Treatment of occasional constipation in adults, adolescents, and children 8 years. Taiwan-approved indication is temporary symptomatic stool softening in adults and children 8 years.

Osmotic laxative. Macrogol 4000 retains water within the intestinal lumen, increasing stool hydration and facilitating defecation.

Acts locally in the gastrointestinal tract with negligible systemic absorption; conventional systemic ADME parameters are not clinically meaningful. Clinical effect generally occurs within 24–48 hours.

Hypersensitivity to macrogol, sorbitol, fructose, or any formulation component; hereditary fructose intolerance; severe inflammatory bowel disease, toxic megacolon, gastrointestinal perforation or risk of perforation, intestinal obstruction or suspected obstruction, and abdominal pain of undetermined cause.

No formal pregnancy category assigned. The Taiwan-approved labeling permits use during pregnancy; clinically significant fetal exposure is unlikely because systemic absorption is negligible.

No formal lactation category assigned. The Taiwan-approved labeling permits use during breastfeeding; clinically significant infant exposure is unlikely.

Common ((1% to <10%): Abdominal pain, abdominal distension, diarrhea, and nausea.

Uncommon ((0.1% to <1%): Vomiting, fecal urgency, and fecal incontinence.

Frequency unknown: Hyponatremia, hypokalemia, dehydration, urticaria, rash, angioedema, and anaphylactic reactions.

Children 8 years, adolescents, and adults: Oral, 10–20 g once daily. Dissolve each 10 g sachet in at least 50 mL of water and administer immediately, preferably in the morning.
Start with the lowest effective dose and adjust according to clinical response. Discontinue when normal bowel function is restored; long-term self-treatment is not recommended.

Children 8 years: 10–20 g once daily. The 10 g product is not indicated for children <8 years. Unless recommended by a physician or pharmacist, pediatric treatment should not exceed 6 days.

No specific dosage adjustment recommendation is provided. Because diarrhea may cause fluid and electrolyte disturbances, monitor patients with renal impairment, older adults, and patients receiving diuretics.

No specific dosage adjustment recommendation is provided. Monitor fluid and electrolyte status if clinically significant diarrhea occurs.

Store below 30°C in the original sachet. Shelf life: 3 years. After dissolution in water, administer immediately.