SafePrep Solution

Adult dose

1. Preparation of the solution Pour 150 mL of this medication into the provided mixing container, add water up to the indicated line on the container (approximately 500 mL), and shake well to prepare a homogeneous solution. 2. Dosage and administration In adults, take the medication by the divided dosing method as follows: 1) The evening before the examination: Consume the entire prepared solution over 30 minutes in the evening before the examination. Additionally, fill the empty container with water to the indicated line (approximately 500 mL) and drink it within 30 minutes. 2) On the day of the examination: In the morning on the day of the examination, consume the entire prepared solution over 30 minutes. Again, fill the empty container with water to the indicated line (approximately 500 mL) and drink it within 30 minutes. This process should be completed at least 4 hours before starting the colonoscopy. If bowel cleanliness is insufficient after taking this medication, do not use electrocautery (refer to the precautions 1. Warning).

This medication contains non-absorbable sugars such as sorbitol, which can produce flammable gases in the bowel after administration; caution is advised when using electrocautery. Though rare, generalized tonic-clonic seizures may occur even in patients without a seizure history, particularly if taking diuretics or ACE inhibitors, which increase the risk of electrolyte imbalances. This drug should not be administered to patients with serious gastrointestinal conditions such as bowel obstruction, gastrointestinal stricture, perforation, or toxic megacolon. Patients with allergies to this medication or its components, those suspected of having gastrointestinal obstruction or perforation, or patients with severe dehydration or congestive heart failure should not use this medication. It should be administered cautiously to elderly or frail patients, those with impaired vomiting reflex, or patients with altered consciousness, as they are at high risk for aspiration. Adverse gastrointestinal reactions such as abdominal distension, abdominal pain, and vomiting may occur; if severe symptoms arise, discontinue use and consult a physician. Adequate hydration before and after administration is essential, and electrolyte and fluid imbalances may occur; patients should be monitored through blood tests. This medication’s effects on driving or operating machinery are unknown, but caution is advised during use. Women who are pregnant or breastfeeding should use this medication cautiously only when diagnosis warrants, as safety has not been established. The safety and efficacy of this drug have not been established in pediatric patients, and caution should be exercised in elderly patients who may demonstrate increased sensitivity to the medication. In cases of overdose, dehydration and severe electrolyte abnormalities may occur, thus patients who have overdosed should receive prompt medical treatment and monitoring. This medication should not be mixed with other components or flavors, and must be taken immediately after mixing with water; solution not used within 24 hours should be discarded. Keep out of reach of children and do not change the container.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, seizures, anaphylaxis, severe allergic reactions, upper gastrointestinal bleeding due to Mallory-Weiss tear, esophageal perforation, severe swelling, respiratory distress, acute pulmonary edema, cardiac arrest, heart failure, severe neurological symptoms

Mild side effects

• Abdominal distension
• fatigue
• abdominal pain
• vomiting
• constipation
• diverticulosis
• colonic mucosal changes
• dyslipidemia
• tachycardia
• palpitations

This medication may be sensitive to air and moisture, thus it should be stored in a tightly-closed container. Additionally, it is advisable to store the medication at room temperature between 15 degrees Celsius and 25 degrees Celsius to maintain its efficacy.

Appearance

A clear or slightly cloudy viscous liquid with a peppermint flavor, contained in a translucent plastic bottle.

Package unit

300 mL/bottle