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Drug Information Sheet("Kusuri-no-Shiori") Internal Revised: 04/2016 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:Nifplus Active ingredient:Sodium chloride Potassium chloride Sodium bicarbonate Anhydrous sodium sulfate Dosage form:white powder Print on wrapping:ニフプラス, NIFPLUS, 137.155g Effects of this medicine This medicine eliminates intestinal contents by cleansing intestines. It is usually used to eliminate intestinal contents in large bowel colonoscopy and pretreatment of intestinal surgery. 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 suspected gastrointestinal or intestinal obstruction. If you have intestinal perforation, toxic megacolon or a risk of aspiration. ・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, dissolve 1 pouch in water to make about 2 L of solution, and take 2 to 4 L of the solution at a time at rate of about 1 L per hour. Stop taking the solution as soon as your excretions turns clear. Do not take more than 4 L of the solution. Strictly follow the instructions. ・Pour the solution (about 180 mL) into a glass and take about 6 glasses (about 1 L) per hour. ・If abdominal pain, nausea or vomiting occurs while or after taking the solution, stop taking it and consult with your doctor or pharmacist. If there is no bowel movement after taking 2 L of the solution, stop taking it and consult with your doctor or pharmacist. ・If you take this medicine at home, take it in the presence of caretaker in case adverse reactions develop and treatment becomes necessary. If you do not have any bowel movement on the day before or just before taking the solution, consult with your doctor or pharmacist. Take the solution slowly especially for the first 2 to 3 glasses, and make sure that no signs of anaphylaxis (facial pallor, hives, vomiting, respiratory distress, etc.) are present before you take any more of the solution. ・If you miss a dose, consult with your doctor or pharmacist. ・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 ・Do not dissolve this medicine in anything other than water, since it causes generation of combustible gas due to a change of osmotic pressure or electrolyte concentration or bacteria in intestines. Possible adverse reactions to this medicine The most commonly reported adverse reactions include vomiting, abdominal bloating, nausea, coldness, abdominal pain, dull, light headedness, headache and insomnia. 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. ・facial pallor, vomiting, respiratory distress [shock, anaphylaxis] ・abdominal pain, nausea, abdominal bloating [intestinal perforation, intestinal obstruction, incarcerated inguinal hernia] ・consciousness disorder, convulsion, nausea/vomiting [hyponatremia] ・abdominal pain, bloody stool, fever [ischemic colitis] ・vomiting/nausea, vomiting of blood, bloody stool [Mallory-Weiss syndrome] 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. 1/2 Storage conditions and other information ・Keep out of the reach of children. Store away from direct sunlight, heat and moisture. Use this medicine promptly after dissolving. If for some reason you cannot, store it in the refrigerator and take it within 48 hours. ・Discard the remainder. Do not store them. For healthcare professional use only / / For further information, talk to your doctor or pharmacist. 2/2