Foster Nexthaler 200 micrograms/6 micrograms per inhalation powder for inhalation

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

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

anhydrous beclometasone dipropionate/formoterol fumarate dihydrate

For use in adults.

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

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor, nurse or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Foster Nexthaler is and what it is used for

Foster Nexthaler is a powder that is inhaled through the mouth and released deeply 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 inflammation and irritation in the lungs.

• Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators, which relax the muscles in the airways, causing them to widen, thereby facilitating the flow of air into and out of the lungs.

The combination of these two active substances helps to make breathing easier and also helps to prevent asthma symptoms such as difficulty breathing, wheezing, and coughing.

Foster Nexthaler is used to treat asthma in adults.

If Foster Nexthaler has been prescribed for you, it is likely because:

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

or:

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

2. What you need to know before using Foster Nexthaler

Do not use Foster Nexthaler:

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

Do not use this medicine to treat acute asthma symptoms such as difficulty breathing, wheezing, or coughing, or during worsening or acute asthma attacks. To relieve symptoms, you must use a fast-acting inhaler, which you should always carry with you.

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

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

• Heart rhythm disorders, such as increased heart rate or irregular heartbeat, rapid pulse, palpitations, or if you have been informed of abnormalities in your electrocardiogram.

• High blood pressure.

• Narrowing of the arteries (also known as atherosclerosis) or if you know you have an aneurysm (an abnormal bulging of the blood vessel wall).

• Overactive 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 concentration, and therefore you may require additional blood tests to monitor your blood sugar when starting this medicine and periodically during treatment.

• Tumour of the adrenal glands (called phaeochromocytoma).

• If you are going to receive anaesthesia. Depending on the anaesthetic agent, you may need to stop using Foster Nexthaler at least 12 hours before anaesthesia.

• If you are currently being treated or have previously been treated for tuberculosis (TB), or if you have a known viral or fungal infection in the lungs.

Always consult your doctor before starting to use Foster if you are in any of the situations mentioned above.

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

Your doctor may want to periodically check your blood potassium levels, especially if you have severe asthma. Like many other bronchodilators, Foster Nexthaler may cause a sudden decrease in serum potassium concentration (hypokalaemia). This is because lack of oxygen in the blood, combined with other treatments you may be taking alongside Foster Nexthaler, can worsen the reduction in potassium levels.

If you take high doses of inhaled corticosteroids for prolonged periods, you may require additional corticosteroids during times of stress. Such situations include hospital admission following an accident, serious injury, or prior to surgery. In such cases, your treating doctor will decide whether corticosteroid dosage needs to be increased and may prescribe steroid tablets or injections.

If you need to go to hospital, remember to bring all your medicines and inhalers with you, including Foster Nexthaler and any other medicines or over-the-counter products you are using, preferably in their original packaging.

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

Children and adolescents

Do not use this medicine in children and adolescents under 18 years of age.

Using Foster Nexthaler with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Foster Nexthaler may affect how some medicines work.

In addition, some medicines may affect how Foster Nexthaler works.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Some medicines may increase the effects of Foster Nexthaler, so your doctor will monitor you closely if you are taking these (including some used for HIV: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines used to treat various conditions such as 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 blocked.
• Beta-adrenergic medicines (medicines with the same action as 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 psychiatric disorders such as monoamine oxidase inhibitors (e.g. phenelzine, isocarbazide) or tricyclic antidepressants (e.g. amitriptyline and imipramine), or phenothiazines.
• Medicines used to treat Parkinson’s disease (levodopa).
• Medicines used to treat hypothyroidism (levothyroxine).
• Medicines containing oxytocin (which causes uterine contractions).
• Medicines used to treat psychiatric 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.

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

Pregnancy, breastfeeding, and fertility

There are no clinical data available on the use of Foster Nexthaler during pregnancy.

If you think you might be pregnant or plan to become pregnant, consult your doctor before using this medicine. During pregnancy, you should only use Foster Nexthaler if prescribed by your doctor. Your doctor will advise whether you should stop using Foster Nexthaler during breastfeeding or whether you should use Foster Nexthaler and avoid breastfeeding. Always follow your doctor’s advice strictly.

Driving and using machines

It is unlikely that Foster Nexthaler will affect your ability to drive or use machines. However, your ability to drive or use machines may be impaired if you experience side effects such as dizziness or tremors.

Foster Nexthaler contains lactose

Lactose contains small amounts of milk proteins, which may cause allergic reactions.

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before using this medicine.

3. How to use Foster Nexthaler

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor, nurse, or pharmacist again.

Foster Nexthaler releases extrafine particles, resulting in a higher dose being delivered to your lungs. For this reason, your doctor may prescribe you a lower dose of this inhaler compared to your previous inhalers.

Your doctor will periodically review you to ensure you are receiving the optimal dose of Foster Nexthaler. When your asthma is well controlled, your doctor may consider gradually reducing the dose of Foster Nexthaler. Under no circumstances should you modify the dose without first consulting your doctor.

How much Foster Nexthaler to use:

Adults and elderly population:

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 think the medicine is not effective, always consult your doctor before increasing the dose.

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

How to use Foster Nexthaler:

Foster Nexthaler is for inhalation use only.

Whenever possible, when inhaling, stand or sit upright.

If you use more Foster Nexthaler than you should:

• contact your doctor or the nearest hospital emergency department immediately. Take the medicine with you so they can check what has been taken;
• adverse effects may occur. Inform your doctor of any unusual symptoms so they can carry out additional tests or decide on any necessary measures.
• in case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested (or go to a medical center).

If you forget to use Foster Nexthaler:

Take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and simply take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop treatment with Foster Nexthaler:

Even if you feel better, do not stop using Foster Nexthaler or reduce the dose. If you wish to do so, consult your doctor. It is very important that you take Foster Nexthaler every day as prescribed by your doctor, even if you have no symptoms.

If your breathing difficulties do not improve:

If your symptoms do not improve after inhaling Foster Nexthaler, you may not be using it correctly. In this case, check the instructions for correct use described in this leaflet and/or contact your doctor, nurse, or pharmacist to have the instructions explained again.

If your asthma worsens:

If symptoms worsen or become difficult to control (for example, if you increase the frequency of use of your fast-acting "rescue" inhaler), or if the fast-acting inhaler does not help improve symptoms, you should continue using Foster Nexthaler but see your doctor as soon as possible. Your doctor may need to adjust the dose of Foster Nexthaler or prescribe an alternative or additional treatment.

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

INSTRUCTIONS FOR USE OF THE NEXTHALER INHALER

1. Contents of the pack

For information on the pack contents, see section 6.

If the pack contents do not match those described in section 6, return it to the person who supplied it and obtain a new one.

1. General warnings and precautions

• Do not remove the inhaler from the protective pouch if you are not going to use it immediately.
• Use your inhaler only as directed.
• Keep the inhaler cap closed until you need to take a dose.
• When not in use, keep the inhaler in a clean, dry place.
• Do not attempt to disassemble your Nexthaler inhaler under any circumstances.

1. Main features of the Nexthaler inhaler

Taking a dose from the Nexthaler inhaler involves three simple steps: Open, Inhale, Close.

1. Before using a new Nexthaler inhaler

2. Open the protective pouch and remove your inhaler.

   • Do not use your inhaler if the protective pouch is not sealed or is damaged – return it to the person who supplied it and obtain a new one.
   • Record the date you opened the pouch on the label of the box.

3. Check your inhaler.

   • If your inhaler appears broken or damaged, return it to the person who supplied it and obtain a new one.

4. Check the dose counter window. If your inhaler is new, you should 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 supplied it and obtain a new one.

1. How to use your Nexthaler inhaler

• If you are unsure whether you are taking the correct dose, contact your pharmacist or doctor.
• If you are unsure whether the dose counter has decreased by one after your inhalation, wait until your next scheduled dose and take it as normal. Do not take an extra dose.

E.1. Opening

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

• If the dose counter window shows “0”, no doses remain – discard the inhaler and obtain a new one.
  1. Fully open the protective cap.

1. Before inhaling, breathe out comfortably.

• Do not breathe out through the inhaler.

E.2. Inhalation

Whenever possible, when inhaling, stand or sit upright.

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

• Do not block the air vent when holding the inhaler.
• Do not inhale through the air vent.

1. Breathe in quickly 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 breathe out through the inhaler.

E.3. Closing

1. Return the inhaler to an upright position and fully close the protective cap.
2. Check that the dose counter has decreased by one unit.

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

2. Cleaning

• Normally, it is not necessary to clean your inhaler.
• If needed, you may clean the inhaler after use with a dry cloth or dry paper towel.
• 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.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

As with other treatments using inhalers, there is a risk of worsening breathing difficulty, cough, or wheezing immediately after using Foster Nexthaler, known as paradoxical bronchospasm. If this occurs, STOP using Foster Nexthaler immediately and use your fast-acting inhaler right away to treat the symptoms. Contact your doctor immediately.

Contact 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 in the eyes, face, lips, or throat.

Other possible adverse effects of Foster Nexthaler are listed below, classified by frequency.

Frequent (may affect up to 1 in 10 patients):

• tremors.

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

• flu-like symptoms, throat irritation
• fungal infections (of the mouth and throat). To prevent these adverse effects, rinse your mouth or gargle with water, or brush your teeth immediately after using the inhaler.
• worsening asthma symptoms, difficulty breathing
• hoarseness
• cough
• unusually fast heartbeat
• unusually slow heartbeat
• sensation of chest tightness
• headache
• nausea
• feeling of tiredness or nervousness
• changes in the electrocardiogram (ECG)
• decreased cortisol concentration in urine or blood
• increased potassium concentration in blood
• increased blood glucose concentration
• increased concentration of free fatty acids in blood.

Adverse effects observed with similar inhaled medicines containing beclometasone dipropionate, formoterol, or both include:

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

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

Blurred vision

Prolonged inhalation of corticosteroids at high doses may cause systemic effects, including:

• adrenal gland function problems (adrenal suppression)
• bone weakening
• growth retardation in children and adolescents
• increased intraocular pressure (glaucoma), cataracts
• rapid weight gain, particularly in the face and trunk
• sleep disorders, depression, or feelings of worry, restlessness, nervousness, overexcitement, or irritability. These effects may occur more frequently in children.
• abnormal behaviour.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, nurse, or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Foster Nexthaler

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 bag, and the label, following "EXP". The expiry date refers to the last day of the month indicated.

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

Before first opening the bag:

This medicine has no special storage temperature requirements.

After first opening the bag:

Do not store above 25°C.

After first opening the bag, the medicine should be used within 6 months.

Use the label on the carton to record the date the bag was opened.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Foster Nexthaler

The active substances are: beclometasone dipropionate anhydrous 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 delivered 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 pack

Foster Nexthaler 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 120 inhalations.

Each inhaler comes in a sealed protective pouch (aluminum foil blister pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Chiesi España, S.A.U.

Plaça d’Europa, 41-43, Planta 10

08908 L'Hospitalet de Llobregat - Barcelona (Spain)

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 Member States of the European Economic Area under the following names:

Austria: Foster NEXThaler	Netherlands: Foster NEXThaler
France: Innovair NEXThaler	Poland: Fostex NEXThaler
Czech Republic: Combair Nexthaler	Portugal: Foster NEXThaler
Greece: Foster NEXThaler	Slovak Republic: Foster NEXThaler
Hungary: Foster NEXThaler	Slovenia: Foster NEXThaler
Italy: Foster	United Kingdom: Fostair NEXThaler
Germany: KANTOS NEXThaler 200 Microgram/6 Microgram per Inhalation Powder for Inhalation

Date of the most recent review of this leaflet: July 2021

Detailed information about this medicinal product is available on the website of the Spanish Agency of 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 at the following internet address:

https://cima.aemps.es/info/80707