100 micrograms / 6 micrograms per inhalation powder. For adults.
beclomethasone dipropionate / formoterol fumarate dihydrate
1. What Innovair Nexthaler Is And What It Is Used For
Innovair nexthaler is a powder that is inhaled through the mouth deep into the lungs. It contains two active substances: beclomethasone dipropionate and formoterol fumarate dihydrate.
- Beclomethasone dipropionate belongs to a group of medicines called corticosteroids that have an anti-inflammatory effect and thus reduce swelling and irritation in the lungs.
- Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators. These cause the muscles in the airways to relax and thus dilate the airways, which makes 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.
Asthma
Innovair nexthaler is used to treat asthma in adults.
If you have been prescribed Innovair nexthaler, it is likely that
- Asthma is not sufficiently controlled with inhaled corticosteroids and in case of need medication with short-acting bronchodilators
or
- Asthma is adequately controlled with both corticosteroids and long-acting bronchodilators.
Chronic obstructive pulmonary disease (COPD)
Innovair nexthaler 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 Nexthaler
Do Not Use Innovair Nexthaler
If you are allergic to beclomethasone dipropionate or formoterol fumarate dihydrate or any of the other ingredients of innovair (listed in section 6).
Warnings And Cautions
Talk to your doctor before using Innovair nexthaler if you have any of the following:
- Heart problems, which include diagnosed heart disease and/or impaired heart function
- Arrhythmias in the heart, such as increased or irregular heart rate, fast heart rate, or palpitations, or if you have a deviating ECG curve
- High blood pressure
- Constriction of the artery (also known as arteriosclerosis/atherosclerosis) or if you know you have aneurysms (aneurysm)
- Overactive thyroid gland
- Low potassium levels in the blood
- Liver or kidney disease
- 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 innovair and also from time to time during treatment.
- Adrenal tumor (also known as a pheochromocytoma )
- You should be anesthetized. Depending on the type of anesthetic, it may be necessary to stop taking Innovair nexthaler at least 12 hours before anesthesia.
- You are being treated or have ever been treated for tuberculosis (TB) or if you have a known viral or fungal infection of the respiratory tract.
If any of the above apply to you, tell your doctor before using Innovair nexthaler.
If you are not sure if you can use Innovair nexthaler, talk to your doctor, asthma nurse, or pharmacist before using the innovair inhaler.
Your doctor may want to measure the potassium levels in your blood from time to time, especially if you suffer from severe asthma.
Like other bronchodilators, Innovair nexthaler may cause a sudden decrease in serum potassium levels ( hypokalaemia ). This is because lack of oxygen in the blood and any other treatment together with Innovair nexthaler can lower the potassium level further.
If you use high doses of inhaled corticosteroids for long periods, you may need more corticosteroids in case of stress.
Stressful situations can be hospitalization after an accident, serious injury, or before surgery. If this happens, 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.
If you need to visit a hospital, remember to take all your medicines and inhalers with you, including Innovair nexthaler, as well as any over-the-counter medicines and tablets and preferably in the original packaging.
Contact a doctor if you experience blurred vision or other visual disturbances.
Children And Young People
Innovair should not be given to children or adolescents under 18 years of age.
Other Medicines And Innovair Nexthaler
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Innovair nexthaler may affect the effectiveness of certain other medicines. Other drugs may in turn affect the effect of Innovair nexthaler.
In particular, tell your doctor or pharmacist if you are taking the following medicines:
- Some medicines may increase the effect of Innovair nexthaler and your doctor may want to monitor you closely if you are taking these medicines (including some anti-HIV medicines: ritonavir, cobicistat).
- Beta blockers. Beta-blockers are medicines used to treat several different diseases including heart disease, high blood pressure or glaucoma ( high blood pressure in the eye). If you need to use beta-blockers (including eye drops ), the effect of formoterol may be reduced or absent altogether.
- Beta-adrenergic drugs (drugs that work in the same way as formoterol) may increase the effect of formoterol.
- Drugs used to treat abnormal heart rhythms ( quinidine, disopyramide, procainamide ),
- Drugs used to treat allergic reactions ( antihistamines such as terfenadine),
- Medicines for the treatment of symptoms of depression or mental disorders such as MAO inhibitors (for example phenelzine and isocarboxazid) or tricyclic antidepressants (for example amitriptyline and imipramine) orphentiazines
- Medicines for the treatment of Parkinson’s disease ( levodopa ),
- Medications to treat underactive thyroid (levothyroxine)
- Medicines containing oxytocin (causes contractions of the uterus)
- Drugs to treat mental disorders such as MAO inhibitors, including drugs with similar effects such as furazolidone and procarbazine
- Drugs for the treatment of heart disease ( digoxin )
- Other drugs for treatment of asthma (theophylline, aminophylline, or steroid’s)
- Diuretics (diuretics)
Tell your doctor or pharmacist if you will be given anesthetics before surgery or dental care.
Pregnancy And Breastfeeding
There are no clinical data on the use of Innovair nexthaler during pregnancy. If you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking innovair.
You should only use Innovair nexthaler during pregnancy if your doctor has told you to continue.
Your doctor will decide if you should stop using Innovair nexthaler during breastfeeding or if you should continue taking Innovair nexthaler and refrain from breastfeeding. Always follow the instructions given by your doctor carefully.
Driving And Using Machines
Inuvair nexthaler side effects
Innovair nexthaler are unlikely to affect your ability to drive or use machines. If you experience side effects such as dizziness and/or tremors, your ability to drive and use machines may be impaired.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and 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 Nexthaler Contains Lactose
Lactose contains small amounts of milk protein that can cause reactions in allergic patients. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How To Use Innovair Nexthaler
Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, nurse, or pharmacist.
Innovair nexthaler produces an extra fine aerosol (extra small particles) so that a larger part of the dose reaches the lungs. For this reason, your doctor may prescribe you a dose that may be lower than in your previous innovair inhaler.
Asthma
Your doctor will perform regular check-ups to ensure that you receive the correct dosage of Innovair nexthaler. When your asthma is under control, your doctor may decide if you should gradually reduce the dosage one. Under no circumstances should you change the dose without first contacting your doctor.
Innovair nexthaler can be prescribed for asthma in two different ways:
- Use Innovair nexthaler daily 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 nexthaler every day to treat your asthma and also use Innovair nexthaler to treat suddenly worsening asthma symptoms, such as shortness of breath, wheezing, and coughing
a) Using Innovair nexthaler together with a separate on-demand inhaler:
Adults and the elderly:
The recommended dose is 1 or 2 inhalations twice daily. The maximum daily dose is 4 inhalations.
Remember! You should always bring your fast-acting emergency inhaler to treat worsening asthma symptoms or a sudden asthma attack.
b) Using Innovair nexthaler as your only asthma inhaler:
Adults and the elderly:
The recommended dose is 1 inhalation in the morning and 1 inhalation in the evening.
Also, use Innovair nexthaler as an on-demand inhaler to treat acute asthma symptoms.
If you get asthma symptoms, take an inhalation and wait for 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 nexthaler is 8 inhalations .
If you regularly need several inhalations per day for your asthma symptoms, consult a doctor who may need to change your treatment.
Do not increase dose one. If you have the impression that the effect of the medicine is not sufficient, always consult a doctor before increasing the dose.
Chronic obstructive pulmonary disease (COPD)
Adults and the elderly:
The recommended dose is 2 inhalations in the morning and 2 inhalations in the evening. ‘
How to use Innovair nexthaler:
Innovair nexthaler is intended for inhalation.
Always stand or sit upright as you inhale if possible.
If You Use More Innovair Nexthaler Than You Should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
- Take the medicine with you so that the healthcare staff can see which medicine you have taken.
- You can get inuvair nexthaler side effects in form of scars. If you experience unusual symptoms tell your doctor so that your doctor can assess the need for further tests or decide on and take the necessary action.
If You Forget To Use Innovair Nexthaler
Take the next dose as soon as you remember. If it is close to the next dose, do not take the missed dose, but take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.
If You Stop Using Innovair Nexthaler
Even if you feel better, do not stop using Innovair nexthaler or reduce the dose. If you want to change anything, contact your doctor. It is very important that you use Innovair nexthaler every day according to what your doctor has prescribed, even when you are symptom-free.
If your breathing does not improve:
If your symptoms are not relieved after inhalation with Innovair nexthaler, it may be due to improper use. See the fostair nexthaler instructions for use below and/or contact a doctor or nurse for guidance.
If your asthma worsens:
If the symptoms get worse or are difficult to control (eg if you use a separate on-demand innovair inhaleror Innovair nexthaler as on on-demand inhaler more often than before) or if your on-demand inhaler or Innovair nexthaler does not help, you should continue to use Innovair nexthaler but contact a doctor as soon as possible.
Your doctor may need to change the dosage of one of Innovair nexthaler or prescribe an additional treatment or alternative treatment.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
INNOVAIR NEXTHALER INHALER INSTRUCTIONS FOR USE
A. Contents of the packaging
For information on the contents of the package, see section 6.
If the contents of the package do not match what is stated in section 6, return the inhaler to the pharmacist and replace it with a new one.
B. General warnings and precautions
- Do not remove the inhaler from the bag until you are ready to start using it.
- Use the inhaler according to the fostair nexthaler instructions in this manual.
- Keep the protective cap closed until you need to take a dose.
- Store the inhaler in a clean and dry place when not in use.
- Never attempt to disassemble the nexthaler inhaler.
C. Most important parts of the Nexthaler inhaler
Taking a dose from the nexthaler inhaler requires only three simple steps: open, inhale and close.
D. Before you start using a new nexthaler inhaler
1. Open the bag and remove the inhaler.
- Do not use the inhaler if the seal is broken or if the bag is broken. Return the inhaler to the pharmacy and replace it with a new one.
- Use the label on the box and note the date you open the bag.
2. Examine the inhaler.
- If the inhaler shows signs of damage or is broken, return it to the pharmacy and replace it with a new one.
3. Check the dose counter. The dose counter should display “120” if the inhaler is unused.
- If the number is less than “120” on a brand-new inhaler, do not use the inhaler – return it to the pharmacy and replace it with a new one.
E. How to use the nexthaler inhaler
- Contact a doctor or pharmacist if you are not sure that you are getting the right amount of medicine.
- If you are not sure if the dose counter has counted down after inhalation one, wait until the next dose and then take dose one as usual. Do not take extra doses.
E.1. Open
- Take a firm grip on the inhaler and hold it upright.
- Check the number of doses remaining: if the number is between “1 and 120”, there are doses left.* If the dose counter shows “0”, there are no doses left. Discard the inhaler and get a new one.
- Open the protective cover completely.
- Exhale as long as it feels good before inhaling one.* Do not exhale through the inhaler.
E.2. Inhale
Stand or sit upright as you inhale if possible.
- Hold up the inhaler and bring it to your mouth, closing your lips around the mouthpiece.* Do not cover the air hole when holding the inhaler.* Do not inhale through the air hole.
- Inhale strongly and deeply through the mouth.* You can feel a taste in your mouth when you inhale.* You can hear or feel a click when you take your dose .* Do not inhale through the nose.* Do not remove the inhaler from your mouth during inhalation one.
- Take the inhaler out of your mouth
- Hold your breath for 5-10 seconds or as long as it feels good.
- Exhale slowly* Do not exhale through the inhaler.
E.3. Close
- Hold the inhaler upright and close the protective cap completely.
- Check that the dose counter has counted down by one.
- If you need to take another dose, repeat steps E.1 – E.3.
F. Cleaning
- The inhaler usually does not need to be cleaned.
- If necessary, the inhaler can be dried with a dry cloth or paper towel after use.* Do not use water or other liquid for cleaning. Keep it dry.
G. Storage and disposal
- For information on storage and disposal, see section 5.
4. Possible Innovair Nexthaler Side Effects
Like all medicines, Innovair nexthaler side effects, although not everybody gets them.
As with other inhaled medicines, there is a risk of worsening shortness of breath, coughing, or wheezing that occurs immediately after using Innovair nexthaler, which is known as paradoxical bronchospasm. If this happens, stop using Innovair nexthaler immediately and use your fast-acting inhaler immediately. You should contact a doctor immediately.
You should contact a doctor immediately if you experience allergic reactions, such as skin allergy, skin itching, rash, reddening of the skin, and swelling of the skin and mucous membranes, especially eyes, face, lips, and throat.
Other innovair nexthaler side effects are listed below according to their frequency.
Common (affects up to 1 in 10 people):
- Shaking
- Pneumonia in COPD patients
Tell your doctor if you have any of the following symptoms while taking Innovair nexthaler as they may be symptoms of pneumonia:
- Fever or chills
- Increased mucus production, changed the color of the mucus
- Increased cough or increased difficulty breathing
Uncommon (affects up to 1 in 100 people):
- Cold-like symptoms, of innovair nexthaler sore throat.
- Fungal infections (in the mouth and throat). Rinsing your mouth or gargling with water and brushing your teeth immediately after inhalation can help prevent this side effect.
- Worsening of asthma symptoms, difficulty breathing.
- Huskiness.
- Cough.
- Unusually fast heart rate.
- Unusually slow heart rate.
- Tightness over the chest.
- Headache.
- Nausea.
- Fatigue or nervousness.
- Changes in the ECG curve.
- Low cortisol levels in the urine or blood.
- High potassium levels in the blood.
- High blood sugar.
- Dyslipidemia.
Has been reported (occurs in an unknown number of users):
- Dimsyn
Side effects observed with similar inhalation preparations containing beclomethasone dipropionate and/or formoterol:
- Palpitation.
- Irregular heartbeat.
- Taste changes.
- Muscle aches and muscle cramps.
- Restlessness, dizziness.
- Anxiety.
- Sleeping problems.
- A decrease in the level of potassium in the blood.
- Increased or decreased blood pressure.
Use of high doses of inhaled corticosteroids for a long time can cause systemic effects (ie affect the whole body) these include:
- Problems with the function of the adrenal glands (inhibited adrenal function).
- Reduction in bone density.
- Growth retardation in children and adolescents.
- Increased pressure in the eyes ( glaucoma ), cataracts.
- Rapid weight gain, especially on the face and torso.
- Sleep problems, depression or anxiety, restlessness, nervousness, feeling rushed or irritable. These side effects are more likely to occur in children.
- Deviant behavior.
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 Nexthaler
Storing fostair nexthaler instructions:
Keep this medicine out of sight and reach of children.
Do not use innovair after the expiry date which is stated on the carton, sachet, and label after EXP. The expiration date is the last day of the specified month.
- Store in the original package. Moisture sensitive. Remove the inhaler from the bag just before the first dose.
- Before opening the bag:
- No special temperature instructions.
- After opening the bag:
- Do not store above 25 ° C.
The medicine should be used within six months of opening the bag. Use the label on the box and note the date you open the bag.
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
Content Declaration
The active substances are beclomethasone dipropionate (anhydrous) and formoterol fumarate dihydrate.
innovair nexthaler instructions
The other innovair nexthaler ingredients are lactose monohydrate (which contains small amounts of milk protein) and magnesium stearate.
What The Medicine Looks Like And Contents Of The Pack
- Innovair nexthaler is a white to almost white inhalation powder in a plastic nexthaler inhaler.
- Each pack contains one, two, or three inhalers with 120 inhalations each.
- Each inhaler is packaged in a sealed protective bag (made of aluminum foil).
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder:
Chiesi Farmaceutici SpA
Via Palermo 26 / A
43122 Parma
Italy
Manufacturer
Chiesi Farmaceutici SpA
Via San Leonardo 96
43122 Parma
Italy
Chiesi SAS
2 rue des Doctors Alberto and Paolo Chiesi
41260 La Chaussée Saint Victor
France
Chiesi Pharmaceuticals GmbH
Gonzagagasse 16/16
1010 Vienna
Austria
This medicinal product is authorized under the European Economic Area under the names:
| Belgium: Inuvair NEXThalerBulgaria: Foster NEXThalerCyprus: Foster NEXThalerDenmark: Innovair NexthalerEstonia: Foster NEXThalerFinland: Innovair nexthaler 100 mikrog / 6 mikrog / annos inhalaatiojauheFrance: Formodual NEXThalerGermany: KANTOS MASTER NEXThaler 100 Micrograms / 6 Micrograms per Dose Powder for inhalation | Greece: Inuvair NEXThalerIreland: Fostair Nexthaler 100 / micrograms / 6micrograms per metered dose of inhalation powderItaly: Inuver Latvia: Foster NEXThaler 100 micrograms / 6 micrograms for powder inhalationLithuania: FosterLuxembourg: Inuvair NEXThalerNorway: InuxairRomania: Foster NEXThaler 100 micrograms / 6 micrograms per dose of inhaled powderSpain: Formodual NEXThalerSweden: Innovair nexthaler |