Picosen

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PICOSEN® (PICOSEN)

Composition:

Active substances: 1 ml contains sodium picosulfate 7.5 mg; dried leaf extract of cassia (Cassiaefolium extractum siccum) (4–6:1) (extraction solvent – methanol 60 %, v/v) 10 mg;

Excipients: sorbitol (E 420), sodium methylparahydroxybenzoate (E 219), "Alpine herbs" flavouring, purified water.

Pharmaceutical form. Oral drops.

Main physicochemical properties: orange-brown liquid with a characteristic odour, sweetish taste; sediment formation may occur during storage.

Pharmacotherapeutic group.

Stimulant laxatives. ATC code A06A B.

Pharmacological Properties

Pharmacodynamics.

PICOSEN® is a combined contact laxative. Sodium picosulfate is a locally acting laxative of the triarylmethane group, which, after bacterial cleavage in the colon, stimulates the mucosa, accelerates peristalsis, and promotes accumulation of water and electrolytes in the lumen of the colon. As a result, defecation is stimulated, intestinal transit time is reduced, and stool softening occurs.

Senna anthraglycosides inhibit fluid absorption and stimulate intestinal wall peristalsis.

Pharmacokinetics.

After oral administration, sodium picosulfate reaches the colon without significant absorption. The onset of action usually occurs 6–12 hours after administration, depending on the release of the active metabolite. After oral administration, only a negligible amount of the drug can be detected in the body organs and systems.

The laxative effect of the drug does not correlate with the plasma levels of the active metabolite.

Clinical characteristics.

Indications.

Constipation or conditions requiring facilitation of defecation.

Like other laxatives, PICOSEN® should not be used daily or for prolonged periods without determining the cause of constipation.

Contraindications.

• Hypersensitivity to the active substances, other triarylmethanes, or to any of the excipients of the drug.
• Intestinal obstruction, bowel obstruction, abdominal pain of unknown origin, acute surgical conditions of abdominal organs (including, for example, acute appendicitis, ulcerative colitis), acute inflammatory bowel diseases.
• Acute abdominal pain accompanied by nausea and vomiting, which may indicate the aforementioned acute conditions, postoperative state following gastrointestinal surgery.
• Crohn's disease, peritonitis, gastric and duodenal peptic ulcer, gastrointestinal bleeding.
• Hemorrhoids, anal fissures.
• Spastic colitis, hepatitis and organic liver damage, pancreatitis, diverticulitis.
• Metrorrhagia.
• Severe disturbances of water-electrolyte balance.
• Hereditary fructose intolerance.
• Nephrosis-nephritis, cystitis.
• Strangulated hernia.

PICOSEN® should be administered under medical supervision in conditions associated with disturbances in fluid and electrolyte balance (e.g., severe renal impairment).

Special precautions.

Patients suffering from chronic constipation should undergo full diagnostic evaluation to determine the cause of constipation if unknown.

Intended for episodic use. Prolonged and excessive use may lead to disturbances in fluid or electrolyte balance, hypokalemia, and increased intestinal atony. Cases of dizziness and/or syncope temporally associated with the administration of sodium picosulfate have been reported. Available data suggest that these events correspond to defecation syncope (associated with the Valsalva maneuver) or are related to vasovagal response to abdominal pain.

The medicinal product contains sorbitol; therefore, patients with rare hereditary fructose intolerance should not take this product.

Interaction with other medicinal products and other types of interactions.

Concomitant use of high doses of PICOSEN® and diuretics or corticosteroids may increase the risk of electrolyte imbalance, potentially leading to increased sensitivity to cardiac glycosides. Concomitant use with antibiotics may reduce the laxative effect of the drug.

Special precautions.

Use during pregnancy or breastfeeding.

There are insufficient studies involving pregnant women. For safety reasons, if possible, PICOSEN® should not be used during pregnancy.

Breastfeeding should be discontinued during the use of this medicinal product, as its components may pass into breast milk and cause frequent loose stools in the infant. However, under appropriate dosing conditions, the occurrence of adverse effects in the infant is unlikely.

Studies evaluating the effect on fertility have not been conducted.

Ability to affect reaction speed when driving or operating machinery.

Studies on the influence of the drug on the ability to drive vehicles or operate machinery have not been conducted. However, patients should be warned about the possible development of side effects such as dizziness and/or syncope due to vasovagal reactions (including abdominal cramps). If abdominal cramps occur, patients should avoid potentially hazardous activities such as driving vehicles or operating machinery.

Method of Administration and Dosage.

Adults and children aged 12 years and older: administer 10–20 drops.

PICOSEN® should be taken once daily at bedtime to ensure bowel movement the following morning.

The lowest effective dose of the medicinal product required to restore normal bowel function should be used.

PICOSEN® should not be used daily or for prolonged periods without determining the cause of constipation.

Children.

Do not administer this medicinal product to children under 12 years of age.

Overdose.

Overdose may lead to watery stools (diarrhea), intestinal spasms, and clinically significant loss of fluids, potassium, and other electrolytes.

In cases of acute overdose, the consequences may be minimized or eliminated by induced emesis or gastric lavage performed shortly after ingestion of PICOSEN®. Rehydration and correction of electrolyte imbalances may be necessary. Antispasmodic agents may be used. Cases of ischemia of the colonic mucosa have been reported following administration of large doses of sodium picosulfate, substantially exceeding the doses usually recommended for constipation.

Like other laxatives, prolonged overdose with PICOSEN® may result in chronic diarrhea and abdominal pain, hypokalemia, secondary hyperaldosteronism, and possibly kidney stone formation. With chronic abuse of laxatives, tubular kidney injury, metabolic alkalosis, and muscle weakness due to hypokalemia have been reported.

Adverse reactions.

Immune system disorders: hypersensitivity reactions, including angioneurotic edema, skin rashes, urticaria, pruritus, localized and generalized exanthema.

Gastrointestinal disorders: digestive disturbances, anorexia, discoloration of urine, pseudomelanosis of the intestine, water-electrolyte imbalance (hypokalemia, hypocalcemia), albuminuria, hematuria, abdominal spasms and pain, diarrhea, flatulence, vomiting, nausea. Prolonged and excessive use of the drug may lead to fluid loss, potassium, and other electrolytes. This, in turn, may result in muscle weakness and impaired cardiac function, especially when the drug is used concomitantly with diuretics or corticosteroids.

Nervous system disorders: dizziness, syncope. The occurrence of dizziness and syncope is likely related to vasovagal reactions (such as abdominal spasm or defecation).

Endocrine system disorders: hyperaldosteronism.

Other: cardiac disturbances, increased fatigue, fainting, somnolence, muscle weakness, cramps.

Shelf life. 3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions. Store at a temperature not exceeding 25 °C in a place inaccessible to children.

Packaging. 15 ml or 25 ml in a bottle; 1 bottle per carton.

Pharmaceutical category. Over-the-counter.

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of business activity.

4, Korolova St., Stanishivka, Zhytomyr district, Zhytomyr region, 12430, Ukraine.