Maa: Malta
Kieli: englanti
Lähde: Malta Medicines Authority
LANTHANUM
Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 D02 HW68, Ireland
V03AE03
LANTHANUM 750 mg
CHEWABLE TABLET
LANTHANUM 750 mg
POM
ALL OTHER THERAPEUTIC PRODUCTS
Authorised
2006-09-20
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FOZNOL 250 MG CHEWABLE TABLETS FOZNOL 500 MG CHEWABLE TABLETS FOZNOL 750 MG CHEWABLE TABLETS FOZNOL 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 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) PAGE 2 OF 6 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 d Lue koko asiakirja
PAGE 1 OF 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. N AME OF THE M EDICINAL P RODUCT Foznol 750 mg chewable tablets. 2. Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Each chewable tablet contains lanthanum carbonate hydrate corresponding to 750 mg lanthanum. Excipient with known effect Chewable tablets also contain on average 1599 mg of dextrates, containing glucose. For the full list of excipients, see section 6.1. 3. P HARMACEUTICAL F ORM Chewable tablet. White, round, 20-mm, bevelled-edge flat tablets debossed with ‘S405/750’ on one side. 4. C LINICAL P ARTICULARS 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 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. The tablets must be chewed completely and not swallowed whole. To aid with chewing the tablets may be crushed. Where Foznol 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) _ 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 a chewable tablet 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 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 patients, Lue koko asiakirja