5 micrograms/7.2 micrograms/160 micrograms inhalation spray, suspension
formoterol fumarate dihydrate/glycopyrronium/budesonide (formoterol fumarase dihydricus/glycopyrronium/budesonide)
What Trixeo Aerosphere is and what it is used for
Trixeo Aerosphere contains three active substances called: formoterol fumarate dihydrate, glycopyrronium, and budesonide.
- Formoterol fumarate dihydrate and glycopyrronium belong to a group of medicines called ‘bronchodilators’ or ‘bronchodilators’. These work in different ways by preventing the muscles around the trachea from contracting, making it easier for air to get in and out of the lungs.
- Budesonide belongs to a group of medicines called “corticosteroids”. These work by reducing inflammation in your lungs.
Trixeo Aerosphere is an inhaler used for adults with a lung disease called “chronic obstructive pulmonary disease” (or “COPD”) a long-term disease of the airways of the lungs.
Trixeo Aerosphere is used to make breathing easier and improve symptoms of COPD such as shortness of breath, wheezing, and coughing. Trixeo Aerosphere can also prevent acute worsening periods when COPD symptoms flare up ( exacerbation ).
Trixeo Aerosphere delivers the active substances to your lungs when you inhale. If you use this medicine regularly twice a day, it will help reduce the effects of COPD in your everyday life.
What you need to know before using Trixeo Aerosphere
Do not use Trixeo Aerosphere
- if you are allergic to formoterol fumarate dihydrate, glycopyrronium, budesonide, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Trixeo Aerosphere is used as a long-term maintenance treatment for COPD. Do not use it to treat a sudden attack of shortness of breath or wheezing.
Sudden difficulty breathing
If you experience chest tightness, coughing, wheezing, or shortness of breath immediately after using Trixeo Aerosphere, stop using it and contact your doctor immediately (see “Serious side effects” at the beginning of section 4 for more information).
If your shortness of breath, chest tightness, wheezing, or cough gets worse while using Trixeo Aerosphere, continue using Trixeo Aerosphere but contact your doctor as soon as possible as you may need further treatment.
Talk to your doctor before using Trixeo Aerosphere if:
- you have high blood pressure or heart problems
- you have diabetes
- you have a lung infection
- you have thyroid problems
- you have low potassium levels in your blood
- you have prostate problems or difficulty urinating
- you have an eye problem called “narrow-angle glaucoma”
- you have reduced kidney or liver function
Talk to your doctor if you think any of these apply to you.
Children and young people
Trixeo Aerosphere has not been studied in children or adolescents. Do not give this medicine to children or adolescents under 18 years of age.
Other medicines and Trixeo Aerosphere
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines. The reason is that Trixeo Aerosphere can affect how certain medicines work. Other medicines can also affect how Trixeo Aerosphere works or make you more likely to get side effects.
Tell your doctor or pharmacist if you are taking any of the following:
- medicines called beta-blockers (such as atenolol or propranolol), which can be used to treat high blood pressure or heart problems or to treat glaucoma (such as timolol )
- medicines used to treat fungal infections such as ketoconazole or itraconazole
- medicines used to treat HIV infection such as ritonavir or cobicistat
- medicines that lower the amount of potassium in your blood such as:
- cortisone that you swallow (such as prednisolone ),
- diuretics – medicines that increase urine production (such as furosemide or hydrochlorothiazide ), which can be used to treat high blood pressure,
- certain medicines used to treat breathing problems (such as theophylline), so-called “methylxanthines”,
- medicines that work in the same way as Trixeo Aerosphere such as tiotropium, ipratropium, aclidinium, umeclidinium or salmeterol, arformoterol, vilanterol, olodaterol, or indacaterol. Do not use Trixeo Aerosphere if you are already using these medicines.
- medicines used to treat heart rhythm problems such as amiodarone
- medicines that can change the electrical activity of the heart (called the “QT interval”) such as medicines to treat:
- depression (such as monoamine oxidase inhibitors or tricyclic antidepressants )
- bacterial infection (such as erythromycin, clarithromycin, or 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 Trixeo Aerosphere.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Do not use Trixeo Aerosphere if you are pregnant, unless your doctor has told you that you can.
Do not use this medicine if you are breastfeeding, unless your doctor has told you that you can.
Driving ability and use of machinery
It is unlikely that this medicine will affect your ability to drive and use machines. However, dizziness is a less common side effect that should be taken into account when driving or using machinery.
How to use Trixeo Aerosphere
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
How much to use
The recommended dose is two puffs twice daily – two puffs in the morning and two puffs in the evening.
You must use Trixeo Aerosphere every day, even if you do not currently have any symptoms of COPD.
Remember: Always rinse your mouth with water after using Trixeo Aerosphere. This is to remove any medicine that remains in the mouth. Spit out the water – do not swallow.
How to use Trixeo Aerosphere
Trixeo Aerosphere is intended for inhalation.
Read “Instructions for use” at the end of this leaflet. Ask your doctor or pharmacist if you are not sure how to use Trixeo Aerosphere.
Use of Trixeo Aerosphere with a breathing container
You may find it difficult to inhale and press the inhaler at the same time. In that case, you should talk to your doctor or pharmacist. It may help to use a spacer with your inhaler.
If you have used too much Trixeo Aerosphere
If you have used more Trixeo Aerosphere then you should contact your doctor or pharmacist immediately. You may need medical attention. You may feel your heart beat faster than normal, feel shaky, have blurred vision, dry mouth, headache, or feel nauseous.
If you forget to use Trixeo Aerosphere
Do not take a double dose to make up for a missed dose. Take it as soon as you remember.
If, however, it is soon time to take the next dose, you should skip the forgotten
dose. Do not take more than two puffs twice on the same day.
If you stop using Trixeo Aerosphere
This medicine is for long-term use. Use this medicine for as long as your doctor tells you to. It will only be effective during the time you use it.
Do not stop taking this medicine unless your doctor tells you to, even if you feel better, because your symptoms may get worse. If you want to stop the treatment, you should first talk to your doctor.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Uncommon (may affect up to 1 in 100 users)
Sudden difficulty breathing:
- If you experience breathing difficulties immediately after using Trixeo Aerosphere such as chest tightness, coughing, wheezing or shortness of breath, stop using this medicine and contact your doctor immediately.
Allergic reactions:
- swelling of the face, especially around the mouth (swelling of the tongue or throat may make swallowing difficult)
- hives along with breathing difficulties
- sudden fainting sensation
These symptoms may be signs of an allergic reaction that can become serious. Stop using this medicine and seek medical attention immediately if you experience the serious side effects above.
Other side effects are
Tell your doctor or pharmacist if you experience any of the following side effects:
Common (may affect up to 1 in 10 users)
- fungal infection of the mouth (“cod”). Rinsing your mouth with water immediately after using Trixeo Aerosphere can help prevent this.
- feeling of worry
- sleep difficulties
- nausea
- headache
- cough or hoarse voice
- muscle cramps
- you feel your heartbeat (palpitations)
- high blood sugar levels (shown in tests)
- pain when urinating and frequent urges to urinate (may be signs of a urinary tract infection)
- pneumonia.
Tell the doctor if you have any of the following while using Trixeo Aerosphere, they may be symptoms of an infection in the lungs:
- fever or chills
- increased mucus production changed the color of the mucus
- increased coughing or increased breathing difficulties.
Uncommon (may affect up to 1 in 100 users)
- shaking, tremors or dizziness
- dry mouth or slight irritation in the throat
- bruises on the skin
- feeling restless, nervous, or agitated
- Depression
- fast or irregular heartbeat
- chest pain or pressure in the chest (angina).
Very rare (may affect up to 1 in 10,000 users)
- behavioral changes
- an effect on the adrenal glands.
Has been reported (occurring in an unknown number of users):
- blurred vision
- clouding of the lens in your eyes (a sign of cataract )
- increased pressure in the eyes ( glaucoma or “glaucoma”)
- swelling of the face, especially around the mouth (swelling of the tongue or throat may cause difficulty in swallowing).
How to store Trixeo Aerosphere
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton, bag, and pressure container after “EXP”. The expiration date is the last day of the specified month.
Once the bag has been opened, the inhaler must be used within 3 months.
Keep the inhaler inside the sealed pouch – just remove the inhaler from the sealed pouch immediately before first use. Write the date the bag was opened in the designated place on the inhaler label.
Store at a maximum of 30 °C. Store dry.
For best results, the inhaler should be at room temperature before use.
You must not destroy, puncture or burn the pressure vessel, even if it appears empty. You must not use or store the container near high heat or an open flame.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substances are formoterol fumarate dihydrate, glycopyrronium, and budesonide.
Each inhalation provides a delivered dose ( dose one leaving the mouthpiece) of 5 micrograms of formoterol fumarate dihydrate, 9 micrograms of glycopyrronium bromide corresponding to 7.2 micrograms of glycopyrronium, and 160 micrograms of budesonide.
Other ingredients are norflurane, 1,2-stearoyl-sn-glycerol-3-phosphocholine, and calcium chloride.
Appearance and package sizes of the medicine
Trixeo Aerosphere is an inhalation spray, suspension.
Trixeo Aerosphere is supplied as a pressurized container with a dose indicator, fitted with a yellow plastic adapter and a white nozzle. The nozzle has a gray protective cover that can be removed. Trixeo Aerosphere is supplied in a foil bag containing desiccant and packed in a cardboard box.
Each inhaler contains 120 puffs. Some multipacks contain 3 pressure containers with 120 puffs in each.
Manufacturer
AstraZeneca Dunkirk Production
224 Avenue de la Dordogne
Dunkirk
59640
France
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
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