About your EASi-KIDNEY study pills

Study treatment (BI 690517 or matching placebo AND empagliflozin)

Oral use only

Storage conditions: keep the pills out of direct sunlight

Keep out of the reach of children

For clinical trial use only.

• Unless otherwise instructed, you should take ONE pill of Type M Treatment (BI 690517 10mg or matching placebo tablet from the bottle) and ONE pill of Type E Treatment (empagliflozin 10mg from the wallet) by mouth each day at about the same time (with or without food).
• If you forget to take one or both pills at your usual time, you may still take it later the same day. However, if you miss a whole day or more, do not make up for the missed pills on the day you restart.
• If you think you will reach the end of your pills before your next clinic visit or if you lose your pills, please contact your local study nurse or call the EASi-KIDNEY^TM office and we will arrange for replacement pills.
• BI 690517 or matching placebo and empagliflozin should generally be temporarily stopped on days that you are unable to eat for prolonged periods, such as during an illness or in preparation for medical procedures. For scheduled major operations, you may be advised to stop treatment for three days before surgery. The study pills should be restarted on discharge, unless you are instructed otherwise by your doctor. For advice regarding empagliflozin use when fasting for non-medical reasons, such as religious occasions, this should be discussed with your local study doctor who will advise you in accordance with local guidance.
• Note that if you permanently stop Type E treatment you will be required to stop Type M also. If however, you permanently discontinue Type M treatment Type E treatment should be continued (as it is indicated for use in adults with chronic kidney disease in many countries).
• Please remember to take a mental note of what time you have taken your pills on clinic days as you will sometimes be asked.
• For women: if you think you may be pregnant, become pregnant or plan to get pregnant while taking the study pills please stop them immediately and inform your local study nurse or call Freephone 0808 164 4060 as soon as possible.