Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Sevelamer carbonate
SYNERRV SDN BHD
Sevelamer carbonate
30 Tablets; 180 Tablets
Aurobindo Pharma Limited (Unit VII)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ LAMSEV 800 (SEVELAMER CARBONATE TABLETS 800MG) Sevelamer Carbonate 800mg 1 WHAT IS IN THIS LEAFLET 1. What LAMSEV 800 is used for 2. How LAMSEV 800 works 3. Before you use LAMSEV 800 4. How to use LAMSEV 800 5. While you are using it 6. Side effects 7. Storage and Disposal of LAMSEV 800 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT IS LAMSEV 800 USED FOR LAMSEV 800 is used for patients who have kidneys that do not work properly or are not able to control the level of serum phosphorus in their blood. The amount of phosphate then rises (your doctor will call this hyperphosphatemia). Increased levels of serum phosphorus can lead to hard deposits in your body called calcification. These deposits can stiffen your blood vessels and make it harder for blood to be pumped around the body. Increased serum phosphorus can also lead to itchy skin, red eyes, bone pain and fractures. HOW LAMSEV 800 WORKS LAMSEV 800 contains sevelamer carbonate as the active ingredient. It binds to phosphate from food in the digestive tract and so reduces serum phosphorus levels in the blood. BEFORE YOU USE LAMSEV 800 _-When you must not use it _ Do not use LAMSEV 800 if you have low levels of phosphate in your blood (your doctor will check this for you) or bowel obstruction. Do not use LAMSEV 800 if you are allergic to sevelamer carbonate or to any of the excipients used in this product which is listed at the end of this leaflet. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. Do not use LAMSEV 800 if you have bowel obstruction. _-Before you start to use it _ Please check with your doctor before taking LAMSEV 800 if: • You have swallowing problems. • You have problems related with motility (movement) in your stomach and bowel. • You are being sick frequently. • You have active inflammation of the bowel. • You have undergone major surgery Les hele dokumentet
1. NAME OF THE DRUG PRODUCT LAMSEV 800 (Sevelamer Carbonate Tablets 800 mg) PHARMACEUTICAL DOSAGE FORM Oral Film Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITIONS Sevelamer Carbonate Tablets 800 mg Each film-coated tablet contains 800 mg of Sevelamer Carbonate. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Product Description White to off white, oval shaped, film-coated tablets, imprinted with “J 75” on one side with edible black ink and plain on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LAMSEV 800 is indicated for the control of hyperphosphatemia in adult patients receiving haemodialysis or peritoneal dialysis. LAMSEV 800 is also indicated for the control of hyperphosphatemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l. LAMSEV 800 should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Because of the rapid disintegration of the carbonate salt tablet and its rapid reaction with the hydrochloric acid in the stomach, the dosing of LAMSEV 800 is anticipated to be similar to that of the hydrochloride salt. LAMSEV 800 should be given three times a day with meals. _Patients Not Taking a Phosphate Binder:_ The recommended starting dose of LAMSEV 800 is 800 to 1600 mg, which can be administered as one or two LAMSEV 800 mg Tablets, with meals based on serum phosphorus level. Table 1 provides recommended starting doses of LAMSEV 800 for patients not taking a phosphate binder. TABLE 1. STARTING DOSE FOR PATIENTS NOT TAKING A PHOSPHATE BINDER SERUM PHOSPHORUS LAMSEV 800 > 1.78 and < 2.42 mmol/L 1 tablet three times daily with meals ≥ 2.42 and < 2.91 mmol/L 2 tablets three times daily with meals ≥ 2.91 mmol/L 2 tablets three times daily with meals _Patients _ _Switching _ _From _ _Sevelamer _ _Hydrochloride:_ For Les hele dokumentet