Expiration date: 05/2025

Dosage form 

round pills Valium white or almost white with Valium and a facet.

Composition

active substance: sodium picosulphate monohydrate (calculated as sodium picosulfate) -7.5 mg;

Excipients: lactose monohydrate - 145.2 mg corn starch - 18.0 mg, pregelatinised starch 1500-5,4 mg colloidal silicon dioxide 1.8 mg magnesium stearate 1.8 mg.

pharmachologic effect

The active ingredient - sodium picosulphate is a laxative triarylmethane groups. As local laxative, sodium picosulphate after bacterial sulfatase cleavage in the colon stimulates sensory nerve endings mucosal increasing motility promotes accumulation of water and electrolytes into the colon. This leads to the stimulation of defecation, reduction of evacuation time and softening stool.

Sodium picosulphate by acting on the level of the colon, stimulates the natural process of emptying of the lower gastrointestinal tract. Therefore, use of the drug is not accompanied by tenesmus and intestinal cramps, affects on digestion or food or calorie intake of essential nutrients in the small intestine.

Pharmacokinetics

Absorption: insignificant, the drug is almost completely metabolized in the intestinal wall and liver to inactive glucuronide.

After receiving oral sodium picosulphate passes unaltered through the stomach and small intestine, entering the large intestine. The absorption of the drug is small, which excludes its enterohepatic circulation. The distal large intestine occurs sodium picosulphate cleavage to form the active metabolite, bis (p-hydroxyphenyl) -pyridyl-2-methane. Time of laxative effect of the drug is determined by the release rate of the active metabolite and is 6-12 hours.

The relationship between the laxative effect of the active metabolite and its concentration in blood plasma is absent.

After receiving the 10 mg dose in about 10.4% of the total dose is excreted by the kidneys as glucuronide 48 hours. In the application of higher doses its excretion by the kidneys generally decreases.

Side effects

With prolonged use of the drug in excessive doses may be the appearance of muscle weakness, cardiac functions and disorders of fluid and electrolyte balance (loss of potassium and other electrolytes, the development of dehydration).

• on the part of the gastrointestinal tract: nausea, vomiting, cramping and abdominal pain, diarrhea;
  
• on the part of the immune system: hypersensitivity reactions, including angioedema, urticaria, skin rash, itching;
  
• on the part of the nervous system: dizziness and fainting that occur after administration of the drug and related, apparently, with a vasovagal reaction (eg, abdominal cramps or strain during bowel movements).
  

Special conditions

As with other laxatives, Guttasil drug should not be taken daily or for a long time. Do not take the medication without consulting your doctor for more than 10 days. If there is a need for a daily intake of laxatives, should find out the cause of constipation. Long-term use of laxatives can lead to loss of fluid, electrolyte imbalance and hypokalemia, and cause addiction and constipation due to the "rebound" effect. Use with caution to elderly people with hypokalemia.

The drug contains lactose, which should be borne in mind people with hereditary lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Effects on driving ability and other mechanisms

Special clinical study of the effect of the drug on the ability to drive vehicles or operate machinery have not been conducted.

Despite this, patients should be informed that they result from a vasovagal reaction (ie, during bowel spasm) can occur dizziness and / or fainting. If patients have intestinal spasm they should avoid potentially hazardous activities, including driving a car or control mechanisms

testimony

As a laxative in the following cases:

• constipation due to atony and hypotonia of the colon (including the elderly, in patients after surgery, after childbirth and during breastfeeding);
  
• constipation caused by taking drugs;
  
• for controlling the chair with haemorrhoids, proctitis, anal fissures (to soften the stool consistency);
  
• gallbladder disease, irritable bowel syndrome with constipation predominance;
  
• constipation caused by intestinal dysbiosis, diet disorders.
  

Contraindications

Hypersensitivity to sodium picosulphate or other ingredients; intestinal obstruction or obstructive bowel disease; acute inflammatory bowel disease, acute abdominal disease, or severe abdominal pain, which may be accompanied by nausea, vomiting, fever, including appendicitis; severe dehydration; lactase deficiency, lactose intolerance, glucose-galactose malabsorption; Children under 4 years old.

Carefully

Advanced age, hypokalemia.

Application of pregnancy and during breastfeeding

For a long experience with the adverse effects of the drug have been identified during pregnancy. However, due to lack of research, the use of the drug Guttasil during pregnancy is recommended only in cases where the potential benefit to the mother outweighs the potential risk to the fetus. During pregnancy, the drug can be used only after consultation with a specialist.

The active metabolite and its glucuronide is not excreted in breast milk. Thus, the drug can be used during breastfeeding.

Drug interactions

While the use of broad-spectrum antibiotics may reduce the laxative action of sodium picosulphate.

While the use of diuretics with corticosteroids may increase the risk of electrolyte abnormalities.

Electrolyte imbalance, occurring in patients receiving sodium picosulfate in high doses, can lead to poor tolerability of cardiac glycosides during their simultaneous use.