Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Lanthanum carbonate hydrate
Takeda Pharmaceuticals International AG Ireland Branch
V03AE; V03AE03
Lanthanum carbonate hydrate
750 milligram(s)
Oral powder
Drugs for treatment of hyperkalemia and hyperphosphatemia; lanthanum carbonate
Not marketed
2012-05-11
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FOZNOL 750 MG ORAL POWDER FOZNOL 1000 MG ORAL POWDER 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 Foznol is and what it is used for 2. What you need to know before you take Foznol 3. How to take Foznol 4. Possible side effects 5. How to store Foznol 6. Contents of the pack and other information 1. WHAT FOZNOL IS AND WHAT IT IS USED FOR Foznol 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). Foznol 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 Foznol cannot be absorbed through the intestinal wall. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOZNOL DO NOT TAKE FOZNOL • 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 Foznol if you know that you have or have had any of the following: • stomach or intestinal cancer • inflammatory bowel disease including ulcerative colitis or Crohn’s disease • abdominal surgery, or infection or inflammation of the abdomen/bowel (perito Baca dokumen lengkapnya
Health Products Regulatory Authority 06 October 2023 CRN00D8S6 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Foznol 750 mg Oral Powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 750 mg lanthanum (as lanthanum carbonate hydrate). Each sachet contains 1000 mg lanthanum (as lanthanum carbonate hydrate). Excipient with known effect 750 mg: Each sachet also contains 641.7 mg dextrates, containing glucose. 1000 mg: Each sachet also contains 855.6 mg dextrates, containing glucose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral powder. White to off-white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Foznol 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). Foznol is also indicated in adult patients with chronic kidney disease not on dialysis with serum phosphate levels ³ 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 Foznol is for oral administration. Foznol oral powder is intended to be mixed with a small quantity of soft food (e.g., applesauce or other similar food product) and consumed immediately (within 15 minutes). The sachet must not be opened until ready to use. Once mixed with food, Foznol oral powder must not be stored for future use. Foznol oral powder is insoluble and must not be dissolved in liquid for administration. _Adults, including elderly (> 65 years)_ Foznol 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. Foznol is presented as an oral powder intended to be mixed with soft food, therefore avoiding the need to take additional fluid. Serum phosphate levels should be monitored and the dose of Foznol titrated every 2 to 3 weeks un Baca dokumen lengkapnya