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CLENPIQ®

CLENPIQ®(sodium picosulfate,
magnesium oxide,
and anhydrous citric acid):

CLENPIQ® is a combination of sodium picosulfate, a stimulant laxative, magnesium oxide and anhydrous citric acid, which form magnesium citrate, an osmotic laxative, indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients ages 9 years and older.

For additional information, please visit www.clenpiq.com or for U.S. prescribing information, click here.

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Important Safety Information

  • Do not take CLENPIQ if your healthcare provider has told you that you have serious kidney problems, a blockage in your intestine (bowel obstruction), an opening in the wall of your stomach or intestines (bowel perforation), a very dilated intestine (toxic megacolon), problems with the emptying of food and fluid from your stomach (gastric retention), or an allergy to any of the ingredients in CLENPIQ.
  • CLENPIQ and other bowel preparations can cause serious side effects, including serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause abnormal heartbeats that may result in death, seizures (this can happen even if you have never had a seizure), or kidney problems. Your chance of having fluid loss and changes in blood salts with CLENPIQ is higher if you have heart problems, have kidney problems, or take water pills or non-steroidal anti-inflammatory drugs (NSAIDS).
  • Your healthcare provider may do blood tests after you take CLENPIQ to check your blood for changes. Tell your healthcare provider right away if you have any of these symptoms resulting from a loss of too much body fluid (dehydration): vomiting, nausea, bloating, dizziness, stomach-area (abdominal) cramping, urinating less often than normal, trouble drinking clear liquids, troubles swallowing, seizures, or heart problems.
  • Tell your healthcare provider if you have a history of fainting. Fainting may occur resulting in a fall requiring hospitalization. Adequately hydrate with a variety of clear liquids including balanced electrolyte solutions such as sports drinks. When getting up from a lying or sitting position, get up gradually.
  • CLENPIQ can cause ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdominal) pain or rectal bleeding.
  • The most common side effects of CLENPIQ in adults include nausea, headache, high magnesium levels in your blood, dehydration or dizziness and stomach area (abdominal) pain. The most common side effects of CLENPIQ in children 9 to 16 years of age include nausea, vomiting and stomach area (abdominal) pain. These are not all the possible side effects of CLENPIQ. Ask your doctor or pharmacist for more information.

To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see accompanying full Prescribing Information, including Medication Guide.