Instructions for Picosen capsules No. 10
Composition
active ingredients: 1 capsule contains: sodium picosulfate 7.5 mg; cassia leaf dry extract (Cassiae folium extractum siccum) (4–6 : 1) (extractant - methanol 60%, v/v) (filler: spray-dried glucose 1–30%) 10 mg;
excipients: povidone K-25, lactose monohydrate, corn starch, magnesium stearate;
hard gelatin capsule: gelatin, titanium dioxide (E 171), iron oxide (E 172), azorubine (E 122).
Dosage form
Capsules.
Main physicochemical properties: capsules with a red-brown body and cap.
Pharmacotherapeutic group
Contact laxatives. ATX code A06A B.
Pharmacological properties
Pharmacodynamics
PICOSEN - 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, 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 drug usually begins to act 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 easier defecation.
Like other laxatives, PICOSEN should not be used daily or for a long period without establishing the cause of constipation.
Contraindication
hypersensitivity to the active substances, other triarylmethanes or to any of the excipients of the medicinal product; dynamic or mechanical intestinal obstruction, intestinal obstruction, abdominal pain of unknown origin, acute surgical diseases of the abdominal cavity (e.g. 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 (severe dehydration); 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).
Special safety measures.
Patients suffering from chronic constipation should undergo a complete diagnosis and establish the cause of constipation if it is unknown.
Discontinuation of PICOSEN may result in a return of symptoms. If PICOSEN has been used for chronic constipation for a long time, any return of symptoms may be more severe.
The drug is intended for occasional use. Prolonged and excessive use may lead to water or electrolyte imbalance, hypokalemia, and increased intestinal atony.
Cases of dizziness and/or syncope have been reported to occur in association with the use of sodium picosulfate. Available information suggests that these events are consistent with defecatory syncope (associated with the Valsalva maneuver) or are related to a vasovagal response to abdominal pain.
Interaction with other medicinal products and other types of interactions
Concomitant use of high doses of PICOSEN and diuretics or corticosteroids increases 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
The gelatin capsule contains azorubine (E 122), which may cause allergic reactions.
PICOSEN contains lactose and glucose, therefore, if the patient has been diagnosed with an intolerance to some sugars, he should consult his doctor before taking 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, it is preferable not to use PICOSEN during pregnancy.
It is recommended to stop breastfeeding during treatment, as the components of the drug can 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 take 1 capsule once a day at night to ensure a bowel movement the next morning.
PICOSEN should not be used daily or for a long period 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 can lead to chronic diarrhea and abdominal pain, hypokalemia, secondary hyperaldosteronism, as well as the formation of kidney stones. With prolonged abuse of laxatives, damage to the renal tubules, metabolic alkalosis, and muscle weakness as a result of hypokalemia have been reported.
Adverse reactions
Adverse reactions are listed by frequency of occurrence: very common (≥ 1/10), common (≥ 1/100 - < 1/10), uncommon (≥ 1/1000 - < 1/100), rare (≥ 1/10,000 - < 1/1000), very rare (< 1/10,000), frequency unknown (frequency cannot be estimated from the available data).
On the part of the immune system: frequency unknown - allergic reactions.
Skin and subcutaneous tissue disorders: frequency unknown - hypersensitivity reactions, including angioedema, skin rashes, urticaria, itching, local and generalized exanthema, toxicoderma.
Gastrointestinal: frequency unknown - indigestion, anorexia, intestinal pseudomelanosis, diarrhea, flatulence, vomiting, nausea, abdominal cramps and pain, pain in the stomach and anus, which disappear when the dose of the drug is reduced.
From the side of water and electrolyte balance: frequency unknown - dehydration, hypokalemia, hypocalcemia. 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.
On the part of the urinary system: frequency unknown - change in urine color (red or brown depending on the pH, which has no clinical significance); with prolonged use/abuse - albuminuria, hematuria.
Nervous system: frequency unknown - dizziness, syncope. The likelihood of dizziness and syncope is associated with a vasovagal reaction (such as abdominal spasm or defecation) (see section "Special precautions").
On the part of the endocrine system: frequency unknown - hyperaldosteronism.
Others: frequency unknown - 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 in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 capsules in a blister, 1 blister 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.
