5 micrograms\/7.2 micrograms\/160 micrograms\u00a0inhalation spray,\u00a0suspension
formoterol fumarate dihydrate\/glycopyrronium\/budesonide (formoterol fumarase dihydricus\/glycopyrronium\/budesonide)<\/p>\n\n\n\n
Trixeo Aerosphere contains three active substances called: formoterol fumarate dihydrate, glycopyrronium, and budesonide.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Trixeo Aerosphere is used to make breathing easier and improve symptoms of COPD such as\u00a0shortness of breath, wheezing, and coughing.\u00a0Trixeo Aerosphere can also prevent acute worsening periods when COPD symptoms flare up (\u00a0exacerbation\u00a0).<\/p>\n\n\n\n
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. Trixeo Aerosphere is used as a long-term maintenance treatment for COPD.\u00a0Do not use it to treat a sudden attack of shortness of breath or wheezing.<\/strong><\/p>\n\n\n\n Sudden difficulty breathing<\/strong><\/p>\n\n\n\n If you experience chest tightness, coughing, wheezing, or shortness of breath immediately after using Trixeo Aerosphere,\u00a0stop using it and contact your doctor immediately<\/strong>\u00a0(see \u201cSerious side effects\u201d at the beginning of section 4 for more information).<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Talk to your doctor before using Trixeo Aerosphere if:<\/strong><\/p>\n\n\n\n Talk to your doctor if you think any of these apply to you.<\/a><\/p>\n\n\n\n Trixeo Aerosphere has not been studied in children or adolescents. Do not give this medicine to children or adolescents under 18 years of age.<\/a><\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.\u00a0This also applies to over-the-counter medicines and herbal medicines.\u00a0The reason is that Trixeo Aerosphere can affect how certain medicines work.\u00a0Other medicines can also affect how Trixeo Aerosphere works or make you more likely to get\u00a0side effects.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking any of the following:<\/p>\n\n\n\n If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before using Trixeo Aerosphere.<\/a><\/p>\n\n\n\n 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.<\/p>\n\n\n\n Do not use Trixeo Aerosphere if you are pregnant, unless your doctor has told you that you can.<\/p>\n\n\n\n Do not use this medicine if you are breastfeeding, unless your doctor has told you that you can.<\/p>\n\n\n\n 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.<\/a><\/a><\/p>\n\n\n\n Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n How much to use<\/strong><\/p>\n\n\n\n The recommended dose is two puffs twice daily – two puffs in the morning and two puffs in the evening.<\/p>\n\n\n\n You must use Trixeo Aerosphere every day, even if you do not currently have any symptoms of COPD.<\/p>\n\n\n\n Remember<\/strong>: Always rinse your mouth with water after using Trixeo Aerosphere.\u00a0This is to remove any medicine that remains in the mouth.\u00a0Spit out the water – do not swallow.<\/p>\n\n\n\n How to use <\/strong>Trixeo Aerosphere<\/strong><\/p>\n\n\n\n Trixeo Aerosphere is intended for\u00a0inhalation.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Use of Trixeo Aerosphere with a breathing container<\/strong><\/p>\n\n\n\n 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.<\/p>\n\n\n\n If you have used more Trixeo Aerosphere then you should contact your doctor or pharmacist immediately.\u00a0You may need medical attention.\u00a0You may feel your heart beat faster than normal, feel shaky, have blurred vision, dry mouth, headache, or feel nauseous.<\/p>\n\n\n\n Do not take a double\u00a0dose\u00a0to make up for a missed\u00a0dose.\u00a0Take it as soon as you remember.<\/p>\n\n\n\n If, however, it is soon time to take the next\u00a0dose, you should skip the forgotten <\/p>\n\n\n\n dose.\u00a0Do not take more than two puffs twice on the same day.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n
<\/a><\/p>\n\n\n\nWhat you need to know before using Trixeo Aerosphere<\/h2>\n\n\n\n
Do not use Trixeo Aerosphere<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Other medicines and Trixeo Aerosphere<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
How to use Trixeo Aerosphere<\/h2>\n\n\n\n
If you have used too much Trixeo Aerosphere <\/h2>\n\n\n\n
If you forget to use Trixeo Aerosphere<\/h2>\n\n\n\n
If you stop using Trixeo Aerosphere<\/h2>\n\n\n\n