英文药名：RENAGEL Tabs（Sevelamer Hydrochloride）

中文药名：盐酸司维拉姆片

生产厂家：中外制药

レナジェル錠250mg

治疗类别名称
治疗高磷酸盐血症剂（磷结合聚合物）
商標名
RENAGEL
一般名
セベラマー塩酸塩（Sevelamer Hydrochloride）（JAN）
本　質
〔英名〕Hydrochloride of prop‐2‐en‐1‐amine polymer with 1‐chloro‐2,3‐epoxypropane
〔日本名〕 丙-2-烯-1-盐酸胺和1-氯-2,3-环氧丙烷的聚合物的盐
構造式

性　状
白的是一个精细的黄白色粉末。
水，乙腈，2-丙醇，并在0.1mol几乎不溶/ L盐酸水溶液和0.1mol / L的氢氧化钠溶液中。
它是在一个非常吸湿性
适应病症
本品适用于正在透析治疗的肾病晚期患者或高磷血症患者，降低血清磷水平而不引起高钙血症。本品对没有透析的肾病晚期患者尚缺乏安全性和疗效学资料。也可利用本品与骨化三醇结合的性质，控制肾衰患者的甲状旁腺素水平
剂量和给药方法
成人口服一次1-2G到3倍餐只是第一如盐酸司维拉姆之前。此外，年龄，症状，尽管根据血清磷浓度的程度调整，最高剂量不超过9克。
包装规格
250mg*100錠（PTP）
250mg*1000錠（PTP）

生产厂商
中外制药有限公司

完整处方资料附件：
1）附件：http://www.info.pmda.go.jp/go/pack/2190025F1036_1_14/
2）附件：http://chugai-pharm.jp/hc/ss/pr/drug/news/detail/1402918519211/2.html
RENAGEL Tablet（Sevelamer hydrochloride）
RENAGEL Tablet 250mg（レナジェル錠250mg）
Brand name : RENAGEL Tablet 250mg
　Active ingredient: Sevelamer hydrochloride
　Dosage form: white to faintly yellowish white tablet (diameter: 9mm, thickness: 6.2mm)
　Print on wrapping: レナジェル250mg
Effects of this medicine
This medicine bonds with phosphorus contained in food inside the stomach and discharges it in the form of stool in order to curb absorption of phosphorus into the body.
It is usually used to improve hyperphosphatemia occurred in chronic renal failure patient on dialysis.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have: intestinal obstruction, narrowing of colon lumen, constipation, diverticulum of intestine, hemorrhoid, serious gastrointestinal motor disorder, bleeding tendency, or dysphagia.
If you ever underwent abdominal surgery.
If you have/had gastrointestinal ulcer.
•If you are pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•In general, for adults, take 4 to 8 tablets (1 to 2 g of the active ingredient) at a time, 3 times a day, just before each meal. It should be adjusted according to your age, symptoms, and serum phosphorus level. The maximum dosage is 36 tablets (9 g of the active ingredient) a day. Strictly follow the instructions.
•If you keep this medicine in the mouth for a while, it will be swollen with water. Swallow it promptly with water or lukewarm water without chewing. Also, do not take the grinded or pounded tablet.
•If you miss a dose and realize it during or just after meals, take the missed dose as soon as possible. Otherwise, skip the missed dose and take the next dose before the next meal. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•This medicine may cause intestinal tract perforation or intestinal obstruction. Check the condition in defecation (whether you defecate or not, stool's condition/color, etc.). If you have such symptoms as aggravated constipation, enlarged feeling of abdomen, continuous abdominal pain, and vomiting, contact your doctor/pharmacist immediately.
•Although you start this medication, keep limiting intake of phosphorus by diet and so on according to the instructions of your doctor.
•While taking this medicine, you are supposed to have blood test to check your serum phosphorus level periodically.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include constipation/aggravated constipation, abdominal pain, abdominal expansion, nausea, indigestion, diarrhea/loose stool, vomiting, upper abdominal pain and flatulence. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•severe abdominal pain, nausea, vomiting  [intestinal tract perforation ]
•vomiting, feeling sick at the stomach, failure of passing stool/gas, severe lower abdominal pain (colic) [intestinal obstruction]
•lower abdominal pain, fever [diverticulitis]
•bloody stool, nausea, vomiting, feeling sick at the stomach, fever, diarrhea, sudden abdominal pain [ischemic enteritis]
•bloody stool, black stool, nausea, vomiting, vomiting of blood, abdominal pain [gastrointestinal bleeding]
•nausea, vomiting, heartburn, vomiting of blood, abdominal pain, severe abdominal pain, stomachache, pain in the pit of the stomach, lower abdominal pain, pain in abdominal area when pressed, black stool, bloody stool [gastrointestinal ulcer]
•general dullness, loss of appetite, nausea, vomiting, itch, yellowness in the skin and/or the white of the eye, dark urine [hepatic function disorder]
•constipation, difficulty in bowel movement [constipation, aggravated constipation]
•abdominal pain  [abdominal pain]
•enlarged feeling of abdomen  [abdominal expansion]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of the reach of children. Store at room temperature (1 to 30℃), away from direct sunlight and moisture.
•Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them. 
Chugai Pharmaceutical Co., Ltd.Internal
Revised: 8/2015
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.