Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Everolimus
A A H Pharmaceuticals Ltd
L01EG02
Everolimus
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500
Common Technical Document Everolimus, 2.5, 5, 10 mg Tablets M1.3.1_03.EVS.tab.001.03.Core Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EVEROLIMUS 2.5MG, 5MG AND 10MG TABLETS 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. - The full name of this medicine is Everolimus 2.5mg, 5mg and 10mg Tablets but within this leaflet it will be referred to as Everolimus Tablets. WHAT IS IN THIS LEAFLET 1. What Everolimus Tablets are and what they are used for 2. What you need to know before you take Everolimus Tablets 3. How to take Everolimus Tablets 4. Possible side effects 5. How to store Everolimus Tablets 6. Contents of the pack and other information 1. WHAT EVEROLIMUS TABLETS ARE AND WHAT THEY ARE USED FOR Everolimus Tablets are 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 Tablets are 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, bowel, lung or pancreas. It is given if the tumours are inoperable and do not overproduce specific hormones or other related natural substances. Everolimus whi Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Everolimus 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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. 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 Everolimus Tablets are 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. Neuroendocrine tumours of pancreatic origin Everolimus Tablets are 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 Everolimus Tablets are 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Everolimus Tablets should be initiated and supervised by a physician experienced in the use of anticancer therapies. Posology For the different dose regimens Everolimus Tablets are available as 2.5 mg, 5 mg and 10 mg tablets. The recommended dose is 10 mg everolimus once daily. Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs. If a dose is missed, the patient should not take an additional dose, but take the next prescribed dose as usual. _Dose adjustment due to adverse reactions _ Management of severe and/or intolerable suspected advers Citiți documentul complet