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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Formodual Nexthaler 200 micrograms/6 micrograms per inhalation, powder for inhalation.

anhydrous beclometasone dipropionate/formoterol fumarate dihydrate

For use in adults.

Read all of 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, 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, because it may harm them.
• If you experience any side effects, talk to your doctor, nurse or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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 the mouth and delivered deep 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 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, thereby facilitating airflow into and out of the lungs.

The combination of these two active substances helps you breathe more easily and also helps prevent asthma symptoms such as breathlessness, wheezing, and coughing.

Formodual Nexthaler is used to treat asthma in adults.

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

• Your asthma is not adequately controlled with inhaled corticosteroids and short-acting bronchodilators used "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 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

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, use your fast-acting inhaler, which you must always carry with you.

Consult your doctor before starting Formodual 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, irregular heartbeat, rapid pulse, or palpitations, or if you have been informed of abnormalities in your electrocardiogram.

• High blood pressure.

• Narrowing of the arteries (also known as arteriosclerosis) or if you know you have an aneurysm (an abnormal bulging of a 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 increase blood glucose levels; therefore, additional blood tests to monitor blood sugar levels may be needed when you start using this medicine and periodically during treatment.

• A tumor of the adrenal glands (called phaeochromocytoma).

• If you are due to receive anesthesia. Depending on the anesthetic agent, you may need to stop using Formodual Nexthaler at least 12 hours before anesthesia.

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

Always consult your doctor before starting Formodual Nexthaler if you are in any of the situations mentioned above.

If you are unsure, consult your doctor, nurse, or pharmacist before using Formodual Nexthaler.

Your doctor may want to periodically check your blood potassium levels, especially if you have severe asthma. Like many other bronchodilators, Formodual Nexthaler may cause a sudden drop in serum potassium levels (hypokalaemia). This is because low oxygen levels 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 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 need to go to hospital, remember to bring all your medicines and inhalers with you, including Formodual Nexthaler and any other medications 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 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 some medicines work.

In addition, some medicines may affect how Formodual 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 Formodual 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 to treat heart rhythm disorders (quinidine, disopyramide, procainamide).
• Medicines to treat allergic reactions (antihistamines such as terfenadine).
• Medicines to treat depression or psychiatric disorders such as monoamine oxidase inhibitors (e.g. phenelzine, isocarboxazid) or tricyclic antidepressants (e.g. amitriptyline, imipramine), or phenothiazines.
• Medicines to treat Parkinson's disease (levodopa).
• Medicines 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 to treat heart disease (digoxin).
• Other medicines used to treat asthma (theophylline, aminophylline, or steroids).
• Diuretics.

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

Pregnancy, breastfeeding, and fertility

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. During pregnancy, Formodual Nexthaler should only be used if prescribed by your doctor. Your doctor will advise whether you should stop using Formodual Nexthaler during breastfeeding or whether you should continue using Formodual Nexthaler and refrain from 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 or use machines may be impaired 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 diagnosed you with an intolerance to certain sugars, consult him before using this medicine.

3. How to use Formodual Nexthaler

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

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

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

How much Formodual Nexthaler to use:

Adults and elderly patients:

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 feel 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 Formodual Nexthaler:

Formodual Nexthaler is for inhalation use only.

Whenever possible, stand or sit 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 check 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 amount ingested (or go to a medical center).

If you forget to use Formodual Nexthaler:

Take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only the next dose at the usual time. Do not take a double dose to make up for a missed 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 take Formodual 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 Formodual Nexthaler, you may not be using it correctly. In this case, review 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 your symptoms worsen or become difficult to control (for example, if you need to use your fast-acting "rescue" inhaler more frequently), or if the fast-acting inhaler does not help improve your symptoms, 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 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 pack contents, see section 6.

If the contents of the pack 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 its protective pouch unless you are 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 in use, store the inhaler in a clean, dry place.
• Do not attempt to dismantle 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. 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 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 usual. 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 until comfortable.

• Do not breathe out through the inhaler.

E.2. Inhaling

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.

1. Breathe in sharply 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 you comfortably can.
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.

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

2. Cleaning

• Normally, there is no need to clean your inhaler.
• If necessary, you may wipe 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, this medicine may cause adverse effects, although not everyone experiences them.

As with other treatments using inhalers, there is a risk of worsening breathing difficulty, cough, and wheezing immediately after using Formodual Nexthaler, known as paradoxical bronchospasm. If this occurs, STOP using Formodual 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, and throat.

Other possible adverse effects of Formodual Nexthaler are listed below according to their 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 of asthma symptoms, difficulty breathing
• hoarseness
• cough
• exceptionally rapid heartbeat
• exceptionally slow heartbeat
• sensation of chest tightness
• headache
• nausea
• feeling of tiredness or nervousness
• changes in the electrocardiogram (ECG)
• decreased concentration of cortisol in urine or blood
• increased concentration of potassium in blood
• increased concentration of glucose in blood
• increased concentration of free fatty acids in blood.

Unknown (frequency cannot be estimated from available data):

Blurred vision

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

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

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

• adrenal gland 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 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 these effects are 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 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, the bag, and the label, after "EXP". The expiry date is 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 does not require any special storage conditions.

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. Dispose of containers and unused medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Formodual 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.

Presentation of the product and pack contents

Formodual Nexthaler is a white or almost white inhalation powder, contained in a plastic inhaler device called Nexthaler.

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

Each inhaler is supplied within a sealed protective pouch (aluminum foil pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Chiesi España, S.A.U.

Plaza de 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 European Economic Area member states under the following names:

Belgium: Inuvair NEXThaler	Greece: Inuvair NEXThaler
Bulgaria: Foster NEXThaler	Ireland: Fostair Nexthaler
Cyprus: Foster NEXThaler	Italy: Inuver
Denmark: Innovair Nexthaler	Latvia: Foster NEXThaler
Estonia: Foster NEXThaler	Lithuania: Foster
Finland: Innovair nexthaler	Luxembourg: Inuvair NEXThaler
France: Formodual NEXThaler	Norway: Inuxair
Germany: KANTOS MASTER NEXThaler 200 Microgram/6 Microgram per Inhalation Powder for Inhalation	Romania: Foster 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 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 this information at the following internet address:

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