Solution
Beclometasone dipropionate + Formoterol fumarate dihydrate
Medicine intended for use in adults.
Formodual is a solution in an inhalation aerosol, containing two active substances, which are delivered directly to the lungs when you inhale through the mouthpiece of the inhaler.
The medicine contains two active substances:
Beclometasone dipropionate, belonging to a group of medicines called corticosteroids, which have an anti-inflammatory effect by reducing swelling and irritation of the lungs.
Formoterol fumarate dihydrate, belonging to a group of long-acting bronchodilators, which relax the muscles in the airways and make breathing easier.
Together, these two active substances make breathing easier. They also help prevent asthma symptoms, such as shortness of breath, wheezing, and coughing.
Formodual is used in patients whose:
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Before using this medicine, you should consult a doctor, pharmacist, or nurse if you have any current or past health problems or allergies, or if you have any doubts about whether Formodual can be used.
in patients with severe asthma.Like other bronchodilators, Formodual may cause a sudden decrease in potassium levels in the blood (hypokalemia). This is related to oxygen deficiency in the blood caused by taking other medicines at the same time as Formodual, which may exacerbate the decrease in potassium levels in the blood.
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If the patient is taking large doses of inhaled corticosteroids for a long time, they may be more likely to require corticosteroid administration during periods of stress. Stressful situations may include hospitalization after an accident, serious injury, or waiting for surgery. In such situations, the doctor will decide on the possible increase in corticosteroid dose or may prescribe other steroids in the form of tablets or injections.
If hospitalization is necessary, the patient should remember to bring all their medicines and inhalers, including Formodual, as well as over-the-counter medicines, if possible, in their original packaging.
Formodual should not be used in children and adolescents under the age of 18.
You should tell your doctor, pharmacist, or nurse about all the medicines you are currently taking or have recently taken, including those available without a prescription.
This is necessary because Formodual may affect the action of some other medicines.
Similarly, some medicines may affect the action of Formodual.
In particular, you should tell your doctor, pharmacist, or nurse if you are taking any of the following medicines:
You should also inform your doctor if you are scheduled to undergo general anesthesia for surgery or a dental procedure.
There are no clinical data on the use of Formodual during pregnancy.
Formodual should not be used if the patient is pregnant, thinks they may be pregnant, or plans to have a child, or if the patient is breastfeeding, unless the doctor decides otherwise.
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It is unlikely that Formodual will affect the ability to drive and use machines.
Formodual contains 9 mg of alcohol (ethanol) per inhalation, which is equivalent to 0.25 mg/kg body weight per dose, when two inhalations are used. The amount of alcohol in two inhalations of this medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medicine is unlikely to have noticeable effects.
This medicine should always be used in accordance with the recommendations of a doctor or pharmacist. In case of doubts, you should consult a doctor or pharmacist.
The doctor will regularly check if the patient is taking the optimal dose of Formodual. The doctor will determine the smallest dose that provides the best control of asthma symptoms.
The recommended dose of the medicine is two inhalations twice a day.
The maximum daily dose is 4 inhalations.
There is no need to adjust the dosage in elderly patients. There is no information on the use of Formodual in patients with liver or kidney function disorders.
This medicine should NOT be used in children and adolescents under 18 years of age.
containing beclometasone dipropionate, the doctor will recommend the appropriate dose of Formodual.
If you feel that the effect of the medicine is insufficient, you should always consult a doctor before increasing the dose of the medicine.
In case of worsening of the disease or difficulties in controlling it (e.g., when the patient needs to use another inhaled reliever medicine more frequently) or when the inhaled reliever medicine does not relieve symptoms, you should immediately inform your doctor. This may indicate worsening of asthma, and the doctor may decide to change the dosage of Formodual or use other treatment.
This medicine is in a pressurized container, in a plastic casing with a mouthpiece. At the back of the inhaler, there is a dose counter that shows how many doses of the medicine are left. After each press of the inhaler, a dose of the medicine is released, and the counter will show one dose less. Be careful not to drop the inhaler, as this may cause the counter to decrement.
Before using the inhaler for the first time, or if the inhaler has not been used for 14 days or more, you should perform an inhaler test to ensure it is working properly.
If possible, you should stand or sit upright while inhaling.
Before inhaling, check the dose counter: any value between "1" and "120" indicates that there are still doses of the medicine left in the canister. If the dose counter shows "0", it means that there are no more doses of the medicine left, and you should discard the old inhaler and purchase a new one.
To take another dose of the medicine, continue to hold the inhaler in an upright position for about half a minute, then repeat the steps described in points 2 to 5.
Important:The steps described in points 2 to 5 should not be performed too quickly.
After use, replace the protective cap and check the dose counter.
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To reduce the risk of fungal infection of the mouth and throat, you should rinse your mouth or throat with water or brush your teeth after each inhalation.
If a "mist" appears over the top opening of the mouthpiece or from the side of the mouth, it means that Formodual is not reaching the lungs as it should. You should take another dose, following the instructions, starting again from point 2.
If you feel that the effect of Formodual is too strong or too weak, you should consult a doctor or pharmacist.
If you have difficulty using the inhaler during inhalation, you can use a spacer (AeroChamber Plus). You should ask your doctor or pharmacist about this device.
It is essential to carefully read the leaflet that comes with the AeroChamber Plus spacer and follow the instructions for use and cleaning recommendations.
The inhaler should be cleaned once a week.
Cleaning the inhaler:
You should take the missed dose as soon as possible. If it is almost time for the next dose, do not take the missed dose, just take the next dose at the usual planned time. Do not take a double doseto make up for the missed dose.
Even if you feel better, you should not stop taking Formodual or reduce the dose without consulting your doctor. It is essential to take the medicine regularly, even when symptoms of the disease have disappeared.
If you have any further doubts about using this medicine, you should consult a doctor or pharmacist.
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Like all medicines, Formodual can cause side effects, although not everybody gets them.
As with other inhaled medicines, there is a risk of worsening shortness of breath and wheezing immediately after taking Formodual, known as paradoxical bronchospasm.You should immediately STOP taking Formodualand use a fast-acting inhaled bronchodilator to relieve shortness of breath and wheezing. You should contact your doctor immediately.
You should immediately inform your doctorif you experience any allergic reactions, such as skin allergies, itching, rash, redness, swelling of the skin or mucous membranes, especially of the eyes, face, lips, and throat.
Other possible side effects are listed below, depending on their frequency.
Uncommon(occurring in less than 1 in 100 people):
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decreased potassium levels in the blood,
increased glucose levels in the blood,
increased insulin, free fatty acids, and ketone bodies in the blood.
The following side effects have also been reported as "uncommon" in patients with chronic obstructive pulmonary disease:
Rare(occurring in less than 1 in 1000 people):
Very rare(occurring in less than 1 in 10,000 people):
cause systemic effects in very rare cases.These include:
Frequency not known(cannot be estimated from the available data):
If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: (22) 49 21 301, fax: (22) 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
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Reporting side effects will help to gather more information on the safety of this medicine.
The medicine should be stored out of sight and reach of children.
Information for the pharmacist:
Store in a refrigerator at a temperature between 2°C and 8°C. Store for a maximum of 18 months.
Information for the patient:
Do not use the medicine after 3 months from the date of dispensing from the pharmacy and do not use this medicine after the expiry date stated on the carton and label after "Exp". The expiry date refers to the last day of the month stated.
Do not store above 25°C.
If the inhaler has been exposed to very low temperatures, you should warm it in your hands for a few minutes before use. Never use other methods to heat the canister.
Important: The canister contains a pressurized liquid. Do not expose to temperatures above 50°C. Do not pierce the canister.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Formodual is available as a solution for inhalation, in an aluminum-coated canister with a dose counter, in a plastic casing with a mouthpiece, in a cardboard box. The casing is equipped with a plastic mouthpiece cover and has a dose counter (canister containing 120 doses) or dose indicator (canister containing 180 doses).
Each pack contains:
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Chiesi Farmaceutici S.p.A, Via Palermo 26/A, 43122 Parma, Italy
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
To obtain detailed information, you should contact the local representative of the marketing authorization holder:
Chiesi Poland Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw
phone: (22) 620 14 21, fax: (22) 652 37 79, email: info-pl@chiesi.com
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
{Marketing authorization holder's logo}
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Like all medications, this medication can cause side effects, although they do not occur in everyone.
Similarly to other inhaled medications, there is a risk of worsening shortness of breath and wheezing immediately after taking Formodual, known as paradoxical bronchospasm.You should then immediately STOP taking Formodual
and use a fast-acting inhaled bronchodilator to relieve shortness of breath and wheezing. You should immediately contact your doctor.
You should immediately inform your doctorif you experience any allergic reactions,
such as: skin allergies, itching, skin rash, skin redness, skin or mucous membrane swelling, especially of the eyes, face, lips, and throat.
Other possible side effects are listed below, depending on the frequency of occurrence.
Frequent(occurring in less than 1 in 10 people):
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increased blood sugar levels,
increased insulin, free fatty acids, and ketone bodies in the blood.
The following side effects have also been reported as "uncommon" in patients with chronic obstructive pulmonary disease:
Rare(occurring in less than 1 in 1000 people):
Very rare(occurring in less than 1 in 10,000 people):
cause systemic side effects in very rare cases.These include:
Frequency not known(cannot be determined from available data):
If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw,
phone: (22) 49 21 301, fax: (22) 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medication.
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The medication should be stored out of sight and out of reach of children.
Information for the pharmacist:
Store in a refrigerator at a temperature between 2°C and 8°C. Store for a maximum of
18 months.
Information for the patient:
The medication should not be used after 3 months from the date of issue from the pharmacy and should not be used after the expiry date stated on the carton and label after the abbreviation "Exp". The expiry date indicates the last day of the given month.
Do not store above 25°C.
If the inhaler has been exposed to very low temperatures, before using the medication, you should warm it in your hands for a few minutes. Never use other methods to heat the container.
Important: The container contains a pressurized liquid. Do not expose to temperatures above 50°C. Do not pierce the container.
Medications should not be disposed of in wastewater or household waste. You should ask your pharmacist how to dispose of medications that are no longer used. This will help protect the environment.
Formodual is available as an inhalation solution, in an aluminum-coated container with a metering valve, placed in a plastic case, in a cardboard box. The case is equipped with a plastic mouthpiece cover and has a dose counter (container containing 120 doses) or dose indicator (container containing 180 doses).
Each pack contains:
Chiesi Farmaceutici S.p.A, Via Palermo 26/A, 43122 Parma, Italy
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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
To obtain detailed information, you should contact the local representative of the marketing authorization holder:
Chiesi Poland Sp. z o.o., Jerozolimskie Avenue 134, 02-305 Warsaw
phone: (22) 620 14 21, fax: (22) 652 37 79, e-mail: info-pl@chiesi.com
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
{Marketing authorization holder's logo}
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