Prospect: information for the patient

FormodualNexthaler 200micrograms/6micrograms per inhalation powder for inhalation.

dipropionato de beclometasona anhidra/fumarato de formoterol dihidrato

For use in adults.

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, nurse or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, nurse or pharmacist, even if they are not listed in this prospect. See section 4.

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.

• Beclometasone dipropionate belongs to a group of medications called corticosteroids that have an anti-inflammatory action, reducing inflammation and irritation in your lungs.

• Formoterol fumarate dihydrate belongs to a group of medications called long-acting bronchodilators, which 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 and also help prevent asthma symptoms, such as difficulty breathing, wheezing, and coughing.

Formodual Nexthaler is used to treat asthma in adults.

If you have been prescribed Formodual Nexthaler, it is likely that:

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

or:

• Your asthma is responding well to a combination treatment of corticosteroids and long-acting bronchodilators.

No use Formodual Nexthaler:

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

Warnings and precautions

Do not use this medication to treat acute asthma symptoms, such as difficulty breathing, wheezing, and coughing, or in case of worsening or acute asthma attacks. To alleviate symptoms, use the rapid-acting inhaler, which should always be carried with you.

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

• Cardiac problems, including any known heart disease or cardiac function disorder.

• Arrhythmias, such as increased heart rate or irregular heart rhythm, rapid pulse, or palpitations, or if you have been informed that you have alterations in the electrocardiogram.

• High blood pressure.

• Arterial narrowing (also known as arteriosclerosis) or if you know you have an aneurysm (an abnormal bulge in the blood vessel wall).

• Hyperactive thyroid gland.

• Low levels of potassium in the blood.

• Any liver or kidney disease.

• Diabetes. Inhaling high doses of formoterol may cause an increase in blood glucose levels, and you will need to undergo additional blood tests to control blood sugar levels when starting this medication and occasionally during treatment.

• Adrenal gland tumor (pheochromocytoma).

• If you are to receive anesthesia. Depending on the anesthetic agent, you may need to discontinue use of Formodual Nexthaler for at least 12 hours before anesthesia.

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

Consult your doctor before starting to use Formodual Nexthaler if you are in any of the mentioned circumstances.

If you are unsure, consult your doctor, nurse, or pharmacist before starting to use Formodual Nexthaler.

Your doctor may want to check your potassium levels in the blood from time to time, especially if you have severe asthma.Like many 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 with Formodual Nexthaler, which can worsen the decrease in potassium levels.

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

In case you need to go to the hospital, remember to bring all your medications and inhalers, including Formodual Nexthaler and other medications or tablets purchased without a prescription, if possible, 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 taking, have taken recently, or may need to take any other medication.This is because Formodual Nexthaler may affect the way some medications work.

Additionally, some medications may affect the way Formodual Nexthaler works.

Particularly, inform 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 perform close monitoring if you are taking these medications (including some for HIV: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medications used to treat various conditions, such as cardiac 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 canceled.
• Beta-adrenergic medications (medications with the same action as formoterol) may increase the effects of formoterol.
• Medications to treat arrhythmias (quinidine, disopyramide, procainamide).
• Medications to treat allergic reactions (antihistamines such as terfenadine).
• Medications to treat depression or psychiatric disorders such as monoamine oxidase inhibitors (e.g. phenelzine, isocarboxazid) or tricyclic antidepressants (e.g. amitriptyline and imipramine), or phenothiazines.
• Medications to treat Parkinson's disease (levodopa).
• Medications to treat hypothyroidism (levotiroxine).
• Medications containing oxytocin (which causes uterine contraction).
• Medications used to treat psychiatric disorders such as monoamine oxidase inhibitors (MAO), including similar substances, such as furazolidone and procarbazine.
• Medications to treat cardiac diseases (digoxin).
• Other medications used to treat asthma (theophylline, aminophylline, or steroids)
• Diuretics

Also inform your doctor if you are to receive general anesthesia for a surgical or dental procedure.

Pregnancy, breastfeeding, and fertility

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 if you should stop using Formodual Nexthaler during breastfeeding or if you should use Formodual Nexthaler and abstain from breastfeeding. Always follow your doctor's advice strictly.

Driving and operating machinery

It is unlikely that Formodual Nexthaler will affect your ability to drive and operate machinery. However, your ability to drive and operate machinery may be affected if you experience side effects such as dizziness or tremors.

Formodual Nexthaler contains lactose

Lactose contains small amounts of milk proteins, which may cause allergic reactions.If your doctor has indicated that you have an intolerance to certain sugars, consult with them before using 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 releases extrafine particles, resulting in a higher dose being released in your lungs. For this reason, your doctor may prescribe a lower dose of this inhaler compared to your previous inhalers.

Your doctor will conduct regular check-ups to ensure you are administering the optimal dose of Formodual Nexthaler. When your asthma is well-controlled, your doctor may consider gradually reducing the dose of Formodual Nexthaler. Do not modify the dose without consulting your doctor first.

How much Formodual Nexthaler to use:

Adults and elderly population:

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

The maximum daily dose is 4 inhalations.

Do not increase the dose.

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

Remember: you must always carry the quick-acting inhaler with you in case your asthma symptoms worsen or if you experience a sudden asthma attack.

How to use Formodual Nexthaler:

Formodual Nexthaler is for inhalation use.

When possible, 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 take any necessary measures.
• In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, Teléfono 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. However, if it is almost time to take the next dose, skip the missed dose and only take the next dose at the scheduled time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Formodual Nexthaler:

Although you may 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 to take 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, check the correct usage instructions described in this leaflet and/or contact your doctor, nurse, or pharmacist to explain the instructions again.

If your asthma worsens:

If your symptoms worsen or become difficult to control (for example, if you increase the frequency of use of the quick-acting inhaler), or if the quick-acting inhaler does not contribute to improving symptoms, you should continue using Formodual Nexthaler but see your doctor as soon as possible. Your doctor may need to adjust the dose of Formodual Nexthaler or prescribe an alternative or additional 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 package contents do not match the description in section 6, return it to the person who provided it and obtain a new one.

1. General warnings and precautions

• Do not remove 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.
• Do not attempt to disassemble your Nexthaler inhaler under any circumstances.

1. Main characteristics of the Nexthaler inhaler

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

1. Before using a new Nexthaler inhaler

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

1. How to use your Nexthaler inhaler

• If you are unsure of the correct dose, contact your pharmacist or doctor.
• If you are unsure if 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. Opening

E.2. Inhalation

When possible, stand or sit upright while inhaling.

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

• Do not cover the vent when holding the inhaler.
• Do not inhale through the vent.

1. Breathe in suddenly and deeply through your mouth.

• You may notice a taste while taking the dose.
• You may hear or feel a click when taking the dose.
• Do not inhale through your nose.
• Do not remove the inhaler from your lips during inhalation.

1. Remove the inhaler from your mouth.
2. Hold your breath for 5 to 10 seconds or as long as possible.
3. Breathe out slowly.

• Do not exhale through the inhaler.

E.3. Closing

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.

1. Repeat steps E.1 to E.3 if you need to take another dose.

1. Cleaning

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

1. Storage and Disposal

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

Like all medicines, this medicine 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, which is known asparadoxical bronchospasm. If this happens,IMMEDIATELY STOP using Formodual Nexthaleranduse your quick-acting 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(may affect 1 in 10 patients):

• shakiness.

Occasional(may affect 1 in 100 patients):

• flu-like symptoms, throat irritation
• oral and throat fungal infections. To prevent these side effects, rinse your mouth or gargle with water or brush your teeth immediately after using the inhaler.
• worsening of asthma symptoms, difficulty breathing
• hoarseness
• cough
• exceptionally fast heart rate
• exceptionally slow heart rate
• chest tightness
• headache
• nausea
• feeling tired or nervous
• electrocardiogram (ECG) abnormalities
• decrease in cortisol concentration in urine or blood
• increase in potassium concentration in blood
• increase in blood glucose concentration
• increase in blood fatty acid concentration.

Unknown(frequency cannot be estimated with available data)

Blurred vision

Side effects observed in similar inhalation medicationscontaining dipropionate beclometasone, formoterol, or both are:

• palpitations
• irregular heartbeat
• alteration or decrease in sense of taste
• muscle pain and cramps
• restlessness, dizziness
• anxiety
• sleep disturbances
• decrease in potassium concentration in blood
• increase/decrease in blood pressure

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

• problems with adrenal gland function (suppression of adrenal function)
• bone weakening
• delayed growth in children and adolescents
• increased intraocular pressure (glaucoma), cataracts
• rapid weight gain, particularly in the face and trunk
• sleep disturbances, depression, or feeling anxious, restless, nervous, overexcited, or irritable. These effects may occur more frequently in children.
• abnormal behavior.

Reporting of side effects

If you experience any type of side effect, consult your doctor, nurse, or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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. Only remove the inhaler from its bag immediately before the first use.

Before opening the bag for the first time:

This medication does not require any special storage temperature.

After opening the bag for the first time:

Do not store at a temperature above 25°C.

After opening the bag for the first time, the medication must be used before 6months.

Use the label on the box to note the date of opening the bag.

Medicines should not be disposed of through the drains or in the trash. Deposit the containers and medicines that you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Formodual Nexthaler

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

Each dose contains 200 micrograms of anhydrous beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a dose released from the mouthpiece of 158.8 micrograms of anhydrous beclometasone dipropionate and 4.9 micrograms of formoterol fumarate dihydrate.

The other components are: lactose monohydrate and magnesium stearate.

Appearance of the product and contents of the package

Formodual Nexthaler 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 inhalations each.

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

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Chiesi España, S.A.U.

Plaza de Europa, 41-43, 10th floor

08908 L'Hospitalet de Llobregat - Barcelona (Spain)

Manufacturer responsible for the release of batches:

Chiesi Farmaceutici S.p.A.

Via San Leonardo 96

43122 Parma - Italy

Alternative manufacturer responsible for the release of batches:

Chiesi S.A.S.

2 rue des Docteurs Alberto and Paolo Chiesi

41260 La Chaussée Saint Victor - France

Alternative manufacturer responsible for the release of batches:

Chiesi Pharmaceuticals GmbH

Gonzagagasse 16/16

1010 Vienna – Austria

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

Last review date of this leaflet:July 2021

More detailed information about this medicine 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 medicine by scanning with your mobile phone (Smartphone) the QR code included in the leaflet and packaging.

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

https://cima.aemps.es/info/80708