Country: Европска Унија
Језик: Енглески
Извор: EMA (European Medicines Agency)
mercaptamine bitartrate
Chiesi Farmaceutici S.p.A
A16AA04
mercaptamine
Other alimentary tract and metabolism products,
Cystinosis
Procysbi is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.
Revision: 16
Authorised
2013-09-05
43 B. PACKAGE LEAFLET 44 PACKAGE LEAFLET: INFORMATION FOR THE USER PROCYSBI 25 MG GASTRO-RESISTANT HARD CAPSULES PROCYSBI 75 MG GASTRO-RESISTANT HARD CAPSULES cysteamine (mercaptamine bitartrate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have 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. WHAT IS IN THIS LEAFLET 1. What PROCYSBI is and what it is used for 2. What you need to know before you take PROCYSBI 3. How to take PROCYSBI 4. Possible side effects 5. How to store PROCYSBI 6. Contents of the pack and other information 1. WHAT PROCYSBI IS AND WHAT IT IS USED FOR PROCYSBI contains the active substance cysteamine (also known as mercaptamine) and is taken for the treatment of nephropathic cystinosis in children and adults. Cystinosis is a disease affecting how the body functions, with an abnormal accumulation of the amino acid cystine in various organs of the body such as the kidney, eye, muscle, pancreas, and brain. Cystine build-up causes kidney damage and excretion of excess amounts of glucose, proteins, and electrolytes. Different organs are affected at different ages. PROCYSBI is a medicine that reacts with cystine to decrease its level within the cells. Cysteamine therapy should be initiated promptly after confirmation of the diagnosis of cystinosis to achieve maximum benefit. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROCYSBI DO NOT TAKE PROCYSBI − If you are allergic to cysteamine (also known as mercaptamine) or any of the other ingredients of this medicine (listed in section 6). − If you are allergic to penicillamine (this is not “penicillin”, but a medicine us Прочитајте комплетан документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT PROCYSBI 25 mg gastro-resistant hard capsules PROCYSBI 75 mg gastro-resistant hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PROCYSBI 25 mg gastro-resistant hard capsule Each gastro-resistant hard capsule contains 25 mg of cysteamine (as mercaptamine bitartrate). PROCYSBI 75 mg gastro-resistant hard capsule Each gastro-resistant hard capsule contains 75 mg of cysteamine (as mercaptamine bitartrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant hard capsule. PROCYSBI 25 mg gastro-resistant hard capsule Light blue size 3 (15.9 x 5.8 mm) hard capsules imprinted “25 mg” in white ink and a light blue cap imprinted with “PRO” in white ink. PROCYSBI 75 mg gastro-resistant hard capsule Light blue size 0 (21.7 x 7.6 mm) hard capsules imprinted “75 mg” in white ink and a dark blue cap imprinted with “PRO” in white ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PROCYSBI is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION PROCYSBI treatment should be initiated under the supervision of a physician experienced in the treatment of cystinosis. Cysteamine therapy must be initiated promptly once the diagnosis is confirmed (i.e., increased WBC cystine) to achieve maximum benefit. Posology White blood cell (WBC) cystine concentration may for instance be measured by a number of different techniques such as specific WBC subsets (e.g., granulocyte assay) or the mixed leukocyte assay with each assay having different target values. Healthcare professionals should refer to the assay-specific therapeutic targets provided by individual testing laboratories when making decisions regarding diagnosis and PROCYSBI dosing Прочитајте комплетан документ