Formodual Nexthaler 100 micrograms/6 micrograms inhalation powder for inhalation

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

For use in adults

Beclometasone dipropionate anhydrous/formoterol fumarate dihydrate

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, consult your doctor, nurse, or pharmacist.
• This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, nurse, or pharmacist, even if these effects are not listed in this leaflet.

Leaflet contents:

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

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

Formodual Nexthaler is a powder that is inhaled through your mouth and delivered deep into your 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 that reduces swelling and irritation in your 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. This makes it easier for air to move in and out of the lungs.

The combination of these two active substances helps you breathe more easily by providing relief from symptoms such as breathlessness, wheezing, and coughing in patients with asthma or COPD. It also helps prevent asthma symptoms.

Asthma

Formodual Nexthaler is used to treat asthma in adults.

You have been prescribed Formodual Nexthaler because:

• Your asthma is not sufficiently controlled with 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

Formodual 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 Formodual Nexthaler

Do not use Formodual 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

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 disorder

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

• high blood pressure

• narrowing of the arteries (also known as arteriosclerosis), 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 require additional blood tests to monitor your blood sugar when starting treatment with the inhaler and periodically during treatment.

• tumour of the adrenal glands (called phaeochromocytoma)

• you are going to receive anaesthesia. Depending on the anaesthetic agent used, you may need to stop using Formodual 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 apply to you, always 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 check your blood potassium levels from time to time, especially if you have severe asthma. Like other bronchodilators, Formodual Nexthaler may cause a sudden drop in serum potassium concentration (hypokalaemia). This is because lack of oxygen in the blood combined with other treatments you may be taking alongside Formodual 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 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.

When going to hospital, remember to bring all your medicines and inhalers with you, including Formodual 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.

Using Formodual 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 Formodual Nexthaler may affect how other medicines work. Also, some medicines may affect how Formodual 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 Formodual Nexthaler, so your doctor will monitor you closely if you are taking these (including some for HIV: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines used to treat various heart conditions, 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 and isocarboxazid) or tricyclic antidepressants (e.g.: amitriptyline and imipramine) or phenothiazines.
• Medicines used to treat Parkinson's disease (L-dopa).
• Medicines used to treat an underactive thyroid gland (L-thyroxine).
• 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 or pharmacist if you are going to receive general anaesthesia for surgery or dental procedures.

Pregnancy and breastfeeding

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

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

Formodual Nexthaler should only be used during pregnancy if prescribed by your doctor. Your doctor will advise you whether you should stop using Formodual Nexthaler during breastfeeding, or whether you should continue using Formodual Nexthaler and discontinue breastfeeding. Always follow your doctor’s advice strictly.

Driving and using machines

It is unlikely that Formodual 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.

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 him before taking this medicine.

3. How to use Formodual Nexthaler

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

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

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

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

3. Use of Formodual Nexthaler together with a separate “rescue” inhaler:

Adults and elderly:

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

The maximum daily dose is 4 inhalations.

Remember: You must always carry a fast-acting “rescue” inhaler to treat worsening asthma symptoms or a sudden asthma attack.

1. Use of Formodual Nexthaler as the sole inhaler for asthma:

Adults and elderly:

The recommended dose is one inhalation in the morning and one inhalation at night.

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

If you experience asthma symptoms, inhale one dose and wait a few minutes.

If you do not feel better, inhale another dose.

Do not inhale more than 6 rescue doses per day.

The maximum daily dose of Formodual Nexthaler is 8 inhalations.

If you feel you need more inhalations per day to control your asthma symptoms, contact your doctor for advice. Your treatment may need to be changed.

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 inhalations in the morning and 2 inhalations at night.

How to use Formodual Nexthaler:

Formodual Nexthaler is for inhalation use only.

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

If you use more Formodual Nexthaler than you should

• Contact your doctor or the nearest hospital emergency department immediately. Take the medicine with you so they can see what has been taken;
• Adverse effects may occur. 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, 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 Formodual 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 scheduled dose. Do not double the dose.

If you stop using Formodual Nexthaler

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

If your breathing difficulties do not improve:

If your symptoms do not improve after inhaling Formodual Nexthaler, you may not be using it correctly. In this case, review the correct usage instructions 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 Formodual Nexthaler as a rescue inhaler), or if the fast-acting inhaler or Formodual Nexthaler does not help improve symptoms, continue using Formodual Nexthaler but contact 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 questions about using this medicine, ask your doctor or pharmacist.

INSTRUCTIONS FOR USING 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 its protective pouch 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 circumstances should you attempt to disassemble your Nexthaler inhaler.

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.
   • Use the label on the box to write the date when you opened the protective pouch.

3. Inspect 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 usual. Do not take an extra dose.

E.1. Open

1. Hold the inhaler firmly in an upright position.

2. Check the number of remaining doses: 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 comfortable.
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.

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 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, Formodual Nexthaler can cause adverse effects, although not everyone experiences them.

As with other inhaled treatments, there is a risk of worsening breathing difficulty, cough, or wheezing immediately after using Formodual Nexthaler, a phenomenon known as paradoxical bronchospasm. If this occurs, DISCONTINUE use of Formodual Nexthaler and immediately use your fast-acting inhaler to treat 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, particularly around the eyes, face, lips, and throat.

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

Frequent (at least 1 in 10 patients):

• Tremor
• Pneumonia (lung infection) in patients with COPD

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

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

Uncommon (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 with water, gargle, or brush your teeth after using the inhaler.
• Worsening asthma symptoms, difficulty breathing
• Hoarseness
• Cough
• Exceptionally rapid heartbeat
• Exceptionally slow heartbeat
• Sensation of chest tightness
• Headache
• Nausea
• Feeling of tiredness or nervousness
• Electrocardiographic (ECG) abnormalities
• Decreased cortisol concentration in urine or blood
• Increased blood potassium concentration
• Increased blood glucose concentration
• Increased concentration of free fatty acids in blood

Frequency not known (frequency cannot be estimated from 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
• Feeling irritable
• Sleep disorders
• Decreased blood potassium concentration
• Increased/decreased blood pressure

Inhaled corticosteroids at high doses over a prolonged period 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 anxiety, restlessness, nervousness, over-excitement, or irritability. These effects may occur more frequently in children.
• Abnormal behaviour.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at https://www.notificaram.es.

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

5. Storage of Formodual 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 after "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 should 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Formodual 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 (which contains 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 powder for inhalation, contained in a plastic inhaler called Nexthaler.

Each pack contains one, two, or three inhalers, each providing 120 or 180 inhalations.

Each inhaler comes in 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 Member States of the European Economic Area under the following names:

Belgium: Inuvair NEXThaler	Greece: Inuvair NEXThaler
Bulgaria: Foster NEXThaler	Ireland: Fostair Nexthaler 100 micrograms/6 micrograms per metered dose inhalation powder
Cyprus: Foster NEXThaler	Italy: Inuver
Denmark: Innovair Nexthaler	Latvia: Foster NEXThaler 100 mikrogrami/6 mikrogrami deva inhalacijas pulveris
Estonia: Foster NEXThaler	Lithuania: Foster
Finland: Innovair nexthaler 100 mikrog/6mikrog/annos inhalaatiojauhe	Luxembourg: Inuvair NEXThaler
France: Formodual NEXThaler	Norway: Inuxair
Germany: KANTOS MASTER NEXThaler 100 Mikrogramm / 6 Mikrogramm pro Dosis Pulver zur Inhalation for inhalation	Romania: Foster NEXThaler 100 micrograme/6 micrograme pe doza pulbere de inhalat
	Spain: Formodual NEXThaler
	Sweden: Innovair nexthaler

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

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (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/76740