Leaflet: information for the patient

Foster Nexthaler 100 micrograms/6 micrograms inhalation powder for inhalation

dipropionato de beclometasona anhidra/fumarato de formoterol dihidrato

For use in adults

Read this leaflet carefully before you start using this medicine,because it contains important information for you.

• Keep this leaflet, as 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, 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.

Foster 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

Foster Nexthaler is used to treat asthma in adults

Foster Nexthaler is prescribed for you because:

• 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.

COPD

Foster 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.

Do not use Foster 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 Foster 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 rhythm, 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 that you have an aneurysm (an abnormal bulging of the blood vessel wall)

• hyperactive thyroid gland

• low blood potassium levels

• 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 Foster 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 lung infections.

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

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

Your doctor may want to check your blood potassium levels from time to time, especially if you have severe asthma.Like other bronchodilators, Foster 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 Foster 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 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 of hospital admission, remember to bring with you all your medications and inhalers, including Foster Nexthaler and any other medications or tablets you have purchased without a prescription, preferably in their original packaging.

Notify 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 Foster 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 Foster Nexthaler may affect the way other medications work. Also, some medications may affect the way Foster 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 Foster 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 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 to treat hypothyroidism (L-thyroxine).
• Medications containing oxytocin (which causes uterine contraction).
• Medications to treat mental disorders such as monoamine oxidase inhibitors (MAOIs), 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 undergo general anesthesia for surgery or dental procedures.

Pregnancy and breastfeeding

No clinical data are available on the use of Foster 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 Foster Nexthaler if your doctor has indicated it. Your doctor will tell you whether to stop using Foster Nexthaler during breastfeeding, or whether to use Foster Nexthaler and avoid breastfeeding. Always follow your doctor's advice.

Driving and operating machinery

Foster Nexthaler is unlikely to affect your ability to drive and operate machinery. However, your ability to drive and operate machinery may be affected if you experience dizziness and/or tremors.

Foster 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.

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

Asthma

Your doctor will conduct regular check-ups to ensure you are taking the optimal dose of Foster Nexthaler. Your doctor will always adjust the treatment to the minimum dose that best controls your symptoms.Do not modify the dose without consulting your doctor first.

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

1. Use Foster 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 Foster Nexthaler daily to treat your asthma and also use Foster Nexthaler to treat a sudden worsening of asthma symptoms, such as difficulty breathing, wheezing and coughing.

1. Use of Foster 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 should always carry a rapid-acting rescue inhaler with you to treat a worsening of asthma symptoms or a sudden asthma attack.

1. Use of Foster 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 should also use Foster 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 Foster Nexthaler is 8 puffs.

If you think 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, always 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 Foster Nexthaler:

Foster Nexthaler is for inhalation use.

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

If you use more Foster 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 Toxicology Information Service, Teléfono 91 562 04 20 indicating the medication and the amount ingested (or visit a medical center).

If you forgot to use Foster Nexthaler:

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

If you interrupt treatment with Foster Nexthaler:

Although you may feel better, do not stop using Foster Nexthaler or reduce the dose. If you want to do so, consult your doctor. It is very important for you to use Foster 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 Foster Nexthaler, you may not be using it correctly. In this case, you should check the correct usage 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 Foster Nexthaler as a rescue inhaler increases, or if the rapid-acting inhaler or Foster Nexthaler does not contribute to improving symptoms), or if the rapid-acting inhaler or Foster Nexthaler does not contribute to improving symptoms, you should continue using Foster Nexthaler but you should see your doctor immediately. Your asthma may be worsening and your doctor may need to adjust the dose of Foster 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 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.
• Under no circumstancestry to disassemble your Nexthaler inhaler.

1. Main features 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 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 not use 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 available.

3. Open the protective cap completely.

4. Before inhaling, exhale until you feel comfortable.

E.2. Inhale

Whenever 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 exhalation port when holding the inhaler.
• Do not inhale through the exhalation port.

2. Breathe in deeply and forcefully 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 not exhale 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 not clean 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 medicines, Foster 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, coughing, and wheezing immediately after using Foster Nexthaler, known asparadoxical bronchospasm. If this happens,STOP using Foster 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 Foster Nexthaler are listed below, grouped by frequency.

Frequent(in at least 1 in 10 patients):

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

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

• Fever or chills
• Increased mucus production, change in mucus color
• Increased coughing 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
• Coughing
• Abnormally fast heart rate
• Abnormally slow heart rate
• Sensation of chest tightness
• Headache
• Nausea
• Feeling tired 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 decreased 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:

• Suppressed adrenal function (suppression of adrenal function)
• Weakened 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 leaflet. You can also report them directly through the national notification system included in the Spanish System of Pharmacovigilance of Medicines 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 medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Foster Nexthaler Composition

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

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

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

Product Appearance and Packaging Contents

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 packaging).

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 96

43122 Parma - Italy

Or

Chiesi S.A.S.

2 rue des Docteurs Alberto and Paolo Chiesi

41260 La Chaussée Saint-Victor

France

Or

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 with your 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/76713