Ország: Svédország
Nyelv: svéd
Forrás: Läkemedelsverket (Medical Products Agency)
lantan(III)karbonattetrahydrat
Orifarm AB
V03AE03
lanthanum(III)karbonattetrahydrat
500 mg
Tuggtablett
lantan(III)karbonattetrahydrat 954 mg Aktiv substans; dextrat, hydratiserat Hjälpämne
Apotek
Receptbelagt
Lantankarbonat
Förpacknings: Burk, 90 (2 x 45) tabletter
Avregistrerad
2014-06-18
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FOSRENOL 250 MG CHEWABLE TABLETS FOSRENOL 500 MG CHEWABLE TABLETS FOSRENOL 750 MG CHEWABLE TABLETS FOSRENOL 1000 MG CHEWABLE TABLETS lanthanum 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 Fosrenol is and what it is used for 2. What you need to know before you take Fosrenol 3. How to take Fosrenol 4. Possible side effects 5. How to store Fosrenol 6. Contents of the pack and other information 1. WHAT FOSRENOL IS AND WHAT IT IS USED FOR Fosrenol is used to lower the phosphate level in the blood of adult patients with chronic kidney disease. Patients who have kidneys that do not work properly are not able to control the level of phosphate in the blood. The amount of phosphate in the blood then rises (your doctor may call this hyperphosphataemia). Fosrenol is a medicine which reduces the body's absorption of phosphate from food by binding with it in your digestive tract. Phosphate which has bonded to Fosrenol cannot be absorbed through the intestinal wall. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSRENOL DO NOT TAKE FOSRENOL - if you are allergic to lanthanum carbonate hydrate or any of the other ingredients of this medicine (listed in section 6) - if you have too little phosphate in your blood (hypophosphataemia). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Fosrenol if you know that you have, or have had, any of the following: - stomach or intestinal cancer - inflammatory bowel disease including ulcerative colitis or Cro Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1. N AME OF THE M EDICINAL P RODUCT Fosrenol 500 mg chewable tablets. 2. Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Each chewable tablet contains lanthanum carbonate hydrate corresponding to 500 mg lanthanum. Excipient(s) with known effect Chewable tablets also contain on average 1066 mg of dextrates, containing glucose. For the full list of excipients, see section 6.1. 3. P HARMACEUTICAL F ORM Chewable tablet. White, round, 18-mm, bevelled-edge flat tablets debossed with ‘S405/500’ on one side. 4. C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Fosrenol is indicated in adult patients as a phosphate binding agent for use in the control of hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Fosrenol is also indicated in adult patients with chronic kidney disease not on dialysis with serum phosphate levels 1.78 mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fosrenol is for oral administration. The tablets must be chewed completely and not swallowed whole. To aid with chewing the tablets may be crushed. Where Fosrenol oral powder is available, it can replace chewable tablets in patients who have difficulty chewing the tablets (see section 4.4). _Adults, including elderly (>65 years)_ Fosrenol should be taken with or immediately after food, with the daily dose divided between meals. Patients should adhere to recommended diets in order to control phosphate and fluid intake. Fosrenol is presented as a chewable tablet therefore avoiding the need to take additional fluid. Serum phosphate levels should be monitored and the dose of Fosrenol titrated every 2 to 3 weeks until an acceptable serum phosphate levels is reached, with regular monitoring thereafter. Control of serum phosphate level has been demonstrated at doses starting from 750 mg per day. The maximum dose studied in clinical trials, in a limited number of pati Olvassa el a teljes dokumentumot