Formodual

Package leaflet: Information for the user

Formodual, (200 micrograms + 6 micrograms)/inhalation dose, inhalation aerosol,
solution
Beclometasone dipropionate + Formoterol fumarate dihydrate
Medicinal product intended for use in adults.
Please 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, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Formodual is and what it is used for

Formodual is a solution in an inhalation aerosol containing two active substances which, when inhaled through the mouthpiece of the inhaler, go directly into the lungs.
Formodual contains two active substances:
Beclometasone dipropionate, belonging to a group of medicines called corticosteroids, which work by reducing inflammation through decreasing swelling and irritation in the lungs.
Formoterol fumarate dihydrate, belonging to a group of long-acting bronchodilator medicines, which relax the muscles in the airways and make breathing easier.
Together, these two active substances help you breathe more easily. They also help prevent asthma symptoms such as: breathlessness, wheezing, and coughing.
Formodual is intended for the treatment of asthma in adults.
Formodual is used in patients:

• whose asthma symptoms are not adequately controlled with inhaled corticosteroids and a short-acting bronchodilator used as needed, or
• who have achieved adequate control of asthma symptoms with both inhaled corticosteroids and long-acting bronchodilators.

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2. Important information before using Formodual

When not to use Formodual:

• if the patient is allergic to beclometasone dipropionate or formoterol fumarate dihydrate, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Formodual, discuss this with your doctor, pharmacist, or
nurse:

• if the patient has heart diseases such as: angina pectoris (chest pain), heart failure, coronary artery disease (narrowing of the heart arteries), heart valve disorders, or any other heart conditions
• if the patient has high blood pressure or a diagnosed aneurysm (abnormal widening of a blood vessel wall)
• if the patient has heart rhythm disorders such as rapid or irregular heartbeat, increased pulse rate, or palpitations, or if there is any history of abnormal heart rhythm
• if the patient has overactive thyroid gland
• if the patient has low potassium levels in the blood
• if the patient has liver or kidney disease
• if the patient has diabetes (inhalation of high doses of formoterol may increase blood glucose levels; therefore, additional blood tests to monitor blood sugar levels may be necessary before starting treatment and periodically during therapy)
• if the patient has a tumour of the adrenal gland (pheochromocytoma)
• if general anaesthesia is planned. Depending on the type of anaesthesia, it may be necessary to discontinue Formodual at least 12 hours before the procedure
• if the patient is currently being treated or has ever been treated for pulmonary tuberculosis, or if the patient has a viral or fungal infection in the chest area
• if the patient must avoid alcohol consumption for any reason.

Always inform your doctor before using Formodual if any of the above warnings apply to you.
Consult your doctor, pharmacist, or nurse if you currently have or have had any medical conditions or allergies, or if you are unsure whether Formodual can be used.
Your doctor may periodically order blood tests to check potassium levels, especially in patients with severe asthma. Like other bronchodilator medicines, Formodual may cause a sudden decrease in serum potassium levels (hypokalaemia). This is associated with low oxygen levels in the blood and may be worsened by concomitant use of other medications, further reducing potassium levels.

If the patient has been using high doses of inhaled corticosteroids for a prolonged period, additional corticosteroid therapy may be required during periods of stress. Stress situations include hospital admission following an accident, serious injury, or prior to surgery. In such cases, your doctor will decide whether to increase the corticosteroid dose or may recommend alternative steroid therapy in tablet form or by injection.

If hospitalization is required, the patient should remember to bring all medications and inhalers, including Formodual, as well as any over-the-counter medicines, preferably in their original packaging.

If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Children and adolescents
Formodual must not be used in children and adolescents under 18 years of age.

Formodual and other medicines
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, including over-the-counter medicines.

This is necessary because Formodual may affect the action of certain other medicines. Likewise, some medicines may affect the action of Formodual.

In particular, inform your doctor, pharmacist, or nurse if the patient is taking the following medicines:

• certain medicines may enhance the effect of Formodual, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV medications: ritonavir, cobicistat);
• beta-blockers. Beta-blockers are medicines used to treat various conditions including heart diseases, high blood pressure, and glaucoma (increased pressure within the eye). If beta-blockers must be used (including eye drops), the effect of formoterol may be reduced or formoter0l may not work at all;
• beta-adrenergic agonists (medicines that act similarly to formoterol) – may enhance the effect of formoterol;
• medicines used to treat abnormal heart rhythms (quinidine, disopyramide, procainamide);
• medicines used to treat allergies (antihistamines);
• medicines used to treat depression or psychiatric disorders, such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazid), tricyclic antidepressants (e.g. amitriptyline and imipramine), phenothiazines;
• medicines used to treat Parkinson’s disease (L-dopa);
• medicines used to treat hypothyroidism (L-thyroxine);
• medicines containing oxytocin (which cause uterine contractions);
• medicines used to treat psychiatric disorders such as monoamine oxidase inhibitors (MAOIs) or medicines with similar properties, such as furazolidone and procarbazine;
• medicines used to treat heart diseases (digoxin);
• other medicines used to treat asthma (theophylline, aminophylline, or steroids);
• diuretics (water tablets).

You should also inform your doctor if the patient has planned general anaesthesia for surgery or a dental procedure.

Pregnancy, breastfeeding and fertility

There are no clinical data on the use of Formodual during pregnancy.
Formodual must not be used if the patient is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, unless otherwise directed by a doctor.
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Driving and operating machinery
It is unlikely that Formodual will affect the ability to drive or operate machinery.

Formodual contains alcohol
Formodual contains 9 mg of alcohol (ethanol) per spray, which is equivalent to 0.25 mg/kg body weight per dose when two sprays are used. The amount of alcohol in two sprays of this medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to use Formodual

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Your doctor will regularly check whether you are taking the optimal dose of Formodual.
The doctor will determine the lowest dose that provides the best control of asthma symptoms.
Dosage:
Adults and elderly patients
The recommended dose is two sprays twice daily.
The maximum daily dose is four sprays.
Important: Always carry a fast-acting inhaled medicine for relief to treat worsening asthma symptoms or sudden asthma attacks.
Special patient groups:
There is no need to adjust the dosage in elderly patients. There is insufficient information
regarding the use of Formodual in patients with impaired liver or kidney function.
Use in children and adolescents under 18 years of age:
This medicine must NOT be used in children and adolescents under 18 years of age.
The dose of beclometasone dipropionate contained in Formodual that is effective
in treating asthma may be lower than the dose contained in other inhaled medicines
containing beclometasone dipropionate. If the patient previously used another inhaled medicine
containing beclometasone dipropionate, the doctor will recommend the appropriate dose of Formodual.
Do not increase the dose.
If you feel the medicine is not working adequately, always consult your doctor before increasing the dose.
In case of worsening asthma symptoms:
If asthma symptoms worsen or become difficult to control (e.g. if you need to use your reliever inhaler more frequently), or if your reliever inhaler does not relieve symptoms, contact your doctor immediately. This may indicate worsening asthma, and your doctor may decide to change the dosage of Formodual or initiate alternative treatment.
Method of administration:
Formodual is intended for inhalation use only.
This medicine comes in a pressurized container made of plastic, fitted with a mouthpiece.
At the back of the inhaler is a dose counter showing how many doses remain. Each time the inhaler is pressed, a dose is released and the counter decreases by one. Be careful not to drop the inhaler, as this may cause an unintended dose to be dispensed.
Inhaler test:
Before first use, or if the inhaler has not been used for 14 days or longer, perform an inhaler test to ensure it is working properly.

• Before first testing the inhaler, check that the dose counter displays the number 121.
• Remove the protective cap from the mouthpiece.
• Hold the container upright with the mouthpiece pointing downwards.
• Point the mouthpiece away from you and firmly (strongly) press the top of the container to release one spray.
• Check the dose counter. After the first test, the dose counter should display the number 120.

How to use the inhaler:
If possible, stand or sit upright during inhalation.
Before inhaling, check the dose counter: any number between "1" and "120" indicates that doses remain in the container. If the dose counter shows "0", no doses remain, and you should discard the old inhaler and obtain a new one.

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust or other debris.
2. Breathe out as deeply and slowly as possible.
3. Hold the container upright with the body pointing upwards, then place the mouthpiece between your lips. Do not bite down on it.
4. Take a deep and slow breath in through your mouth. Just as you begin to inhale, firmly (strongly) press the top of the inhaler to release one spray. For people with weak grip, it may be easier to hold the inhaler with both hands: place both index fingers on the top of the inhaler and both thumbs on the base.
5. Hold your breath as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not breathe out into the inhaler.

To take a second dose, keep holding the inhaler upright for about half a minute, then repeat steps 2 to 5.
Important: Do not perform steps 2 to 5 too quickly.
After use, replace the protective cap and check the dose counter.
To reduce the risk of developing a fungal infection of the mouth or throat, rinse your mouth or throat with water immediately after each inhalation, or brush your teeth.
When the dose counter shows 20, you should have a new inhaler ready.
Stop using the inhaler when the counter shows 0, as any remaining medicine in the container may not deliver a full dose.
If you see a "mist" above the top opening of the mouthpiece or around the mouth, this means Formodual is not reaching your lungs as it should. Take another dose according to the instructions, starting again from step 2.
If you feel that the effect of Formodual is too strong or too weak, consult your doctor or pharmacist.
If you have difficulty using the inhaler during inhalation, you may use a spacer device (spacer) AeroChamber Plus. Ask your doctor or pharmacist about this device.
It is important to carefully read the leaflet provided with the AeroChamber Plus spacer and follow the instructions for use and cleaning recommendations.
Cleaning the inhaler:
The inhaler should be cleaned once a week.
Do not remove the container from the plastic housing. Do not use water or other liquids to clean the inhaler.
Cleaning the inhaler:

1. Remove the protective cap by pulling it off the inhaler.
2. Wipe the mouthpiece and actuator inside and outside with a dry cloth or tissue.
3. Replace the protective cap.

Use of a higher than recommended dose of Formodual

• Using more formoterol than recommended may cause the following symptoms: nausea, vomiting, faster heartbeat, palpitations, heart rhythm disturbances, changes in the electrocardiogram (ECG), headache, tremor, drowsiness, excess acid metabolites in the blood, decreased blood potassium levels, increased blood glucose levels. Your doctor may recommend a blood test to check potassium and glucose levels.
• Using too high a dose of beclometasone dipropionate may cause temporary adrenal gland function disturbances, which resolve spontaneously within a few days. Your doctor may recommend a blood test to check serum cortisol levels. If any of these symptoms occur, inform your doctor.

Missed dose of Formodual
Take the missed dose as soon as possible. If it is almost time for the next dose, do not take the missed dose; instead, take the next dose at the usual scheduled time. Do not take a double dose to make up for a missed dose.
Stopping Formodual treatment
Even if you feel better, do not stop using Formodual or reduce the dose without consulting your doctor. It is very important to take the medicine regularly, even when symptoms have subsided.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
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4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
As with other inhaled medicines, there is a risk of worsening breathlessness and wheezing immediately after inhaling Formodual, known as paradoxical bronchospasm. In such a case, Formodual must be STOPPED IMMEDIATELY and a fast-acting inhaled bronchodilator should be used to relieve symptoms of breathlessness and wheezing. You must contact your doctor immediately.
You should inform your doctor immediately if any hypersensitivity reactions occur, such as: skin allergies, skin itching, skin rash, skin redness, swelling of the skin or mucous membranes, especially eyes, face, lips, and throat.

Other possible adverse reactions are listed below according to their frequency of occurrence.

Common (occur in fewer than 1 in 10 people):

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

Uncommon (occur in fewer than 1 in 100 people):

• palpitations, unusual rapid heartbeat and heart rhythm disturbances,
• changes in electrocardiogram (ECG),
• increased blood pressure,
• influenza-like symptoms,
• sinusitis,
• inflammation of the nasal mucosa,
• ear infection,
• throat irritation,
• cough and productive cough,
• asthma attack,
• vaginal fungal infections,
• nausea,
• taste disturbances,
• burning of the lips,
• dryness of the oral mucosa,
• difficulty swallowing,
• indigestion,
• stomach discomfort,
• diarrhoea,
• muscle pain and muscle cramps,
• facial flushing,
• increased blood flow to certain tissues,
• increased sweating,
• tremor,
• restlessness, especially motor restlessness,
• dizziness,
• urticaria,
• changes in certain blood parameters:
  o decrease in white blood cell count,
  o increase in platelet count,
  o decrease in blood potassium concentration,
  o increase in blood glucose concentration,
  o increase in blood insulin, free fatty acids, and ketone bodies concentration.

The following adverse reactions have also been reported as "uncommon" in patients with chronic obstructive pulmonary disease (COPD):

• pneumonia: inform your doctor if any of the following symptoms occur: increased sputum production, change in sputum colour, fever, worsening cough, increased breathing difficulties,
• decreased blood cortisol concentration, caused by the effect of corticosteroids on the adrenal glands,
• irregular heartbeat.

Rare (occur in fewer than 1 in 1,000 people):

• chest tightness,
• heart rhythm disturbances (caused by premature ventricular contractions),
• low blood pressure,
• kidney inflammation,
• swelling of the skin and mucous membranes lasting for several days.

Very rare (occur in fewer than 1 in 10,000 people):

• breathlessness,
• worsening of asthma,
• decreased platelet count,
• swelling of hands and feet.

Long-term use of inhaled corticosteroids at high doses may very rarely lead to systemic effects. These include:

• adrenal gland dysfunction (suppression of adrenal function),
• decreased bone mineral density (bone thinning),
• growth retardation in children and adolescents,
• increased intraocular pressure (glaucoma),
• cataract.

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

• sleep disturbances,
• depression or depressed mood,
• nervousness,
• excessive excitability or irritability. These adverse reactions are more likely in children, but their frequency is unknown.
• blurred vision.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: (22) 49 21 301, fax: (22) 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Thanks to reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Formodual medicine

Keep the medicine out of sight and reach of children.
Information for the pharmacist:
Store in a refrigerator at a temperature of 2°C to 8°C. May be stored for a maximum of 18 months.
Information for the patient:
Do not use this medicine more than 3 months after it was dispensed from the pharmacy, and do not use the medicine after the expiry date stated on the carton and label following the abbreviation "Exp". The expiry date refers to the last day of the stated month.
Do not store at temperatures above 25°C.
If the inhaler has been exposed to very low temperatures, warm it in your hands for several minutes before using. Never use other methods to heat the container.
Important: The container contains pressurised liquid. Do not expose to temperatures above 50°C. Do not pierce the container.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Formodual contains:

• The active substances are: beclometasone dipropionate and formoterol fumarate dihydrate. Each metered dose from the inhaler contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to the delivered dose via the mouthpiece, containing 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate.
• Other ingredients are: norflurane (HFC 134a), anhydrous ethanol, hydrochloric acid. This medicine contains fluorinated greenhouse gases. Each inhaler contains 10.356 g of norflurane (HFC 134a), equivalent to 0.015 tonnes of CO₂ equivalent (global warming potential GWP = 1430).

What Formodual looks like and contents of the pack
Formodual is available as a solution for inhalation in an aluminium container coated with a
metering valve, placed in a plastic housing, with a plastic mouthpiece protector, packed in a
cardboard box. The device is equipped with a dose counter (container containing 120 doses) or a dose indicator (container containing 180 doses).
Each pack contains:

• one pressurised container (delivering 120 actuations),
• two pressurised containers (each delivering 120 actuations),
• one pressurised container (delivering 180 actuations). Not all pack sizes may be marketed.

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Marketing Authorisation Holder:
Chiesi Farmaceutici S.p.A, Via Palermo 26/A, 43122 Parma, Italy
Manufacturer:
Chiesi Farmaceutici S.p.A, Via San Leonardo 96, 43122 Parma, Italy
Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria
Chiesi SAS, 2 rue des Docteurs Alberto et Paolo Chiesi, 41260 La Chaussee Saint Victor, France
For detailed information, contact the local representative of the Marketing Authorisation Holder:
Chiesi Poland Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw, Poland
Tel.: (22) 620 14 21, Fax: (22) 652 37 79, E-mail: [email protected]
This medicinal product is authorised for marketing in the European Economic Area countries
under the following trade names:
Bulgaria, Cyprus, Estonia, Lithuania, Latvia, Romania: Foster
Belgium, Greece, Luxembourg: Inuvair
Denmark, Finland, Sweden: Innovair
France, Spain, Poland, United Kingdom: Formodual
Germany: Kantos Master
Ireland: Fostair
Italy: Inuver
Norway: Inuxair
{Logo of the Marketing Authorisation Holder}
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