Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Mitotane
HRA Pharma Rare Diseases
L01XX23
mitotane
Antineoplastic agents
Adrenal Cortex Neoplasms
Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. The effect of Lysodren on non-functional adrenal cortical carcinoma is not established.
Revision: 18
Authorised
2004-04-28
18 B. PACKAGE LEAFLET 19 PACKAGE LEAFLET: INFORMATION FOR THE USER LYSODREN 500 MG TABLETS mitotane 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. ALWAYS KEEP WITH YOU THE LYSODREN PATIENT CARD INCLUDED AT THE END OF THIS LEAFLET. WHAT IS IN THIS LEAFLET : 1. What Lysodren is and what it is used for 2. What you need to know before you take Lysodren 3. How to take Lysodren 4. Possible side effects 5. How to store Lysodren 6. Contents of the pack and other information 1. WHAT LYSODREN IS AND WHAT IT IS USED FOR Lysodren is an antitumoral medicine. This medicine is used for the treatment of symptoms of advanced non operable, metastatic or recurrent malignant tumours of the adrenal glands. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LYSODREN DO NOT TAKE LYSODREN - if you are allergic to mitotane or any of the other ingredients of this medicine (listed in section 6). - if you are breast-feeding. You must not breast-feed while taking Lysodren. - if you are being treated with medicines containing spironolactone (see "Other medicines and Lysodren"). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Lysodren. You should tell your doctor if any of the following applies to you: - if you have an injury (shock, severe trauma), an infection or if you have any illness while you are taking Lysodren. Tell your doctor immediately, who may decide to temporarily stop treatment. - if you have liver problems: Tell your doctor if you develop any of the following signs and symptoms of liver problems during Lysodren treatment: itc Lesen Sie das vollständige Dokument
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Lysodren 500 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg of mitotane. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, biconvex, round, scored tablets. They are bisected on one side and impressed "BL" over "L1" on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma (ACC). The effect of Lysodren on non functional adrenal cortical carcinoma is not established. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and followed by a suitably experienced specialist. _ _ Posology Treatment in adults should be started with 2 - 3 g mitotane per day and increased progressively (e.g. at two-week intervals) until mitotane plasma levels reach the therapeutic window 14 – 20 mg/L. If it is urgent to control Cushing’s symptoms in highly symptomatic patients, higher starting doses between 4 - 6 g per day could be necessary and daily dose increased more rapidly (e.g. every week). A starting dose higher than 6 g/day is generally not recommended. _Dose adjustments, monitoring and discontinuation_ Dose adjustment is aimed to reach a therapeutic window (mitotane plasma levels 14 - 20 mg/L) which ensures optimal use of Lysodren with acceptable safety. Indeed, neurologic toxicity has been associated with levels above 20 mg/L and therefore this threshold should not be reached. There are some data suggesting that mitotane plasma above 14 mg/L may result in enhanced efficacy (see section 5.1). Mitotane plasma levels higher than 20 mg/L may be associated with severe undesirable effects and offer no further benefit in terms of efficacy. Mitotane plasma levels should therefore be monitored in order to adjust the Lysodren dose and to avoid reaching toxic levels. For further information on the sample testing please contact the Marketing Authorisatio Lesen Sie das vollständige Dokument