Possible side-effects: Empagliflozin

You may be at risk of ketoacidosis (lack of insulin causing harmful substances called ketones to build up in the blood). This risk is higher if you have diabetes, particularly if you are taking insulin. Always stop your empagliflozin if you are unable to eat, if you are unwell or awaiting an operation. If you are fasting for non-medical reasons (such as for religious reasons) then please discuss this with your study team and follow their advice and guidance.

Empagliflozin might increase the chance of a fungal genital tract infection, like thrush. These infections are usually easily treated with a course of antifungal cream or pills. Occasionally it may also cause a urine infection, which may require antibiotics (but most urine infections are not caused by the drug). If such treatment is ever needed, your GP or local study team could help diagnose and treat you. If you develop groin pain, please seek medical advice urgently.

ALLERGIES

In addition to the study medications (BI 690517/placebo and empagliflozin), the study tablets are manufactured from hypromellose, calcium carbonate, isomalt, triglycerides, hydroxypropylcellulose, croscarmellose, magnesium stearate, mannitol, iron oxide, lactose and cellulose. If you have any allergies to any of these components (or the study medications) please stop the pills and inform the study team.

Further information about side effects of study treatment (vicadrostat (BI 690517) or matching placebo and empagliflozin) is given in the EASi-KIDNEY^TM Participant Information Leaflet and on our website: www.easikidney.org. If any new important information arises during the course of the study the study staff will discuss this with you. If you develop any symptoms that you think are related to your study pills, please contact your local study nurse or call Freephone 0808 164 4060 for further advice.