Sodium Picosulfate is indicated in the following conditions:

• Constipation of any cause
• Relief of prolonged and recurrent constipation
• Bowel cleansing before surgery, childbirth, or radiological investigations

Sodium Picosulfate is a stimulant laxative belonging to the triarylmethane group. After oral administration, it is activated by colonic bacteria and acts locally in the colon. The active form stimulates the nerve endings of the intestinal wall, leading to increased colonic peristalsis and enhanced accumulation of water and electrolytes in the colonic lumen. This results in stimulation of defecation, reduced intestinal transit time, and softening of stool. Stimulation of the rectum increases motility and produces a feeling of rectal fullness. This rectal effect helps restore the normal urge to defecate (“call to stool”).

For oral administrationThe following dosages are recommended to be taken at night to produce evacuation the following morning. It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum recommended dose to produce regular stools. The maximum recommended daily dose should not be exceeded:

10 mg tablet dose

• Adults and children over 10 years of age: 5–10 mg per day.
• Children aged 4–10 years: 2.5–5 mg per day.

Oral Solution (5 mg/5 ml) dose

• Adults and children over 10 years of age: 5–10 ml or one to two teaspoonful per day.
• Children aged 4–10 years: 2.5–5 ml or half to one teaspoonful per day.
• Children from one month to 4 years of age: 0.25 ml/kg body weight per day.

Concentrated Oral Solution (7.5 mg/ml) dose

• Adults and children over 10 years of age: 0.67–1.33 ml per day.
• Children aged 4–10 years: 0.33–0.67 ml per day.

Concomitant use of diuretics or adrenocorticosteroids may increase the risk of electrolyte imbalance if excessive doses are taken. Concurrent use of antibiotics may reduce the laxative effect of this product.

Intestinal obstruction or ileus, severe painful and/or febrile acute abdominal conditions (e.g. appendicitis) possibly associated with nausea and vomiting, acute inflammatory bowel diseases, severe dehydration, and known hypersensitivity to Sodium Picosulfate or any other component of the product.

Hypersensitivity reactions, dizziness, syncope, vasovagal response, gastrointestinal disturbances, diarrhea, abdominal pain and cramps, nausea, and vomiting.

There are no reports of harmful effects on pregnancy or the fetus associated with this product. However, use should be avoided during the first trimester. Clinical data indicate that neither Sodium Picosulfate’s active metabolite (BHPM) nor its glucuronides are excreted into breast milk of healthy lactating women.

Prolonged or excessive use may lead to fluid and electrolyte imbalance and hypokalemia. It should be used with caution in patients with alcoholism. Special care is needed in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.

Chronic overdose of laxatives may lead to persistent diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, and renal stones. Renal tubular damage, metabolic alkalosis, and muscle weakness due to hypokalemia have also been reported with laxative abuse.

Stimulant Laxative

Store below 30°C, protected from light and moisture. Keep out of the reach of children.