Innovair is intended for regular treatment of asthma in adult patients when:<\/p>\n\n\n\n
- asthma is not sufficiently controlled with inhaled corticosteroids and in case of need medication with short-acting bronchodilators<\/li><\/ul>\n\n\n\n
or<\/p>\n\n\n\n
- asthma is well controlled with treatment with both corticosteroids and long-acting bronchodilators .<\/li><\/ul>\n\n\n\n
Chronic obstructive pulmonary disease (COPD)<\/strong><\/p>\n\n\n\n
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.<\/p>\n\n\n\n
2. What you need to know before using Innovair<\/h2>\n\n\n\n
Do not use Innovair<\/h2>\n\n\n\n
- 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.<\/li><\/ul>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor, pharmacist, or nurse before using Innovair.<\/strong><\/p>\n\n\n\n
- 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)<\/li>
- if you have narrowing of the artery were ( “hardening of the arteries”; atherosclerosis ), high blood pressure or if you know you have aneurysms (aneurysm)<\/li>
- 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<\/li>
- if you have impaired thyroid function<\/li>
- if you have low potassium levels in your blood<\/li>
- if you have liver or kidney disease<\/li>
- 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)<\/li>
- if you have a tumor in the adrenal medulla ( pheochromocytoma )<\/li>
- 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.<\/li>
- 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<\/li>
- if you must avoid alcohol for any reason.<\/li><\/ul>\n\n\n\n
If any of the above applies to you, you must inform your doctor before using Innovair.<\/strong><\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Treatment with beta 2<\/sub> – agonist which is formoterol contained in Fostair can cause a sharp decrease in serum potassium levels ( hypokalemia ).<\/p>\n\n\n\n
If you have severe asthma<\/strong>, 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.<\/p>\n\n\n\n
If you use high doses of inhaled corticosteroids for long periods of time,<\/strong> 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.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Contact a doctor if you experience blurred vision or other visual disturbances.<\/strong><\/p>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Innovair should not be used in children and adolescents under 18 years of age until further information becomes available.<\/p>\n\n\n\n
Other medicines and Innovair<\/h2>\n\n\n\n
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.<\/p>\n\n\n\n
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).<\/p>\n\n\n\n
Do not use beta-blockers with Innovair. <\/strong>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.<\/p>\n\n\n\n
Use of Innovair together with:<\/strong><\/p>\n\n\n\n
- 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.<\/li>
- 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<\/sub> – agonists such as formoterol<\/li>
- MAO inhibitors , including drugs with similar effects such as furazolidone and procarbazine (in case of mental disorders), can cause high blood pressure<\/li>
- 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.<\/li>
- 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<\/li>
- Some anesthetics may increase the risk of abnormal heart rhythms<\/li><\/ul>\n\n\n\n
Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n
There are no clinical data on the use of Innovair during pregnancy.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
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.<\/p>\n\n\n\nInnovair contains alcohol<\/h2>\n\n\n\n
Innovair contains a small amount of alcohol. Each spray dose contains about 7 mg of ethanol.<\/p>\n\n\n\n
3. How to use Innovair<\/h2>\n\n\n\n
Innovair is intended for inhalation.<\/strong><\/p>\n\n\n\nAlways use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n
Asthma<\/em><\/strong><\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Innovair can be prescribed for asthma in two different ways<\/strong> :<\/p>\n\n\n\n
- 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<\/strong>
<\/li>- 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<\/strong><\/li><\/ol>\n\n\n\n
a) To use Innovair together with a separate on-demand inhaler<\/strong> :<\/p>\n\n\n\n
Adults and the elderly: The<\/strong>
recommended dose is 1-2 sprays twice daily. The maximum dose per day is 4 sprays.<\/p>\n\n\n\nRemember! You should always bring your fast-acting emergency inhaler to treat worsening asthma symptoms or a sudden asthma attack<\/strong>.<\/p>\n\n\n\n
b) Using Innovair as your only asthma inhaler<\/strong> :<\/p>\n\n\n\n
Adults and the elderly<\/strong> :<\/p>\n\n\n\nThe recommended dose is 1 spray in the morning and 1 spray in the evening.<\/p>\n\n\n\n
Also, use Innovair as an on-demand inhaler to treat emergencies<\/p>\n\n\n\n
asthma symptoms.<\/p>\n\n\n\n
If you get asthma symptoms, inhale once and wait a few minutes.<\/p>\n\n\n\n
If you do not feel better, inhale again.<\/p>\n\n\n\n
Do not take more than 6 in case of need inhalation per day<\/strong>.<\/p>\n\n\n\n
The maximum daily dose of Innovair is 8 sprays.<\/strong><\/p>\n\n\n\n
If you regularly need several inhalations a day for your asthma symptoms, visit your doctor who may need to change your treatment.<\/p>\n\n\n\n
Use in children and adolescents under 18 years of age:
<\/strong>Children and adolescents under 18 years of age should NOT use this medicine.<\/strong><\/p>\n\n\n\nChronic obstructive pulmonary disease (COPD)<\/em><\/strong><\/p>\n\n\n\n
Adults and the elderly<\/strong> :<\/p>\n\n\n\n
The recommended dose is 2 sprays in the morning and 2 sprays in the evening.<\/p>\n\n\n\n
Patients at risk:<\/strong>
Elderly patients do not need a dose adjustment. There is no information on the use of Innovair in patients with hepatic or renal impairment.<\/p>\n\n\n\nInnovair 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.<\/strong><\/p>\n\n\n\n
Do not increase dose one<\/strong>
If you feel that the medicine does not give enough effect, consult your doctor before increasing dose one.<\/p>\n\n\n\nIf you have used too much Innovair <\/h2>\n\n\n\n
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.<\/p>\n\n\n\n
- 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.<\/li>
- 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.<\/li><\/ul>\n\n\n\n
Tell your doctor if you have any of the above symptoms.<\/strong><\/p>\n\n\n\n
If you forget to use Innovair<\/h2>\n\n\n\n
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<\/strong> to make up for a forgotten dose .<\/p>\n\n\n\n
If you stop using Innovair<\/h2>\n\n\n\n
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.<\/p>\n\n\n\nIf your breathing deteriorates<\/strong>
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 .<\/p>\n\n\n\nIf your asthma worsens<\/strong>
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.<\/p>\n\n\n\nIf you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n
Method of administration<\/strong><\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Test your inhaler<\/strong><\/p>\n\n\n\n
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.<\/p>\n\n\n\n
- Remove the protective sleeve from the nozzle<\/li>
- Hold the inhaler upright with the mouthpiece down<\/li>
- Point the nozzle away from you and firmly press down on the container to spray a dose<\/li>
- Check the dose counter. If you are testing your inhaler for the first time, the dose counter should be set to 120.<\/li><\/ol>\n\n\n\n
<\/a><\/figure>\n\n\n\n
- 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<\/strong><\/li><\/ol>\n\n\n\n
- 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.<\/li><\/ul>\n\n\n\n
- asthma is well controlled with treatment with both corticosteroids and long-acting bronchodilators .<\/li><\/ul>\n\n\n\n