100/6 micrograms per dose of inhalation spray, solution. For adults.
beclomethasone dipropionate / formoterol fumarate dihydrate
1. What Innovair is and what it is used for
Innovair is an inhalation spray that contains two active substances that are inhaled through the mouth and carried directly into the lungs.
The two active substances are beclomethasone dipropionate and formoterol fumarate dihydrate. Beclomethasone dipropionate belongs to a group of medicines called corticosteroids that prevent inflammation and thus reduce swelling and irritation in the lungs.
Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators, which have a relaxing effect on the muscles in the airways and make it easier to breathe.
Together, these two active substances facilitate breathing by relieving symptoms such as shortness of breath, wheezing, and coughing in patients with asthma or chronic obstructive pulmonary disease (COPD) and they also help prevent asthma symptoms.
Innovair is intended for regular treatment of asthma in adult patients when:
- asthma is not sufficiently controlled with inhaled corticosteroids and in case of need medication with short-acting bronchodilators
- asthma is well controlled with treatment with both corticosteroids and long-acting bronchodilators .
Chronic obstructive pulmonary disease (COPD)
Innovair can also be used to treat the symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a long-term disease of the respiratory tract that is mainly caused by smoking.
2. What you need to know before using Innovair
Do not use Innovair
- if you are allergic to any of the active substances or any of the other ingredients of this medicine (listed in section 6) or if you are allergic to other medicines for asthma . Contact your doctor for advice.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Innovair.
- if you have heart problems such as angina (pain in the heart or chest), recent heart attack, heart failure , coronary heart disease, heart valve disease or other known heart defect, or a condition called hypertrophic obstructive cardiomyopathy (a condition where the heart muscle is abnormal)
- if you have narrowing of the artery were ( “hardening of the arteries”; atherosclerosis ), high blood pressure or if you know you have aneurysms (aneurysm)
- if you have heart rhythm disorders such as increasing or irregular heartbeat, high heart rate or palpitations or if you have been diagnosed with an abnormal heart rhythm
- if you have impaired thyroid function
- if you have low potassium levels in your blood
- if you have liver or kidney disease
- if you have diabetes (if you inhale high doses of formoterol your blood sugar may increase and therefore you may need to do extra blood tests to check your blood sugar when you start using the inhaler and also from time to time during treatment)
- if you have a tumor in the adrenal medulla ( pheochromocytoma )
- if you are to be anesthetized. Depending on the type of anesthetic, it may be necessary to stop treatment with Innovair at least 12 hours before anesthesia.
- if you are being treated or have ever been treated for tuberculosis (TB) or if you have a viral or fungal infection of the respiratory tract
- if you must avoid alcohol for any reason.
If any of the above applies to you, you must inform your doctor before using Innovair.
If you have or have had any medical problems or allergies or if you are not sure if you can use Innovair, consult your doctor, asthma nurse, or pharmacist before using the inhaler.
Treatment with beta 2 – agonist which is formoterol contained in Fostair can cause a sharp decrease in serum potassium levels ( hypokalemia ).
If you have severe asthma, you should be especially careful. The bronchodilator in Innovair can lower the level of potassium in the blood. Innovair in combination with a lack of oxygen in the blood, which can occur in severe asthma, can lower the potassium level further. Innovair in combination with any other treatment, such as medicines for heart disease or high blood pressure (so-called diuretics or diuretic tablets) or other medicines for asthma, can also lower the potassium level further. For this reason, your doctor may want to measure the potassium levels in your blood from time to time.
If you use high doses of inhaled corticosteroids for long periods of time, you may need extra corticosteroids in case of stress. Stress situations can be hospitalization after an accident, serious injury, or before surgery. In such cases, your doctor will decide if you need to increase the dose of one of your corticosteroids and may prescribe steroid tablets or a steroid injection.
Should you need to visit a hospital, remember to take all your medicines and inhaler with you, including Innovair, as well as any over-the-counter medicines, preferably in their original packaging.
Contact a doctor if you experience blurred vision or other visual disturbances.
Children and young people
Innovair should not be used in children and adolescents under 18 years of age until further information becomes available.
Other medicines and Innovair
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Innovair and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat).
Do not use beta-blockers with Innovair. If you need to use beta-blockers (including eye drops ), the effect of formoterol may be reduced or absent altogether. On the other hand, the use of other beta-adrenergic agents (drugs that act in the same way as formoterol) may increase the effect of formoterol.
Use of Innovair together with:
- drugs for the treatment of abnormal heart rhythms ( quinidine , disopyramide , procainamide ), drugs for the treatment of allergic reactions ( antihistamines ), medicines for the treatment of symptoms of depression or mental disorders such as MAO inhibitors (eg phenelzine and isocarboxazide), tricyclic antidepressants ( eg amitriptyline and imipramine) or phentiazines may cause ECG ( electrocardiogram ) changes . They can also increase the risk of heart rhythm disorders.
- drugs for the treatment of Parkinson’s disease ( L-dopa ), for the treatment of underactive thyroid gland (L- thyroxine ), drugs containing oxytocin (causes uterine contraction) and alcohol may reduce the heart’s tolerance to beta 2 – agonists such as formoterol
- MAO inhibitors , including drugs with similar effects such as furazolidone and procarbazine (in case of mental disorders), can cause high blood pressure
- Drugs for the treatment of heart disease ( digoxin ) can cause decreased levels of potassium in the blood. This may increase the risk of abnormal heart rhythm.
- other drugs for the treatment of asthma (theophylline, aminophylline or steroid s ( cortisone )), and diuretics (water tablets) may cause reduced level of potassium in the blood
- Some anesthetics may increase the risk of abnormal heart rhythms
Pregnancy, breastfeeding and fertility
There are no clinical data on the use of Innovair during pregnancy.
Innovair should not be used if you are pregnant, think you may be pregnant or are planning to have a baby, or if you are breastfeeding, unless specifically agreed by your doctor.
Driving and using machines
Innovair is unlikely to affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Innovair contains alcohol
Innovair contains a small amount of alcohol. Each spray dose contains about 7 mg of ethanol.
3. How to use Innovair
Innovair is intended for inhalation.
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will do regular check-ups to make sure you are getting the right dosage of Innovair. Your doctor will adjust the treatment to the lowest dose that controls your symptoms.
Innovair can be prescribed for asthma in two different ways :
- Use Innovair every day to treat your asthma together with a separate on-demand inhaler to treat suddenly worsening asthma symptoms, such as shortness of breath, wheezing and coughing
- Use Innovair every day to treat your asthma and also use Innovair to treat suddenly worsening asthma symptoms, such as shortness of breath, wheezing and coughing
a) To use Innovair together with a separate on-demand inhaler :
Adults and the elderly: The
recommended dose is 1-2 sprays twice daily. The maximum dose per day is 4 sprays.
Remember! You should always bring your fast-acting emergency inhaler to treat worsening asthma symptoms or a sudden asthma attack.
b) Using Innovair as your only asthma inhaler :
Adults and the elderly :
The recommended dose is 1 spray in the morning and 1 spray in the evening.
Also, use Innovair as an on-demand inhaler to treat emergencies
If you get asthma symptoms, inhale once and wait a few minutes.
If you do not feel better, inhale again.
Do not take more than 6 in case of need inhalation per day.
The maximum daily dose of Innovair is 8 sprays.
If you regularly need several inhalations a day for your asthma symptoms, visit your doctor who 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 use this medicine.
Chronic obstructive pulmonary disease (COPD)
Adults and the elderly :
The recommended dose is 2 sprays in the morning and 2 sprays in the evening.
Patients at risk:
Elderly patients do not need a dose adjustment. There is no information on the use of Innovair in patients with hepatic or renal impairment.
Innovair is effective in treating asthma in a dose of beclomethasone dipropionate which may be lower than in another inhaler containing beclomethasone dipropionate. If you have previously used another inhaler containing beclomethasone dipropionate, your doctor will tell you the exact dose of Innovair you need for your asthma.
Do not increase dose one
If you feel that the medicine does not give enough effect, consult your doctor before increasing dose one.
If you have used too much Innovair
If you have ingested too much medicine or if e.g. a child inhaled the medicine accidentally contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
- If you use too much formoterol, the following effects may occur: Nausea, vomiting, increased heart rate, palpitations, heart rhythm disturbances, certain changes in ECG , headache, tremors, drowsiness and low pH , low potassium levels and high blood glucose levels. Your doctor may want to take some blood tests to measure your potassium and glucose levels.
- Too much beclomethasone dipropionate can lead to short-term adrenal problems. This goes away after a few days but the doctor may still need to measure the cortisol levels in the blood.
Tell your doctor if you have any of the above symptoms.
If you forget to use Innovair
Take the next dose as soon as you remember. If it is close to the next dose, you can skip the missed dose and take the next regular dose instead . Do not take a double dose to make up for a forgotten dose .
If you stop using Innovair
Do not reduce dose one and do not stop using the medicine.
Even if you feel better, do not stop using Innovair or reduce the dose . If you want to change the dose , contact your doctor. It is very important that you use Innovair regularly, even when you are symptom-free.
If your breathing deteriorates
If shortness of breath or wheezing (whistling breathing) gets worse immediately after inhalation , stop using Innovair immediately and use your fast-acting inhaler immediately . Contact a doctor immediately. Your doctor will assess your symptoms and possibly change your treatment. See also section 4, Possible side effects .
If your asthma worsens
If the symptoms get worse or are difficult to control (eg if you use a separate emergency inhaler or Innovair as an emergency inhaler more often than before) or if your emergency inhaler or Innovair does not help, you should contact a doctor immediately. Your asthma may have worsened and your doctor may need to change the dosage of one of Innovair or prescribe another treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Method of administration
This medicine is stored in a pressure vessel with a nozzle fitted with a plastic protective sleeve. On the back of the inhaler there is a dose counter, which shows how many doses you have left. Each time you press the container, a dose of medicine will be released and the dose counter will count down one dose . Be careful not to drop the inhaler as this may cause the dose counter to count down.
Test your inhaler
Before using the inhaler for the first time or if you have not used it for 14 days or more, test your inhaler to ensure that the inhaler is working properly.
- Remove the protective sleeve from the nozzle
- Hold the inhaler upright with the mouthpiece down
- Point the nozzle away from you and firmly press down on the container to spray a dose
- Check the dose counter. If you are testing your inhaler for the first time, the dose counter should be set to 120.
Use of the inhaler
If possible, stand or stand upright when inhaling.
- Remove the protective sleeve from the nozzle and check that the nozzle is clean and free of dust and dirt and other foreign matter.
- Exhale as slowly and deeply as possible.
- Hold the inhaler vertically with the metal container facing up and close your lips around the mouthpiece. Do not bite into the nozzle.
- Inhale slowly and deeply through the mouth. After inhalation, press down the metal container to spray a dose .
- Hold your breath for as long as possible and finally remove the inhaler from your mouth and exhale slowly. Do not exhale through the inhaler.
If an additional dose is needed; hold the inhaler upright for about half a minute and then repeat steps 2-5.
Important: Do not perform steps 2-5 too fast.
After use, replace the protective sleeve and check the dose counter.
You should get a new inhaler when the dose counter shows that there are 20 doses left. Stop using the inhaler when the dose counter shows that there are 0 doses left as any remaining sprays in the container may be too small to give you a full dose .
If spray mist comes from the top of the inhaler or through the mouth pores, this means that Innovair is not reaching your lungs properly. Spray again, following the instructions from step 2.
If you have weak hands, it may be easier to hold the inhaler with both hands. Both index fingers should then be placed on top of the inhaler and both thumbs under the inhaler.
You should rinse your mouth, gargle with water or brush your teeth after each use of the inhaler to reduce the risk of fungal infections in your mouth and throat.
If you have the impression that the effect of Innovair is too strong or too weak, talk to your doctor or pharmacist.
If you find it difficult to handle the inhaler while inhaling, you can use the AeroChamber Plus® respirator. Ask your doctor, pharmacist or nurse, for this medicine.
It is important that you read the package leaflet that comes with the AeroChamber Plus® Respiratory Container and that you carefully follow the instructions for use on how to use and clean the AeroChamber Plus® Respiratory Container.
You should clean your inhaler once a week. When cleaning, do not remove the pressure vessel from the inhaler. Do not use water or other liquids to clean your inhaler .
To clean your inhaler:
- Remove the nozzle guard by pulling it away from the inhaler.
- Wipe the inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or paper handkerchief.
- Replace the nozzle cap.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
As with other inhaled medicines, there is a risk of worsening shortness of breath or wheezing that occurs immediately after using Innovair; this is called paradoxical bronchospasm . If this happens, stop using Innovair immediately and instead use your fast-acting inhaler immediately . Contact a doctor immediately.
Tell your doctor immediately if you experience a hypersensitivity reaction such as skin allergies, itching , rashes, reddening of the skin, swelling of the skin and mucous membranes, especially eyes, face, lips and tongue.
Other possible side effects are listed below by occurrence.
Common (affects less than 1 in 10 people):
Fungal infections (in the mouth and throat), headache, hoarseness, sore throat.
Pneumonia in COPD patients: tell your doctor if you have any of the following symptoms while taking Innovair as they may be symptoms of pneumonia:
- fever or chills
- increased mucus production, changed color of the mucus
- increased cough or increased difficulty breathing
Uncommon (affects less than 1 in 100 people):
Palpitations, fast heartbeat and arrhythmias, certain types of ECG changes .
Influenza-like symptoms , fungal infections of the vagina, sinusitis, runny nose, ear infections, throat irritation, cough, mucus cough, asthma attacks.
Nausea, taste changes or loss of taste, burning sensation on the lips, dry mouth , difficulty swallowing, indigestion, upset stomach, diarrhea.
Muscle pain and cramps, facial flushing, increased blood flow to certain parts of the body, excessive sweating, tremors, restlessness, dizziness, hives or hives.
Changes in certain blood levels; decrease in the number of white blood cells , increase in the number of platelets , low potassium level, high blood sugar level, high levels of insulin , free fatty acids and ketone bodies in the blood.
In patients with chronic obstructive pulmonary disease , the following less common side effects have also been reported:
- decreased amount of cortisol in the blood, which is caused by the effect of corticosteroids on the adrenal glands.
- irregular heartbeats.
Rare (affects less than 1 in 1,000 people):
Feeling of tightness over the chest, skipped heartbeat (due to premature contraction of the heart chambers), high or low blood pressure , kidney inflammation, swelling of the skin and mucous membranes that last for several days.
Very rare (affects less than 1 in 10,000 people):
Shortness of breath, worsening of asthma , reduction of platelets , swollen hands and feet.
Has been reported (occurs in an unknown number of users):
Prolonged use of high- dose inhaled corticosteroids can in very rare cases cause systemic effects (effects that affect the whole body): These include impaired adrenal function, decreased bone density, growth retardation in children and adolescents, increased pressure in the eyes ( glaucoma ) and cataract. Sleep problems, depression or anxiety, restlessness, anxiety, feeling very hurried and / or irritable. These side effects are more likely to occur in children, but the frequency is unknown.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Innovair
Keep this medicine out of the sight and reach of children.
The single pack contains an inhaler with 120 doses .
Do not use Innovair for more than 3 months after the date stated on the pharmacy label and never after the expiry date which is stated on the label and carton. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
The double pack contains two inhalers with 120 doses each.
Before use: store the inhaler in the refrigerator (at 2‑8 ° C).
After first use: store the inhaler at a maximum of 25 ° C for a maximum of three months. Do not use the inhaler after this period and never use it after the expiry date which is stated on the carton and label. Do not freeze.
If the inhaler has been exposed to severe cold, warm it in your hands a few minutes before use. Never heat in any other way.
Warning: Pressure vessel. Do not expose the container to temperatures higher than 50 ºC. Do not puncture the container.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
- The active substances are beclomethasone dipropionate and formoterol fumarate dihydrate.
Each metered dose contains 100 micrograms beclomethasone dipropionate and 6 micrograms formoterol fumarate dihydrate.
This corresponds to a given dose (the dose leaving the mouthpiece) of 84.6 micrograms beclomethasone dipropionate and 5 micrograms formoterol fumarate dihydrate.
- The other ingredients are anhydrous ethanol and hydrochloric acid . Propellant: Norflurane (HFA-134a)
What the medicine looks like and contents of the pack
The inhalation solution is enclosed in an aluminum pressure vessel, sealed with a metering valve and placed in a polypropylene inhaler with a nozzle fitted with a plastic protective sleeve.
Each pack contains 1 or 2 inhalers with 120 spray doses.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder : Chiesi Farmaceutici SpA
Via Palermo 26 / A
Manufacturer responsible for batch release:
Chiesi Farmaceutici SpA
Via Palermo 26 / A
Alternative manufacturer responsible for batch release:
Chiesi Pharmaceuticals GmbH
1010 Vienna – Austria
17, avenue de l’Europe
92270 Bois Colombes
This medicinal product is authorized under the European Economic Area under the names:
Formodual: France, the Netherlands, Poland, Slovenia, Spain, the United Kingdom, Hungary, Austria
Foster: Bulgaria, Cyprus, Estonia, Latvia, Lithuania, Romania
Innovair: Denmark, Finland, Sweden
Inuvair: Belgium, Greece, Luxembourg
Kantos Master: Germany