Trimbow Patient Counseling Information

Instructions for use: Priming the inhaler: Before using the inhaler for the first time, the patient should release one actuation into the air in order to ensure that the inhaler is working properly (priming). Before priming the 120 actuation pressurised containers, the counter/indicator should read 121. After priming, the counter/indicator should read 120.
Use of the inhaler: Patients should stand or sit in an upright position when inhaling from their inhaler. The steps should be followed as follows.
IMPORTANT: Steps 2 to 5 should not be performed too quickly: 1. Patients should remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects.
2. Patients should breathe out slowly and as deeply as comfortable, in order to empty their lungs.
3. Patients should hold the inhaler vertically with its body upwards and place the mouthpiece between their teeth without biting. Their lips should then be placed around the mouthpiece, with the tongue flat under it.
4. At the same time, patients should breathe in slowly and deeply through the mouth until the lungs are full of air (this should take approximately 4 - 5 seconds). Immediately after starting to breathe in, patients should firmly press down on the top of the pressurised container to release one puff.
5. Patients should then hold their breath for as long as comfortably possible, then remove the inhaler from the mouth and breathe out slowly. Patients should not breathe out into the inhaler.
6. Patients should then check the dose counter or dose indicator to ensure it has moved accordingly.
To inhale the second puff, patients should keep the inhaler in a vertical position for approximately 30 seconds and repeat steps 2 to 6.
If mist appears after the inhalation, either from the inhaler or from the sides of the mouth, the procedure should be repeated from step 2.
After use, patients should close the inhaler with the protective mouthpiece cover and check the dose counter or dose indicator.
After inhaling, patients should rinse their mouth or gargle with water without swallowing it or brush their teeth (see Dosage & Administration and Precautions).
When to get a new inhaler: Patients should be advised to get a new inhaler when the dose counter or indicator shows the number 20. They should stop using the inhaler when the counter or indicator shows 0 as any puffs left in the device may not be enough to release a full actuation.
Additional instructions for specific groups of patients: For patients with weak hands, it may be easier to hold the inhaler with both hands. Therefore, the index fingers should be placed on the top of the pressurised container and both thumbs on the base of the inhaler.
Patients who find it difficult to synchronise aerosol actuation with inspiration of breath may use the AeroChamber Plus spacer device, properly cleaned as described in the relevant leaflet.
They should be advised by their doctor or pharmacist about the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled active substance to the lungs. This may be obtained by the patients using the AeroChamber Plus by one continuous slow and deep breath through the spacer, without any delay between actuation and inhalation. Alternatively, patients may simply breathe in and out (through the mouth) after the actuation, as instructed in the spacer leaflet, to obtain the active substance. See Precautions and Pharmacology: Pharmacokinetics under Actions.
Cleaning: For the regular cleaning of the inhaler, patients should remove weekly the cap from the mouthpiece and wipe the outside and inside of the mouthpiece with a dry cloth. They should not remove the pressurised container from the actuator and should not use water or other liquids to clean the mouthpiece.