- beclometasone dipropionate
- formoterol fumarate dihydrate
- glycopyrronium bromide
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/17/1208/001, EU/1/17/1208/003, EU/1/17/1208/004, EU/1/17/1208/005, EU/1/17/1208/002.
Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution
Package leaflet: Information for the user
87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution
beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Trimbow is and what it is used for
2. What you need to know before you use Trimbow
3. How to use Trimbow
4. Possible side effects
5. How to store Trimbow
6. Contents of the pack and other information
1. What Trimbow is and what it is used for
Trimbow is a medicine to help breathing that contains the three active substances:
Beclometasone dipropionate belongs to a group of medicines called corticosteroids which act to reduce the swelling and irritation in your lungs.
Formoterol and glycopyrronium are medicines called long-acting bronchodilators. They act in different ways to relax the muscles in your airways, helping to open the airways wider and allowing you to breathe more easily.
Regular treatment with these three active substances helps to relieve and prevent symptoms such as shortness of breath, wheezing and cough in adult patients with chronic obstructive pulmonary disease (COPD). Trimbow can reduce exacerbations (flare-ups) of COPD symptoms. COPD is a serious long-term disease in which the airways become blocked and air sacs inside the lungs become damaged, leading to difficulty breathing.
2. What you need to know before you use Trimbow
Do not use Trimbow:
If you are allergic to beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions:
Trimbow is used as a maintenance treatment for your COPD. Do not use this medicine to treat a sudden attack of breathlessness or wheezing.
If your breathing gets worse:
If you develop worsening shortness of breath or wheezing (breathing with a whistling sound), straight after inhaling your medicine, stop using Trimbow inhaler and use your quick-acting “reliever” inhaler straightaway. You should contact your doctor straightaway. Your doctor will assess your symptoms and if necessary may start you on a different treatment.
See also section 4, “Possible side effects”.
If your COPD gets worse:
If your symptoms get worse or are difficult to control (e.g. if you are using a separate “reliever” inhaler more frequently) or if your “reliever” inhaler does not improve your symptoms, see your doctor immediately. Your COPD may be getting worse and your doctor may need to prescribe different treatment.
Talk to your doctor or pharmacist before using Trimbow:
If any of the above applies to you, tell your doctor before you use Trimbow.
If you have or have had any medical problems or any allergies or if you are not sure if you can use Trimbow, talk to your doctor or pharmacist before using the inhaler.
If you are already using Trimbow
If you are using Trimbow or high doses of other inhaled corticosteroids over long periods and you come into a situation of stress (e.g. being taken to hospital after an accident, having a serious injury or before an operation) you may need more of this medicine. In such a situation, your doctor may need to increase your dose of corticosteroids to cope with the stress and may prescribe them as tablets or injections. Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
Do not give this medicine to children and adolescents below the age of 18 years.
Other medicines and Trimbow
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines similar to Trimbow used for your lung disease.
Some medicines may increase the effects of Trimbow and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Do not use this medicine with a beta-blocker medicine (used for treating certain heart problems such as angina or for reducing blood pressure) unless your doctor has chosen a beta-blocker that does not affect your breathing. Beta-blockers (including beta-blocker eye-drops) may reduce the effects of formoterol or make it not work at all. On the other hand, using other beta2-agonist medicines (which work in the same way as formoterol) may increase the effects of formoterol.
Using Trimbow together with:
Pregnancy and breast-feeding
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 this medicine.
You should only use Trimbow during pregnancy if you are advised to do so by your doctor. It is preferable to avoid the use of Trimbow during labour due to the inhibitory effects of formoterol on uterine contractions.
You should not use Trimbow during breast-feeding.
You and your doctor must make a decision whether to discontinue breast-feeding or to discontinue/abstain from Trimbow therapy taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.
Driving and using machines
Trimbow is unlikely to affect your ability to drive and use machines.
3. How to use Trimbow
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is two puffs in the morning and two puffs in the evening.
If you feel that the medicine is not very effective, talk to your doctor.
If you have been using a different inhaler containing beclometasone dipropionate previously, ask your doctor for advice, as the effective dose of beclometasone dipropionate in Trimbow for the treatment of COPD may be lower than that of some other inhalers.
Route of administration
Trimbow is for inhalation use.
You should inhale the medicine through your mouth and this takes the medicine directly into your lungs.
This medicine is contained in a pressurised container in a plastic inhaler with a mouthpiece.
Trimbow is available in three container sizes:
If you have been prescribed a container providing 60 puffs or 120 puffs
There is a counter on the back of the inhaler, which tells you how many doses are left. Each time you press the pressurised container, a puff of medicine is released and the counter will count down by one. Take care not to drop the inhaler as this may cause the counter to count down.
If you have been prescribed a container providing 180 puffs
There is an indicator on the back of the inhaler, which tells you how many doses are left. Each time you press the pressurised container, a puff of medicine is released and the dose indicator rotates by a small amount. The number of puffs remaining is displayed in intervals of 20. Take care not to drop the inhaler as this may cause the dose indicator to count down.
Testing your inhaler
Before using the inhaler for the first time, you should test your inhaler to make sure that it is working properly, as follows.
1. Depending on the container size prescribed to you, check that the dose counter reads 61 or 121 and that the dose indicator reads 180
2. Remove the protective cap from the mouthpiece
3. Hold your inhaler upright with the mouthpiece at the bottom
4. Direct the mouthpiece away from yourself and firmly press the pressurised container to release one puff
5. Check the dose counter or dose indicator. If you are testing your inhaler for the first time, the counter should read:
How to use your inhaler
Stand or sit up when inhaling.
IMPORTANT: Do not perform steps 2 to 5 too quickly.
1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt.
2. Breathe out as slowly and deeply as possible, in order to empty your lungs.
3. Hold the inhaler upright with the mouthpiece at the bottom and place the mouthpiece between your teeth without biting it. Then place your lips around the mouthpiece, with the tongue flat under it.
4. Breathe in slowly and deeply through your mouth to fill your lungs with air (this should take about 4–5 seconds). Just after starting to breathe in, press down firmly on the top of the pressurised container to release one puff.
5. Hold your breath for as long as possible and, finally, remove the inhaler from your mouth and breathe out slowly. Do not breathe out into the inhaler.
6. Check that the dose counter (60/120 puffs) has moved down by one or that the dose indicator (180 puffs) has rotated by a small amount.
For the second puff, keep the inhaler in the upright position for about half a minute, then repeat steps 2 to 5.
If you see ‘mist’ coming from the top of the inhaler or the sides of your mouth, this means that Trimbow will not be getting into your lungs as it should. Take another puff, following the instructions starting again from step 2.
After use, replace the protective cap.
To prevent a fungal infection in the mouth and throat, rinse your mouth or gargle with water without swallowing it or brush your teeth after each use of your inhaler.
When to get a new inhaler
You should get a replacement when the counter or indicator shows the number 20. Stop using the inhaler when the counter or indicator shows 0, as any medicine left in the inhaler may not be enough to give you a full puff.
If you have a weak grip, it may be easier to hold the inhaler with both hands: hold the upper part of the inhaler with both index fingers and its lower part with both thumbs.
If you find it difficult to use the inhaler while starting to breathe in, you may use the AeroChamber Plus spacer device. Ask your doctor or pharmacist about this device. It is important that you read the package leaflet which is supplied with your AeroChamber Plus spacer device and that you carefully follow the instructions on how to use the AeroChamber Plus spacer device and how to clean it.
Cleaning of the Trimbow inhaler
You should clean your inhaler once a week.
1. Do not remove the pressurised container from the inhaler and do not use water or other liquids to clean your inhaler.
2. Remove the protective cap from the mouthpiece by pulling it away from your inhaler.
3. Wipe inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or tissue.
4. Replace the mouthpiece cap.
If you use more Trimbow than you should
It is important that you take your dose as advised by your doctor. Do not exceed your prescribed dose without talking to your doctor.
If you use more Trimbow than you should, side effects, as described in section 4, may occur.
Tell your doctor if you have used more Trimbow than you should and if you experience any of these symptoms. Your doctor may wish to carry out some blood tests.
Tell your doctor if you have any of these symptoms.
If you forget to use Trimbow
Use it as soon as you remember. If it is almost time for your next dose, do not take the dose you have missed, but just take the next dose at the correct time. Do not double the dose.
If you stop using Trimbow
It is important to use Trimbow every day. Do not stop using Trimbow or lower the dose, even if you are feeling better or you have no symptoms. If you want to do this, talk to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
There is a risk of worsening shortness of breath and wheezing immediately after using Trimbow and this is known as paradoxical bronchospasm (may affect up to 1 in 1,000 people). If this occurs you should stop using Trimbow and use your quick-acting “reliever” inhaler straightaway to treat the shortness of breath and wheezing. You should contact your doctor straightaway.
Tell your doctor immediately
Tell your doctor if you have any of the following while using Trimbow as they could be symptoms of a lung infection (may affect up to 1 in 10 people):
Possible side effects are listed below according to their frequency.
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Very rare (may affect up to 1 in 10,000 people):
Not known (frequency cannot be estimated from the available data):
Using high-dose inhaled corticosteroids over a long time can cause in very rare cases effects on the body:
Trimbow does not contain a high-dose inhaled corticosteroid, but your doctor may wish to measure the cortisol levels in your blood from time to time.
The following side effects can also occur with high-dose inhaled corticosteroids used over a long time, but the frequency is not known (frequency cannot be estimated from the available data) at present:
These events are more likely to occur in children.
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
United Kingdom: Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Trimbow
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 label and carton after EXP. The expiry date refers to the last day of that month.
Prior to dispensing:
Store in a refrigerator (2°C-8°C).
Do not freeze.
Do not expose to temperatures higher than 50°C.
Do not pierce the pressurised container.
60 actuation pressurised container:
After dispensing, the inhaler may be stored at a temperature up to 25°C for a maximum of 2 months.
120 and 180 actuation pressurised container:
After dispensing, the inhaler may be stored at a temperature up to 25°C for a maximum of 4 months.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Content of the pack and other information
What Trimbow contains
The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium.
Each delivered dose (the dose leaving the mouthpiece) contains 87 micrograms of beclometasone dipropionate, 5 micrograms of formoterol fumarate dihydrate and 9 micrograms of glycopyrronium (as 11 micrograms glycopyrronium bromide).
Each metered dose (the dose leaving the valve) contains 100 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate and 10 micrograms of glycopyrronium (as 12.5 micrograms of glycopyrronium bromide).
The other ingredients are: ethanol anhydrous, hydrochloric acid, propellant: norflurane.
What Trimbow looks like and contents of the pack
Trimbow is a pressurised inhalation, solution.
Trimbow comes in a pressurised container (coated aluminium), with a metering valve. The pressurised container is inserted in a plastic inhaler. This incorporates a mouthpiece provided with a plastic protective cap, and either a dose counter (containers with 60 and 120 puffs) or a dose indicator (containers with 180 puffs).
Each pack contains one pressurised container either providing 60 puffs, 120 puffs or 180 puffs. Additional there are multipacks containing either 2 or 3 pressurised containers with 120 puffs, each.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in January 2019.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.