FORMODUAL 100 mg/6 mg Powder For Inhalation

Leaflet: Information for the Patient

Formodual Nexthaler 100 micrograms/6 micrograms inhalation powder for inhalation

For use in adults

dipropionate of beclometasone anhydrous/fumarate of formoterol dihydrate

Read this leaflet carefully before starting to use this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, nurse or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, nurse or pharmacist, even if they are not listed in this leaflet.

Formodual Nexthaler is a powder that is inhaled through the mouth and is released deeply into the lungs. It contains two active ingredients: anhydrous beclometasone dipropionate and formoterol fumarate dihydrate.

• Anhydrous beclometasone dipropionate belongs to a group of medications called corticosteroids that have an anti-inflammatory action, reducing swelling and irritation of the lungs.

• Formoterol fumarate dihydrate belongs to a group of medications called long-acting bronchodilators that relax the muscles of the airways, causing them to dilate, making it easier for air to enter and leave the lungs.

These two active ingredients combined facilitate breathing, as they provide relief from symptoms such as difficulty breathing, wheezing, and coughing in patients with asthma or COPD, and also help to prevent asthma symptoms.

Asthma

Formodual Nexthaler is used to treat asthma in adults

Formodual Nexthaler is prescribed if:

• Asthma is not sufficiently controlled using inhaled corticosteroids and short-acting bronchodilators administered "as needed".

or:

Asthma is responding well to a combination treatment of corticosteroids and long-acting bronchodilators.

COPD

Formodual Nexthaler may also be used to treat the symptoms of chronic obstructive pulmonary disease (COPD) in severe patients. COPD is a chronic disease of the pulmonary airways caused mainly by smoking cigarettes.

No use Formodual Nexthaler:

if you are allergic to beclometasone dipropionate anhydrous or formoterol fumarate dihydrate or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor before starting to use Formodual Nexthaler, if you have any of the following conditions:

• heart problems, including any known heart disease and/or cardiac function problems

• heart rhythm disorders, such as increased heart rate or irregular heart rate, rapid pulse or palpitations, or if you have been informed that you have electrocardiographic alterations

• high blood pressure

• arterial narrowing (also known as arteriosclerosis), or if you know you have an aneurysm (an abnormal bulging of the vascular wall)

• hyperactive thyroid gland

• low potassium levels in the blood

• any liver or kidney disease

• diabetes. Inhaling high doses of formoterol may cause an increase in blood glucose levels, and you should undergo additional blood tests to control blood sugar levels when starting to use the inhaler and occasionally during treatment.

• pheochromocytoma (a tumor of the adrenal glands)

• if you are to receive anesthesia. Depending on the anesthetic agent, you may need to stop using Formodual Nexthaler for at least 12 hours before anesthesia.

• if you are being treated or have been treated for tuberculosis (TB) or if you have any known viral or fungal infections in the lungs.

If any of the above conditions apply to you, inform your doctor before using Formodual Nexthaler.

If you are unsure whether you can use Formodual Nexthaler, consult your doctor, nurse, or pharmacist before using the inhaler.

Your doctor may want to measure your potassium levels in the blood from time to time, especially if you have severe asthma.Like other bronchodilators, Formodual Nexthaler may cause a sudden drop in serum potassium levels (hypokalemia). This is due to a lack of oxygen in the blood combined with other treatments you may be taking at the same time as Formodual Nexthaler, which can worsen the decrease in potassium levels.

If you take high doses of inhaled corticosteroids for prolonged periods, you may need more corticosteroids in situations of stress. Such situations include hospital admission after an accident, the presence of a serious injury, or before surgery. In this case, your treating doctor will decide whether to increase the dose of corticosteroids and may prescribe tablets or injections of steroids.

In case of hospital admission, remember to bring with you all your medications and inhalers, including Formodual Nexthaler and any other medications or tablets you have purchased without a prescription, preferably in their original packaging.

Contact your doctor if you experience blurred vision or other visual disturbances.

Children and Adolescents

Do not use this medication in children and adolescents under 18 years old.

Using Formodual Nexthaler with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This is because Formodual Nexthaler may affect the way other medications work. Also, some medications may affect the way Formodual Nexthaler works.

In particular, contact your doctor or pharmacist if you are using any of the following medications:

• Some medications may increase the effects of Formodual Nexthaler, so your doctor will make close checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medications used to treat various heart problems, high blood pressure, or glaucoma (increased intraocular pressure). If you need to use beta-blockers (including eye drops), the effect of formoterol may be reduced or even cancelled.
• Beta-adrenergic medications (medications with the same action as formoterol) may increase the effects of formoterol.
• Medications to treat heart rhythm disorders (quinidine, disopyramide, procainamide).
• Medications to treat allergic reactions (antihistamines such as terfenadine).
• Medications to treat depression or mental disorders such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazid) or tricyclic antidepressants (e.g. amitriptyline and imipramine) or phenothiazines.
• Medications to treat Parkinson's disease (L-dopa).
• Medications containing L-thyroxine (to treat hypothyroidism).
• Medications containing oxytocin (which causes uterine contractions).
• Medications to treat mental disorders such as monoamine oxidase inhibitors (MAO), including similar drugs, such as furazolidone and procarbazine.
• Medications to treat heart disease (digoxin).
• Other medications used to treat asthma (theophylline, aminophylline, or steroids).
• Diuretics.

Also, inform your doctor or pharmacist if you are to receive general anesthesia for surgery or dental procedures.

Pregnancy and Breastfeeding

No clinical data are available on the use of Formodual Nexthaler during pregnancy.

If you think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.

During pregnancy, you should only use Formodual Nexthaler if your doctor has indicated it. Your doctor will tell you whether to stop using Formodual Nexthaler during breastfeeding or if you should use Formodual Nexthaler and avoid breastfeeding. Always follow your doctor's advice.

Driving and Operating Machines

It is unlikely that Formodual Nexthaler will affect your ability to drive and operate machines. However, your ability to drive and operate machines may be affected if you experience dizziness and/or tremors.

Formodual Nexthaler contains lactose

Lactose contains small amounts of milk proteins that may cause allergic reactions. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor, nurse or pharmacist again.

Formodual Nexthaler provides a fine particle size distribution that results in a higher dose released in your lungs. Therefore, your doctor may prescribe a lower dose of this inhaler compared to your previous inhalers.

Asma

Your doctor will conduct regular check-ups to ensure you are taking the optimal dose of Formodual Nexthaler. Your doctor will always adjust the treatment to the minimum dose that best controls your symptoms.In no casemodifythe dose without consulting your doctor first.

Formodual Nexthaler may be prescribed by your doctor in two different ways:

1. Use Formodual Nexthaler daily to treat your asthma along with a separate "rescue" inhaler to treat a sudden worsening of asthma symptoms, such as difficulty breathing, wheezing and coughing
2. Use Formodual Nexthaler daily to treat your asthma and also use Formodual Nexthaler to treat a sudden worsening of asthma symptoms, such as difficulty breathing, wheezing and coughing

1. Use of Formodual Nexthaler along with a separate "rescue" inhaler:

Adults and elderly:

The recommended dose of this medication is 1 or 2 inhalations twice a day.

The maximum daily dose is 4 puffs.

Remember: You must always carry a rapid-acting rescue inhaler with you to treat a worsening of asthma symptoms or a sudden asthma attack.

1. Use of Formodual Nexthaler as a single inhaler for asthma:

Adults and elderly:

The recommended dose is 1 puff in the morning and 1 puff at night.

You must also use Formodual Nexthaler as a rescue inhaler to treat sudden asthma symptoms.

If you have asthma symptoms, inhale 1 puff and wait a few minutes.

If you do not feel better, inhale another puff.

Do not inhale more than 6 rescue puffs per day.

The maximum daily dose of Formodual Nexthaler is 8 puffs.

If you consider that you need more puffs per day to control your asthma symptoms, contact your doctor for advice. You may need to change your treatment.

Do not increase the dose.

If you think the medication is not very effective, consult your doctor before increasing the dose.

Chronic Obstructive Pulmonary Disease (COPD)

Adults and elderly:

The recommended dose is 2 puffs in the morning and 2 puffs at night.

How to use Formodual Nexthaler:

Formodual Nexthaler is for inhalation use.

Whenever possible, patients should stand or sit upright while inhaling.

If you use more Formodual Nexthaler than you should

• Contact your doctor or the nearest hospital emergency service immediately. Bring the medication with you so they can check what has been taken;
• You may experience adverse effects. Inform your doctor of any unusual symptoms so they can perform additional tests or decide on any necessary measures.
• In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, Phone 91 562 04 20 indicating the medication and the amount ingested (or visit a medical center).

If you forgot to use Formodual Nexthaler

Take it as soon as you remember. If it is almost time for your next dose, do not take the dose you missed; limit yourself to taking the next dose.Do not double the dose.

If you interrupt treatment with Formodual Nexthaler

Although you feel better, do not stop using Formodual Nexthaler or reduce the dose. If you want to do so, consult your doctor. It is very important for you to use Formodual Nexthaler every day, as prescribed by your doctor, even if you do not have symptoms.

If your breathing difficulties do not change:

If your symptoms do not improve after inhaling Formodual Nexthaler, you may not be using it correctly. In this case, you should check the correct use instructions described below and/or contact your doctor or nurse for further instruction.

If asthma worsens:

If symptoms worsen or are difficult to control (for example, if the frequency of use of the separate rapid-acting inhaler or Formodual Nexthaler as a rescue inhaler increases, or if the rapid-acting inhaler or Formodual Nexthaler does not contribute to improving symptoms), or if the rapid-acting inhaler or Formodual Nexthaler does not contribute to improving symptoms, you should continue using Formodual Nexthaler but you should see your doctor immediately. Your asthma may be worsening and your doctor may need to adjust the dose of Formodual Nexthaler or prescribe an alternative treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

INSTRUCTIONS FOR USE OF THE NEXTHALER INHALER

1. Contents of the package

For information on the contents of the package, see section 6.

If the contents of the package are not the same as those described in section 6, return the inhaler to the person who supplied it and obtain a new one.

1. General warnings and precautions

• Do notremove the inhaler from the protective bag if you are not going to use it immediately.
• Use only your inhaler as instructed.
• Keep the inhaler cap closed until you need to take a dose.
• When not using the inhaler, keep it in a clean and dry place.
• Under no circumstancestry to disassemble your Nexthaler inhaler.

1. Main characteristics of the Nexthaler inhaler

Taking a dose of the Nexthaler inhaler requires following three simple steps: Open, Breathe, Close

1. Before using a new Nexthaler inhaler

1. Open the protective bag and remove your inhaler.
   • Do notuse your inhaler if the protective bag is not sealed or is damaged – return it to the person who supplied it and obtain a new one.
   • Use the box label to write the date when you open the protective bag.
2. Check your inhaler.
   • If your inhaler appears broken or damaged, return it to the person who supplied it and obtain a new one.
3. Check the dose counter window. If your inhaler is new, you will see “120 or 180” in the dose counter window.
   • Do notuse a new inhaler if the number shown is less than “120 or 180” – return it to the person who supplied it and obtain a new one.

1. How to use your Nexthaler inhaler

• If you are unsure that you are receiving the correct dose, contact your pharmacist or doctor..
• If you are unsure that the dose counter has decreased after your inhalation, wait until the next scheduled dose and take it normally. Do not take an extra dose.

E.1. Open

1. Hold the inhaler firmly in a vertical position.

2. Check the number of doses remaining: any number between “1” and “120 or 180” shows that there are doses remaining.

3. Open the protective cap completely.

4. Before inhaling, exhale until you feel comfortable.

E.2. Breathe

Whenever possible, stand or sit upright while inhaling.

1. Bring the inhaler to your mouth and place your lips around the mouthpiece.

• Do nottape the mouthpiece when holding the inhaler.
• Do notinhale through the mouthpiece.

2. Breathe in deeply and energetically through your mouth.

3. Remove the inhaler from your mouth.

4. Hold your breath for 5 to 10 seconds or as long as possible.

5. Breathe out slowly.

• Do notexhale through the inhaler.

E.3. Close

1. Place the inhaler in a vertical position and close the protective cap completely.

2. Check that the dose counter has decreased by one unit.

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

1. Cleaning

• Normally, it is not necessary to clean your inhaler.
• If necessary, you can clean the inhaler after use with a dry cloth or paper towel.
• Do notclean your inhaler with water or other liquids. Keep it dry.

1. Storage and disposal

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

Like all medications, Formodual Nexthaler may cause side effects, although not everyone will experience them.

As with other treatments using inhalers, there is a risk of worsening difficulty breathing, cough, and wheezing immediately after using Formodual Nexthaler, known asparadoxical bronchospasm. If this happens,STOP using Formodual Nexthaleranduse your quick-relief inhaler right awayto treat the symptoms. Contact your doctor immediately.

Contact your doctor immediately if you experience hypersensitivity reactions, such as skin allergies, itching, rash, skin redness, swelling on the skin or mucous membranes, especially on the eyes, face, lips, and throat.

Other possible side effects of Formodual Nexthaler are listed below in order of frequency.

Frequent(in at least 1 in 10 patients):

• Tremors
• Pneumonia (lung infection) in patients with COPD.

Inform your doctor if you have any of the following symptoms while inhaling Formodual Nexthaler, which may be symptoms of a lung infection:

• Fever or chills
• Increased mucus production, change in mucus color
• Increased cough or difficulty breathing

Rare(in at least 1 in 100 patients):

• Flu-like symptoms, throat irritation
• Fungal infections (of the mouth and throat). To reduce these side effects, rinse your mouth or gargle with water or brush your teeth after using the inhaler.
• Worsening of asthma symptoms, difficulty breathing
• Hoarseness
• Cough
• Exceptionally fast heart rate
• Exceptionally slow heart rate
• Sensation of chest tightness
• Headache
• Nausea
• Sensation of fatigue or neurasthenia
• Electrocardiogram (ECG) abnormalities
• Decreased cortisol concentration in urine or blood
• Increased potassium concentration in blood
• Increased glucose concentration in blood
• Increased concentration of fatty acids in blood.

Unknown frequency(frequency cannot be estimatedcannot be estimated with available data):

• Blurred vision.

Side effects observed in similar inhalation medicationscontaining dipropionate beclometasone and/or formoterol are:

• Palpitations
• Cardiac rhythm disorders
• Alterations or decrease in sense of taste
• Muscle pain and cramps
• Restlessness, dizziness
• Feeling irritable
• Sleep disorders
• Decreased potassium concentration in blood
• Increased/decreased blood pressure.

The inhalation of high doses of corticosteroids for a prolonged period may cause systemic effects,including:

• Suppression of adrenal function (adrenal insufficiency)
• Weakening of bones
• Delayed growth in children and adolescents
• Increased intraocular pressure (glaucoma), cataracts
• Rapid weight gain, particularly in the face and trunk
• Sleep disorders, depression, or feeling anxious, restless, nervous, over-excited, or irritable. These effects may occur more frequently in children.
• Abnormal behavior.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in the Spanish System of Pharmacovigilance of Medicinal Products for Human Usehttps://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box, bag, and label after "Cad." The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture. Remove the inhaler from the bag immediately before the first use.

Before the first opening of the bag:

This medication does not require any special storage temperature.

After the first opening of the bag:

Do not store at a temperature above 25°C.

After the first opening of the bag, the medication must be used within the next 6 months. Use the label on the box to note the date of opening the bag.

Medications should not be disposed of through drains or trash. Deposit the containers and unused medications at the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition of Formodual Nexthaler

• The active principles are: anhydrous beclometasone dipropionate and formoterol fumarate dihydrate.

Each dose contains 100 micrograms of anhydrous beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a dose released from the mouthpiece of 81.9 micrograms of anhydrous beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.

• The other components are: lactose monohydrate (which contains small amounts of milk proteins) and magnesium stearate.

Appearance of the product and contents of the package

The medication is an inhalation powder, white or almost white in color, contained in a plastic inhaler called Nexthaler.

Each package contains one, two, or three inhalers that provide 120 or 180 inhalations each.

Each inhaler comes inside a thermosealed protective bag (aluminum foil package).

Only some package sizes may be marketed.

Marketing Authorization Holder:

Chiesi España S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L'Hospitalet de Llobregat - Barcelona (Spain)

Manufacturer and batch release responsible:

Chiesi Farmaceutici S.p.A.

Via San Leonardo 9643122 Parma - Italy

O

Chiesi S.A.S.

2 rue des Docteurs Alberto and Paolo Chiesi

41260 La Chaussée Saint-Victor

France

O

Chiesi Pharmaceuticals GmbH

Gonzagagasse 16/16

1010 Vienna - Austria

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: July 2021

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.

You can access detailed information on how to administer this medication by scanning the QR code included in the leaflet and packaging with your smartphone.

You can also access the same information on the following internet address:

https://cima.aemps.es/info/76740