Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Everolimus
Accord-UK Ltd
L01EG02
Everolimus
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500; GTIN: 5055565748084
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. EU-Artwork-Support@accord-healthcare.com EVEROLIMUS 10MG TABLETS PIL - UK Black Profile BBBB1586 RH 09-06-21 152x440 9pt Synthon ES 10-06-21 01 Version 7 12.02.2020 German GTIN 14 (incorporating PZN): Cartons and label leaflets only (labels only when specified) EVEROLIMUS 2.5MG, 5MG AND 10MG TABLETS PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Everolimus 2.5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg everolimus. Excipient with known effect Each tablet contains 74.3 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. 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). Renal cell carcinoma Everolimus Tablets are indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF- targeted therapy. 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 mi Olvassa el a teljes dokumentumot