Land: Malta
Språk: engelsk
Kilde: Medicines Authority
Reddy Pharma Iberia S.A. Avinguda De Josep Tarradellas 38 Barcelona, 08029, Spain
L01EG02
EVEROLIMUS 5 mg
TABLET
EVEROLIMUS 5 mg
POM
ANTINEOPLASTIC AGENTS
Authorised
2023-01-16
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Everolimus Dr. Reddy’s Tablets 2.5 mg Everolimus Dr. Reddy’s Tablets 5 mg Everolimus Dr. Reddy’s Tablets 10 mg Everolimus READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Everolimus Dr. Reddy’s Tablets is and what it is used for 2. What you need to know before you take Everolimus Dr. Reddy's tablets 3. How to take Everolimus Dr. Reddy's tablets 4. Possible side effects 5. How to store Everolimus Dr. Reddy's tablets 6. Contents of the pack and other information 1. WHAT EVEROLIMUS DR. REDDY’S TABLETS IS AND WHAT IT IS USED FOR Everolimus Dr. Reddy’s Tablets is an anticancer medicine containing the active substance everolimus. Everolimus reduces the blood supply to the tumour and slows down the growth and spread of cancer cells. Everolimus Dr. Reddy’s Tablets is used to treat adult patients with: - hormone receptor-positive advanced breast cancer in postmenopausal women, in whom other treatments (so called “non-steroidal aromatase inhibitors”) no longer keep the disease under control. It is given together with a medicine called exemestane, a steroidal aromatase inhibitor, which is used for hormonal anticancer therapy. - advanced tumours called neuroendocrine tumours that originate from the stomach, bowels, lung or pancreas. It is given if the tumours are inoperable and do not overproduce specific hormones or other related natural substances. - advanced kidney cancer (advanced renal cell carcinoma), where other treatments (so-call Les hele dokumentet
1 1. NAME OF THE MEDICINAL PRODUCT Everolimus Dr. Reddy's Tablets 2.5mg Everolimus Dr. Reddy's Tablets 5 mg Everolimus Dr. Reddy's Tablets 10 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Everolimus Dr. Reddy's Tablets 2.5mg Each tablet contains 2.5 mg everolimus. Excipient with known effect Each tablet contains 74.3 mg lactose Everolimus Dr. Reddy's Tablets 5 mg Each tablet contains 5 mg everolimus. Excipient with known effect Each tablet contains 148.5 mg lactose Everolimus Dr. Reddy's Tablets 10 mg Each tablet contains 10 mg everolimus. Excipient with known effect Each tablet contains 297.0 mg lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 2.5 mg tablet: white to off white oval biconvex tablets (approximately 10 x 5 mm), debossed with E9VS on one side and 2.5 on the other side. 5 mg tablet: white to off white oval and biconvex tablets (approximately 13 x 6 mm), debossed with E9VS 5 on one side. 10 mg tablet: white to off white oval and biconvex tablets (approximately 16 x 8 mm), debossed with E9VS 10 on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone receptor-positive advanced breast cancer [product name] is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. 2 Neuroendocrine tumours of pancreatic origin [product name] is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease. Neuroendocrine tumours of gastrointestinal or lung origin [product name] is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease (see sections 4.4 and 5.1). Renal cell carcinoma [product na Les hele dokumentet