Country: Kesatuan Eropah
Bahasa: Inggeris
Sumber: EMA (European Medicines Agency)
ferric citrate coordination complex
Akebia Europe Limited
V03AE
ferric citrate coordination complex
Drugs for treatment of hyperkalaemia and hyperphosphataemia
Hyperphosphatemia; Renal Dialysis
Fexeric is indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD).
Revision: 2
Withdrawn
2015-09-23
20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FEXERIC 1 G FILM-COATED TABLETS ferric citrate coordination complex This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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. WHAT IS IN THIS LEAFLET 1. What Fexeric is and what it is used for 2. What you need to know before you take Fexeric 3. How to take Fexeric 4. Possible side effects 5. How to store Fexeric 6. Contents of the pack and other information 1. WHAT FEXERIC IS AND WHAT IT IS USED FOR Fexeric contains ferric citrate coordination complex as the active ingredient. In adults with impaired kidney function it is used to lower high blood phosphorus levels. Phosphorus is contained in many foods. Patients with kidneys that do not work properly are not able to eliminate phosphorus from their body adequately. This can lead to high phosphorus levels in the blood. Keeping the phosphorus level normal is important to maintain healthy bones and blood vessels and to prevent itchy skin, red eyes, bone pain or bone fractures. Fexeric binds to the phosphorus from food in your digestive tract to prevent it from being absorbed into your blood. The Fexeric - bound phosphorus is then excreted from your body in faeces. You may have been advised to follow a special diet to prevent the phosphorus in your blood rising to high levels. If this is the case, y Baca dokumen lengkap
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Fexeric 1 g film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 g of ferric citrate coordination complex (equivalent to 210 mg of ferric iron). Excipients with known effect: Each film-coated tablet contains sunset yellow FCF (E110) (0.99 mg) and Allura Red AC (E129) (0.70 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Peach-coloured, oval shaped, film-coated tablet, embossed with “KX52”. Tablets are 19 mm long, 7.2 mm thick and 10 mm wide. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fexeric is indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Starting dose_ _ _ The recommended starting dose of Fexeric is 3 to 6 g (3 to 6 tablets) per day based on serum phosphorus levels. CKD patients who are not on dialysis require the lower starting dose, 3 g (3 tablets) per day. Fexeric must be taken in divided doses with or immediately after meals of the day. _ _ Patients previously on other phosphate binders who are switched to Fexeric should start taking 3 to 6 g (3 to 6 tablets) per day. Patients receiving this medicine should adhere to their prescribed low phosphate diets. _Dose titration_ _ _ Serum phosphorus concentrations should be monitored within 2 to 4 weeks of starting or changing the dose of Fexeric, and approximately every 2-3 months when stable. The dose can be increased or 3 decreased by 1 to 2 g (1 to 2 tablets) per day at 2- to 4-week intervals as needed to maintain serum phosphorus at recommended target levels up to a maximum of 12 g (12 tablets) per day. There are li Baca dokumen lengkap