Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
telotristat etiprate
SERB SAS
A16A
telotristat ethyl
Other alimentary tract and metabolism products
Carcinoid Tumor; Neuroendocrine Tumors
Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
Revision: 15
Authorised
2017-09-17
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XERMELO 250 MG FILM-COATED TABLETS telotristat ethyl 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Xermelo is and what it is used for 2. What you need to know before you take Xermelo 3. How to take Xermelo 4. Possible side effects 5. How to store Xermelo 6. Contents of the pack and other information 1. WHAT XERMELO IS AND WHAT IT IS USED FOR WHAT XERMELO IS This medicine contains the active substance telotristat ethyl. WHAT XERMELO IS USED FOR This medicine is used in adults with a condition called ‘carcinoid syndrome’. This is when a tumour, called a ‘neuroendocrine tumour’, releases a substance called serotonin into your bloodstream. Your doctor will prescribe this medicine if your diarrhoea is not well controlled with injections of other medicines called ‘somatostatin analogues’ (lanreotide or octreotide). You should keep having injections of these other medicines when taking Xermelo. HOW XERMELO WORKS When the tumour releases too much serotonin into your bloodstream you can get diarrhoea. This medicine works by reducing the amount of serotonin made by the tumour. It will reduce your diarrhoea. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XERMELO DO NOT TAKE XERMELO - if you are allergic to telotristat or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Xermelo: • if you have liver problems. This is because this m Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Xermelo 250 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains telotristat etiprate equivalent to 250 mg telotristat ethyl. Excipient with known effect Each tablet contains 168 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to off-white film-coated oval tablets (approximately 17 mm long by 7.5 mm wide) with ‘T-E’ debossed on one side and ‘250’ debossed on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 250 mg three times daily (tid). Available data suggest that clinical response is usually achieved within 12 weeks of treatment. It is recommended to reassess the benefit of continued therapy in a patient not responding within this time period. Based on the high inter-subject variability observed, accumulation in a subset of patients with carcinoid syndrome cannot be excluded. Therefore, intake of higher doses is not recommended (see section 5.2). _Missed doses _ In the event of a missed dose, patients should take their subsequent dose at the next scheduled time point. Patients should not take a double dose to make up for a missed dose. _ _ _Special population _ _ _ _Elderly _ _ _ No specific dose recommendations are available for elderly patients (see section 5.2). _ _ 3 _Renal impairment _ _ _ No change in dose is required in patients with mild, moderate or severe renal impairment; who are not requiring dialysis (see section 5.2). As a precautionary measure, it is recommended that patients with severe renal impairment will be monitored for signs of reduced tolerability. The use of Xermelo is not recommended in patients with end-stage renal disease Przeczytaj cały dokument