FORMODUAL 100 micrograms / 6 micrograms / actuation pressurized solution for inhalation

Introduction

Package Leaflet: Information for the User

Formodual 100micrograms/6micrograms/puff Pressurised inhalation solution

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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Formodual and what is it used for

Formodual is a pressurised inhalation solution that contains two active substances that are inhaled through the mouth and released directly into the lungs.

The two active substances are beclometasone dipropionate and formoterol fumarate dihydrate. Beclometasone dipropionate belongs to a group of medicines called corticosteroids that have an anti-inflammatory action which reduces inflammation and irritation in your lungs.

Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators that relax the muscles in the airways so that you can breathe more easily.

These two active substances combined make it easier to breathe, 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

Formodual is indicated for the regular treatment of asthma in adult patients in whom:

• Asthma is not adequately controlled with inhaled corticosteroids and short-acting bronchodilators administered "as needed".

Or:

• Asthma is well controlled with a combination treatment of corticosteroids and long-acting bronchodilators.

COPD

Formodual may also be used to treat symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic disease of the airways in the lungs that is mainly caused by smoking cigarettes.

2. What you need to know before you use Formodual

Do not use Formodual:

• If you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate or if you are allergic to other medicines or inhalers used to treat asthma or to any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information), ask your doctor for advice.

Warnings and precautions

Consult your doctor or pharmacist or nurse before using Formodual:

• If you have heart problems, such as angina (heart pain, chest pain), a recent heart attack (myocardial infarction), heart failure, narrowing of the arteries that supply the heart (coronary heart disease), heart valve disease or any other known heart abnormality, or if you have a disease called hypertrophic obstructive cardiomyopathy (also known as HOCM, where the heart muscle is enlarged).

• If you have narrowing of the arteries (also known as arteriosclerosis), if you have high blood pressure or if you know you have an aneurysm (an abnormal bulge in the blood vessel wall).

• If you have heart rhythm disorders, such as increased heart rate or irregular heartbeat, have a rapid pulse or suffer from palpitations, or have been informed that you have electrocardiographic abnormalities.

• If your thyroid gland is overactive.

• If your blood potassium levels are low.

• If you have any liver or kidney disease.

• If you are diabetic (inhalation of high doses of formoterol may cause an increase in blood glucose levels and therefore you may need to have additional blood tests to monitor your blood sugar levels when you start using the inhaler and from time to time during treatment).

• If you have a tumour of the adrenal glands (called phaeochromocytoma).

• If you are going to have an anaesthetic. Depending on the anaesthetic agent, you may need to stop using Formodual at least 12 hours before the anaesthetic.

• If you are going to be treated or have been treated for tuberculosis (TB) or if you have a known viral or fungal lung infection.

• If you cannot drink alcohol for any reason.

If any of the above applies to you, always inform your doctor before using Formodual.

If you have or have had medical problems or allergies or if you are not sure if you can use Formodual, consult your doctor, nurse or pharmacist before using the inhaler.

Treatment with a beta2 agonist such as the formoterol contained in Formodual may cause a sudden fall in blood potassium levels (hypokalaemia).

Be particularly careful if you have severe asthma.The reason is that lack of oxygen in the blood and other treatments you may be receiving with Formodual, such as medicines for heart disease or high blood pressure (known as diuretics) or other medicines used to treat asthma, may worsen the fall in potassium levels. Therefore, your doctor will want to check your blood potassium levels from time to time.

If you take higher doses of inhaled corticosteroids for long periods, you may need corticosteroids in stressful situations. These situations include hospitalisation after an accident, severe injury or before surgery. In such cases, the doctor treating you will decide whether it is necessary to increase the dose of corticosteroids and may prescribe tablets or injections of steroids.

If you go to hospital, remember to take all your medicines and inhalers, including Formodual and any other medicines or tablets you have bought without a prescription, with you to the hospital, if possible in their original packaging.

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

Children and adolescents

Formodual should not be used in children and adolescents under 18 years of age, until more data are available.

Other medicines and Formodual

Tell your doctor if you are using or have recently used other medicines, including those obtained without a prescription.

Some medicines may increase the effects of Formodual, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Do not use beta-blockers with this medicine. If you need to use beta-blockers (including eye drops), the effect of formoterol may be reduced or even nullified. On the other hand, the use of other beta-adrenergic drugs (drugs that work in the same way as formoterol) may enhance the effects of formoterol.

The combined use of Formodual with:

• Medicines for treating heart rhythm disorders (quinidine, disopyramide, procainamide), medicines for treating allergic reactions (antihistamines), medicines for treating symptoms of depression or mental disorders, such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazid), tricyclic antidepressants (e.g. amitriptyline and imipramine) and phenothiazines, may cause electrocardiographic changes (ECG, electrocardiogram). They may also increase the risk of heart rhythm disorders (ventricular arrhythmias).

• Medicines for treating Parkinson's disease (L-dopa) or for treating an underactive thyroid gland (L-thyroxine), medicines that contain oxytocin (which causes the uterus to contract) and alcohol, may reduce cardiac tolerance to beta2 agonists such as formoterol.

• Monoamine oxidase inhibitors (MAOIs), including drugs with similar properties, such as furazolidone and procarbazine, used to treat mental disorders, may cause an increase in blood pressure.

• Medicines for treating heart disease (digoxin), may cause a fall in blood potassium levels. This may increase the risk of heart rhythm disorders.

• Other medicines used to treat asthma (theophylline, aminophylline or steroids) and diuretics, may cause a fall in blood potassium levels.

• Some anaesthetics may increase the risk of heart rhythm disorders.

Pregnancy, breast-feeding and fertility

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

Do not use Formodual if you are pregnant or think you may be pregnant, if you plan to become pregnant or if you are breast-feeding, unless your doctor advises you to do so.

Driving and using machines

Formodual has no or negligible influence on the ability to drive and use machines.

Formodual contains alcohol

Formodual contains 7 mg of alcohol (ethanol) in each puff, which is equivalent to 0.20 mg/kg per dose of two puffs. The amount in two puffs of this medicine is equivalent to less than 1 ml of wine or beer. The small amount of alcohol in this medicine does not produce any noticeable effect.

3. How to use Formodual

Formodual is for inhalation use only.

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

Asthma

Your doctor will perform periodic reviews to ensure that you are taking the optimal dose of Formodual. Your doctor will always adjust the treatment to the minimum dose that best controls your symptoms.

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

1. Use Formodual daily to treat your asthma along with a separate "rescue" inhaler to treat sudden worsening of asthma symptoms, such as difficulty breathing, wheezing, and coughing
2. Use Formodual daily to treat your asthma and also use Formodual to treat sudden worsening of asthma symptoms, such as difficulty breathing, wheezing, and coughing

1. Using Formodual with a separate "rescue" inhaler.

Adults and elderly patients:

The recommended dose of this medication is one to two puffs twice a day.

The maximum daily dose is 4 puffs.

Remember: You should always carry a rapid-acting "rescue" inhaler with you to treat worsening asthma symptoms or a sudden asthma attack.

1. Using Formodual as the only inhaler for asthma:

Adults and elderly patients:

The recommended dose of this medication is one puff in the morning and one puff in the evening.

You should also use Formodual as a "rescue" inhaler to treat sudden asthma symptoms.

If you have asthma symptoms, inhale one 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 Formodual 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.

Use in children and adolescents under 18 years of age:

Children and adolescents under 18 years of age should NOT take this medication.

COPD

Adults and elderly patients:

The recommended dose is two puffs in the morning and two puffs in the evening.

Patients at risk:

Elderly patients do not need to have their dose adjusted. There is no information available on the use of Formodual in patients with liver or kidney problems.

Formodual is effective for the treatment of asthma at a dose of beclometasone dipropionate that may be lower than that of other inhalers containing the same component. If you have previously been using another inhaler that contained beclometasone dipropionate, your doctor will advise you on the exact dose of Formodual you should take for asthma.

Do not increase the dose.

If you think the medication is not very effective, always consult your doctor before increasing the dose.

If you use more Formodual than you should

• If you use more formoterol than you should, you may experience the following adverse effects: nausea, vomiting, rapid heartbeat, palpitations, heart rhythm disorders, certain electrocardiographic changes (heart signal), headache, tremors, drowsiness, excess acid in the blood, low potassium levels in the blood, and high glucose levels in the blood. Your doctor may request blood tests to check your potassium and glucose levels in the blood.
• Taking too much beclometasone dipropionate may cause short-term changes in the functioning of the adrenal glands. This situation will improve in a few days; however, your doctor may check your cortisol level in the serum.

Consult your doctor if you experience any of these symptoms.

If you forget to use Formodual:

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 stop treatment with Formodual:

Do not decrease the dose or stop using the medication.

Even if you feel better, do not stop using Formodual or decrease the dose. If you want to do so, consult your doctor. It is very important to use Formodual regularly even if you do not have symptoms.

If your breathing difficulties increase:

If, immediately after inhaling the medication, your difficulty breathing or wheezing (audible wheezing) worsens, stop using Formodual immediately and use your rapid-acting inhaler right away. Contact your doctor quickly. Your doctor will evaluate the symptoms and, if necessary, modify the treatment. See also section 4 "Possible side effects".

If your asthma worsens:

If your symptoms worsen or become difficult to control (for example, if you increase the frequency of use of the separate rapid-acting inhaler or Formodual as a rescue inhaler), or if the rapid-acting inhaler or Formodual does not contribute to improving the symptoms, go to the doctor immediately. Your asthma may be worsening, and your doctor may need to modify the dose of Formodual or prescribe an alternative treatment.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Method of administration:

This medication is in a pressurized container inside a plastic casing with a mouthpiece.

There is a counter on the back of the inhaler, which indicates how many doses are left. Each time you press the container, a puff of medication is released, and the counter decrements one dose. Avoid dropping the inhaler, as this could cause the counter to decrement a dose.

Checking the inhaler

Before using the inhaler for the first time, or if you have not used it for 14 days or more, you must check your inhaler to ensure it is working correctly.

1. Remove the protective cap from the mouthpiece.
2. Hold the inhaler upright with the mouthpiece at the bottom.
3. Direct the mouthpiece away from you and firmly press the container to release a dose.
4. Check the dose counter. If you are checking your inhaler for the first time, the counter should indicate 120.

How to use your inhaler

When possible, stand or sit upright to perform the inhalation.

1. Remove the protective cap from the mouthpiece and check that it is clean, i.e., that there are no dust, dirt, or other foreign particles.
2. Exhale slowly and deeply as much as possible.
3. Hold the container upright with the body facing up and place the mouthpiece between your lips. Do not bite the mouthpiece.
4. Inhale slowly and deeply through your mouth, and just as you start to inhale, firmly pressthe top of the inhaler to release a dose. If you have weakness in your hands, you may find it easier to hold the inhaler with both hands, placing your two index fingers on the top of the inhaler and your two thumbs on the bottom of the inhaler.
5. Hold your breath for as long as you can, and finally, remove the inhaler from your mouth and exhale slowly. Do not blow into the inhaler.

In case you need to inhale a new dose, hold the inhaler upright for about half a minute, and then repeat steps 2 to 5.

Important: Do not perform steps 2 to 5 too quickly.

After administration, close with the protective cap and check the dose counter.

You should have a replacement inhaler when the counter shows the number 20. Stop using the inhaler when the counter reads 0, as even if there are remaining puffs in the device, they may not be sufficient to take the full dose.

If some of the gas escapes from the top of the inhaler or from the corner of your lips, it means that Formodual will not reach your lungs as it should. Take another dose following the instructions, starting again from step 2.

To reduce the risk of fungal infection in the mouth and throat, rinse your mouth or gargle with water or brush your teeth each time you use the inhaler.

If you think the effect of Formodual is too strong or insufficient, consult your doctor or pharmacist.

If you find it difficult to press the inhaler while starting to inhale, you can use the AeroChamber Plus device. Consult your doctor, pharmacist, or nurse about using this device.

It is essential that you read the leaflet that comes with the AeroChamber Plus device and carefully follow the instructions on how to use the AeroChamber Plus device and how to clean it.

Cleaning

You should clean the inhaler once a week. When you clean it, do not remove the pressurized container from the device, and do not use water or other liquids to clean the inhaler.

To clean the inhaler:

1. Remove the mouthpiece cap from the inhaler.
2. Pass a clean, dry cloth or paper through the inside and outside of the mouthpiece and device.
3. Put the mouthpiece cap back on.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

As with other inhaler treatments, there is a risk of worsening breathing difficulties and wheezing immediately after using Formodual, which is known as paradoxical bronchospasm. If this happens, STOP using Formodualand use your rapid-acting inhaler immediately to treat breathing difficulty and wheezing symptoms. Contact your doctor immediately.

Tell your doctor immediately if you experience hypersensitivity reactions, such as skin allergies, itching, rash, redness, swelling of the skin or mucous membranes, especially in the eyes, face, lips, and throat.

Other side effects are listed below according to their frequency.

Common(at least 1 in 10 patients):

Fungal infections (of the mouth and throat), headache, hoarseness, sore throat.

Pneumonia (lung infection) in patients with COPD: inform your doctor if you have any of the following symptoms while inhaling Formodual; they could be symptoms of a lung infection:

• Fever or chills
• Increased mucus production, change in mucus color
• Increased coughing or increased breathing difficulties

Uncommon(at least 1 in 100 patients):

Palpitations, exceptionally fast heartbeat, and heart rhythm disorders, certain electrocardiographic changes (ECG).

Flu-like symptoms, fungal infections of the vagina, sinusitis (inflammation of the paranasal sinuses), rhinitis, ear inflammation, throat irritation, cough, and productive cough, asthma attacks.

Nausea, changes or decrease in taste, burning of the lips, dry mouth, difficulty swallowing, indigestion, stomach discomfort, diarrhea.

Muscle pain and cramps, facial redness, increased blood flow in certain tissues of the body, excessive sweating, tremors, restlessness, dizziness, rash or hives.

Changes in certain blood components: decreased white blood cell count, increased platelet count, decreased potassium levels in the blood, increased glucose levels in the blood, increased insulin levels, free fatty acids, and ketones in the blood.

The following side effects have also been reported as "uncommon" in patients with Chronic Obstructive Pulmonary Disease.

• Decreased cortisol levels in the blood; this is caused by the effect of corticosteroids on your adrenal gland.
• Irregular heartbeats.

Rare(at least 1 in 1,000 patients)

Chest tightness, feeling of missed heartbeats (due to premature contraction of the heart ventricles), increased or decreased blood pressure, kidney inflammation, persistent swelling of the skin and mucous membranes for several days.

Very rare(at least 1 in 10,000 patients)

Difficulty breathing, worsening of asthma, decreased platelet count, swelling of the hands and feet.

Unknown

Blurred vision

Inhaling corticosteroids at high doses for a prolonged period may cause systemic effects in very rare cases:these include problems with the functioning of the adrenal glands (suppression of adrenal function), decreased bone density (weakening of bones), growth retardation in children and adolescents, increased intraocular pressure (glaucoma), cataracts.

Sleep disorders, depression, or feeling worried, restless, nervous, overexcited, or irritable: these effects may occur especially in children, but their frequency is unknown.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish Medicines Agency's Pharmacovigilance System for Human Use https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Formodual

Keep this medication out of sight and reach of children.

Single pack containing 1 inhaler of 120 doses

Do not use Formodual after 3 months from the date it was dispensed by your pharmacist and never use it after the expiration date shown on the box and label. Do not store the inhaler at a temperature above 25°C.

Double pack containing 2 inhalers of 120 doses

Before use: Store the inhaler in the refrigerator (at 2-8°C).

After first use: Use the inhaler for a maximum of 3 months and do not store at a temperature above 25°C. Do not use the inhaler after this period and never use it after the expiration date shown on the box and label. Do not freeze.

If the inhaler has been exposed to intense cold, warm it up with your hands for a few minutes before use. Never heat it artificially.

Warning: The container contains a pressurized liquid. Do not expose the container to temperatures above 50°C. Do not puncture the container.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Formodual

• The active ingredients are: beclometasone dipropionate, formoterol fumarate dihydrate.

Each puff of the dosing valve contains 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a released dose from the mouthpiece of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate.

• The other ingredients are: anhydrous ethanol, hydrochloric acid, propellant: norflurane (HFC-134a). This medication contains fluorinated greenhouse gases. Each inhaler contains 8.147 g of norflurane (HFC-134a), which corresponds to 0.012 tons of CO2 equivalent (global warming potential GWP = 1430).

Appearance of the product and package contents

Formodual is a pressurized solution contained in an aluminum-coated container with a dosing valve, equipped with a plastic polypropylene actuator with a protective cap.

Each pack contains a container that provides 120 puffs.

Only some pack sizes may be marketed.

Marketing authorization holder:

Chiesi Spain S.A.U.

Plaza de 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

Alternative manufacturing sites responsible for manufacturing and batch release:

Chiesi S.A.S.

2 rue des Docteurs Alberto et Paolo Chiesi

41260 La Chaussée Saint-Victor

France

Chiesi Pharmaceuticals GmbH

Gonzagagasse 16/16

Vienna-1010 - Austria

This medication is authorized in the following Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following trademarks:

Austria: Formodual

France: Formodual

Germany: Kantos Master

Greece: Inuvair

Hungary: Formodual

Italy: Inuver

Spain: Formodual

Belgium: Inuvair

Norway: Inuxair

Luxembourg: Inuvair

Sweden: Innovair

Poland: Formodual

Portugal: Formodual

Slovenia: Formodual

Netherlands: Formodual

United Kingdom: Formodual

Bulgaria: Foster

Cyprus: Foster

Denmark: Innovair

Estonia: Foster

Finland: Innovair

Latvia: Foster

Lithuania: Foster

Romania: Foster

Date of the last revision of this leaflet:November 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.