Foster Nexthaler 100 micrograms/6 micrograms/inhalation powder for inhalation

Patient Information Leaflet

Introduction

Patient Information Leaflet

Foster Nexthaler 100 micrograms/6 micrograms per inhalation, powder for inhalation

anhydrous beclometasone dipropionate/formoterol fumarate dihydrate

For use in adults

Read the 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 may 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.

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 is Foster Nexthaler and what is it used for

Foster Nexthaler is a powder that is inhaled through your mouth and released deep into your 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 by reducing swelling and irritation in your lungs.

• Formoterol fumarate dihydrate belongs to a group of medicines known as long-acting bronchodilators, which relax the muscles in the airways, causing them to widen, thus making it easier for air to flow in and out of the lungs.

These two active substances, when combined, help you breathe more easily by providing relief from symptoms such as breathlessness, wheezing, and coughing in patients with asthma or COPD, and also help prevent asthma symptoms.

Asthma

Foster Nexthaler is used to treat asthma in adults.

You have been prescribed Foster Nexthaler because:

• Your asthma is not adequately 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.

COPD

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

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

Talk to 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 disorder

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

• high blood pressure

• narrowing of the arteries (also called atherosclerosis), or if you know you have an aneurysm (an abnormal bulging of the blood vessel wall)

• overactive thyroid gland

• low potassium levels in the blood

• any liver or kidney disease

• diabetes. Inhaling high doses of formoterol may increase blood glucose levels and therefore you may need additional blood tests to monitor your blood sugar when you start using the inhaler and periodically during treatment.

• tumour of the adrenal glands (called phaeochromocytoma)

• 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.

• you are being treated or have previously been treated for tuberculosis (TB), or if you have a known viral or fungal lung infection.

If any of the above conditions apply to you, always 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 (hypokalaemia). This is because lack of oxygen in the blood, combined with other treatments you may be taking at the same time as Foster Nexthaler, can worsen the decrease 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 before 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 go to hospital, remember to bring all your medicines and inhalers with you, including Foster Nexthaler and any other medicines or tablets 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 medicine in children and adolescents under 18 years of age.

Use of Foster Nexthaler with other medicines

Tell 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 other medicines work. Also, some medicines may affect how Foster Nexthaler works.

In particular, contact 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 medicines (including some for HIV: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines 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 blocked.
• Beta-adrenergic medicines (medicines with the same action as formoterol) may increase the effects of formoterol.
• Medicines for treating heart rhythm disorders (quinidine, disopyramide, procainamide).
• Medicines for treating allergic reactions (antihistamines such as terfenadine).
• Medicines for treating symptoms of depression or psychiatric disorders such as monoamine oxidase inhibitors (e.g.: phenelzine and isocarboxazide) or tricyclic antidepressants (e.g.: amitriptyline and imipramine) or phenothiazines.
• Medicines for treating Parkinson's disease (L-dopa).
• Medicines for treating an underactive thyroid gland (L-thyroxine).
• Medicines containing oxytocin (which causes uterine contractions).
• Medicines for treating psychiatric disorders such as monoamine oxidase inhibitors (MAOIs), including drugs with similar properties, such as furazolidone and procarbazine.
• Medicines for treating heart disease (digoxin).
• Other medicines used to treat asthma (theophylline, aminophylline or steroids).
• Diuretics.

Also, inform your doctor or pharmacist if you are going to receive general anaesthesia for surgery or any dental procedure.

Pregnancy and breastfeeding

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

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

Foster Nexthaler should only be used during pregnancy if prescribed by your doctor. Your doctor will advise you whether you should stop using Foster Nexthaler during breastfeeding, or whether you should continue using 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 and use machines may be impaired 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 him before taking 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 delivers an extrafine particle size distribution resulting in a higher dose delivered to your lungs. Therefore, your doctor may prescribe a lower dose of this inhaler compared to your previous inhalers.

Asthma

Your doctor will review you periodically to ensure you are taking the optimal dose of Foster Nexthaler. Your doctor will always adjust treatment to the lowest dose that best controls your symptoms. Under no circumstances should you change the dose without first consulting your doctor.

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

1. Use Foster Nexthaler daily to treat your asthma, together with a separate “reliever” inhaler to treat 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 as a reliever to treat sudden worsening of asthma symptoms such as difficulty breathing, wheezing, and coughing

3. Use of Foster Nexthaler together with a separate “reliever” inhaler:

Adults and elderly:

The recommended dose of this medicine is 1 or 2 inhalations twice daily.

The maximum daily dose is 4 actuations.

Remember: Always carry a fast-acting “reliever” inhaler with you to treat worsening asthma symptoms or a sudden asthma attack.

1. Use of Foster Nexthaler as the only inhaler for asthma:

Adults and elderly:

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

You should also use Foster Nexthaler as a “reliever” inhaler to treat sudden asthma symptoms.

If you have asthma symptoms, inhale one actuation and wait a few minutes.

If you do not feel better, inhale another actuation.

Do not inhale more than 6 reliever actuations per day.

The maximum daily dose of Foster Nexthaler is 8 actuations.

If you feel you need more actuations 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 medicine 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 actuations in the morning and 2 actuations in the evening.

How to use Foster Nexthaler:

Foster Nexthaler is for inhalation use only.

Whenever possible, patients should be standing or sitting upright when inhaling.

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 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. If it is almost time for your next dose, do not take the missed dose; simply take the next dose as scheduled. Do not double the dose.

If you stop using 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 use Foster Nexthaler every day as prescribed by your doctor, even if you have no 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 instructions for correct use described below and/or contact your doctor or nurse for retraining.

If asthma worsens:

If symptoms worsen or become difficult to control (for example, if you increase the frequency of use of the separate fast-acting inhaler or Foster Nexthaler as a reliever), or if the fast-acting inhaler or Foster Nexthaler does not help improve symptoms, continue using Foster Nexthaler but contact 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 further questions about the use of this medicine, ask your doctor or pharmacist.

INSTRUCTIONS FOR USING THE NEXTHALER INHALER

1. Contents of the pack

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

If the contents of the pack differ from 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 pouch if you are not going to use it immediately.
• Use your inhaler only 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 circumstances attempt to dismantle your Nexthaler inhaler.

1. Main features of the Nexthaler inhaler

Taking a dose from the Nexthaler inhaler requires 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.
   • Use the label on the box to write the date you opened the protective pouch.

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 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 whether you are receiving the dose correctly, 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. Open

1. Hold the inhaler firmly in an upright position.

2. Check the number of doses remaining: any number between “1” and “120 or 180” indicates that doses remain.

   • If the dose counter window shows “0”, no doses are left – discard the inhaler and obtain a new one.

3. Fully open the protective cap.

1. Before inhaling, breathe out until comfortable.
   • Do not breathe out through the inhaler.

E.2. Inhale

Whenever possible, stand or sit upright when inhaling.

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

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

2. Breathe in quickly and deeply through your mouth.

   • You may notice a taste while taking the dose.
   • You may hear or feel a click while 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 you can comfortably manage.
3. Breathe out slowly.
   • Do not breathe out through the inhaler.

E.3. Close

1. Return the inhaler to an upright position and completely 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 necessary, 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, Foster Nexthaler can cause adverse effects, although not everyone experiences them.

As with other treatments using inhalers, there is a risk of worsening breathing difficulty, cough, or wheezing immediately after using Foster Nexthaler. This is known as paradoxical bronchospasm. If this occurs, STOP using Foster Nexthaler and immediately use your fast-acting inhaler 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, and throat.

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

Frequent (affects at least 1 in 10 patients):

• tremors.
• pneumonia (lung infection) in patients with COPD.

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

• fever or chills
• increased mucus production, change in mucus color
• increased coughing or worsening breathing difficulty

Uncommon (affects at least 1 in 100 patients):

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

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

• blurred vision.

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

• palpitations
• cardiac rhythm disorders
• taste disturbances or reduced sense of taste
• muscle pain and cramps
• restlessness, dizziness
• irritability
• sleep disorders
• decreased potassium concentration in blood
• increased/decreased blood pressure.

Inhalation of corticosteroids at high doses over a prolonged period may cause systemic effects, including:

• adrenal gland function problems (adrenal suppression)
• weakening of bones
• 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 anxiety, restlessness, nervousness, over-excitement, or irritability. These effects may occur more frequently in children.
• abnormal behavior.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the national reporting system included in the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es.

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, bag, and 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 the bag immediately before first use.

Before first opening of the bag:

This medicine does not require any special storage temperature.

After first opening of the bag:

Do not store above 25°C.

After first opening of the bag, the medicine must be used within 6 months. Use the label on the carton to record the date the bag was opened.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Foster Nexthaler

• The active substances 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 delivered 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 (containing small amounts of milk proteins) and magnesium stearate.

Appearance of the medicine and contents of the pack

The 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 120 or 180 inhalations.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Chiesi España S.A.U.

Plaça d’Europa, 41-43, Planta 10

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 et Paolo Chiesi

41260 La Chaussée Saint-Victor

France

Or

Chiesi Pharmaceuticals GmbH

Gonzagagasse 16/16

1010 Vienna - Austria

This medicine is authorized in the European Economic Area member states under the following names:

Austria: Foster NEXThaler	The Netherlands: Foster NEXThaler
France: Innovair NEXThaler	Poland: Fostex NEXThaler
Czech Republic: Combair Nexthaler	Portugal: Foster NEXThaler
Germany: KANTOS NEXThaler 100 microgram / 6 microgram per dose powder for inhalation
	Slovak Republic: Foster NEXThaler
Greece: Foster NEXThaler	Slovenia: Foster NEXThaler 100 micrograms /6 micrograms per inhalation, powder for inhalation
Hungary: Foster NEXThaler	Spain: Foster NEXThaler
Italy: Foster NEXThaler	United Kingdom: Fostair NEXThaler

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

Detailed information on 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/76713