PICORAL

SODIUM PICOSULFATE

Short term relief of prolonged and recurrent constipation and for the management of constipation of any etiology.

Osmotic purgatives

Sodium picosulfate is a stimulant laxative that in conjunction with magnesium citrate, produces a purgative effect on stools. In a multicentre, observational study comprising of patients undergoing colonoscopy, more than 93% of the patients receiving sodium picosulfate-containing preparations reported the colon cleansing effect to be effective Sodium picosulfate is a contact laxative. It inhibits the absorption of water and electrolytes, and increases their secretion into the intestinal lumen. It is hydrolyzed by colonic bacterial enzyme, sulfatase, to form an active metabolite bis-(p-hydroxy-phenyl)-pyridyl-2-methane (BHPM), which acts directly on the colonic mucosa to stimulate colonic peristalsis

For oral administration. The 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: Adults and children over 10 years of age- Tablet: 5-10 mg per day. Oral Solution: 5-10 ml or one to two teaspoonful per day. Children aged 4-10 years- Tablet: 2.5-5 mg per day. Oral Solution: 2.5-5 ml or Half to one teaspoonful per day. Children under 4 years of age- Oral Solution: 0.25 ml/kg body weight per day.

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses are taken. Concurrent administration of antibiotics may reduce the laxative action of this product.

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

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

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Long experience has shown no evidence of undesirable or damaging effects during pregnancy. Lactation: Clinical data show that neither the active moiety of sodium Picosulfate (BHPM or bis-(p hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into the milk of healthy lactating females.

Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalemia. It should not be taken by children under 10 years without medical advice. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

Store at temperature not exceeding 308C.