País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tegafur; Gimeracil; Oteracil potassium
Nordic Pharma Ltd
L01BC53
Tegafur; Gimeracil; Oteracil potassium
15mg ; 4.35mg ; 11.8mg
Capsule
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 08010300
2 PACKAGE LEAFLET: INFORMATION FOR THE USER TEYSUNO 15 MG/4.35 MG/11.8 MG HARD CAPSULES_ _ Tegafur/gimeracil/oteracil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What Teysuno is and what it is used for 2. Before you take Teysuno 3. How to take Teysuno 4. Possible side effects 5. How to store Teysuno 6. Further information 1. WHAT TEYSUNO IS AND WHAT IT IS USED FOR Teysuno belongs to the fluoropyrimidine class of medicine known as “antineoplastic agents” which stop the growth of cancer cells. Teysuno is prescribed by doctors for the treatment of adults with advanced stomach (gastric) cancer and is taken with cisplatin, another anti-cancer medicine. 2. BEFORE YOU TAKE TEYSUNO DO NOT TAKE TEYSUNO IF YOU: - are allergic (hypersensitive) to tegafur, gimeracil, oteracil or any of the other ingredients of Teysuno - are taking other fluoropyrimidine anti-cancer medicine such as fluorouracil and capecitabine, or have had severe and unexpected reactions to fluoropyrimidines - have known genetic deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD) - are pregnant or breastfeeding - have severe blood disorders - have kidney disease requiring dialysis - are currently being treated or have been treated in the last 4 weeks with sorivudine, brivudine or a similar class of anti-viral medicines TAKE SPECIAL CARE WITH TEYSUNO - Before treatment with Teysuno, tell your doctor if you have: - blood disorders - kidney disease - stomach and/or bowel problems such as pain, diarrhoea, vomiting and dehydration - eye disorders, such as “dry eye” or increased tearing - Teysuno is Leer el documento completo
OBJECT 1 TEYSUNO 15MG/4.35MG/11.8MG HARD CAPSULES Summary of Product Characteristics Updated 31-May-2018 | Nordic Pharma Limited 1. Name of the medicinal product Teysuno 15 mg/4.35 mg/11.8 mg hard capsules 2. Qualitative and quantitative composition Each hard capsule contains 15 mg tegafur, 4.35 mg gimeracil and 11.8 mg oteracil (as monopotassium). Excipient with known effect Each hard capsule contains 70.2 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Hard capsule (capsule). The capsule has an opaque white body and opaque brown cap imprinted “TC448” in grey. 4. Clinical particulars 4.1 Therapeutic indications Teysuno is indicated in adults for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5.1). 4.2 Posology and method of administration Teysuno should only be prescribed by a qualified physician experienced in treating cancer patients with anti-neoplastic medicinal products. Posology The recommended standard dose of Teysuno when administered in combination with cisplatin is 25 mg/m 2 (expressed as tegafur content) twice daily, morning and evening, for 21 consecutive days followed by 7 days rest (1 treatment cycle). This treatment cycle is repeated every 4 weeks. The standard and reduced Teysuno and cisplatin doses and calculations according to body surface area (BSA) for doses of Teysuno given in combination with cisplatin are provided in Table 1 and Table 2, respectively. The patient's BSA must be recalculated and the Teysuno dose adjusted accordingly if a patient's weight increases or decreases by ≥10% from the one used for the previous calculation of BSA and the change is clearly not related to fluid retention. The recommended dose of cisplatin with this regimen is 75 mg/m 2 by intravenous infusion administered once every 4 weeks. Cisplatin should be discontinued after 6 cycles without withdrawal of Teysuno. If cisplatin is discontinued before 6 cycles, Teysuno treatment alone can be resumed when the criter Leer el documento completo