Renagel – english – public assessment report.
Information about Renagel.
Do not use sevelamer carbonate if you have a history of bowel obstruction or if you are allergic to sevelamer carbonatesevelamer hydrochloride or to any of the ingredientsTalk to your doctor if you have had difficulty swallowing or swallowing disordersor if you have had digestive tract surgery or other digestive disordersincluding severe constipationThe most frequently occurring side effects with sevelamer carbonate tablets include nausea and vomitingSide effects with sevelamer carbonate powder taken three times a day are similar to those reported for sevelamer carbonate tabletsThe most common side effects with sevelamer include vomitingnauseadiarrheaindigestionabdominal painflatulenceand constipationCases of itchingrashfecal impaction andless commonlyslow bowel activitybowel obstructionand bowel perforation have been reportedUncommon cases of difficulty swallowing with sevelamer carbonate tablet have been reportedTalk to your doctor if you have difficulty swallowing medicines in tablet formSevelamer carbonate for oral suspension may be considered by your doctor if you have a history of difficulty swallowingYour doctor should monitor your bicarbonate and chloride blood levelsReduced vitamins DEand Kclotting factorsand folic acid blood levels may be followed by your doctorTalk to your doctor when taking sevelamer carbonate with other medicationsPromptly contact your doctor if you experience severe abdominal painnew or worsening constipationor other severe intestinal symptoms while on sevelamer carbonateTake sevelamer carbonate with meals and adhere to your prescribed diet.
A risk management plan has been developed to ensure that Renagel is used as safely as possibleBased on this plansafety information has been included in the summary of product characteristics and the package leaflet for Renagelincluding the appropriate precautions to be followed by healthcare professionals and patients.
May decrease serum levels of fat soluble vitamins and folic acid in pregnant womenconsider supplementation.
Patients taking anti-arrhythmic medicinal products for the control of arrhythmias and anti-seizure medicinal products for the control of seizure disorders were excluded from clinical trialsCaution should be exercised when prescribing sevelamer hydrochloride to patients also taking these medicinal products.
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tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you re taking, especially antacids calcium supplements questran cholestyramine colestid colestipol hydrochloride lanoxin digoxin diuretics water pills nizoral ketoconazole fosrenol lanthanum carbonate laxatives oral steroids, such as decadron or dexone dexamethasone , medrol methylprednisolone , or deltasone prednisone other forms of vitamin d luminal or solfoton phenobarbital dilantin phenytoin renagel sevelamer hydrochloride drisdol or calciferol ergocalciferol .