Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 08/2015
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.
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
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[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.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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