in children, but their frequency is unknown.

Reporting of side effects
If you experience any side effect, including those 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.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 FORMODUAL

Keep this medicine out of the sight and reach of children.
For pharmacists:
Store in a refrigerator (2 °C – 8 °C) for up to 18 months.
For patients:
Do not use this medicine for more than 3 months after the date of purchase from the pharmacy, and never use it after the expiry date stated on the packaging and label after EXP. The expiry date refers to the last day of that month.
Do not store the inhaler at temperatures above 25°C.
If the inhaler has been exposed to low temperatures, warm it with hands for a few minutes before use. Never warm it using artificial methods.
Caution: The container contains liquid under pressure. Do not expose it to temperatures above 50°C. Do not pierce the container.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What FORMODUAL contains:
The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate.
Each metered valve actuation delivers 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to an inhaled dose from the mouthpiece of 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate.
The other components are: norflurane (HFC 134-a), anhydrous ethanol, hydrochloric acid.
This medicinal product contains fluorinated greenhouse gases. Each inhaler contains 14.239 g of norflurane (HFC-134a), equivalent to 0.020 tonnes of CO2 (global warming potential = 1430).

Description of the appearance of FORMODUAL and contents of the package
FORMODUAL is a pressurized solution for inhalation contained in an aluminum canister coated with a metering valve, inserted into a plastic inhaler incorporating either a dose counter (120 actuations) or a dose indicator (180 actuations), with a plastic protective cap.
Each package contains:
1 pressurized container (providing 120 inhalations)
2 pressurized containers (providing 120 inhalations each)
1 pressurized container (providing 180 inhalations)
Not all pack sizes may be marketed.

Marketing Authorization Holder
Promedica S.r.l.
Via Palermo 26/A
43122 Parma - Italy

Responsible manufacturer for batch release
Chiesi Farmaceutici S.p.A.
Via San Leonardo, 96
43122 Parma - Italy

Alternative responsible manufacturers for batch release
Chiesi Pharmaceuticals GmbH
Gonzagagasse 16/16
1010 Vienna - Austria
Chiesi S.A.S
2 rue des Docteurs Alberto et Paolo CHIESI, La Chaussée Saint Victor
41260 - France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Patient information leaflet

FORMODUAL 200 micrograms/6 micrograms per inhalation powder for inhalation

For use in adults only
beclometasone dipropionate anhydrous/formoterol fumarate dihydrate
Please read this entire leaflet carefully before 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, nurse, or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, nurse, or pharmacist. See section 4.

Contents of this leaflet

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

1. What FORMODUAL is and what it is used for

FORMODUAL is a powder that is inhaled through the mouth and delivered directly into the lungs.
It contains two active substances: anhydrous beclometasone dipropionate and formoterol fumarate dihydrate.

• Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which have an anti-inflammatory action, reducing swelling and irritation in the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators. These medicines relax the muscles of the airways, widening them and thereby making it easier to breathe air in and out of the lungs.

Together, these two active substances make breathing easier and also help prevent asthma symptoms, such as shortness of breath, wheezing and coughing.
FORMODUAL is used for the treatment of asthma in adults.
If FORMODUAL has been prescribed for you, it is likely because:

• your asthma is not adequately controlled using inhaled corticosteroids and short-acting bronchodilators "as needed", or

• your asthma responds well to treatment with both corticosteroids and long-acting bronchodilators.

2. What you need to know before using FORMODUAL

Do not use FORMODUAL
If you are allergic to anhydrous beclometasone dipropionate or to anhydrous formoterol fumarate or to any
of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Do not take this medicine if you experience acute symptoms of asthma, such as shortness of breath,
wheezing and coughing, or if your asthma is worsening or during treatment of acute asthma attacks. To
relieve symptoms, use your "rescue" fast-acting inhaler, which you must always carry with you.
Talk to your doctor before using FORMODUAL if you have any of the following conditions:

• heart problems, including any known heart disease and/or cardiac function disorders
• heart rhythm disorders, such as increased or irregular heartbeat, rapid pulse or palpitations, or if you have been informed that your electrocardiogram (ECG) is abnormal
• high blood pressure
• narrowing of the arteries (also known as arteriosclerosis), or if you have an aneurysm (an abnormal dilation of blood vessel walls)
• overactivity of the thyroid gland
• low levels of potassium in the blood
• any liver or kidney disorders
• diabetes. If you inhale high doses of formoterol, blood glucose levels may increase, and therefore additional blood tests may be needed to monitor blood sugar levels both when starting this medicine and periodically throughout treatment.
• tumour of the adrenal gland (called phaeochromocytoma)
• if you are due to undergo anaesthesia. Depending on the type of anaesthetic, you may need to stop treatment with FORMODUAL at least 12 hours before anaesthesia.
• if you are taking, or have taken, medicines to treat tuberculosis (TB), or if you have known viral or fungal chest infections.

V.7.0_2021_10 2
If you fall into any of the above categories, always inform your doctor before using
FORMODUAL.
If you are unsure whether you can use FORMODUAL, consult your doctor, an asthma nurse specialist, or
pharmacist before using this medicine.
Your doctor may decide to periodically monitor your blood potassium levels,
especially if you have severe asthma. Like many bronchodilators, FORMODUAL may
cause a sudden drop in serum potassium levels (hypokalaemia). This may occur because reduced blood oxygen levels, associated with certain other treatments taken together with FORMODUAL, can worsen the reduction in potassium levels.
If you take high doses of inhaled corticosteroids for long periods of time, you may require additional corticosteroids during stressful situations. Stressful situations may include hospitalisation following an accident, serious injury, or the period before surgery. In such cases, your doctor will decide whether or not to increase your corticosteroid dose and may prescribe steroid tablets or injectable steroids.
If you need to be admitted to hospital, remember to bring all your medicines and inhalers, including FORMODUAL, and any over-the-counter medicines or tablets, preferably in their original packaging.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
This medicine must not be administered to children and adolescents under 18 years of age.
Other medicines and FORMODUAL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is necessary because FORMODUAL may alter the effect of other medicines. In addition, other medicines may affect the activity of FORMODUAL.
In particular, consult your doctor or pharmacist if you are taking any of the following medicines:

• Some medicines may increase the effects of FORMODUAL, and your doctor may wish to monitor you closely if you are taking these (including certain HIV treatments: ritonavir, cobicistat).
• Beta-blockers. Do not use this medicine together with beta-blockers. Beta-blockers are medicines used to treat various conditions, including heart problems, high blood pressure or glaucoma (increased pressure in the eyes). If you use beta-blockers (including eye drops), the effect of formoterol may be reduced or blocked.
• Beta-adrenergic drugs (medicines with activity similar to formoterol) may increase the effects of formoterol.
• Medicines used to treat heart rhythm disorders (quinidine, disopyramide, procainamide).
• Medicines used to treat allergic reactions (antihistamines, such as terfenadine).
• Medicines used to treat depression or mental disorders such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazide), or tricyclic antidepressants (e.g. amitriptyline and imipramine), or phenothiazines.

V.7.0_2021_10 3

• Medicines used to treat Parkinson's disease (L-dopa).
• Medicines used to treat an underactive thyroid (L-thyroxine).
• Medicines containing oxytocin (which causes uterine contractions).
• Medicines used to treat mental disorders such as monoamine oxidase inhibitors (MAOIs), including drugs with similar properties such as furazolidone and procarbazine.
• Medicines used to treat heart disease (digoxin).
• Other medicines used to treat asthma (theophylline, aminophylline or steroids).
• Diuretics ("water tablets").

Also inform your doctor or pharmacist if you intend to use a general anaesthetic for
surgery or dental procedures.
Pregnancy, breastfeeding and fertility
There are no clinical data available on the use of FORMODUAL during pregnancy.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor before using this medicine. FORMODUAL should only be used during
pregnancy if your doctor advises you to do so. Your doctor will decide whether you should stop taking
FORMODUAL during breastfeeding or whether you should continue taking FORMODUAL but stop
breastfeeding. Always follow your doctor's advice carefully.
Driving and using machines
It is unlikely that FORMODUAL will affect your ability to drive or operate machinery.
However, if you experience side effects such as dizziness and/or tremor, your ability to drive
or use machinery may be impaired.
FORMODUAL contains lactose
Lactose contains small amounts of milk proteins, which may cause reactions in patients with milk
allergy. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before
taking this medicine.
For those engaged in sports activities:
Using the drug without therapeutic need constitutes doping and may lead to positive results in
anti-doping tests.

3. How to use FORMODUAL

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor, pharmacist, or nurse.
FORMODUAL delivers an extrafine powder, allowing a greater proportion of the drug contained in the dose to reach the lungs. Therefore, your doctor may prescribe you a lower dose of this inhaled medicine compared to what you previously used with other inhalers.
Your doctor will monitor you regularly to ensure you are taking the correct dose of FORMODUAL. Once your asthma is well controlled, your doctor may consider it appropriate to gradually reduce the dose of FORMODUAL. Do not under any circumstances change the dose without first consulting your doctor.
V.7.0_2021_10 4
How much FORMODUAL to use:
Adults and elderly:
The recommended dose of this medicine is 2 inhalations twice daily.
The maximum daily dose is 4 inhalations.
Do not increase the dose.
If you feel the medicine is not effective, always contact your doctor before increasing the dose.
Remember: you must always carry your rapid-acting “rescue” inhaler with you to treat worsening symptoms or a sudden asthma attack.
How to use FORMODUAL:
FORMODUAL is for inhalation use only.
If possible, stand or sit upright when inhaling.
If you use more FORMODUAL than you should:

• contact your doctor or the nearest hospital emergency department immediately for advice. Take the medicine with you so that healthcare professionals can see which drug you have taken;
• adverse effects may occur. Inform your doctor if you notice any unusual symptoms, as further investigations or necessary therapeutic measures may be required.

If you forget to use FORMODUAL:
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next one at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop using FORMODUAL:
Even if you feel better, do not stop using FORMODUAL or reduce your dosage without first talking to your doctor. It is very important that you use FORMODUAL every day as prescribed by your doctor, even when you have no symptoms.
If your breathing does not improve
If your symptoms do not improve after inhaling FORMODUAL, you may be using the device incorrectly. Therefore, review the instructions for proper use of the device provided below and/or contact your doctor, nurse, or pharmacist to have them explain the correct way to use it.
If asthma worsens
If your symptoms worsen or become difficult to control (for example, if you are using your “as-needed” inhaler more frequently), or if your “as-needed” inhaler does not relieve your symptoms, continue using FORMODUAL but contact your doctor as soon as possible. Your doctor may decide to adjust your dose of FORMODUAL or prescribe additional or alternative treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
V.7.0_2021_10 5

INSTRUCTIONS FOR USE OF THE NEXTHALER INHALER

A. Pack Contents
For information on pack contents, see section 6. If the contents do not match what is stated above,
return the inhaler to the person who supplied it to you (e.g. pharmacist or doctor) and obtain a new one.
B. General Warnings and Precautions

• Do not remove the inhaler from its pouch unless you intend to use it immediately.
• Use the inhaler only as directed.
• Keep the inhaler cap closed until it is time to take your dose.
• When not in use, store the inhaler in a clean, dry place.
• Do not attempt to disassemble the Nexthaler inhaler for any reason. C. Main Features of the Nexthaler Inhaler

of air
Taking a dose from the Nexthaler inhaler requires only three simple steps: Opening, Inhaling, Closing
D. Before Using a New Nexthaler Inhaler

1. Open the pouch and remove the inhaler.
   • Do not use the inhaler if the pouch is not sealed or is damaged – return it to your supplier and obtain a new one.
   • Use the adhesive label on the pack to write the date of first opening of the pouch.
2. Check the inhaler.
   • If the inhaler appears broken or damaged, return it to your supplier and obtain a new one.
3. Check the dose counter window. If the inhaler is new, the number “120” should appear in the dose counter window.
   • Do not use a new inhaler if the number shown is less than “120” – return it to your supplier and obtain a new one.

V.7.0_2021_10 6

E. How to Use the Nexthaler Inhaler

1. If you are unsure whether you are receiving the dose correctly, contact your pharmacist or doctor.
2. If you are unsure whether the number shown on the dose counter has decreased by one after inhalation, wait until your next scheduled dose and take it as normal. Do not take a double dose.

E.1 Opening
1. Hold the inhaler firmly in an upright position.
2. Check the number of doses remaining: any number between “1” and “120” indicates
that doses are still available.

• If the dose counter window shows “0”, this means no doses remain – the inhaler must be disposed of and a new one obtained.

3. Fully open the cap.

4. Before inhaling, breathe out as much as possible.

o Do not breathe through the inhaler.
E.2 Inhalation
Whenever possible, remain standing or sit in an upright position during inhalation.

1. Lift the inhaler, bring it to mouth level, and close your lips around the mouthpiece.
   o Do not cover the air intake while holding the inhaler.
   o Do not inhale through the air intake.

2. Breathe in quickly and deeply through the mouth.

o You may taste something in your mouth while taking the dose.
o You may hear or feel a "click" while taking the dose.
o Do not breathe in through the nose.
o Do not move your lips away from the inhaler during inhalation.
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3. Remove the inhaler from your mouth.
4. Hold your breath for 5 to 10 seconds, or for as long as is comfortable.
5. Breathe out slowly.
o Do not breathe out through the inhaler.
E.3 Closing
1. Place the inhaler upright and fully close the cap.
2. Check that the dose counter has decreased by one number.

3. If you need to take another dose, repeat the steps from point E.1 to point

E.3.
F. Cleaning

• Normally, there is no need to clean the inhaler.
• If necessary, you can keep the inhaler clean after use by wiping it with a dry cloth or dry paper tissue.
• Do not clean the inhaler with water or other liquids. Always keep the device dry. G. Storage and disposal For information on storage conditions and disposal instructions, see section 5.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
As with other inhaled treatments, there is a risk of worsening shortness of breath, coughing, or wheezing immediately after using FORMODUAL, an event known as paradoxical bronchospasm. If this occurs, you must STOP
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using FORMODUAL immediately and use your “rescue” fast-acting inhaler as soon as possible
to treat your symptoms. You must contact your doctor immediately.
Inform your doctor immediately if you experience allergic reactions, including skin allergies, skin itching, rash, skin redness, or swelling of the skin or mucous membranes, especially of the eyes, face, lips, and throat.
Below are other possible side effects of FORMODUAL, listed in order of frequency.
Common (may affect up to 1 in 10 people):

• tremor

Uncommon (may affect up to 1 in 100 people):

• cold-like symptoms, sore throat
• fungal infections (of the mouth and throat). Rinsing your mouth or gargling with water and brushing your teeth immediately after inhalation may help prevent these side effects
• worsening of asthma symptoms, breathing difficulties
• hoarseness
• cough
• unusually rapid heartbeat
• unusually slow heartbeat
• tight chest pain
• headache
• feeling unwell
• feeling of fatigue or nervousness
• changes in electrocardiogram (ECG)
• low level of cortisol in urine or blood
• high level of potassium in blood
• high level of glucose in blood
• high level of fats in blood

Not known (frequency cannot be estimated from the available data):

• blurred vision

Side effects observed with similar inhaled medicines containing beclometasone dipropionate and/or formoterol are the following:

• palpitations
• irregular heartbeat
• taste disturbances or alterations
• muscle pain and muscle cramps
• restlessness, dizziness
• feeling of anxiety
• sleep disorders
• decrease in blood potassium levels
• increase/decrease in blood pressure

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The use of inhaled corticosteroids at high doses and for prolonged periods of time may
cause systemic effects, including :

• disorders of adrenal gland function (adrenal suppression)
• thinning of the bones
• growth retardation in children and adolescents
• increased eye pressure (glaucoma), cataract
• rapid weight gain, particularly in the face and trunk
• sleep disturbances, depression or feelings of worry, agitation, nervousness, hyperexcitability, or irritability. These effects are more likely to occur in children
• abnormal behaviour

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the website: 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 FORMODUAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, on the pouch, and on the label after "Exp". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. Remove the inhaler from its protective pouch only immediately before first use.
Before first opening the pouch:
This medicine requires no special temperature storage conditions.
After first opening the pouch:
Do not store above 25°C.
After first opening the pouch, the medicine must be used within 6 months.
Use the label on the carton to write down the date the pouch was opened.
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. Package contents and other information

What FORMODUAL contains
The active substances are: beclometasone dipropionate anhydrous and formoterol fumarate dihydrate.
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Each metered dose contains 200 micrograms of beclometasone dipropionate anhydrous and 6
micrograms of formoterol fumarate dihydrate. This corresponds to an inhaled dose delivered
through the mouthpiece of 158.8 micrograms of beclometasone dipropionate anhydrous and 4.9 micrograms
of formoterol fumarate dihydrate.
The other components are: lactose monohydrate and magnesium stearate.

Description of the appearance of FORMODUAL and contents of the pack
FORMODUAL is a white or almost white inhalation powder contained in a plastic inhaler device called Nexthaler.
Each pack contains one, two or three inhalers, each providing 120 inhalations.
Each inhaler is packaged in a protective thermoformed blister.
Not all pack sizes may be marketed.

Marketing Authorization Holder
PROMEDICA S.r.l.
Via Palermo 26/A
43122 Parma
Italy

Manufacturer responsible for batch release:
Chiesi Farmaceutici S.p.A.
Via San Leonardo 96
43122 Parma - Italy

Alternative manufacturer responsible for batch release:
Chiesi S.A.S.
2 rue des Docteurs Alberto et Paolo Chiesi
41260 La Chaussée Saint Victor - France

Alternative manufacturer responsible for batch release:
Chiesi Pharmaceuticals GmbH
Gonzagagasse 16/16
1010 Vienna – Austria

This medicinal product is authorized in the European Economic Area countries under the following
names:

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Up-to-date and detailed information about this product is available by scanning with a
smartphone or other device the QR code included in the Package Leaflet and on the
outer packaging.

The same information is also available at the following URL: https://qrco.de/Nexthaler200-6-120.
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