Instructions for Picosen oral drops, 25 ml bottle
Composition
active ingredients: 1 ml contains sodium picosulfate 7.5 mg; cassia leaf dry extract (Cassiae folium extractum siccum) (4–6:1) (extractant – methanol 60%, v/v) 10 mg;
excipients: sorbitol (E 420), sodium methyl parahydroxybenzoate (E 219), Alpine herbs flavoring, purified water.
Dosage form
Oral drops.
Main physicochemical properties: orange-brown liquid with a characteristic odor, sweetish taste; sediment formation is allowed during storage.
Pharmacotherapeutic group
Contact laxatives. ATX code A06A B.
Pharmacological properties
Pharmacodynamics
PICOSEN® is a combined contact laxative. Sodium picosulfate is a local laxative of the triarylmethane group, which, after bacterial cleavage in the colon, stimulates its mucous membrane, accelerating peristalsis, and promotes the accumulation of water and electrolytes in the lumen of the colon. The result is stimulation of defecation, reduction of transit time, and softening of feces.
Cassia anthraglycosides inhibit fluid absorption and stimulate peristalsis of the intestinal walls.
Pharmacokinetics
After oral administration, sodium picosulfate reaches the large intestine 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 small amount of the drug can be detected in the organs and systems of the body.
The laxative effect of the drug does not correlate with the level of the active metabolite in plasma.
Indication
Constipation or cases requiring relief of bowel movements. Like other laxatives, PICOSEN® should not be used daily or for a long period of time without establishing the cause of constipation.
Contraindication
Hypersensitivity to the active substances, other triarylmethanes or to any of the excipients of the drug. Intestinal obstruction, intestinal obstruction, abdominal pain of unknown origin, acute surgical diseases of the abdominal cavity (including, for example, acute appendicitis, nonspecific ulcerative colitis), acute inflammatory bowel diseases. Acute abdominal pain accompanied by nausea and vomiting, which may indicate the above-mentioned acute diseases, condition after surgery on the gastrointestinal tract. Crohn's disease, peritonitis, peptic ulcer of the stomach and duodenum, gastrointestinal bleeding. Hemorrhoids, rectal fissures. Spastic colitis, hepatitis and organic liver lesions, pancreatitis, diverticulitis. Metrorrhagia. Severe disturbances of water and electrolyte balance. Hereditary fructose intolerance. Nephrosonephritis, cystitis. Strangulated hernia.
PICOSEN® should be taken under medical supervision in conditions associated with impaired water and electrolyte balance (e.g., severe renal impairment).
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, which may lead to increased sensitivity to cardiac glycosides. Concomitant use with antibiotics may weaken the laxative effect of the drug.
Application features
Patients suffering from chronic constipation should undergo a complete diagnosis and determine the cause of constipation if it is unknown.
Intended for occasional use. Prolonged and excessive use may result in fluid or electrolyte imbalance, hypokalemia, and increased intestinal atony. Dizziness and/or syncope have been reported to occur in association with sodium picosulfate use. Available information suggests that these events are consistent with defecatory syncope (associated with Valsalva maneuver) or are related to a vasovagal response to abdominal pain.
The medicine contains sorbitol, therefore patients with rare hereditary fructose intolerance should not take this medicine.
Ability to influence reaction speed when driving vehicles or other mechanisms
Studies on the effects on the ability to drive and use machines have not been conducted. However, patients should be warned about the possibility of developing adverse reactions such as dizziness and/or syncope due to vasovagal reactions (including abdominal spasms). In the event of abdominal spasms, the patient should avoid potentially hazardous activities such as driving or operating machinery.
Use during pregnancy or breastfeeding
There are no adequate studies in pregnant women. For safety reasons, PICOSEN® should not be used during pregnancy if possible.
It is recommended to stop breastfeeding while using the drug, as the components of the drug may penetrate into breast milk and cause frequent loose stools in the child. At the same time, with proper dosage, the occurrence of undesirable effects in the child is unlikely.
Studies to assess the effect on fertility have not been conducted.
Method of administration and doses
Adults and children over 12 years of age should use 10-20 drops.
PICOSEN® should be taken once a day at night so that bowel movements occur the next morning.
The lowest effective dose of the drug necessary to restore normal bowel function should be taken.
PICOSEN® should not be used daily or for a long period of time without establishing the cause of constipation.
Children
Do not prescribe the medicine to children under 12 years of age.
Overdose
Overdose may result in loose stools (diarrhea), intestinal cramps, and clinically significant loss of fluid, potassium, and other electrolytes.
In acute overdose, the effects can be minimized or eliminated by inducing vomiting or gastric lavage shortly after taking PICOSEN®. Fluid replacement and correction of electrolyte balance may be necessary. Antispasmodics may be used. Ischemia of the colonic mucosa has been reported with the use of large doses of sodium picosulfate, significantly higher than those usually recommended for constipation.
PICOSEN®, like other laxatives, in case of prolonged overdose may lead to chronic diarrhea and abdominal pain, hypokalemia, secondary hyperaldosteronism and, possibly, to the formation of kidney stones. Renal tubular damage, metabolic alkalosis, and muscle weakness as a result of hypokalemia have been reported with prolonged abuse of laxatives.
Adverse reactions
Immune system disorders: hypersensitivity reactions, including angioedema, skin rashes, urticaria, pruritus, local and generalised exanthema.
From the gastrointestinal tract: indigestion, anorexia, urine discoloration, intestinal pseudomelanosis, water and electrolyte imbalance (hypokalemia, hypocalcemia), albuminuria, hematuria, abdominal cramps and pain, diarrhea, flatulence, vomiting, nausea. Prolonged and excessive use of the drug can lead to loss of fluid, potassium and other electrolytes. This, in turn, can lead to muscle weakness and impaired cardiac function, especially when the drug is used simultaneously with diuretics or corticosteroids.
Nervous system: dizziness, syncope. The likelihood of dizziness and syncope is associated with a vasovagal reaction (such as abdominal spasm or defecation).
From the endocrine system: hyperaldosteronism.
Others: cardiac disorders, increased fatigue, fainting, drowsiness, muscle weakness, convulsions.
Expiration date
3 years.
Do not use the medicine after the expiry date stated on the packaging.
Storage conditions
Store at a temperature not exceeding 25 ºС in a place inaccessible to children.
Packaging
25 ml in a bottle; 1 bottle in a pack.
Vacation category
Without a prescription.
Producer
LLC "SKP "Pharmaceutical Factory".
Location of the manufacturer and its business address
Ukraine, 12430, Zhytomyr region, Zhytomyr district, Stanyshivka village, Koroleva st., bldg. 4.
