7.2 micrograms / 5 micrograms inhalation spray , suspension glycopyrronium / formoterol fumarate dihydrate
1. What Bevespi Aerosphere is and what it is used for
Bevespi Aerosphere contains two active substances called glycopyrronium and formoterol fumarate dihydrate. These belong to a group of drugs called long-acting bronchodilators.
Bevespi Aerosphere is used to make it easier for adults to have a lung disease called COPD (chronic obstructive pulmonary disease ). COPD is a long-term disease of the lungs’ airways, which is often caused by smoking. If you have COPD, the muscles in the trachea become tense, which makes it difficult to breathe.
This medicine prevents the muscles in the trachea from becoming tense, making it easier for air to get in and out of the lungs.
Bevespi Aerosphere delivers the active ingredients directly to the lungs’ airways when you inhale. This will help reduce the effects of COPD in your daily life
2. What you need to know before using Bevespi Aerosphere
Do not use Bevespi Aerosphere
- if you are allergic to glycopyrronium, formoterol fumarate dihydrate, or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor or pharmacist before using Bevespi Aerosphere.
Warnings and cautions
Bevespi Aerosphere is regularly used as a long-term treatment for COPD. Do not use this medicine to treat sudden attacks of shortness of breath or wheezing.
Sudden difficulty breathing
If you get pressure over your chest, cough, wheeze or shortness of breath immediately after using Bevespi Aerosphere:
Stop using this medicine and seek immediate medical attention as this may be a serious condition called parodoxal bronchospasm.
Talk to your doctor or pharmacist before using Bevespi Aerosphere
- you have asthma. Do not use this medicine to treat asthma
- you have heart problems
- you have diabetes
- you have low potassium levels in your blood
- you have thyroid problems (called “thyrotoxicosis”)
- you have an eye problem called narrow-angle glaucoma
- you have prostate problems or difficulty urinating
- you have impaired kidney or liver function.
Always tell your doctor about other health problems.
Children and young people
Bevespi Aerosphere should not be used by children and adolescents under 18 years of age.
Other medicines and Bevespi Aerosphere
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may affect the way this medicine works or make you more likely to experience side effects. These medicines include:
- medicines that work in the same way as Bevespi Aerosphere, for example, medicines that contain active substances such as tiotropium, ipratropium, aclidinium, umeclidinium, salmeterol, vilanterol, olodaterol, or indacaterol. If you are not sure, ask your doctor or pharmacist. It is not recommended to use Bevespi Aerosphere with these medicines.
- drugs that can reduce potassium in the blood. These medicines include:
- cortisone that is swallowed (such as prednisolone ),
- diuretics (such as furosemide or hydrochlorothiazide ) used for high blood pressure ,
- certain drugs used to treat respiratory problems, so-called methylxanthines (such as theophylline).
- medicines called beta-blockers that can be used to treat high blood pressure or other heart problems (such as atenolol or propranolol) or to treat glaucoma (such as timolol )
- drugs that can cause so-called QT prolongation (a change in the electrical activity of the heart). These include drugs for the treatment of:
- depression (such as monoamine oxidase inhibitors or tricyclic antidepressants)
- bacterial infections (such as erythromycin, clarithromycin, telithromycin)
- allergic reactions ( antihistamines )
If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before using Bevespi Aerosphere.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using Bevespi Aerosphere.
Do not use Bevespi Aerosphere if you are pregnant unless your doctor tells you to.
Do not use Bevespi Aerosphere if you are breast-feeding unless your doctor tells you to
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machines. However, dizziness and nausea are common side effects that can occur. If this occurs, do not drive or use machines.
3. How to use Bevespi Aerosphere
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How much to use
The recommended dose is two puffs twice daily.
It is important that you use Bevespi Aerosphere every day, even if you do not have any symptoms of COPD at that time.
How to use Bevespi Aerosphere
Bevespi Aerosphere is intended for inhalation .
Read the instructions for use at the end of this leaflet. If you are not sure how to use Bevespi Aerosphere, talk to your doctor or pharmacist.
Use of Bevespi Aerosphere with a respirator
If you have problems breathing in and pressing the inhaler at the same time, talk to your doctor or pharmacist. It is possible that you can use a “breathing container” together with your inhaler.
If you use more Bevespi Aerosphere than you should
If you have used more Bevespi Aerosphere than you should contact a doctor or pharmacist immediately. You may need medical attention. You may feel your heartbeat faster than normal, feel shaky, have visual disturbances, have a dry mouth, have a headache, or feel nauseous.
If you forget to use Bevespi Aerosphere
Do not take a double dose to make up for a forgotten dose . Take it as soon as you remember. However, if it is soon time to take the next dose, skip the missed dose. Do not take more than two puffs twice daily.
If you stop using Bevespi Aerosphere
This medicine is for long-term use. It will only take effect while you use it. Do not stop taking this medicine unless your doctor tells you to, even if you feel better, as your symptoms may get worse. If you want to stop treatment, talk to your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Serious side effects are
Stop using Bevespi Aerosphere and contact a doctor immediately if you experience any of the following symptoms:
Uncommon: may affect up to 1 in 100 people
- swelling of the face, especially around the mouth (swelling of the tongue or throat, which may make it difficult to swallow)
- rash or hives in combination with difficulty breathing
- sudden feeling of fainting.
These symptoms may be a sign of a severe allergic reaction .
Other possible side effects are
Common: may affect up to 1 in 10 users
- headache
- dry mouth
- nausea
- painful and frequent urination (may be a sign of urinary tract infection)
- muscle cramps
- chest pain
- concern
- dizziness
Uncommon : may affect up to 1 in 100 people
- shaking or trembling
- high blood sugar
- agitation ( agitation )
- restlessness
- difficulty sleeping
- fast or irregular heartbeat
- difficulty urinating ( urinary retention ).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Bevespi Aerosphere
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, bag, or pressure container after “EXP”. The expiration date is the last day of the specified month.
Once opened, the inhaler can be used for up to 3 months. Write down the date the bag was opened in the designated place on the inhaler label.
Do not store above 30 ° C.
Warning: Do not destroy, puncture, or burn the pressure vessel, even if it appears empty. Do not expose the container to temperatures above 50 ° C.
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 glycopyrronium and formoterol fumarate dihydrate.
Each individual puff provides an added dose of 9 micrograms glycopyrronium bromide (equivalent to 7.2 micrograms glycopyrronium) and 5 micrograms formoterol fumarate dihydrate.
Other ingredients are norflurane, 1,2-distearoyl-sn-glycero-3-phosphocholine, and calcium chloride.
What the medicine looks like and contents of the pack
Bevespi Aerosphere is an inhalation spray , suspension .
Bevespi Aerosphere consists of a pressure container with a dose indicator, equipped with a white plastic adapter and a nozzle (see figure 1 in the operating instructions at the end of this leaflet). The nozzle has an orange protective cover. Bevespi Aerosphere comes in a foil bag that contains a desiccant and is packed in a carton.
The active ingredients are contained in a suspension inside the pressure vessel.
Bevespi Aerosphere in packs containing an inhaler with 120 puffs and in multipacks containing three inhalers s each with 120 puffs.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
AstraZeneca Dunkirk Production
224 Avenue de la Dordogne
Dunkirk
59640
France
AstraZeneca GmbH
Tinsdaler Weg 183
22880 Wedel
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienAstraZeneca SA / NVTel: +32 2 370 48 11 | LithuaniaUAB AstraZeneca LietuvaTel: +370 5 2660550 |
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| GreeceAstraZeneca AE:Ηλ: +30 210 6871500 | AustriaAstraZeneca Österreich GmbHTel: +43 1 711 31 0 |
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